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Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Oct 2021

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Moderna Booster Shot Backed by FDA Advisory Panel

Vaccine experts advising the Food and Drug Administration voted 19 to 0 Thursday to recommend authorization of an extra dose of Moderna Inc.’s MRNA 3.23% Covid-19 shot, a key step in making booster doses available to millions more people. A vaccine-advisory panel voted in favor of giving a Moderna booster shot at least six months after the second dose, to adults 65 years and older, as well as adults under 65 who are at high risk of severe Covid-19 or serious complications because of their jobs, living conditions or underlying medical conditions.
14th Oct 2021 - The Wall Street Journal

FDA Panel Backs Moderna Booster for Older, High-Risk People

Booster shots of Moderna Inc.’s Covid-19 vaccine should be given to older people and those at high risk of the disease, advisers to U.S. regulators said. Additional doses of the two-shot messenger RNA vaccine should be offered to people 65 and older, along with adults 18 and older who are at high risk for medical or occupational reasons, the Food and Drug Administration’s vaccine advisory panel said Thursday in a unanimous, 19-0 vote. The booster, which is half the original dose, should be given at least six months after the initial inoculation, the panel said. Moderna shares gained as much as 4.9% in Thursday afternoon trading in New York.
14th Oct 2021 - Bloomberg

FDA advisers back Moderna COVID-19 booster shots for older and high-risk people

A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna's COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus. If the FDA signs off on Moderna's booster, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.
14th Oct 2021 - Reuters

FDA vaccine advisers are meeting to consider Moderna Covid-19 vaccine boosters

Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna's Covid-19 vaccine. The FDA's Vaccines and Related Biological Products Advisory Committee agreed use of a booster dose would be safe and effective in some people six months out from their primary series. But some were clearly reluctant. Moderna had asked for emergency use authorization for a half dose of its vaccine to be used as a booster for certain people.
14th Oct 2021 - CNN

Hungary will receive technology to produce Sputnik V COVID-19 vaccine -foreign minister

Hungary will receive technology this year to produce Russia's Sputnik V COVID-19 vaccine at a Hungarian plant currently under construction, Foreign Minister Peter Szijjarto said in Moscow on Thursday according to a foreign ministry statement. This would be the first concrete step towards making the vaccine in the European Union, even though it is not yet approved in the bloc. The Sputnik V vaccine, widely used in Russia and approved for use in more than 70 countries, is still undergoing a review by the World Health Organization (WHO) and the European Medicines Agency.
14th Oct 2021 - Reuters

J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study

People who got Johnson & Johnson Inc’s COVID-19 vaccine as a first shot had a stronger immune response when boosted with vaccines from Pfizer Inc/BioNTech SE or Moderna Inc, a study run by the National Institutes of Health showed on Wednesday. The study, which is preliminary and hasn't been peer reviewed, is the latest challenge to J&J's efforts to use its COVID-19 vaccine as a booster in the United States. The study, which included more than 450 adults who received initial shots from Pfizer, Moderna, or Johnson & Johnson, showed that "mixing and matching" booster shots of different types is safe in adults. Moderna's and Pfizer's vaccines are based on messenger RNA while J&J's uses viral vector technology.
14th Oct 2021 - Reuters

EU starts real-time review of AstraZeneca COVID-19 antibody cocktail

Europe's drug regulator said on Thursday it had started a real-time review of AstraZeneca's antibody-based COVID-19 therapy, the first protective shot other than vaccines against coronavirus. The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review was based on early results from clinical studies, the regulator said. It did not say when a conclusion was expected. The move to start a real-time review, so called because data is evaluated as it is made available, came roughly a week after the Anglo-Swedish drugmaker sought emergency approval from U.S. authorities.
14th Oct 2021 - Reuters

COVID-19: New WHO team may be 'last chance' to understand origins of coronavirus

A newly formed World Health Organisation (WHO) team may be "our last chance" to understand the origins of coronavirus, the body's top emergency expert has said. The WHO has named 26 proposed members of its Scientific Advisory Group on the Origins of Novel Pathogens (SAGO), to determine the origins of coronavirus. Maria Van Kerkhove, WHO technical lead on COVID-19, said she hoped there would be further WHO-led international missions to China to encourage the country to cooperate.
14th Oct 2021 - Sky News

What’s the latest advice on the type of mask I should wear?

What’s the latest advice on the type of mask I should wear? It depends on your situation, but health officials say it should cover your nose and mouth, and fit snugly so there aren’t any gaps on the sides of your face. The U.S. Centers for Disease Control and Prevention also says to pick masks with two or more layers and a nose wire to prevent air from leaking out the top. It suggests holding your mask up to check if it blocks light, which means the fabric will probably filter out more particles. If you want added protection, experts also suggest wearing two masks or pairing them with a mask fitter to ensure they don’t leave any gaps.
14th Oct 2021 - Reuters

China warns against ‘manipulation’ of WHO virus probe

China’s Foreign Ministry on Thursday warned against what it called possible “political manipulation” of a renewed probe by the World Health Organization into the origins of the coronavirus, while saying it would support the international body’s efforts. The WHO on Wednesday released a proposed list of 25 experts to advise it on next steps in the search for the virus’ origins after its earlier efforts were attacked for going too easy on China, where the first human cases were detected in late 2019. Beijing was accused of withholding raw data on early cases during a visit by a WHO team in February and has since resisted calls for further investigation, saying the U.S. and others were politicizing the matter.
14th Oct 2021 - The Associated Press

COMMENTARY: What can masks do? Part 1: The science behind COVID-19 protection

Confusion continues to abound over the effectiveness of masks to protect people from COVID-19, and recent news stories touting imperfect studies are only compounding the situation. First, there was confusion and then intransigence about the modes of transmission, with the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) insisting for many months after SARS-CoV-2 emerged that the virus was transmitted only by large droplets or hand contact. Only fairly recently did those agencies finally recognize that inhalation of small infectious particles in the air ("aerosols") is a more important mode of transmission. That was followed by substantial misinformation and misunderstanding about the role of cloth face coverings, surgical masks, and respirators in preventing SARS-CoV-2 spread. Then we had misunderstandings and poor messaging about the efficacy of different interventions, the effectiveness of one intervention versus another, and why interventions should be considered in a particular order or hierarchy.
14th Oct 2021 - CIDRAP

The hidden cost of Covid-19: years of life lost among the young

Body counts appear to support the common perception that Covid-19 does its worst damage among the old and vulnerable. But body counts mask another reality, and focusing on them is skewing policy decisions and individual choices. There’s no question that deaths were most common among old and vulnerable individuals early in the pandemic. Some politicians and academics have used death rates to conclude that the pandemic’s toll has been largely confined to the elderly and sick, and that widespread mitigation measures such as mask and vaccine mandates are unjustified. We looked at Covid-related deaths through a different lens — years of life lost — which revealed a very different picture about the burden of illness than deaths alone.
14th Oct 2021 - CIDRAP

Tracking the FDA advisory panel meeting on Moderna’s Covid vaccine booster

With people who received the Pfizer-BioNTech Covid-19 vaccine already in the process of getting booster shots, attention is shifting this week to what to do with people who received one of the two other vaccines in use in the U.S., the two-dose Moderna vaccine and the one-shot Johnson & Johnson product. Members of the Food and Drug Administration’s vaccine expert panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), are meeting today to discuss Moderna’s application for a booster shot for its product and again Friday to discuss the J&J application. The Biden administration has made it clear that it wants to boost all Americans who have been vaccinated, suggesting they should receive an additional jab six months or later after the last dose in their original vaccine regimen. Though the World Health Organization has asked wealthy countries to hold off on using boosters to make more vaccine available to low-income countries, and some experts have argued most people don’t currently need boosters, the administration has been unswerving on this policy.
14th Oct 2021 - STAT News

WHO says approval for Russia’s Sputnik V vaccine ‘still on hold’

The World Health Organization has said the Emergency Use Listing process for Russia’s Sputnik V COVID-19 vaccine was on hold pending some missing data and legal procedures, which the UN body hopes will be “sorted out quite soon”. “We are working almost on a daily basis with the ministry of health in Russia to address the remaining issues to be fulfilled by the Russian Direct Investment Fund,” Mariangela Simao, WHO assistant director-general for access to medicines and health products, said on Wednesday. Simao said that as soon as an agreement was reached, the WHO will reopen the case and assess data that was submitted, even though it was “still incomplete” and resume manufacturing site inspections in Russia. “All submissions that we have, they are addressed the same way,” she said and did not specify a timeline for when the listing process could be completed.
13th Oct 2021 - AlJazeera

Most COVID-19 survivors have symptoms 6 months on, review finds

A systematic review of 57 studies involving more than 250,000 COVID-19 survivors reveals that 54% still had at least one symptom 6 months or more after initial diagnosis or release from the hospital. In the review, published today in JAMA Network Open, a team led by Hershey (Pennsylvania) Medical Center researchers searched the literature from December 2019 through March 2021 for studies on persistent COVID-19–related symptoms diagnosed using lab results, radiologic findings, or clinical signs or symptoms at or after 1 month.
13th Oct 2021 - CIDRAP

Moderna criticized for COVID-19 vaccine strategy putting once feel-good success story in jeopardy

Since it was approved 10 months ago, the Moderna COVID-19 vaccine has enjoyed a relatively unfettered run on its way to being considered one of the world’s two elite shots. But while COVID vaccine rival and pharmaceutical goliath Pfizer has faced a demanding spotlight, biotech Moderna has skipped along under the radar, avoiding scrutiny and gaining favor as a feel-good, success story. But that’s starting to change. With evidence mounting that other vaccine producers have made their shots more readily available to poorer countries, the shine is wearing off the Boston-based company. And with Tuesday’s revelation to the Associated Press that Moderna has no intention of sharing its mRNA vaccine formula with the rest of the world, the company has taken another public relations hit.
13th Oct 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Oct 2021

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J. & J. Recipients May Be Helped More by Other Brands’ Booster, Study Says

People who received a Johnson & Johnson coronavirus vaccine may be better off with a booster shot from Moderna or Pfizer-BioNTech, according to preliminary data from a federal clinical trial published on Wednesday. That finding, along with a mixed review of Johnson & Johnson’s booster data from the Food and Drug Administration released earlier in the day, could lead to a heated debate about whether and how to offer additional shots to the 15 million Americans who have received the single-dose vaccine. The agency’s panel of vaccine advisers will meet on Friday and vote on whether to recommend that the agency authorize the company’s application for boosters for recipients of its vaccine.
13th Oct 2021 - The New York Times

Covid-19 Vaccine Effects on Death Rates Differ by Country, Why?

It’s one of the great puzzles of the pandemic. Most developed economies are now highly vaccinated with some of the most effective shots on offer, so why are the latest Covid-19 outbreaks more deadly in some places than in others? While it’s clear vaccines led to a drop in fatalities during the most recent delta variant-driven waves compared with earlier bouts with the virus, some countries saw deaths fall to a greater degree than others, an outcome scientists still don’t have answers for. Countries like Germany, Denmark and the U.K. have seen Covid deaths fall to roughly a tenth of previous peaks, according to Bloomberg calculations using data compiled by Johns Hopkins University. In Israel, Greece and the U.S., fatalities fell but remained more than half of the previous peaks.
13th Oct 2021 - Bloomberg

Fifth death in Scotland due to Covid-19 vaccine complications is recorded

A further person has died in Scotland due to underlying adverse effects from the Covid-19 vaccine. The National Records of Scotland has confirmed that the fifth person in the country has now died as a result of complications stemming from receiving the jab. The statistics also show that 4.2 million people had been given the first dose of the vaccine as of September 30. A total of 11,262 have now died from the virus in Scotland, it added. The latest data shows that during the week of October 4-10, 126 registered fatalities included the cause was Covid-19 on their death certificate, a decrease of 17 on the previous week.
13th Oct 2021 - Edinburgh Live

Do COVID vaccines prevent transmission of the virus?

But do vaccines actually limit the spread of the virus? A large study, not yet peer-reviewed, led by a team at Oxford University and looking specifically at the Delta variant has shown that both the Pfizer and AstraZeneca vaccines do indeed reduce transmission of the disease. The study looked at almost 150,000 contacts who were traced from nearly 100,000 initial cases of COVID. The initial COVID-positive cases contained a mix of vaccinated and unvaccinated people and the aim was not only to see which groups were most likely to pass on the virus, but also which of the Pfizer or AstraZeneca vaccines were most effective in reducing transmission.
13th Oct 2021 - Al Jazeera English

BRIEF—Russia recommends RA drug olokizumab for COVID-19 of any severity

The Russian Ministry of Health has issued the 12th version of the Temporary guidelines for the prevention, diagnosis and treatment of COVID-19. This time the expert analysis resulted in a significant expansion of olokizumab usage in clinical practice. Olokizumab is the first in Russia novel genetically engineered biological drug developed by R-Pharm, one of the country’s leading biotechs. In the new document, olokizumab is additionally included in treatment regimens for mild and critical COVID-19 patients in hospital setting.
13th Oct 2021 - The Pharma Letter

Russia to test COVID-19 vaccine in form of nasal spray

Russia will test a nasal spray form of its Sputnik V vaccine against COVID-19 among adult volunteers, according to a state document published on Tuesday, as the country struggles to rein in rising numbers of infections and deaths. read more Russia was quick to develop and launch its Sputnik vaccine when the coronavirus pandemic struck last year, but take-up has been slow, with many Russians citing distrust of the authorities and fear of new medical products. The nasal spray is to be applied in two doses in a clinic in St Petersburg, according to the document published on the state register of medicines, which did not provide the planned timing of the clinical tests.
13th Oct 2021 - Reuters

China to test thousands of Wuhan blood samples in Covid-19 probe

China is preparing to test tens of thousands of blood bank samples from the city of Wuhan as part of a probe into the origins of Covid-19, according to a Chinese official. The move comes amid increasing calls for transparency over the emergence of the virus. The store of up to 200,000 samples, including those from the closing months of 2019 were pinpointed in February this year by the World Health Organization's panel of investigators as a possible source of key information that could help determine when and where the virus first crossed into humans. The samples are kept in the Wuhan Blood Center, and are thought to span 2019, providing real-time tissue samples from a wide swathe of the population in the Chinese city where SARS-CoV-2 is thought to have first infected humans.
13th Oct 2021 - CNN

Panama approves Pfizer COVID-19 booster for high-risk people

Panama has approved a booster dose of Pfizer Inc's (PFE.N) COVID-19 vaccine for high-risk people, including healthcare workers, bedridden patients, nursing home residents and people over 55, health officials said on Tuesday. The Central American country has reported 469,440 COVID-19 infections since the start of the pandemic and 7,275 deaths. More than 5.5 million vaccine doses have been administered since January, covering most of the eligible population. "We have decided to begin the process of applying a booster shot to the population with the Pfizer vaccine, starting tomorrow in public and private hospitals," Health Minister Luis Sucre said.
13th Oct 2021 - Reuters

FDA says Moderna does not meet all criteria for Covid-19 boosters

Scientists at the US Food and Drug Administration said that Moderna has not met all of the agency’s criteria to support use of booster doses of its Covid-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong. FDA staff said in documents that data for Moderna’s vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high. The documents were released on Tuesday ahead of a meeting later this week of the FDA’s outside expert advisers to discuss booster doses of the vaccine.
13th Oct 2021 - The Independent

Watch: Merck’s Covid pill could transform treatment. Here’s how it works

Earlier this month, study results showed that molnupiravir, Merck’s investigational antiviral pill, cut hospitalization rates of Covid-19 patients by about half. Molnupiravir is the first oral treatment that has shown promise in treating Covid-19. Another antiviral, remdesivir, can only be administered intravenously. “Having an oral option will be a big change,” said Benjamin Gewurz, associate director of the Ph.D. program in virology at Harvard Medical School. “Some people could just take a pill rather than having an IV or injection of some sort. And that’s what would be a huge, huge advance.”
13th Oct 2021 - Stat News

WHO advisers recommend 3rd COVID vaccine dose for highest-risk groups

The group, called the Strategic Advisory Group of Experts (SAGE), said people in the immunocompromised groups should be offered an additional dose in the vaccine series, since they are less likely to respond adequately to vaccination with the standard series and are at high risk for severe disease. WHO leaders have previously urged countries to postpone broader use of booster doses to free up more vaccine for countries that had much less access to supplies. SAGE said its third-dose recommendation applies to all vaccines that the WHO has approved for emergency use. They include Pfizer-BioNTech, AstraZeneca-Oxford, Johnson & Johnson, Moderna, Sinopharm, and Sinovac. For Sinopharm and Sinovac, two inactivated vaccines from China, SAGE said a third dose should be offered to people ages 60 and older as part of an extended primary series. It added that a third dose of a different vaccine could be considered, based on vaccine supply and access. However, SAGE urged countries to prioritize 2-dose coverage in that age group, then administer third doses, starting with the oldest age groups.
12th Oct 2021 - CIDRAP

FDA scientists neutral on Moderna Covid-19 vaccine booster ahead of key meeting

Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. Posted ahead of a two-day meeting convened by the FDA on booster shots of both the Moderna and Johnson & Johnson vaccines, the documents laid out the case for authorizing Moderna’s proposed booster — a half dose of the existing vaccine — but also noted that data so far make it unclear that the third dose is needed. “Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not,” FDA scientists wrote in a briefing document. However, they wrote, current data suggest that Covid vaccines that are available in the U.S. still protect against severe Covid-19 disease and death.
12th Oct 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Oct 2021

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FDA Staff Don’t Take Position on Moderna Covid-19 Booster

Food and Drug Administration staffers didn’t take a firm stance on Moderna Inc.’s application for a booster dose, indicating there may not be sufficient data to support the extra dose. FDA staff, after reviewing a drugmaker’s application, often weigh whether it should be given a go-ahead. But they also didn’t take a position on Pfizer Inc.’s booster request, later granted. FDA staff reviews are part of the normal process before the agency makes a decision whether to clear a product. In documents made public Tuesday, FDA staff simply restated Moderna’s request and analyzed Moderna’s study data. The extra dose of Moderna’s vaccine appeared to be safe and work well, but the staff said its benefit would depend on how much the protection from the primary series has waned.
12th Oct 2021 - The Wall Street Journal

Moderna Argues to FDA for Half-Dose of Vaccine as Booster

In documents released Tuesday morning, Moderna argued that the Food and Drug Administration should authorize a half-dose of its coronavirus vaccine as a booster shot for recipients at least six months after the second dose, citing evidence that the vaccine’s potency against infection wanes over time. The agency noted in its own analysis that, overall, available data show Moderna and the other vaccines “still afford protection against severe Covid-19 disease and death in the United States.” Moderna cited the rate of breakthrough infections, “real world evidence of reduced effectiveness against the Delta variant,” and falling levels of neutralizing antibodies from its vaccine six to eight months after a second dose. The company said its clinical trial studies showed that a third injection boosted antibody levels — one measure of the immune system’s response — higher than what they had been before the second dose.
12th Oct 2021 - The New York Times

Rapid Covid Tests Can Beat Pandemic: Harvard's Michael Mina

The 37-year-old epidemiologist, immunologist, and physician says it didn’t have to be this way: Workplaces, schools, event spaces, and more that have been desolate for better than a year could have stayed open—and safely—with a technology that’s been here all along. Mina has been an early and tireless champion of inexpensive, do-it-yourself SARS-CoV-2 antigen tests that can return a positive or negative result in about 15 minutes, arguing for their wider deployment in op-ed articles, on Twitter, and in conversations with health authorities.
12th Oct 2021 - Bloomberg

CureVac drops COVID-19 vaccine, pins hope on next-generation shots

CureVac NV said on Tuesday it will give up on its first-generation COVID-19 vaccine candidate and instead focus on collaborating with GSK to develop improved mRNA vaccine technology. The German biotechnology company's shares were off about 8% after earlier plunging as much as 13%, hitting their lowest since going public in August last year. CureVac said it would abandon its application for approval from the European Medicines Agency for its first COVID-19 vaccine candidate, CVnCoV, after late-stage trials delivered disappointing results in June with 47% efficacy.
12th Oct 2021 - Reuters

Moderna, J&J push for COVID-19 vaccine boosters ahead of FDA meeting

Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong. FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.
12th Oct 2021 - Reuters

Covid study linking vaccines to rare side effect of myocarditis was wrong, researchers admit

A research study that linked a very rare side effect to the Covid-19 mRNA vaccines has been withdrawn by researchers after they made a major mathematical error. The Canadian study attracted headlines after it suggested there was a 1 in 1,000 risk of people developing myocarditis or inflammation of the heart after receiving the Moderna or Pfizer/BioNTech vaccines. But the paper’s conclusions were wrong, and the calculation flawed. The numbers used by the researchers, from the Ottawa Heart Institute, underestimated the amount of vaccines delivered in Ottawa over a two-month period with the result being 25 times smaller than the true figure. They had initially based their estimate on a total of 32,379 vaccines doses and 32 cases of myocarditis, when in reality more than 854,000 doses had been given between June 1 to July 31. The study’s findings have been used by anti-vaccination websites and social media accounts in Britain, the United States and Canada.
12th Oct 2021 - The Independent

AZ’s long-acting antibody combo shows benefit in COVID-19 trial

AstraZeneca has announced positive results from a Phase III trial evaluating its long-acting antibody (LAAB) combination AZD7442 in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. In the Phase III TACKLE trial, a total of 90% of participants enrolled were from populations with a high-risk of progressing to severe COVID-19, including individuals with co-morbidities. The late-stage trial hit its primary endpoint, with AZD7442 600 mg given by intramuscular injections (IM) reducing the risk of developing severe COVID-19 or death from any cause by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.
12th Oct 2021 - PharmaTimes

AstraZeneca's long-acting antibody combination treats and prevents COVID-19

Positive high-level results from the TACKLE Phase III COVID-19 treatment trial have shown that AstraZeneca’s AZD7442, a long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. On 5 October 2021, the company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19. A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.
12th Oct 2021 - Pharmafield

Merck aims to double supply of Covid-19 antiviral pill on rising demand

Merck plans to double manufacturing capacity for its antiviral pill to treat Covid-19 next year as governments scramble to procure a treatment that a late-stage trial showed cuts hospital admission and death rates in half. The mounting demand for Merck’s drug, the first oral treatment shown to prevent severe disease in vulnerable people with coronavirus, is a sign that it could trigger the same kind of worldwide rush faced by makers of early Covid-19 vaccines. Merck, which this week asked US regulators to authorise use of the drug called molnupiravir, told the Financial Times it had secured deals with Singapore, New Zealand, Australia and South Korea to supply doses in the past week and is in talks with several other governments.
12th Oct 2021 - Financial Times

A primer on what we know about mixing and matching Covid vaccines

Later this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how Covid vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the Covid vaccines authorized in the U.S. in combinations with each other. The goal of the trial was to see whether using a different vaccine as a booster shot improves protection. So does getting a dose of Pfizer vaccine after getting a single dose of Johnson & Johnson’s vaccine trigger production of more antibodies than a second dose of the J&J would? Are the messenger RNA vaccines made by Pfizer and Moderna virtually interchangeable, or does switching even there produce a broader set of immune responses?
12th Oct 2021 - Stat News

COVID infects all ages in family equally, but immunity plays a role

Two new studies explore the risk of SARS-CoV-2 transmission among household members, one finding that children and adults are at similar risk and one showing that COVID-19–naïve family members' risk was 45% to 97% lower, depending on the number of members immune through infection or full vaccination.
11th Oct 2021 - Scientific Viewpoint

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Oct 2021

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French study of over 22m people finds vaccines cut severe Covid risk by 90%

Vaccination reduces the risk of dying or being hospitalised with Covid-19 by 90%, a French study of 22.6 million people over the age of 50 has found. The research published on Monday also found that vaccines appear to protect against the worst effects of the most prevalent virus strain, the Delta variant. “This means that those who are vaccinated are nine times less at risk of being hospitalised or dying from Covid-19 than those who have not been vaccinated,” the epidemiologist Mahmoud Zureik, who oversaw the research, told Agence France-Presse. The study – the largest of its kind so far – was carried out by Epi-Phare a scientific group set up by France’s health system, its national health insurance fund, l’Assurance Maladie (CNAM), and the country’s ANSM medicines agency.
11th Oct 2021 - The Guardian

AstraZeneca antibody cocktail trials show it can halve risk of severe disease, prevent, treat Covid

AstraZeneca's antibody drug cut the risk of severe Covid-19 by at least 50% in a late stage study, the company announced on Monday. The injection, called AZD7442, contains two different antibodies developed from the the blood of people who previously contracted Covid-19. It's the drug first of its kind shown to both prevent and treat Covid-19 in late-stage trials, the company said in a press release. The company has already requested Food and Drug Administration (FDA) approval to use AZD7442 to prevent Covid-19, after late-stage trial results in August showed it reduced the risk of Covid-19 with symptoms by 77%.
11th Oct 2021 - Business Insider

Monoclonal antibody from AstraZeneca lowers risk for serious COVID-19, company says

An experimental drug developed by AstraZeneca reduces the risk for serious illness or death from COVID-19, company officials announced Monday. The drug, a combination of two monoclonal antibodies called AZD7442, lowers the risk of severe COVID-19 or death by 50% in people who have had symptoms for seven days or less, data from a clinical trial showed. Monoclonal antibodies are lab-created proteins modeled on those produced by the immune system to fight off infections. AZD7442 is delivered via injection and both prevents serious illness and treats its symptoms, the company said..
11th Oct 2021 - UPI.com

WHO experts back booster jabs for people with weak immune systems

The World Health Organization (WHO) on Monday recommended that immunocompromised people be given an additional dose of Covid-19 vaccine, due to their higher risk of breakthrough infections after standard immunisation. The Strategic Advisory Group of Experts on immunisation said the additional dose should be offered “as part of an extended primary series since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe Covid-19 disease”. WHO vaccine director Kate O’Brien, referring to people with lower immunity due to other conditions, told a news briefing: “The recommendation is for a third vaccination, an additional vaccination in the primary series and again that is based on the evidence showing that the immunogenicity and evidence on breakthrough infections is highly disproportionately represented by those people.”
11th Oct 2021 - South China Morning Post

New Clues Emerge About Whether Vaccines Can Help Fight Long Covid

Millions of people suffer from symptoms of long Covid, doctors estimate. Now, early research is offering some clues about whether vaccinations might help. When the vaccines first came out, some people who had suffered from debilitating symptoms for months after their initial Covid-19 infections told their doctors they felt better after getting vaccinated. The response intrigued scientists. Now, emerging research suggests that vaccines may help reduce symptoms in some people. Other recent research indicates that vaccination can reduce the likelihood of developing long-term Covid-19 symptoms in the first place.
11th Oct 2021 - The Wall Street Journal

Merck Asks F.D.A. for Emergency Approval of Covid Pill

Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid. Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used. The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.
11th Oct 2021 - The New York Times

Merck Covid-19 Pill: Emergency Use Authorization Sought for Molnupiravir

Merck & Co. and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir, moving the pill closer to becoming the first oral antiviral treatment for Covid-19. An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate Covid-19 in adults at risk of developing a severe illness that may require hospitalization, the companies said in a statement Monday. Submissions to regulatory authorities worldwide are expected in the coming months after an interim analysis of clinical trial data found it cut the risk of hospitalization for such patients by half.
11th Oct 2021 - Bloomberg

Merck seeks first U.S. authorization for COVID-19 pill

Merck & Co Inc said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home. The treatment, molnupiravir, cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier this month.
11th Oct 2021 - Reuters

COVID-19 vaccine trial participants to be offered additional doses

The government has announced the COVID-19 vaccine clinical trial participants in England will be offered additional approved vaccine for international travel to countries which currently only accept vaccination records with approved for deployment COVID-19 jabs. Although the UK recognises those who are in COVID-19 vaccine trials as fully vaccinated for the purpose of certification, most other countries do not currently recognise clinical trial volunteers who have not had a vaccine that is approved for deployment. As such, the government will now offer these volunteers two additional doses of an approved vaccine, allowing them to gain the necessary certification status to travel abroad with more ease.
11th Oct 2021 - PharmaTimes

Brii Biosciences files EUA with US FDA for Covid-19 combination therapy

Brii Biosciences has filled an emergency use authorization (EUA) application with the US Food and Drug Administration (FDA) for its combination therapy, BRII-196/BRII-198, to treat Covid-19 patients. BRII-196/BRII-198 is a SARS-CoV-2 neutralising monoclonal antibody combination therapy, which is intended to treat non-hospitalised Covid-19 patients at high risk of clinical progression to severe disease. The EUA submission is based on the positive Phase III results obtained from the ACTIV-2 clinical trial that was announced in August.
11th Oct 2021 - Pharmaceutical Technology

INOVIO Gets Approval To Conduct Phase 3 Trial Of COVID-19 DNA Vaccine Candidate,INO-4800 In Colombia

INOVIO said Monday that it has received authorization from Colombia's INVIMA to conduct the phase 3 segment of the company's global Phase 2/3 trial, INNOVATE in Colombia, for INO-4800, its DNA vaccine candidate for COVID-19. The company noted that it is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries in Latin America, Asia, and Africa.
11th Oct 2021 - Business Insider

Merck seeks first U.S. authorization for COVID-19 tablet

Merck & Co Inc said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home.
11th Oct 2021 - Reuters

Japan's Chugai files to expand use of COVID-19 antibody drug

Japan's Chugai Pharmaceutical Co said on Monday it has applied to regulators to expand the use of an antibody treatment for COVID-19 to also allow for preventative care. Japanese regulators approved an antibody cocktail known as Ronapreve as a treatment for COVID-19 in July. The latest filing seeks to use the drug as both a prophylaxis for COVID-19 and as treatment of asymptomatic cases, Chugai said in a release.
11th Oct 2021 - Reuters

New antibody treatment ‘both prevents and treats Covid-19’

An antibody treatment developed by pharmaceutical giant AstraZeneca has shown its ability to both prevent and treat Covid-19, according to new data. AstraZeneca submitted a request to the US Food and Drug Administration (FDA) last week for emergency use authorisation for AZD7442, which is made up of two antibodies, as a preventative treatment. In new data released on Monday morning from its Tackle trial, AstraZeneca showed AZD7442 was effective in preventing severe disease in non-hospitalised patients with mild to moderate coronavirus, when compared with a placebo. Most of the 903 people in the trial were at high risk of progression to severe Covid-19, including those with multiple health conditions.
11th Oct 2021 - Evening Standard

Doctors claim Brazil hospitals gave dodgy COVID-19 care

Irene Castilho didn’t even have a day to grieve after her husband died of COVID-19. She was sick, too, coughing and struggling to breathe; he was barely gone when she started using his oxygen mask. The same day, on March 22, she was admitted to a hospital in Sao Paulo. The 71-year-old had followed doctors’ instructions to the letter – dutifully taking her doses of hydroxychloroquine. She also took ivermectin and a battery of anti-inflammatories and vitamins in the so-called “COVID kit” that her health care company, Prevent Senior, mailed to her home. Still, her condition had deteriorated. At the hospital, Castilho received dialysis and was intubated. When physicians consulted Castilho’s daughters about giving her flutamide — a drug typically used for prostate cancer – they declined, worried about possible side effects for their mother who recently had liver cancer.
11th Oct 2021 - The Associated Press

AstraZeneca says drug helps cut risk of severe COVID

Drugmaker AstraZeneca said that its COVID-19 antibodies’ cocktail has helped cut the risk of severe disease or deaths in a late-stage study. The pharma company announced the results on Monday, marking a boost in its effort to develop coronavirus medicines beyond vaccines. The drug, a mix of two antibodies called AZD7442, reduced the risk of severe COVID-19 or death by 50 percent in non-hospitalised patients who have had symptoms for seven days or fewer, meeting the main goal of the study. AstraZeneca’s therapy, delivered via injection, is the first of its kind to show promise as a preventive medicine and as a treatment for COVID-19 following multiple trials. It is designed to protect people who do not have a strong enough immune response to vaccines.
11th Oct 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Oct 2021

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7% of Israel’s serious COVID cases had three vaccine shots

Some 7% of Israel’s serious and critical COVID-19 cases were vaccinated with three shots of the coronavirus vaccine, according to data released Friday morning by the Health Ministry. However, the number of new daily cases is declining and the government voted to roll out the Green Class outline in several green cities on Sunday to help keep children out of isolation. “I cannot say that 7% is a lot,” Health Minister Director-General Prof. Nachman Ash told The Jerusalem Post. “The vaccine, even the third shot, does not work at 100%. It is 95% effective.”
9th Oct 2021 - The Jerusalem Post

Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

Moderna, whose coronavirus vaccine appears to be the world’s best defense against Covid-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit. After developing a breakthrough vaccine with the financial and scientific support of the U.S. government, Moderna has shipped a greater share of its doses to wealthy countries than any other vaccine manufacturer, according to Airfinity, a data firm that tracks vaccine shipments. About one million doses of Moderna’s vaccine have gone to countries that the World Bank classifies as low income. By contrast, 8.4 million Pfizer doses and about 25 million single-shot Johnson & Johnson doses have gone to those countries.
9th Oct 2021 - The New York Times

Novel vaccine strategy protects mice from COVID-19 and 4 related coronaviruses

The three marketed COVID-19 shots have validated the effectiveness of two vaccination technologies, mRNA and viral vector delivery. But the vaccines—from Pfizer/BioNTech, Moderna and Johnson & Johnson—only protect against SARS-CoV-2, the coronavirus that sparked the pandemic. So a team of researchers in Japan set out to develop a universal coronavirus vaccine in the hopes of preventing future pandemics. Scientists at Osaka University engineered antibodies that prevented SARS-CoV-2 from infecting healthy cells in mice, they reported in the Journal of Experimental Medicine. They were also effective against SARS-CoV-1, which caused a small outbreak in the early 2000s, and three coronaviruses found in pangolins and bats, they said. The experimental vaccination approach exploits the biology of the SARS-CoV-2 spike protein, which shuttles the virus into human cells by binding to a cell surface receptor called ACE2. The spike protein’s receptor-binding domain has a “head” region that facilitates that binding as well as a “core” region. While the head of each type of coronavirus is distinctive, the core regions are virtually identical.
9th Oct 2021 - FierceBiotech

Pregnant women with symptomatic COVID-19 have an increased risk of emergency deliveries

Pregnant women who contract symptomatic cases of COVID-19 are much more likely to suffer emergency complications or have babies who need intensive care, a new study suggests. Researchers from the University of Texas Medical Branch, Galveston, Texas, looked at more than 100 mothers-to-be who were diagnosed with the virus. More than half of pregnant women who developed symptoms had emergency deliveries compared to about four in 10 women without symptoms. Additionally, babies born to symptomatic mothers were more likely to need respiratory support or be admitted to neonatal intensive care units (NICUs).
9th Oct 2021 - Daily Mail on MSN.com

With more Covid-19 booster shots on the horizon, one expert says mixing and matching doses may be an effective approach

Amid the growing prospect of more Covid-19 booster shots becoming available, an expert has suggested that some people could receive a dose of a different vaccine from the one they initially received. "I hope that when the FDA and CDC review data around Moderna and Johnson & Johnson that they will allow a mix-and-match approach," CNN medical analyst Dr. Leana Wen said Friday. Vaccine advisers for the US Food and Drug Administration will meet October 14 and 15 to discuss applications for booster doses from Moderna and J&J's vaccine arm Janssen. And on October 20 and 21, vaccine experts with the US Centers for Disease Control and Prevention are slated to discuss the same course of action.
9th Oct 2021 - CNN

Merck drug less effective against moderate COVID -India regulatory source

Merck & Co's experimental antiviral drug molnupiravir has not shown "significant efficacy" against moderate COVID-19, a source with the Drug Controller General of India said. Aurobindo Pharma Ltd wants to discontinue a late-stage trial of molnupiravir in moderate COVID-19 patients, the regulator's expert committee said on Friday. "There is no significant efficacy against moderate COVID and the effective efficacy is towards mild cases," the source said on condition of anonymity due to the sensitive nature of the discussions.
9th Oct 2021 - Reuters

Iceland Joins Nordic Peers in Halting Moderna Covid Vaccinations

Iceland is joining its Nordic peers in halting inoculations with Moderna Inc.’s Spikevax shot on concern over side effects. The Moderna jab, which has mostly been used in Iceland for second doses, won’t be used until more information over its safety has been collected, the chief epidemiologist said on Friday. Sweden, Denmark and Finland have this week suspended the jabs for younger people because of the risk of heart inflammation as a potential side effect. Norway said men under 30 should consider choosing the Pfizer Inc.’s and BioNTech SE’s rival vaccine, and the other Nordic nations also recommended that as an alternative. Both vaccinations use messenger RNA technology to prompt an immune reaction.
9th Oct 2021 - Bloomberg

Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19

Two Indian drugmakers have requested permission to end late-stage trials of their generic versions of Merck & Co's promising experimental oral antiviral drug molnupiravir to treat moderate COVID-19, a week after Merck said its own trial had succeeded for mild-to-moderate patients. Merck earlier this year suspended its own development of molnupiravir as a treatment for hospitalized COVID-19 patients since many of them have reached a phase of the disease that is too late for an antiviral drug to provide much help.
9th Oct 2021 - Reuters

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Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving. “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid-19,” Pfizer said on Thursday.
7th Oct 2021 - The New York Times

Covid Protection Wanes Months After Second Shot, Studies Show

Immunity provided by the Covid-19 vaccine from partners Pfizer Inc. and BioNTech SE weakens significantly within months, with men having less protection than women, according to research that supports the use of booster doses. Protective antibodies decreased continuously during the six months after the administration of the second dose of the vaccine, according to a study of about 5,000 Israeli health workers, published Wednesday in the New England Journal of Medicine. The levels fell first at a sharp pace and later at a more moderate one. Researchers worldwide are trying to identify the critical threshold of antibodies needed to prevent coronavirus infection, severe illness and death, said Gili Regev-Yochay, one of the authors of the study.
7th Oct 2021 - Bloomberg

Heart Damage Plagues Covid Survivors a Year After Infection, Study Shows

Heart damage from Covid-19 extends well beyond the disease’s initial stages, according to a study that found even people who were never sick enough to need hospitalization are in danger of developing heart failure and deadly blood clots a year later. Heart disease and stroke are already the leading causes of death worldwide. The increased likelihood of lethal heart complications in Covid survivors -- who number in the hundreds of millions globally -- will add to its devastation, according to the study, which is under consideration for publication by a Nature journal. “The aftereffects of Covid-19 are substantial,” said Ziyad Al-Aly, director of the clinical epidemiology center at the Veterans Affairs St. Louis Health Care System in Missouri, who led the research. “Governments and health systems must wake up to the reality that Covid will cast a tall shadow in the form of long Covid, and has devastating consequences. I am concerned that we are not taking this seriously enough.”
7th Oct 2021 - Bloomberg

Germany recommends booster shots for over 70s

Germany's vaccination authority, STIKO, recommended COVID-19 vaccine booster shots for people older than 70 on Thursday. All residents of care homes, as well as workers who come into direct contact with them, should also be offered a third vaccine dose, the body said. The same was also recommended for medical workers in direct contact with patients. STIKO gave its recommendation on the grounds that vaccine protection "declines over time, particularly in terms of preventing asymptomatic and mild infections." Previously booster shots had only be recommended in Germany for people with a weakened immune system.
7th Oct 2021 - DW (English)

Pfizer officially asks the FDA to authorize its COVID vaccine for kids aged 5-11

Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11. Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to the Food and Drug Administration. "With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," the pharmaceutical giant said.
7th Oct 2021 - NPR

Long Covid officially defined for first time - with three top symptoms listed

Long Covid has finally been given its own definition by the World Health Organisation as more than a million in the UK are said to be battling the condition. The condition has remained one of the most mysterious aspects of the virus as the list of symptoms continued to baffle medics. The WHO has sought to come up with clinical analysis of the symptoms as it formally says Long Covid is a "post-Covid condition". Common symptoms officially include fatigue, shortness of breath, cognitive dysfunction
7th Oct 2021 - The Mirror

Pfizer vaccine for children may be ready by Thanksgiving -White House adviser

Pfizer Inc's new vaccine for children aged five to 11 could be ready as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on Thursday. The Food and Drug Administration has scheduled time to review the Pfizer/BionNTech application for emergency use with its advisory panel at the end of October, to be followed by recommendations from the Centers for Disease Control and Prevention, Zients told CNN.
7th Oct 2021 - Reuters

Pfizer, BioNTech ask U.S. regulators to OK COVID-19 vaccine for kids

Pfizer Inc and BioNTech said on Thursday they had asked U.S. regulators to approve emergency use of their COVID-19 vaccine for children aged from five to 11, Pfizer said in a post on Twitter.
7th Oct 2021 - Reuters on MSN.com

Covid vaccination on top of past coronavirus infection 'gives greater protection'

Previous Covid-19 infection gives double jabbed people greater protection, new research suggests. According to the Zoe study, past Covid infection together with being fully vaccinated increases an individual’s protection against the virus to as much as 94%.
7th Oct 2021 - The Scotsman

Pfizer study to vaccinate whole Brazilian town against COVID-19

Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the entire population over the age of 12 in a town in southern Brazil, the company said on Wednesday. The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil's National Vaccination Program, local health authorities, a hospital and a federal university. Pfizer, which developed the vaccine with German partner BioNTech SE , said the purpose was to study transmission of the coronavirus in a "real-life scenario" after the population has been vaccinated.
7th Oct 2021 - Reuters

Long COVID: More than one million people report ongoing coronavirus symptoms, ONS data shows

More than one million people living in the UK are experiencing the after-effects of COVID-19 following infection, according to the Office for National Statistics. It is the largest monthly increase - up from 970,000 in the previous ONS survey - with 1.1 million people in private households reporting having long COVID during the four weeks to 5 September. Long COVID is defined as symptoms which last for more than four weeks after individuals first suspect they are infected, and are not explained by something else.
7th Oct 2021 - Sky News

Seven people may have brought Covid-19 into NI, experts say

Seven people who were exposed to Covid-19 but had neither symptoms nor were infectious may have brought the virus into Northern Ireland on 1 March 2020. Researchers at Queen's University Belfast suggest it took about 9.6 days for someone exposed to Covid to develop symptoms and become infectious. They said a symptomatic patient could spread the disease for nine days. Experts from the school of mathematics and physics used modelling to reach their conclusions. Dr Gabor Kiss, who led the research, said the number seven was significant because while this seems a small number, the consequences demonstrate "just how infectious Covid-19 is".
7th Oct 2021 - BBC News

Pfizer asks US to allow COVID shots for kids ages 5 to 11

Parents tired of worrying about classroom outbreaks and sick of telling their elementary school-age children no to sleepovers and family gatherings felt a wave of relief Thursday when Pfizer asked the U.S. government to authorize its COVID-19 vaccine for youngsters ages 5 to 11. If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks. That could bring many families a step closer to being done with remote learning, virus scares and repeated school shutdowns and quarantines.
7th Oct 2021 - The Associated Press

Merck's molnupiravir will be a blockbuster drug during pandemic. What about endemic COVID-19?

After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s molnupiravir looks on track to secure an FDA emergency use authorization and become a blockbuster earner during the pandemic. But what kind of longer-term market will the drug face once COVID-19 makes the likely shift from pandemic to endemic? After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s molnupiravir looks on track to secure an FDA emergency use authorization and become a blockbuster earner during the pandemic. But what kind of longer-term market will the drug face once COVID-19 makes the likely shift from pandemic to endemic?
7th Oct 2021 - FiercePharma

Flu shots and Moderna's COVID-19 booster can be given during the same doctor's visit, Sanofi study finds

With the arrival of autumn and warnings of a potential “twindemic,” many are prioritizing vaccinations with more urgency this year. Thursday, Sanofi provided timely data that show elderly people can take care of their COVID-19 booster and flu inoculation needs in one stop. Interim results from co-administration of Sanofi’s Fluzone high-dose quadrivalent vaccine and a Moderna COVID-19 booster in the same doctor’s visit show that both provide similar immunogenicity responses—in addition to comparable safety and tolerability profiles—to when they are provided individually.
7th Oct 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Oct 2021

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Booster shot improves immune response of chemotherapy patients; post-COVID depression helped by widely used drugs

A new study helps quantify the improved protection against COVID-19 achieved with a third booster dose of the vaccine from Pfizer Inc (PFE.N) and BioNTech SE in cancer patients who are undergoing chemotherapy. "Chemotherapy can weaken the ability of cancer patients to fight off infections and to respond appropriately to vaccines," said Deepta Bhattacharya of the University of Arizona College of Medicine, coauthor of the study reported in Nature Medicine. Her team studied 53 patients receiving chemotherapy for solid-tumor cancers who received two shots of the vaccine. Almost all of the subjects had an immune response after vaccination. But "the magnitude of these responses was worse than in people without cancer in almost every metric that we measured," Bhattacharya said. "In all likelihood, this leaves cancer patients more susceptible to infection and COVID-19 than healthy vaccinated people." The researchers were able to bring back 20 of the study participants for a third vaccine dose, to see if immune responses would improve.
7th Oct 2021 - Reuters

FDA Is Reviewing Data on Mixing and Matching Boosters, Fauci Says

A study of adults who received booster doses of different Covid-19 vaccines than their original shots has been completed, Fauci said in an interview on Bloomberg Television’s “Balance of Power with David Westin,” and the data have been presented to the U.S. Food and Drug Administration. The National Institutes of Health study looked at the safety, immunogenicity and efficacy of mixing and matching of the three U.S. authorized vaccines for booster purposes. The vaccine from partners Pfizer Inc. and BioNTech SE has been cleared as a booster for vulnerable people, such as the elderly and immunocompromised. Next up for the FDA and the Centers for Disease Control and Prevention is consideration of boosters from Moderna Inc. and Johnson & Johnson.
6th Oct 2021 - Bloomberg on MSN.com

Sweden Halts Moderna's Covid Vaccine for People Aged 30 or Under

Sweden and Denmark decided to halt vaccinations with Moderna Inc.’s Covid-19 shot for younger people because of potential side effects. The Swedish health authority Wednesday cited new data on the increased risk of heart inflammation as a reason for the pause for those aged 30 and under. Denmark will stop giving the shot to those younger than 18. Moderna shares fell as much as 5.3% in New York trading. “We are monitoring the situation closely and are acting rapidly to ensure that Covid-19 vaccinations are constantly as safe as possible, while also providing protection,” said Anders Tegnell, Sweden’s chief epidemiologist.
6th Oct 2021 - Bloomberg

Italy says mRNA COVID jab effectiveness stable after 7 months, but not for all

Seven months after the second dose, there is no reduction in the efficacy of COVID-19 mRNA vaccines in the general population in Italy, while a slight decline is seen for some specific groups, the National Health Institute (ISS) said on Wednesday. The report led by ISS and the health ministry examined data up to Aug. 29 from more than 29 million people who had received two doses of an mRNA vaccine such as those produced by Pfizer and Moderna. It said that in the general population, effectiveness against infection after seven months remained at 89%, while against hospitalisation and death, this time six months after the second dose, it remained at 96% and 99% respectively.
6th Oct 2021 - Reuters

Sweden pauses use of Moderna COVID vaccine, cites rare side effects

Sweden will pause the use of Moderna's COVID-19 vaccine for people born 1991 and later after reports of possible rare side effects, such as myocarditis, the Swedish health agency said on Wednesday. "The Swedish Public Health Agency has decided to suspend the use of Moderna's vaccine Spikevax, for everyone born 1991 and later, for precautionary reasons," it said in a statement. "The cause is signals of an increased risk of side effects such as myocarditis and pericarditis. However, the risk of being affected is very small," it said.
6th Oct 2021 - Reuters on MSN.com

Scancell Doses First Subject in Coronavirus Vaccine Trial

Scancell Holdings PLC said Tuesday that it has dosed its first subject in its clinical trial for its Scov1 and Scov2 vaccine candidates, which aim to protect against all Covid-19 variants of concern. The biopharmaceutical company said that the first patient was dosed in South Africa as part of the program dubbed Covidity, and the candidate was administered using the PharmJet needle-free injection system. The objectives of the first part of the trial are to assess the safety and immunogenicity of Scov1 and Scov2, which target the original virus and variant viruses respectively, in healthy, non-vaccinated subjects.
6th Oct 2021 - MarketWatch

Merck says deal signed with Singapore on COVID-19 antiviral pill

Merck announced on Wednesday a supply and purchase agreement that will provide Singapore with access to its experimental oral COVID-19 antiviral drug, the latest Asian country to try to snap up supplies. Molnupiravir is designed to introduce errors into the genetic code of the virus and would be the first oral antiviral medication for COVID-19. Merck is seeking approval by the United States Food and Drug Administration for the pill.Singapore's health ministry did not immediately respond to a request for confirmation of the Merck agreement.
6th Oct 2021 - Reuters

Long COVID may affect almost 37% of COVID-19 patients

Individuals with long COVID exhibit lingering symptoms, such as fatigue and brain fog, that persist beyond the typical recovery period of 3–4 weeks after the symptom onset. A recent study assessed the incidence of long COVID symptoms using data extracted from de-identified electronic health records. The study found that more than one in three individuals experienced long COVID symptoms 3–6 months after receiving a COVID-19 diagnosis. The study also reports that women, older adults, and individuals with severe illness during the initial phase of a SARS-CoV-2 infection had an increased likelihood of experiencing long COVID symptoms.
6th Oct 2021 - Medical News Today

Australia's Ellume recalls some COVID-19 test kits over false positives

Australian diagnostic test maker Ellume has recalled some lots of its COVID-19 home test, saying they may show false-positive results due to a recently identified manufacturing issue. The company said of the 427,000 tests that were affected, it had recalled about 195,000 tests as they were unused. "Ellume has investigated the issue, identified the root cause and implemented additional controls," the company told Reuters on Wednesday.
6th Oct 2021 - Reuters

UAE authorises Sputnik Light COVID-19 vaccine -Russia's RDIF

The United Arab Emirates has authorised the Russia-developed one-shot Sputnik Light as both a standalone COVID-19 vaccine and a booster shot, Russia's sovereign fund RDIF said on Wednesday.
6th Oct 2021 - Reuters

Swindon site to produce Covid-19 vaccines, PM says

Doses of the Pfizer Covid-19 vaccine are to be made in Swindon, Prime Minister Boris Johnson has announced. It will be made at the Thermo Fisher Scientific site and production is expected to start in 2022. The firm already makes the vaccine at its facility in Monza, Italy. A statement from Pfizer said that regulatory approval, transfer of technology and on-site development work means production cannot immediately begin. It added: "The support from Thermo Fisher - one of more than 20 contract manufacturers across four continents that are - or will be - helping manufacture the vaccine is an example of our efforts to deliver the vaccine to people around the world as quickly as possible."
6th Oct 2021 - BBC News

Covid-19 reinfection rate remains low, analysis shows

The rate of Covid-19 reinfections “remains low”, according to new analysis. When people do get infected for a second time, the virus is much less likely to cause serious illness, according to the Office for National Statistics (ONS). Reinfections become more likely as time goes on, the analysis suggested. It also highlighted how some people are more likely to be reinfected than others. Kara Steel, senior statistician for the Covid-19 Infection Survey, said: “The analysis shows that the estimated number of Covid-19 reinfections in the UK remains low.
6th Oct 2021 - Evening Standard

Cloth vs N95: Which coronavirus mask should you wear?

Mask wearing has been a hotly debated topic, but most scientists agree that face coverings do help reduce the spread of the coronavirus, though the degree to which they do so depends on the quality of the masks themselves. Because about one in three people who have COVID-19 display no symptoms at all, widespread use of masks remains important. A study which reviewed the evidence on mask wearing found in favour of widespread mask use by infected people as a way to help reduce community transmission, concluding that the available evidence suggests that near-universal adoption of any face covering at all, in combination with complementary public health measures, could successfully reduce the community spread of COVID. Models suggest that public mask wearing is most effective at reducing the spread of the virus when compliance is high.
6th Oct 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Oct 2021

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Long Covid Symptoms May Be Caused by Micro Clots, Scientists Say

Some of the symptoms of so-called long-covid, the ailments that can persist for months after a Covid-19 infection, may be caused by inflammatory molecules trapped inside tiny blood clots, a scientist at South Africa’s Stellenbosch University said. High levels of inflammatory molecules were found in micro clots in blood samples from people with long-covid, Resia Pretorius, a researcher at the university, said in a statement on Monday. The molecules contained fibrinogen, a clotting protein, and alpha(2)-antiplasmin, which prevents the breakdown of blood clots, she said. These “might be the cause of some of the lingering symptoms experienced by individuals with long-covid,” the university said in the statement. This “provides further evidence that Covid-19, and now long-covid, have significant cardiovascular and clotting pathologies.”
5th Oct 2021 - Bloomberg

Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows

The effectiveness of the Pfizer Inc/BioNTech SE vaccine in preventing infection by the coronavirus dropped to 47% from 88% six months after the second dose, according to data published on Monday that U.S. health agencies considered when deciding on the need for booster shots. The data, which was published in the Lancet medical journal, had been previously released in August ahead of peer review. The analysis showed that the vaccine's effectiveness in preventing hospitalization and death remained high at 90% for at least six months, even against the highly contagious Delta variant of the coronavirus.
5th Oct 2021 - Reuters

Spain approves COVID booster shot for over 70s

Spain on Tuesday approved administering of third doses of the Pfizer and Moderna vaccines, which are based on the same messenger RNA technology, for people aged 70 or over, the health ministry said. Spain has fully vaccinated around 78% of its population, and authorised the booster shot from six months after people receive their second jab, the ministry said in a statement. The campaign to administer the boosters will begin at the end of October. The country had already authorised booster shots for cancer patients, nursing home residents and other vulnerable groups.
5th Oct 2021 - Reuters

Johnson & Johnson seeks emergency authorization from FDA for coronavirus booster shot

Johnson & Johnson asked the Food and Drug Administration on Tuesday to grant emergency use authorization for a booster dose of its single-shot coronavirus vaccine. The action is part of an effort by Biden administration officials to provide increased protection against covid-19, the disease caused by the coronavirus, which has claimed more than 700,000 lives in the United States. Johnson & Johnson “is asking the FDA to look at our data and agree with us that we have enough data to support a boost” for people 18 and older, said Mathai Mammen, global head of research and development for the Janssen Pharmaceuticals division of Johnson & Johnson.
5th Oct 2021 - The Washington Post

CHMP positive option for Pfizer-BioNTech COVID-19 vaccine in the EU

Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the administration of the Pfizer-BioNTech COVID-19 vaccine as a booster shot six months after the second dose. CHMP, part of the EMA, has approved the use of the booster jab for individuals over the age of 18. Following the CHMP positive opinion, the European Commission (EC) will make a final decision on its update to the vaccine’s current Conditional Marketing Authorisation in the EU. In the clinical trial data provided by Pfizer and BioNTech, the COVID-19 vaccine, Comirnaty, was found to elicit significantly higher neutralising antibody titers against SARS-CoV-2, and protection from both the Beta and Delta variants of the disease.
5th Oct 2021 - PharmaTimes

Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%

Merck, known as MSD outside of the United States and Canada, and Ridgeback Therapeutics announced on Oct. 1st, 2021, that their investigational oral antiviral medicine molnupiravir significantly reduced severe outcomes associated with COVID-19. According to a planned interim analysis, molnupiravir reduced the risk of hospitalization or death by 50% in non-hospitalized adult COVID-19 patients with mild-to-moderate symptoms. According to a company press release, 7.3% of patients who received molnupiravir (28/385) were either hospitalized or died through Day 29 of the study. Conversely, 14.1% of patients given placebo (53/377) were either hospitalized or died as a result of COVID-19 through Day 29. Additionally, no patients that were given molnupiravir died, whereas eight of those given the placebo did.
5th Oct 2021 - PharmTech

COVID-19: AstraZeneca requests emergency authoritisation in US or drug that reduces risk of developing coronavirus symptoms by 77%

AstraZeneca has requested US authorisation for emergency use of its new treatment to prevent COVID-19 in people who have a lessened response to vaccines because of a weakened immune system. The drugmaker included data in its filing with the Food and Drug Administration from a late-stage trial showing the jab reduced the risk of people developing any coronavirus symptoms by 77%. The antibody therapy, called AZD7442, could be used to protect people who do not have a strong enough immune response to COVID vaccines, or as a booster for those such as military personnel, AstraZeneca said.
5th Oct 2021 - Sky News

COVID-19: Pfizer-BioNTech vaccine effectiveness wanes to 47% against infection after six months

Two doses of the Pfizer-BioNTech vaccine are 90% effective against COVID-19 hospitalisation for at least six months but only 47% effective against infection after that period, according to a new study. The peer-reviewed analysis of the coronavirus jab, published in The Lancet, also found that reductions in the vaccine's effectiveness against COVID-19 infection was due to this waning over time rather than the Delta variant escaping protection. Researchers analysed the electronic health records of 3,426,957 people who had received the Pfizer-BioNTech vaccine as part of the study, 5.4% of which (184,041) belonged to people who were infected and 6.6% (12,130) of those which were hospitalised.
5th Oct 2021 - Sky News

J&J seeks US clearance for COVID-19 vaccine booster doses

Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans. J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators. Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.
5th Oct 2021 - The Associated Press

EU regulator OKs Pfizer vaccine booster for 18 and older

The European Union’s drug regulator gave its backing Monday to administering booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older. The European Medicines Agency said the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.” The agency’s human medicines committee issued the recommendation after studying data for the Pfizer vaccine that showed a rise in antibody levels following boosters given around 6 months after the second dose in people from 18 to 55 years old. The agency also said it supports giving a third dose of either the Pfizer-BioNTech or the Moderna vaccine to people with severely weakened immune systems at least 28 days after their second shot.
5th Oct 2021 - The Associated Press

Merck's molnupiravir will be 'complementary, but not a competitor' to COVID-19 vaccines: analyst

What do Merck’s eye-opening data, recently released for its antiviral molnupiravir on high-risk COVID-19 patients, mean for manufacturers of vaccines? Analysts from the ODDO BHF financial services group see little impact in the short and intermediate term. Even though inoculation rates are low in most lesser developed countries, ODDO says it’s unlikely that countries will shift away from vaccination campaigns to focus primarily on treating high-risk patients with COVID. This is the case despite trial data showing molnupiravir providing a 50% reduction in the hospitalization rate and a 100% reduction in the death rate among patients within five days of symptomatic illness. “The impact on vaccine manufacturers such as Moderna should be limited,” ODDO wrote in a report to investors. “We believe that molnupiravir can be complementary to the COVID-19 vaccine but not a competitor.”
5th Oct 2021 - FiercePharma

Why U.S. pandemic management has failed: lack of attention to America’s epidemic engines

Few U.S. journalists, politicians, or public health officials expressed any extraordinary concern when reports of a novel respiratory virus began to emerge out of China in late 2019 and early 2020. After all, the U.S. had just ranked number one among 195 countries in the 2019 Global Health Security Index — the first major comparative assessment of national capacity to prevent, detect, and respond to infectious disease outbreaks. Experts believed the wealthiest large nation on earth to be well-prepared to weather whatever might come its way. Now, nearly two years since the first documented cases of Covid-19 appeared in Wuhan, more than 700,000 U.S. residents have been killed by a pandemic during which U.S. public health management has been among the world’s worst. Despite American wealth, monopolization of the global vaccine supply, and unparalleled spending on medical care, SARS-CoV-2 has decimated U.S. communities — especially those of color and lower incomes. Repeated policy failures have paved the way for the virus to rapidly replicate, mutate, and fuel deadly outbreaks not just inside this country but worldwide.
5th Oct 2021 - STAT News

What we know — and don’t know — about Merck’s new Covid-19 pill

The announcement that a pill from Merck and partner Ridgeback Biotherapeutics kept Covid patients out of the hospital made headlines and moved stocks late last week. But as is so often true when data are released by press release, there are still many questions left unanswered. Doctors are excited about the medicine, molnupiravir, because a regimen of pills, even one that involves taking several pills twice a day for five days, should be far easier to deliver to patients than current antiviral Covid-19 treatments, which must be given intravenously. But it’s still unclear how widely this treatment will be used. There will also be debate among financial analysts at investment banks regarding exactly how many billions of dollars in sales the new drug will generate.
4th Oct 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Oct 2021

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EU regulator backs Pfizer vaccine booster for all adults after 6 months

Europe’s drugs regulator on Monday advised that healthy adults can receive a third, booster dose of the BioNTech/Pfizer COVID-19 vaccine six months after the second dose. The European Medicines Agency’s medicines committee said the recommendation was based on data from a study of 18 to 55-year-olds, showing an increase in antibodies after a third shot. Data has shown that immunity wanes with the vaccines currently in use, and appears to wane more quickly with the BioNTech/Pfizer jab. The EMA also said that people with severely weakened immune systems may be given a booster dose of either the BioNTech/Pfizer or Moderna jabs just 28 days after their second dose. While there is no direct evidence linking antibody levels to stronger protection in those with weakened immune systems, “it is expected that the extra dose would increase protection at least in some patients,” the EMA said.
4th Oct 2021 - POLITICO Europe

Covid-19 Treatment News: What Drugs, Medicines Are Available for Coronavirus?

In the battle against the Covid-19 pandemic, vaccines have emerged as the weapon of choice. Prevention of disease is always preferable to treatment, and in this case, vaccines have proven far more targeted and effective than the few Covid therapies that have emerged so far. Several, including some that received emergency-use authorization from regulators, have lost favor or been discarded as the struggle goes on to understand the coronavirus that causes Covid and how it impacts cells, tissues and ultimately the human body. While the list of disappointments is long, some treatments have been shown to work, although more research is needed to provide effective therapy for severely ill patients.
4th Oct 2021 - Bloomberg

Pfizer, Moderna Boosters Win EU Approval for Vulnerable

A European Union advisory committee endorsed extra shots of Pfizer Inc.’s Covid-19 vaccine for all adults, as well as extra doses of Moderna Inc.’s for those with severely weakened immune systems. Those ages 18 and older can get a third dose of the Pfizer vaccine, developed with BioNTech SE, at least six months after their second shot, the European Medicines Agency said in a statement Monday. For the immunocompromised, extra doses of Pfizer or Moderna can be given at least 28 days after the second. The recommendation on the Pfizer shot is slightly broader than in the U.S., where it’s been recommended for those ages 65 or older, those in long-term health-care facilities and those ages 50 to 64 with underlying medical conditions. “Studies showed that an extra dose of these vaccines increased the ability to produce antibodies against the virus that causes Covid-19 in organ transplant patients with weakened immune systems,” the EMA said. “It is expected that the extra dose would increase protection at least in some patients.”
4th Oct 2021 - Bloomberg

Israel requires COVID-19 booster shots for stricter "green pass"

Israel on Sunday piled pressure on its vaccinated citizens to get a booster shot by making only those who received their third dose of the COVID-19 vaccine eligible for a "green pass" allowing entry to restaurants, gyms and many other venues. Israel was an early adopter of Pfizer/BioNtech booster shots -- administering them to members of risk groups in July and by the end of August to anyone above the age of 12. Its campaign is being watched closely by other countries. The new green pass is being issued to those who received three shots or recently recovered from COVID-19, replacing a previous system that required just two shots. It raises the bar for what the government considers full immunization
4th Oct 2021 - Reuters

Covid-19 vaccines, declining antibodies and the immune memory

Countries around the world are considering or already rolling out Covid-19 vaccine booster shots amid reports of waning immunity and breakthrough infections. As debate rages over boosters, some are asking why they might be necessary so soon after vaccination, when there should still be immune memory. Vaccines work to “train” the body to fight a specific pathogen, using inactive or weakened parts of it, or a blueprint of it, to prompt an immune system response. The body then produces antibodies, but also white blood cells known as memory cells. When the antibodies gradually level off, the memory cells remain and swing into action when faced with the real pathogen – a process known as memory response.
4th Oct 2021 - South China Morning Post

Coronavirus: BioNTech CEO says new vaccine will be needed in 2022

The CEO of BioNTech, the company that paired with Pfizer to develop a COVID-19 vaccine, told The Financial Times on Sunday that a new vaccine formula will probably be needed by the middle of next year, as new variants to the virus are likely to emerge. Ugur Sahin, who co-founded BioNTech, said that the variants seen now are not so different from the original virus as to evade the protection that the current vaccine offers. However, Sahin warns that new variants will emerge that will be able to evade vaccines and booster shots. “This year [a different vaccine] is completely unneeded,” he said. “But, by mid-next year, it could be a different situation.”
4th Oct 2021 - KIRO Seattle

To Prevent the Next Pandemic, Scientists Seek One Vaccine for Many Coronaviruses

Kayvon Modjarrad is out to win the war against this pandemic—and the next one. An emerging-infectious-diseases researcher with the U.S. Army, Dr. Modjarrad is pursuing a vaccine to protect against a range of coronaviruses that cause disease in humans—including Covid-19 variants that might elude today’s vaccines. The goal is to prevent the next new one from spreading around the globe. Such a shot might even stop coronaviruses that cause some common colds. His research team is one of roughly 20 groups around the world working on so-called universal, or pan-coronavirus, vaccines: shots that would block many related viruses at once, including ones that have yet to infect anyone. After years of battling Ebola, Zika, H1N1 pandemic flu and other new pathogens, Dr. Modjarrad and other emerging-disease experts say they want to have a vaccine in hand to blunt the next new pathogen to come along, whatever it may be.
4th Oct 2021 - The Wall Street Journal

Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot

Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection. Federal officials have become increasingly worried that the more than 15 million Americans who received the Johnson & Johnson vaccine face too much risk of severe Covid-19. The Food and Drug Administration on Friday scheduled a meeting on Oct. 15 of its expert advisory committee to discuss whether to grant emergency use authorization of a booster shot of Johnson & Johnson’s vaccine. That is part of a broader effort by the government to shore up the protection provided by all three vaccines. Regulators last month authorized a booster shot for many recipients of Pfizer-BioNTech’s vaccine and are contemplating doing the same this month for recipients of Moderna’s.
4th Oct 2021 - The New York Times

Largest COVID-19 PCR provider announces expansion of ‘cube’ labs

The UK’s largest laboratory diagnostics company, Randox, has announced a nationwide expansion of ten new adaptive ‘cube’ laboratories across Great Britain, with facilities that provide a rapid and cost-effective model to expand laboratory provision.
4th Oct 2021 - PharmaTimes

Pregnant Women Benefit from Getting the COVID-19 Vaccination

The number of women who were pregnant and also hospitalized for COVID-19 increased from 10% to 15% in late August 2021 and early September 2021, which is more than double the percentages of a year earlier, results of a study posted in the American Journal of Obstetrics and Gynecology show. "If they are exposed and infected, they run a higher risk of severe illness from this most recent Delta variant," Emily Adhikari, MD, medical director of perinatal infectious diseases at Parkland Health and Hospital System, said in a statement. "Pregnant women should get immunized as soon as possible." Investigators found that these findings are the first objective evidence of the number and severity of illness in pregnant individuals alongside the spike in the Delta variant.
4th Oct 2021 - Pharmacy Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Oct 2021

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Covid-19: Immunosuppressed to be offered booster jab 'shortly'

People who are immunosuppressed in Northern Ireland will be notified shortly about receiving a third dose of the vaccine. The Department of Health told BBC News NI those classed as immunosuppressed have now been identified. "They will be receiving a letter shortly advising them to book online to receive the third dose," it said. "Those identified by GPs will be given a letter advising them to receive a third dose at a community pharmacy." Vaccine experts recommended on 1 September that those affected should be given the extra dose to give them fuller protection.
3rd Oct 2021 - BBC News

Merck says experimental pill cuts worst effects of COVID-19

Drugmaker Merck said Friday If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.
2nd Oct 2021 - San Francisco Chronicle

Merck says COVID-19 pill cuts risk of death, hospitalization

In a potential leap forward in the global fight against the pandemic, drugmaker Merck said Friday that its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths by half. If cleared by regulators, it would be the first pill shown to treat COVID-19, adding a whole new, easy-to-use weapon to an arsenal that already includes the vaccine. The company said it will soon ask health officials in the U.S. and around the world to authorize the pill’s use. A decision from the U.S. Food and Drug Administration could come within weeks after that, and the drug, if it gets the OK, could be distributed quickly soon afterward.
2nd Oct 2021 - The Associated Press

Merck Pill Intended to Be Covid-19’s Tamiflu Succeeds in Key Study

Drug jointly developed by Merck with Ridgeback Biotherapeutics cut risk of hospitalization or death by 50% in early look at progress. Merck & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people early in the course of the disease in a pivotal study from becoming seriously ill and dying, a big step toward providing the pandemic’s first easy-to-use, at-home treatment. The pill cut the risk of hospitalization or death in study subjects with mild to moderate Covid-19 by about 50%, the companies said Friday. The drug, called molnupiravir, was performing so well in its late-stage trial that Merck and Ridgeback said they stopped enrolling subjects after discussions with the U.S. Food and Drug Administration.
2nd Oct 2021 - The Wall Street Journal

F.D.A. Panel to Weigh Pfizer Shots for Children, Boosters for Moderna and Johnson & Johnson Recipients

The Food and Drug Administration on Friday scheduled three days of public meetings with its panel of independent vaccine experts for later this month, as the agency prepares to make high-profile decisions on whether to authorize emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11 and booster shots for adult recipients of the Moderna and Johnson & Johnson vaccines. The F.D.A. typically issues its decisions within a few days of advisory committee meetings, during which members discuss safety and efficacy data. The timing of the upcoming meetings indicates that the agency intends to move quickly to decide whether to authorize both the booster and children’s shots.
2nd Oct 2021 - The New York Times

Is the Coronavirus Getting Better at Airborne Transmission?

Newer variants of the coronavirus like Alpha and Delta are highly contagious, infecting far more people than the original virus. Two new studies offer a possible explanation: The virus is evolving to spread more efficiently through air. The realization that the coronavirus is airborne indoors transformed efforts to contain the pandemic last year, igniting fiery debates about masks, social distancing and ventilation in public spaces. Most researchers now agree that the coronavirus is mostly transmitted through large droplets that quickly sink to the floor and through much smaller ones, called aerosols, that can float over longer distances indoors and settle directly into the lungs, where the virus is most harmful.
2nd Oct 2021 - New York Times

Flu's Return Will Shape the Pandemic's Impact in Coming Months

Charting the course of the pandemic during the coming months is likely to involve a more traditional winter nuisance: the flu. As countries from Italy to Canada lift restrictions, travel resumes and colder temperatures set in, influenza will probably start circulating as well. That’s after measures to thwart Covid-19 such as masks and ventilation kept the flu at bay for the past year and a half. Efforts have already been under way to lessen the potential strain on health systems dealing with both illnesses. A U.K. study released late Thursday showed that it’s safe for people to get Covid and flu shots at the same time, which might help increase vaccine uptake and cut down on appointments as the country rolls out booster doses.
1st Oct 2021 - Bloomberg

FDA advisory panel to discuss J&J, Moderna booster shots this month

An advisory panel of experts to the U.S. drug regulator will hold meetings this month to review data on Pfizer Inc's COVID-19 vaccine in young children, and whether to clear booster doses of Moderna and Johnson & Johnson's vaccines. The U.S. Food and Drug Administration's announcement on Friday comes as health authorities seek to mitigate a potential surge of cases this fall, with schools already open nationwide. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel will hold a meeting on Oct. 14 to discuss a booster dose of Moderna vaccine, and Johnson & Johnson on Oct. 15.
1st Oct 2021 - Reuters

Britain's antiviral chief hints at interest in Merck COVID-19 pill

The chair of Britain's antivirals taskforce declined to comment directly about talks over Merck & Co Inc's (MRK.N) experimental oral COVID-19 drug molnupiravir, but hinted at Britain's interest in buying the potential breakthrough pill. Taskforce chair Eddie Gray was speaking to reporters after interim clinical trial results published on Thursday showed molnupiravir reduced the chance of hospitalisation or death for patients at risk of severe disease by about 50%. "We are involved in looking closely at all of the options available, but we're really not in a position to give out the details around specific conversations at this moment in time," he told a briefing about molnupiravir after the results were published, which was also attended by a Merck representative.
1st Oct 2021 - Reuters

J&J's one-shot COVID vaccine is linked to ANOTHER blood clotting condition by EU regulators

The European Medicines Agency (EMA) on Friday found a possible link between. Johnson & Johnson's COVID-19 vaccine and venous thromboembolism (VTE). VTE is a condition in which a blood clot forms in a deep vein, usually in a leg, arm or groin, and may travel to the lungs causing a blockage of the blood supply. It could cause possible life-threatening consequences, especially to seniors. The agency is recommending that the condition be listed as a rare side effect. It also recommends that immune thrombocytopenia (ITP) be listed as a side effect of the J&J vaccine and AstraZeneca's vaccine. ITP is a bleeding disorder which sees sufferers' bodies mistakenly attack their own platelets
1st Oct 2021 - Daily Mail

US, UK adults report pandemic-related distress, disruptions

Yesterday in JAMA Network Open, Johns Hopkins University and University of California Los Angeles researchers analyzed self-reported health and psychological status among nationally representative survey respondents worried about eviction or foreclosure in November 2020. Among 1,218 study respondents, 128 (12%) reported that they were behind on rent or mortgage payments or didn't know if they could afford the next payment. Just over half (51%) of all participants were women, 46% were 30 to 54 years old, 45% were 55 and older, 69% were White, and 13% each were Black or Hispanic. Of the 128 housing-insecure respondents, 42 (34%) said they were behind on rent or mortgage payments, 55 (38%) said they had little to no confidence that they could afford the next payment, and 31 (28%) reported both. Of all participants, 46% reported moderate to severe psychological distress, and 18% said they were in fair to poor health. Respondents with unstable housing reported more distress (57% vs 45% in housing-secure participants) and poorer health (30% vs 16%).
1st Oct 2021 - CIDRAP

Moderna report says 'human error' to blame for contamination found in 3 vaccine lots from Rovi plant

Five weeks after Japan suspended the use of three lots of the Moderna COVID-19 vaccine, the company and its Japanese distributor Takeda have concluded that “human error” caused the presence of metallic particles in vials. The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The fourth and fifth lots from the series were held back, Moderna explained in the 16-page report. Rovi made Moderna aware of the foreign matter when it was discovered. But Rovi incorrectly attributed the contamination to a “vial breakage event,” which happened after the first three lots had been completed.
1st Oct 2021 - FiercePharma

Merck’s antiviral pill reduces hospitalization of Covid patients, a possible game-changer for treatment

An investigational antiviral pill reduced the chances that patients newly diagnosed with Covid-19 would be hospitalized by about 50%, a finding that could give doctors a desperately needed new way to treat the sick, the drug maker Merck announced Friday. A five-day course of molnupiravir, developed by Merck and Ridgeback Biotherapeutics, reduced both hospitalization and death compared to a placebo. In the placebo group, 53 patients, or 14.1%, were hospitalized or died. For those who received the drug, 28, or 7.3%, were hospitalized or died. A simple oral medication to help treat Covid-19 has been an elusive goal since the start of the pandemic. Other drugs, including Gilead’s remdesivir, have also been shown to reduce hospitalizations if given early in the course of disease, but must be given intravenously.
1st Oct 2021 - STAT News

More U.S. parents are willing to vaccinate their children, a survey finds.

A new survey found that more parents were willing to vaccinate their children in mid-September than were willing to do so in July, a shift that coincided with schools reopening in the middle of a wave of hospitalizations and deaths caused by the highly contagious Delta. The latest monthly survey about vaccine attitudes by the Kaiser Family Foundation also found that about one in four U.S. parents reported that a child of theirs had to quarantine at home because of a possible exposure to Covid-19 since the beginning of the school year. That is even as two-thirds of parents say they feel that their school is taking appropriate measures to contain the spread of the coronavirus.
30th Sep 2021 - The New York Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Oct 2021

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Coronavirus: Giving children two vaccine doses could prevent thousands of long COVID cases, study suggests

Thousands of long COVID cases in children could be prevented if they are given two vaccine doses, a study suggests. Children between 12 and 15 in the UK are now being offered a single dose of the Pfizer jab to cut their chance of catching the disease and passing it on. But a new study looked at 12-17-year-olds getting both shots and concluded the benefits outweighed the risks "unless case rates are sustainably low". The research, in the Journal of the Royal Society of Medicine, examined rates of hospital admissions, intensive care support, and death among children in England with the virus.
30th Sep 2021 - Sky News

NRx reports positive safety data of Zyesami from Phase III Covid-19 trial

NRx Pharmaceuticals has reported the latest positive safety data from the Phase III ACTIV-3b Critical Care trial of its experimental product, Zyesami (aviptadil) for Covid-19. Sponsored by the National Institutes of Health, the randomised, placebo-controlled ACTIV-3b trial is analysing Zyesami and remdesivir (Veklury) as monotherapy and in combination in hospitalised Covid-19 patients with acute respiratory failure. It enrolled subjects who need high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation or extracorporeal membrane oxygenation.
30th Sep 2021 - Pharmaceutical Technology

AstraZeneca COVID-19 vaccine shows 74% efficacy in large U.S. trial

AstraZeneca Plc's COVID-19 vaccine demonstrated 74% efficacy at preventing symptomatic disease, a figure that increased to 83.5% in people aged 65 and older, according to long-awaited results of the company's U.S. clinical trial published on Wednesday. Overall efficacy of 74% was lower than the interim 79% figure reported by the British drugmaker in March, a result AstraZeneca revised days later to 76% after a rare public rebuke from health officials that the figure was based on "outdated information.
30th Sep 2021 - Reuters

New Study Finds More Than A Third Of COVID-19 Patients Have Symptoms Months Later

Symptoms of COVID-19 persist or recur months after diagnosis for more than a third of all people who get the illness, a new study finds, potentially pushing the number of so-called long COVID cases higher than previously thought. In the study published Tuesday in the journal PLOS Medicine, researchers found that about 36% of those studied still reported COVID-like symptoms three and six months after diagnosis. Most previous studies have estimated lingering post-COVID symptoms in 10% to 30% of patients. The study, led by University of Oxford scientists in the United Kingdom, searched anonymized data from millions of electronic health records, primarily in the United States, to identify a study group of 273,618 patients with COVID-19 and 114,449 patients with influenza as a control.
30th Sep 2021 - NPR

What Science Knows Now About the Risk of Covid-19 Transmission on Planes

Fliers have yearned for reliable data on the risks of air travel since the pandemic began. Recent research on Covid-19 transmission on flights suggests that airlines could adopt new policies to better protect their passengers. Scientists have found a sharp increase in possible spread during in-flight meal service when everyone has masks off. They’ve also learned more about the importance of precautions during boarding and deplaning. The chances of viral spread aboard planes remain very low. But papers published in medical journals suggest they may not be as low as suggested earlier in the pandemic. “It’s still, at this point, safe to travel if you take proper precautions,” says Mark Gendreau, chief medical officer at Beverly Hospital near Boston and an expert in aviation medicine. “I do think it could be safer.”
30th Sep 2021 - The Wall Street Journal

Am I fully vaccinated without a COVID-19 vaccine booster?

Am I fully vaccinated without a COVID-19 vaccine booster? Yes, people who got a two-dose vaccine or the single-dose Johnson & Johnson shot are considered fully vaccinated — even without a booster. The U.S. Centers for Disease Control and Prevention says you're fully vaccinated two weeks after receiving a second dose of the Pfizer or Moderna vaccine, or one dose of the J&J. The vaccines offer strong protection against serious illness. But U.S. health officials now recommend boosters for some people at higher risk for severe illness from COVID-19 based on evidence that protection against milder disease can wane, especially among older adults.
30th Sep 2021 - The Independent

Regeneron's COVID-19 antibody cocktail pads case for saving lives in hospitalized patients as FDA decision nears

REGEN-COV, a combination of casirivimab and imdevimab, reduced the risk of death by 36% over placebo at Day 29 in hospitalized COVID-19 patients who didn’t require high-flow oxygen or mechanical ventilation when entering the trial, Regeneron unveiled at IDWeek 2021. All patients also received standard-of-care treatments. Regeneron already has a request under FDA review to expand REGEN-COV’s emergency use authorization to cover hospital settings. The two-drug combo is currently authorized for treating certain outpatients and as a post-exposure prophylaxis method to prevent the development of symptomatic COVID-19 in high-risk individuals. The 36% improvement didn’t meet the statistical significance bar. An early stop of the phase 2/3 trial thanks to slow enrollment was partly to blame. The efficacy data came from nearly 1,200 patients, just over a third of the trial size originally planned.
30th Sep 2021 - FiercePharma

Angola Resumes Restrictions as Covid Turns Deadlier Than Malaria

Angola will again close the country’s beaches and other leisure and public-gathering facilities from Oct. 1, a month after they were opened, following a spike in Covid-19 infections. From Oct. 15, access to public services will be subject to proof of vaccination or a negative test. Nearly all citizens 18 years or older will be required to get vaccinated, including pregnant women, state minister Adao de Almeida said in Luanda late Thursday. Angola recorded 14,549 infections and 558 deaths during September. That’s a higher number of deaths than those caused by malaria for first time, health minister Silvia Lutucuta said without providing details for malaria, which is widespread in the nation.
30th Sep 2021 - Bloomberg

Two studies tie long COVID-19 to severe initial illness

Today, in JAMA Network Open, Chinese researchers describe "long COVID" symptoms of fatigue, sweating, chest tightness, anxiety, and muscle pain among 2,433 COVID-19 survivors released from one of two hospitals in Wuhan, China, from Feb 12 to Apr 10, 2020. The team conducted phone interviews and chronic obstructive pulmonary disease (COPD) assessment tests (CATs) with the patients from Mar 1 to Mar 20, 2021. Among 2,433 patients, median age was 60 years, 49.5% were men, 27.9% had survived severe COVID-19, 29.3% had high blood pressure, 45.0% reported having at least one persistent symptom, and 15.8% reported at least three symptoms. The most common symptoms were fatigue (27.7%), sweating (16.9%), chest tightness (13.0%), anxiety (10.4%), and muscle pain (7.9%). While cough, anorexia, and shortness of breath decreased over the year since hospital release, several new symptoms appeared, including heart palpitations (4.2%), swelling of the lower limbs (1.4%), and changes in taste (1.4%) and smell (1.3%).
29th Sep 2021 - CIDRAP

CDC urges COVID-19 vaccination in pregnancy

The Centers for Disease Control and Prevention (CDC) released an official health advisory, encouraging COVID-19 vaccination for pregnant and lactating Americans, as well as those considering pregnancy. According to CDC data, only 3% of pregnant women have been vaccinated against COVID-19, and vaccination rates vary markedly by race and ethnicity. Pregnant Asian Americans have the highest coverage (45.7%), while only 15.6% of Black pregnant women are vaccinated. "Pregnancy can be both a special time and also a stressful time—and pregnancy during a pandemic is an added concern for families," said CDC Director Rochelle Walensky, MD, MPH. "I strongly encourage those who are pregnant or considering pregnancy to talk with their healthcare provider about the protective benefits of the COVID-19 vaccine to keep their babies and themselves safe."
29th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Sep 2021

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Covid: 37% of people have symptoms six months after infection

One in three people infected with coronavirus will experience at least one symptom of long Covid, a new study suggests. Much of the existing research into the condition – a mixture of symptoms reported by people often months after they were originally ill with Covid-19 – has been based either on self-reported symptoms or small studies. Now researchers at the University of Oxford, the National Institute for Health Research (NIHR) and the Oxford Health Biomedical Research Centre (BRC) have shed fresh light on the scale of the problem after studying more than 270,000 people recovering from coronavirus in the US. They found 37% of patients had at least one long Covid symptom diagnosed three to six months after infection. The most common symptoms were breathing problems, abdominal symptoms, fatigue, pain and anxiety or depression.
29th Sep 2021 - The Guardian

Coronavirus can transform pancreas cell function; certain genes may protect an infected person's spouse

Coronavirus transforms pancreas cell function - When the coronavirus infects cells, it not only impairs their activity but can also change their function, new findings suggest. For example, when insulin-producing beta cells in the pancreas become infected with the virus, they not only produce much less insulin than usual, but also start to produce glucose and digestive enzymes, which is not their job, researchers found. "We call this a change of cell fate," said study leader Dr. Shuibing Chen, who described the work in a presentation on Tuesday at the annual meeting of the European Association for the Study of Diabetes, held virtually this year. It is not clear whether the changes are long-lasting, or if they might be reversible, the researchers noted earlier in a report published in Cell Metabolism. Chen noted that some COVID-19 survivors have developed diabetes shortly after infection. "It is definitely worth investigating the rate of new-onset diabetes patients in this COVID-19 pandemic," she said in a statement. Her team has been experimenting with the coronavirus in clusters of cells engineered to create mini-organs, or organoids, that resemble the lungs, liver, intestines, heart and nervous system. Their findings suggest loss of cell fate/function may be happening in lung tissues as well, Chen, from Weill Cornell Medicine in New York, told Reuters.
29th Sep 2021 - Reuters

Merck says research shows its COVID-19 pill works against variants

Laboratory studies show that Merck & Co's experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective against known variants of the coronavirus, including the dominant, highly transmissible Delta, the company said on Wednesday. Since molnupiravir does not target the spike protein of the virus - the target of all current COVID-19 vaccines - which defines the differences between the variants, the drug should be equally effective as the virus continues to evolve, said Jay Grobler, head of infectious disease and vaccines at Merck. Molnupiravir instead targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus.
29th Sep 2021 - Reuters on MSN.com

EU to decide on Pfizer booster on Oct. 4 - document

The EU's drugs regulator will decide on Monday whether to approve Pfizer's COVID-19 booster vaccine, but it is unlikely to give precise guidance on who should receive it, according to an internal document and two officials. If the European Medicines Agency (EMA) gives its backing for the jab, the 27-member block would join the United States, Britain and Israel which have already received the green light to deploy boosters, even though there is no consensus among scientists that they are necessary.
29th Sep 2021 - Reuters

Covid-19 Cases Improving in 47 of 50 States

The U.S. recovery from the latest Covid-19 wave is taking hold across the country, with cases dropping or poised to start falling in the vast majority of states. In 47 states plus the nation’s capital, a measure of average new infections from one newly infected person is below the key level of 1, signaling that cases are expected to decline, according to covidestim, a modeling project with contributers from Yale School of Public Health, Harvard’s T.H. Chan School of Public Health and Stanford Medicine.
29th Sep 2021 - Bloomberg

Too slow Sanofi calls time on coronavirus vaccine program

As rivals entrench their lead in the coronavirus vaccine market, French vaccines giant Sanofi has finally called time on its COVID-19 vaccine development programme, arguing there is not room now for a fresh vaccine in a highly active vaccine market place.
29th Sep 2021 - The Pharma Letter

NIAID awards approximately $36.3 million to fuel vaccine research for coronaviruses

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants. The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses, such as SARS-CoV-2. The new awards are funded by NIAID's Division of Microbiology and Infectious Diseases and its Division of Allergy, Immunology, and Transplantation through the Emergency Awards Notice of Special Interest (NOSI) on Pa.n-Coronavirus Vaccine Development Program Projects. The notice was issued in November 2020 while many SARS-CoV-2 vaccines were still under development because a critical need remained for prophylactic vaccines offering broad protective immunity against other coronaviruses, such as Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV).
29th Sep 2021 - News-Medical.Net

Sanofi reports positive Phase I/II interim trial data of Covid-19 vaccine

Sanofi has reported positive interim results from a Phase I/II clinical trial of its messenger ribonucleic acid (mRNA)-based Covid-19 vaccine candidate. These results establish the potential of the lately acquired mRNA and lipid nanoparticle (LNP) platform from Translate Bio and also back Sanofi’s mRNA strategy. According to the preliminary data from the trial, neutralising antibody seroconversion defined as a four-times rise compared to baseline was observed in 91% to 100% of trial subjects two weeks after the second vaccine dose. This trend was noted across all the three dosages tested, Sanofi said. Furthermore, no safety concerns were reported while the tolerability profile was in line with that of other unmodified mRNA Covid-19 vaccines. Sanofi Pasteur Research and Development (R&D) global head Jean-Francois Toussaint said: “We have made an impressive move just nine months after the worldwide proof of concept of mRNA vaccines and only 17 since we started this first mRNA vaccine project.
29th Sep 2021 - Pharmaceutical Technology

COVID-19: Vitamin A nasal drops to be trialled to help restore smell loss

A 12-week trial will look at whether nasal drops can help those who lost their sense of smell after having COVID-19. The "Apollo trial" will treat people who have experienced a loss of smell or altered sense of smell because of coronavirus using vitamin A nasal drops. The University of East Anglia (UEA) said research from Germany has shown the potential benefit of the vitamin, and its team "will explore how this treatment works to help repair tissues in the nose damaged by viruses". They hope the trial "could one day help improve the lives of millions around the world who suffer from smell loss, by returning their fifth sense".
29th Sep 2021 - Sky News

Algeria to start Sinovac COVID-19 vaccine production Wednesday

Algeria will start production of COVID-19 vaccine Sinovac in partnership with China on Wednesday with the aim of meeting domestic demand and exporting the surplus, the prime minister's office said on Tuesday. The government has said production capacity will stand at 1 million, 2 million and 3 million doses in October, November and December respectively, before reaching 5 million doses per month from January. The North African country has been importing vaccines, mainly Sinovac, since the coronavirus pandemic began in March 2020.
29th Sep 2021 - Reuters

Some may have ‘protective version of gene which resists severe Covid-19’ – study

Some people possess a version of a gene which can potentially restrain the virus which causes Covid-19, a study has indicated. The findings offer an explanation for why some people have better natural defences against serious Sars-CoV-2 infection, say scientists. Scientists suggest antiviral responses are better in people who have a more protective “prenylated” version of the OAS1 gene, while others have a version which fails to detect the virus. But if new variants learn to evade the protection offered by the prenylated gene they could become “substantially more pathogenic and transmissible in unvaccinated populations”, say experts.
29th Sep 2021 - Evening Standard

At least one long-term symptom seen in 37% of COVID-19 patients -study

At least one long-term COVID-19 symptom was found in 37% of patients three to six months after they were infected by the virus, a large study from Oxford University and the National Institute for Health Research showed on Wednesday. The most common symptoms included breathing problems, fatigue, pain and anxiety, Oxford University said, after investigating symptoms in over 270,000 people recovering from COVID-19. The symptoms were more frequent among people who had been previously hospitalised with COVID-19 and were slightly more common among women, according to the study.
29th Sep 2021 - Reuters

How COVID-19 can damage all five senses

Considering how sick he was, Michael Goldsmith seemed like one of the lucky ones, because he survived. After becoming severely ill with COVID-19 in March 2020, he spent 22 days on a ventilator in the ICU. Fortunately, Goldsmith’s condition improved, and he was moved to an intermediate level of care in the hospital as he recovered. That’s when he began to realise he had lost most of his hearing in his left ear. “Anything I did hear had to be loud, and then it sounded like Charlie Brown’s teacher,” says Goldsmith, now 35, referencing the nonsensical noises the teacher made in the popular cartoon show. He also had a static sound in that ear that turned out to be tinnitus. After he fully recovered from the infection and went back to his home in Bergenfield, New Jersey, the IT security analyst and father of two saw one doctor after another, seeking relief for his hearing problems. He tried several different prescription medicines, and still he was no better off.
29th Sep 2021 - National Geographic UK

Pfizer vaccine for kids may not be available until November

Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November. The company said Tuesday it provided health regulators with data from a recent study of its vaccine in children 5 to 11 years old. Officials had said previously they would file an application with the FDA to authorize use in the coming weeks. Once the company files its application, U.S. regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend use.
29th Sep 2021 - The Associated Press

A new study points to the power of wearables to predict even presymptomatic infections, suggesting use one day against Covid-19

A new study that infected willing participants with common cold and flu viruses provides the most rigorous evidence yet that wearable health monitors could predict infections, even before a person starts experiencing symptoms. If the wearables can similarly predict infections in real-world conditions, the technology could add to existing disease surveillance and testing methods. But unresolved issues with standardizing wearables and testing them on diverse populations raise questions about their immediate utility. The new study, published Wednesday in JAMA Network Open, took aim at a research problem that has plagued other efforts to study wearables as infection detectors: small sample size. In two previous studies that looked at wearable devices like Apple Watches and Fitbits, tens of thousands of enrolled individuals corresponded to around 50 cases of Covid-19. In these studies and similar ones, it wasn’t clear when infected people first contracted the virus, further constraining the possibility of making predictions.
29th Sep 2021 - STAT News

Side effect rates from a third Covid-19 vaccine dose similar to those after second shot, early data indicate

People who’ve received a third dose of a Covid-19 vaccine are reporting rates of side effects similar to those after the second dose, according to data released Tuesday by the Centers for Disease Control and Prevention. The new report, published in the Morbidity and Mortality Weekly Report, relies on submissions from thousands of people who received third shots of the mRNA vaccines from Pfizer-BioNTech and Moderna after such doses were authorized for people with compromised immune systems. People submitted their reactions to v-safe, the CDC’s smartphone-based surveillance network. Among more than 12,500 people who completed surveys after each shot, 79.4% of people reported local reactions (including itching, pain, or redness at the injection site), while 74.1% reported systemic reactions (mostly fatigue, muscle aches, and headaches), typically the day after the shot. That compared to 77.6% and 76.5% of the people who reported local or systemic reactions, respectively, after their second shot.
28th Sep 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Sep 2021

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Sanofi Ends a Covid-19 Vaccine Effort, Saying Market Is Already Well Served

Sanofi SA won’t proceed with the development of one of its experimental Covid-19 vaccines, saying it didn’t make sense to go forward in an already-crowded market. The decision comes despite promising early results for the shot. The French healthcare giant said Tuesday that the vaccine—a so-called mRNA shot that uses the same technology as shots developed by Pfizer Inc. and Moderna Inc. —produced neutralizing antibodies against the virus in early-stage clinical trials. But it said it had decided not to proceed with larger studies, called Phase 3 trials, which would be required to win regulatory approval. Thomas Triomphe, head of Sanofi’s vaccine business, said it didn’t make sense to pursue the mRNA vaccine when the market was already well served. Instead, Sanofi will pivot its mRNA research efforts toward other infectious diseases. It is already conducting early-stage clinical trials on an experimental mRNA shot against flu.
28th Sep 2021 - The Wall Street Journal

South Africa, Oxfam call for fairer trade rules in response to pandemic

South Africa's president and the head of Oxfam heaped pressure on World Trade Organization members and manufacturers to allow fairer access to COVID-19 vaccines on Tuesday, including through a waiver on intellectual property rights. At a WTO public event on trade and COVID-19 also attended by German vaccine maker BioNTech, Cyril Ramaphosa said a waiver on patents was needed to save millions of lives during the pandemic,
28th Sep 2021 - Reuters

FOCUS-COVID-19 pill developers aim to top Merck, Pfizer efforts

As Merck & Co and Pfizer Inc prepare to report clinical trial results for experimental COVID-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own. Enanta Pharmaceuticals, Pardes Biosciences, Japan's Shionogi & Co Ltd and Novartis AG said they have designed antivirals that specifically target the coronavirus while aiming to avoid potential shortcomings such as the need for multiple pills per day or known safety issues. Infectious disease experts stressed that preventing COVID-19 through wide use of vaccines remains the best way to control the pandemic. But they said the disease is here to stay and more convenient treatments are needed
28th Sep 2021 - YAHOO!Finance

Brazil to give COVID-19 booster shots to people over 60 years old

Brazil will provide COVID-19 vaccine booster shots to all its people over 60-years-old, Health Minister Marcelo Queiroga said on Tuesday. Queiroga said in a tweet that the decision comes in line with progress in the country's vaccination program. About 7 million Brazilians could get the booster shot under these conditions, he said. Brazil had already started giving booster shots to people over 70-years-old and healthcare workers. According to Health Ministry data, about 600,000 booster shots have been administered up to now.
28th Sep 2021 - Reuters

Pfizer submits data for COVID-19 vaccine use in younger kids

Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in 5-11 year olds and said they would make a formal request to U.S. regulators for emergency use in the coming weeks. The U.S. Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months. That could mean an authorization of the shot for children by the end of October, sources have told Reuters.
28th Sep 2021 - Reuters

India allows Serum Institute to enrol 7-11 year olds in COVID-19 vaccine trial

India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of U.S. drugmaker Novavax's COVID-19 vaccine, as the country prepares to protect children from the novel coronavirus. The South Asian nation has already administered more than 870 million doses to adults among its population of nearly 1.4 billion.
28th Sep 2021 - Reuters

Early data shows ButanVac vaccine induces potent immune response

Developed by the Sao Paulo-based Butantan Biological Institute, the ButanVac coronavirus vaccine showed " an acceptable safety profile and potent immunogenicity" in clinical trials held in Thailand. The study showed that there were "no vaccine-related serious adverse events." The vaccine is also being tested in Brazil and Vietnam, but trial data from the two countries have not been made available so far.
28th Sep 2021 - The Brazilian Report

Half of young people willing to get Covid jab - study

Half of children and young people aged nine to 18 are willing or eager to be vaccinated against Covid, a large survey in England suggests. It is one of the first polls to ask pupils, rather than parents, their views on teenage Covid jabs. Carried out during the summer term, the responses from more than 27,000 students at 180 schools reveal half would opt to get protected. More than a third were undecided and just over one in 10 would decline. The findings, published in the journal EClinicalMedicine, were carried out before the UK recommended all children aged 12 to 15 should be offered one dose of the Pfizer/BioNTech Covid jab.
28th Sep 2021 - BBC News

COVID-19 pill developers aim to top Merck, Pfizer efforts

As Merck & Co and Pfizer Inc prepare to report clinical trial results for experimental COVID-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own. Enanta Pharmaceuticals, Pardes Biosciences, Japan's Shionogi & Co Ltd and Novartis AG said they have designed antivirals that specifically target the coronavirus while aiming to avoid potential shortcomings such as the need for multiple pills per day or known safety issues.
28th Sep 2021 - Reuters

A pill to treat Covid-19: 'We're talking about a return to, maybe, normal life'

Within a day of testing positive for covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room. When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: "I thought, 'I hope to God we don't wind up on ventilators. We have children. Who's going to raise these kids?" But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutch cancer research center that's part of an international effort to test an antiviral treatment that could halt covid early in its course.
28th Sep 2021 - CNN

Pfizer/BioNTech submit initial data on Covid-19 vaccine for people ages 5 to 11 to FDA, but aren't seeking EUA yet

Pfizer and BioNTech said Tuesday they have submitted Covid-19 vaccine data on children ages 5 to 11 to the US Food and Drug Administration for initial review, but are not yet seeking emergency use authorization. A formal submission to request EUA for the vaccine is expected to follow in the coming weeks, the companies said in a statement. Submissions to the European Medicines Agency and other regulatory authorities are also planned, they said. This is the first submission of data to the FDA for a Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.
28th Sep 2021 - CNN

Pfizer Submits Favorable Initial Data To The FDA On Kids' COVID-19 Vaccine Trial

Pfizer and BioNTech are another step closer to seeking authorization for young children to receive the COVID-19 coronavirus vaccine, submitting data to the Food and Drug Administration that shows a "robust" antibody response and "favorable" safety outcomes in kids ages 5 to 11 who received the two-dose regimen in clinical trials. The companies plan to submit a formal request for emergency-use authorization of the vaccine for that age range "in the coming weeks," they said Tuesday. News of the data submission comes a week after Pfizer announced promising results from the trials, which have been closely watched by parents eager to protect their children from the coronavirus. COVID-19 has now killed more than 690,000 people in the U.S., with millions more sickened by the disease.
28th Sep 2021 - NPR

Smokers up to 80% more likely to be admitted to hospital with Covid, study says

Smokers are 60%-80% more likely to be admitted to hospital with Covid-19 and also more likely to die from the disease, data suggests. A study, which pooled observational and genetic data on smoking and Covid-19 to strengthen the evidence base, contradicts research published at the start of the pandemic suggesting that smoking might help to protect against the virus. This was later retracted after it was discovered that some of the paper’s authors had financial links to the tobacco industry.
28th Sep 2021 - The Guardian

Sanofi ditches mRNA COVID-19 vaccine after rivals' success

Sanofi is dropping plans for its own mRNA-based COVID-19 vaccine because of the dominance achieved by BioNTech-Pfizer and Moderna in using the technology to fight the pandemic, the company said on Tuesday. The move highlights the challenges of competing in particular with pioneer BioNTech, which rose from obscurity through its alliance with pharma major Pfizer last year. They have delivered close to 1.5 billion doses so far to become the Western world's largest COVID-19 vaccine maker.
28th Sep 2021 - Reuters

COVID-19: One in 10 secondary school pupils with coronavirus suffered ongoing symptoms, ONS research finds

More than one in 10 secondary school students and over a third of school staff who have had COVID-19 have suffered ongoing symptoms, new research has found. Staff and pupils commonly reported weakness and tiredness, while staff were more likely to experience shortness of breath, according to a small study of schools in England. The Office of National Statistics (ONS) estimates that 35.7% of staff and 12.3% of students, who previously tested positive for COVID-19, reported experiencing ongoing symptoms more than a month after contracting the virus.
28th Sep 2021 - Sky News

Covid-19 may stay with us forever

The major problem is that the rise of more infectious strains of Sars-CoV-2 have quashed hopes of herd immunity, even in countries with high vaccine uptake. Scientists such as Francois Balloux, who directs the UCL Genetics Institute, say that this outcome was inevitable as soon as Covid-19 became a truly global pandemic. “I believe the opportunity for global eradication was gone very, very early in the pandemic,” says Balloux. “You can eliminate it locally, but as long as there’s a focus somewhere in the world, whether that’s Iran, Afghanistan, Somalia, it will eventually come back. As of February 2020, it was clear that elimination would not be possible.”
28th Sep 2021 - Wired.co.uk

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Sep 2021

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EU reviewing data on Moderna's COVID-19 booster shot

Pfizer Inc said on Monday it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus. The drugmaker and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop an easy-to-administer antiviral pill for COVID-19
27th Sep 2021 - Reuters

Pfizer begins study of oral drug for prevention of COVID-19

Pfizer Inc said on Monday it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus. The drugmaker and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop an easy-to-administer antiviral pill for COVID-19.
27th Sep 2021 - Reuters

Covid: New Delta mutation found in Italy can be beaten by vaccines, study suggests

An outbreak of a new strain of coronavirus among card-playing pensioners in northern Italy suggests it may not threaten vaccines as much as scientists fear. Public health chiefs are monitoring the strain – a combination of the highly infectious Delta variant and the E484K mutation associated with vaccine evasion – which has been identified in 19 people in the UK and a further 99 around the world. The strain is not yet a variant of concern due to the small numbers, but scientists are concerned it could take off as more people are vaccinated, which creates conditions for strains that can dodge vaccines.
27th Sep 2021 - iNews

Alberta's former chief medical officer of health calls for 'urgent' COVID-19 change

Alberta Premier Jason Kenney rejected calls for a "hard lockdown" during an appearance on a radio program Sunday, the same day that his province's former top doctor signed a letter calling for immediate "firebreak" measures to deal with surging cases of COVID-19. Kenney told radio host Roy Green that a lockdown would make "no sense for the 80 per cent of the population that is vaccinated," who he said are much less likely to transmit the disease and are far less likely to be hospitalized. He also said the roughly 20 per cent who aren't vaccinated and are behind the surge in cases are less likely to follow public health measures. Dr. James Talbot, Alberta's former chief medical officer of health, co-wrote a letter to the province's new health minister, Jason Copping, strongly recommending additional measures in the province, as the pandemic's fourth wave continues to strain hospital capacity.
27th Sep 2021 - CBC.ca

Covid-19: Aussie doctors reveal why your next vaccination shot is going up your nose

Scientists are working on a nasal spray vaccine for Covid-19. 'You are 11 times more likely to die from Covid if you are unvaccinated.' The nose and mouth are the doorways to getting the virus. Getting vaccinated significantly reduces the risk of being infected
27th Sep 2021 - Daily Mail

Japan approves GSK's Sotrovimab COVID-19 antibody treatment

Japan has approved GlaxoSmithKline and Vir Biotechnology's Sotrovimab as an antibody treatment for coronavirus, Health Minister Norihisa Tamura said on Monday. The antibody treatment is for mild to moderate COVID-19 cases which do not require oxygen supplementation, GSK said when it applied for fast-track approval this month.
27th Sep 2021 - Reuters

Small study shows antibody growth from AstraZeneca, Sputnik Light COVID-19 vaccine mix

A small-scale clinical study of the combined use of the AstraZeneca and Sputnik Light vaccines against COVID-19 has shown strong antibody growth in a majority of the study's participants, the Russian Direct Investment Fund said on Monday. The data was collected from 20 people who took part in a 100-person study in Azerbaijan that began in February. They first received the AstraZeneca shot followed by the one-dose Russian-made Sputnik Light shot 29 days later, RDIF said.
27th Sep 2021 - Reuters

Covid-19: England sees biggest fall in life expectancy since records began in wake of pandemic

The covid-19 pandemic led to the biggest year-on-year drop in life expectancy in England since statistics were first collected in 1981, Public Health England has said. In 2020, the agency said that “the very high level” of excess deaths because of the pandemic caused life expectancy in England to fall 1.3 years for men to 78.7 and 0.9 years for women to 82.7. This was the lowest life expectancy in England for both sexes since 2011. Not all countries have reported life expectancy data for 2020 yet. But of those that have, PHE noted that Italy, Poland, and Spain experienced similar decreases in life expectancy to England in 2020, while France had a smaller decrease. Germany had little or no relative excess mortality in men or women. The US and Poland had the highest relative excess mortality in 2020, in both men and women.
27th Sep 2021 - The BMJ

COVID-19: Llama nanobodies may offer new treatment

Although vaccines are highly effective in preventing COVID-19, scientists still need to identify better treatments for the disease. Some scientists are investigating whether llama-derived antibodies might be a useful treatment approach. A recent study has shown that so-called nanobodies that scientists harvested from a llama reduced SARS-CoV-2 viral load in Syrian hamsters.
27th Sep 2021 - Medical News Today

Venezuelan academy of medicine expresses concern over use of Cuban vaccine

Venezuela’s National Academy of Medicine on Monday expressed concern over the use of Cuba’s Abdala coronavirus vaccine due to a lack of scientific research on its safety and efficacy. Cuba said on Saturday it had exported the three-shot vaccine for the first time, sending an initial shipment to Vietnam as part of a contract to supply five million doses to the Southeast Asian country. The government of Venezuelan President Nicolas Maduro has so far been relying on the Russian Sputnik V and the Chinese Sinopharm vaccines, and in recent months received its first shipment of doses via the global COVAX program.
27th Sep 2021 - Reuters

WHO backs Regeneron drug for COVID-19, urges action on price

The World Health Organisation (WHO) has added the Regeneron antibody drug cocktail – casirivimab and imdevimab – to its list of treatments for people with COVID-19, urging the manufacturer to reduce the price and ensure equitable distribution. Clinical studies showed the drug combination was effective in patients who were not severely ill but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies, the WHO said in a statement on Friday.
24th Sep 2021 - AlJazeera

WHO adds new recommendation for COVID-19 monoclonal antibody combo

The WHO's conditional recommendation for the monoclonal antibody cocktail, which consists of casirimivab and imdevimab, applies to patients with nonsevere COVID-19 who are at high risk for hospitalization and for people who have severe and critical infections who have no antibodies to SARS-COV-2. In November, the US Food and Drug Administration issued an emergency use authorization for the drug combination for adults and kids ages 12 and older who have mild- to moderate COVID-19. The combination is administered through intravenous (IV) infusion or injection. It made headlines when it was used to treat former President Donald Trump's COVID-19 infection. Demand for the treatment has been skyrocketing in US hot spots such as Florida, where officials have opened state-run centers to deliver the treatment. As a result, the Biden administration recently took steps to address shortages by taking over distribution and buying 1.4 million more doses. In the United States, the drug costs about $1,250 per dose and is covered by the federal government.
24th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Sep 2021

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Behind Covid-19 Booster Authorization Were Disagreements on Evidence, Broad Access

The Biden administration publicly touted its plan to roll out Covid-19 boosters to almost all the fully vaccinated during the week of Sept. 20, saying data from Israel supported the approach. Yet behind the scenes, federal regulators tasked with clearing boosters and recommending who should get them were locked in a pitched battle over whether the data supported the plan, according to people familiar with the matter. Some regulators argued that only certain vulnerable groups such as seniors needed an additional shot and that the decision-making timeline was too rushed, the people said. The dissenters also bristled at the Biden administration’s declaration, in August, that boosters would be widely available if authorized by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention, arguing it put pressure on the agencies to follow the announced course, the people said.
25th Sep 2021 - The Wall Street Journal

Since Covid-19 Hit, Research on Viruses Has Exploded. Is it Safe?

Laboratories around the globe increasingly are experimenting with emerging viruses, sometimes giving them new capabilities, as they seek to identify dangerous ones and find ways to combat them. While the goal is to protect health, some of the projects carry the chance of a misstep that could unleash an epidemic, some scientists say. Experiments in the U.S. are reviewed in advance by researchers’ institutions or government funders, but risky projects can go forward without being subjected to the highest level of scrutiny, especially in some other countries. Some scientists and officials in the Biden administration are pushing for more oversight, globally, of risky bioresearch. One focus is laboratory work that enhances a pathogen or endows it with new properties—sometimes called “gain-of-function” research—which is often done to assess its potential to infect humans.
25th Sep 2021 - The Wall Street Journal

Schools without mask mandate 3.5 times more likely to have COVID-19 outbreaks: CDC study

A Centers for Disease Control and Prevention (CDC) study found that schools in two Arizona counties that didn’t require universal masking were 3.5 times more likely to endure COVID-19 outbreaks than schools with mask mandates. Out of the 191 schools in Maricopa and Pima counties that experienced outbreaks by the end of August, 59.2 percent did not have a mask requirement, compared to 8.4 percent that required masks from the start of the school year. Almost a third of outbreaks occurred in schools that implemented mask mandates after the school year began.
25th Sep 2021 - The Hill

Pfizer in talks over full license for COVID-19 vaccine in Singapore

Pfizer Inc is in discussions with Singapore's Health Sciences Authority regarding obtaining a full license application for its COVID-19 vaccine, the company said in response to a query from Reuters. Pfizer-BioNTech's COVID-19 vaccine has interim authorisation under the pandemic special access route in Singapore. The U.S. Food and Drug Administration granted full approval to the vaccine last month. Kenneth Mak, Singapore's director of medical services, said in a briefing on Friday Pfizer and Moderna had not submitted applications for full registration to authorities.
25th Sep 2021 - Reuters

Even Mild Cases of COVID May Leave a Mark on the Brain

With more than 18 months of the pandemic in the rearview mirror, researchers have been steadily gathering new and important insights into the effects of COVID-19 on the body and brain. These findings are raising concerns about the long-term impacts that the coronavirus might have on biological processes such as aging. As a cognitive neuroscientist, my past research has focused on understanding how normal brain changes related to aging affect people’s ability to think and move – particularly in middle age and beyond. But as more evidence came in showing that COVID-19 could affect the body and brain for months or longer following infection, my research team became interested in exploring how it might also impact the natural process of aging.
25th Sep 2021 - Scientific American

It Took Years to Reach Vaccine Warp Speed

The story begins on Sept. 18, 2001—a week after 9/11—when the New York Post, NBC News and other media organizations received letters containing military-grade anthrax bacteria. Three weeks later, similar letters arrived at the offices of Sens. Tom Daschle and Patrick Leahy. Congress responded to this very direct threat by enacting the Bioterrorism Act of 2002, the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. That last law established the Biomedical Advanced Research and Development Authority, or Barda, an agency within the Department of Health and Human Services. Barda reports to the HHS’s assistant secretary of preparedness and response (the position Dr. Kadlec held during the Trump administration). Its mission is to facilitate the development of new medical products that would enable preparedness and respond to threats.
24th Sep 2021 - The Wall Street Journal

A daily pill to treat Covid could be just months away, scientists say

Within a day of testing positive for Covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room. When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought: ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?’” But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutchinson Cancer Research Center that’s part of an international effort to test an antiviral treatment that could halt Covid early in its course.
24th Sep 2021 - NBC News

Children, covid-19, and India's looming third wave

Makepeace Sitlhou reports on how covid-19 has affected children in India, and how the authorities are making plans to improve provision of care In September 2020, 15 year old Well Done Boy Marbaniang was brought to hospital in Shillong, India, with fever, cough, and breathing difficulties. He was immediately put on non-invasive ventilation and given intravenous fluids, but just five and a half hours after his admission, Marbaniang died. He was the first child to die of covid-19 in Meghalaya. The northeastern state had the highest case fatality rate (8.3%) in India during the first wave of covid-19, and one of the highest rates of positive test results (7-8% against the national average of 2.5%) during the second wave. Around 22% of total infections through to August were in under 18s.
24th Sep 2021 - The BMJ

C.D.C. Chief Overrules Agency Panel and Endorses Pfizer Boosters for Frontline Workers

The director of the Centers for Disease Control and Prevention on Friday overruled a recommendation by an agency advisory panel that had refused to endorse booster shots of the Pfizer-BioNTech Covid vaccine for frontline workers. It was a highly unusual move for the director, Dr. Rochelle Walensky, but aligned C.D.C. policy with the Food and Drug Administration’s endorsements over her own agency’s advisers. The C.D.C.’s Advisory Committee on Immunization Practices on Thursday recommended the boosters for a wide range of Americans, including tens of millions of older adults and younger people at high risk for the disease. But they excluded health care workers, teachers and others whose jobs put them at risk. That put their recommendations at odds with the F.D.A.’s authorization of booster shots for all adults with a high occupational risk.
24th Sep 2021 - The New York Times

Biden tells 60 million Americans to get booster shots after CDC director overruled advisers

Biden urged Americans over 65 and with certain medical conditions or jobs to get booster shots. 'I'll be getting my booster shot,' said Biden, 78. Frontline workers and those with medical conditions like diabetes are encouraged to get jabs under new CDC guidance. CDC Director Rochelle Walensky intervened to expand eligibility
24th Sep 2021 - Daily Mail

Moderna CEO Stéphane Bancel says vaccines can end pandemic in one year

Moderna’s chief executive says that the coronavirus pandemic could be over in a year and that a boost in production will mean enough vaccines for “everyone on this Earth” by then. More booster shots should be available, too, to some extent, and even babies will be able to get vaccines, Stéphane Bancel told a Swiss newspaper in an interview published Thursday. Asked whether that could spell “a return to normal” next year, he replied: “As of today, in a year, I assume.” With the vaccine industry as a whole expanding production, “enough doses should be available by the middle of next year so that everyone on this Earth can be vaccinated,” the French billionaire said.
23rd Sep 2021 - The Washington Post

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Sep 2021

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Does My Mask Protect Me if Nobody Else Is Wearing One?

There is also plenty of evidence showing that masks protect the wearer even when others around them are mask-free. The amount of protection depends on the quality of the mask and how well it fits. During a hotel outbreak in Switzerland, for instance, several employees and a guest who tested positive for the coronavirus were wearing only face shields (with no masks); those who wore masks were not infected. And a Tennessee study found that communities with mask mandates had lower hospitalization rates than areas where masks weren’t required.
23rd Sep 2021 - The New York Times

Covid-19 Vaccines Can Be Updated for the Delta Variant. Here’s How.

Scientists are working to develop shots that would target the Delta variant specifically. The mRNA platform behind some vaccines might make this process relatively straightforward, according to Matthew Johnson, senior director of product development at the Duke Human Vaccine Institute. Vaccines work by exposing the body to a harmless version or portion of a virus. This teaches our immune systems to recognize and fight the real virus if our bodies become infected with it. The mRNA-based vaccines developed for Covid-19—including the two made by Moderna Inc. and by Pfizer Inc. and partner BioNTech SE —rely on the outer spike proteins of the new coronavirus to prime our immune defenses. Spike proteins stud the outer surface of the virus and help it latch onto and infect healthy cells.
23rd Sep 2021 - The Wall Street Journal

Novavax applies to WHO for emergency listing of COVID-19 vaccine

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing of Novavax's COVID-19 vaccine, potentially clearing the way for the shot to ship to many poorer countries, the company said on Thursday. Novavax has been prioritizing regulatory submissions to low- and middle-income countries after falling behind in the race for authorization in the United States and Europe, which have already vaccinated most of their residents.
23rd Sep 2021 - Reuters

EU drugs regulator says to decide on Pfizer vaccine booster in early October

The European Medicines Agency (EMA) aims to decide in early October whether to endorse a third dose of the Pfizer-BioNTech, COVID-19 vaccine to be given half a year after the initial two-shot course, saying breakthrough infections added some urgency to its review. "The outcome of this evaluation is expected in early October, unless supplementary information is needed," EMA's head of vaccines strategy, Marco Cavaleri, told a press briefing on Thursday. Cavaleri's statement confirmed a Reuters report earlier in the day on EMA's expected review time on the matter
23rd Sep 2021 - Reuters

The Vaccinated Aren't ‘Just as Likely’ to Spread COVID

For many fully vaccinated Americans, the Delta surge spoiled what should’ve been a glorious summer. Those who had cast their masks aside months ago were asked to dust them off. Many are still taking no chances. Some have even returned to all the same precautions they took before getting their shots, including avoiding the company of other fully vaccinated people.
23rd Sep 2021 - The Atlantic

Coronavirus unlikely to become more deadly because it’s run out of ‘places to go’, says Oxford jab creator

Covid is unlikely to mutate into a deadlier, vaccine-evading, variant because it’s run out of “places to go” , the creator of the Oxford jab has said. Dame Sarah Gilbert said coronavirus is likely to become less severe in its effects. Speaking at a Royal Society of Medicine webinar on Wednesday, she said: “We normally see that viruses become less virulent as they circulate more easily and there is no reason to think we will have a more virulent version of Sars-CoV-2.” Dame Sarah said that some variations were to be expected but predicted that coronavirus would eventually become like the flu virus, saying: “What tends to happen over time is there’s just a slow drift, that’s what happens with flu viruses. You see small changes accumulating over a period of time and then we have the opportunity to react to that.”
23rd Sep 2021 - The Independent

Oxford researchers find Llama antibodies have “significant potential” as potent Covid-19 treatment

A unique type of tiny antibody produced by llamas could provide a new frontline treatment against Covid-19 that can be taken by patients as a simple nasal spray. Research led by scientists at the Rosalind Franklin Institute in Oxford has shown that nanobodies – a smaller, simple form of antibody generated by llamas and camels – can effectively target the SARS-CoV-2 virus that causes Covid-19. They found that short chains of the molecules, which can be produced in large quantities in the laboratory, significantly reduced signs of the Covid-19 disease when administered to infected animals. The nanobodies, which bind tightly to the SARS-CoV-2 virus, neutralising it in cell culture, could provide a cheaper and easier to use alternative to human antibodies taken from patients who have recovered from Covid-19.
23rd Sep 2021 - ITV News

Beijing Wantai plans large trial for nasal spray COVID-19 vaccine candidate

Chinese vaccine developer Beijing Wantai Biological Pharmacy Enterprise plans to start a large trial for its nasal spray-based COVID-19 vaccine candidate next month, a clinical trial registration record showed. The company aims to recruit 40,000 adult participants for the Phase III clinical trial, according to an entry posted on the Chinese Clinical Trial Registry on Wednesday
23rd Sep 2021 - Reuters

New Zealand's strategy to eliminate Covid-19 faces defeat by Delta strain, admits health chief

New Zealand’s strategy to eliminate the coronavirus may have been defeated by the Delta strain, the country’s health chief has conceded. With the country’s largest city, Auckland, in lockdown since mid-August, the health director-general Dr Ashley Bloomfield has warned that the nation may not return to zero Covid-19 cases. Jacinda Ardern, the prime minister, has previously committed to elimination of the virus despite the view of her Australian counterpart, Scott Morrison, that this goal was “absurd”.
23rd Sep 2021 - The Times

Valneva expands trials on COVID-19 vaccine candidate

French vaccine maker Valneva (VLS.PA) is expanding trials of a COVID-19 vaccine candidate called VLA2001, and remains in talks with the European Commission over a potential contract, the company said on Thursday. Valneva shares plunged 42% after Britain said on Sept 13 that it cancelled its contract for about 100 million doses of the vaccine the company is developing, partly over concerns about when it would win approval for use.
23rd Sep 2021 - Reuters

Covid-19: Abnormalities in the womb detected among pregnant women even after they tested negative

Analysis of 115 women in the UK, Canada and France who gave birth over the last 18 months showed far more physical abnormalities in the placenta than doctors would expect to see in a pre-2020 pregnancy. The pandemic is taking a physical toll on pregnant women – even if they do not catch Covid-19, a small international study suggests. Analysis of 115 women in the UK, Canada and France who gave birth over the last 18 months showed far more physical abnormalities in the placenta than doctors would expect to see in a pre-pandemic pregnancy. Rates of problems with the placenta, the baby’s support system in the womb, tripled among expectant mothers with Covid-19 but doubled even among those who tested negative, suggesting the changes can be caused by the sheer stress of the pandemic as well as the virus itself.
23rd Sep 2021 - iNews

Heart inflammation after COVID-19 vaccine: Are boys at higher risk?

A new, non-peer-reviewed study concluded that healthy boys aged 12–17 years had a higher hospitalization rate due to heart inflammation after their second mRNA COVID-19 vaccination than the expected hospitalization rate for COVID-19 in that age group. A non-peer-reviewed study reports on scientific research that other experts in the field have not evaluated before publication; it should not guide clinical decision-making. In the case of this paper, there are several issues with the data that the researchers used, which limits the accuracy and applicability of the study’s findings. A CDC analysis of reports of heart inflammation after COVID-19 vaccines is currently under review at a major peer-reviewed journal.
23rd Sep 2021 - Medical News Today

‘Covid-19 will become like common cold’ by next spring, say experts who claim worst of pandemic is over

Covid-19 could soon resemble the common cold as the virus weakens and people’s immunity is boosted by vaccines and exposure, two leading experts have said. Professor Sir John Bell, regius professor of medicine at Oxford University, has claimed the coronavirus could become like a cold by as soon as next spring. He also claimed the UK “is over the worst” of the pandemic and things “should be fine” once winter has passed.
23rd Sep 2021 - iNews

‘I Know Who Caused Covid-19’ review – the global blame game

t’s not surprising that Covid-19 has made people angry: their lives have become disrupted in unimaginable ways. People have lost family members to the disease, or suffered for months with long Covid. With the restrictions needed to keep health services afloat, small businesses have gone under, city centres have been shuttered and people have spent months without seeing loved ones. Basic freedoms that we took for granted were taken away in order to stop the spread of a dangerous virus. The questions of where it came from, and just who is responsible for all this devastation and loss, have assumed outsize importance.
23rd Sep 2021 - The Guardian

EU drugs regulator to decide on Pfizer vaccine booster in early October

The European Medicines Agency aims to decide in early October whether to endorse a third dose of the Pfizer-BioNTech, COVID-19 vaccine to be given half a year after the initial two-shot course, saying breakthrough infections added some urgency to its review. "The outcome of this evaluation is expected in early October, unless supplementary information is needed," EMA's head of vaccines strategy, Marco Cavaleri, told a press briefing.
23rd Sep 2021 - Reuters

U.S. CDC advisers back COVID-19 booster shots for those 65 and older, not for high-risk workers

A U.S. Centers for Disease Control and Prevention (CDC) advisory panel on Thursday recommended a booster shot of the Pfizer and BioNTech COVID-19 vaccine for Americans aged 65 and older and some adults with underlying medical conditions that put them at risk of severe disease.
23rd Sep 2021 - Reuters

4DMedical lung imagery sheds more light on 'long COVID' effects

The scans by 4DMedical allow physicians to detect areas of high and low lung ventilation using existing equipment in hospitals, said founder and Chief Executive Andreas Fouras. The 'four dimensions' refers to the scan's ability to measure the phases of breath as it passes into and out of the lungs. "It takes a short video sequence. We use about 20 seconds worth of video sequence of the patient just breathing naturally," said Fouras. "From that video sequence, we're able to mathematically calculate the motion and then the airflow everywhere around the lungs."
23rd Sep 2021 - Reuters

EU drugs regulator to decide on Pfizer vaccine booster in early October

The European Medicines Agency (EMA) aims to decide in early October whether to endorse a third dose of the Pfizer-BioNTech, COVID-19 vaccine to be given half a year after the initial two-shot course, saying breakthrough infections added some urgency to its review. "The outcome of this evaluation is expected in early October, unless supplementary information is needed," EMA's head of vaccines strategy, Marco Cavaleri, told a press briefing on Thursday. Cavaleri's statement confirmed a Reuters report earlier in the day on EMA's expected review time on the matter
23rd Sep 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Sep 2021

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Moderna vs. Pfizer: Both Knockouts, but One Seems to Have the Edge

Roughly 221 million doses of the Pfizer-BioNTech vaccine have been dispensed thus far in the United States, compared with about 150 million doses of Moderna’s vaccine. In a half-dozen studies published over the past few weeks, Moderna’s vaccine appeared to be more protective than the Pfizer-BioNTech vaccine in the months after immunization. The latest such study, published on Wednesday in The New England Journal of Medicine, evaluated the real-world effectiveness of the vaccines at preventing symptomatic illness in about 5,000 health care workers in 25 states. The study found that the Pfizer-BioNTech vaccine had an effectiveness of 88.8 percent, compared with Moderna’s 96.3 percent.
22nd Sep 2021 - The New York Times

Pfizer Study of Covid-19 Vaccine in Pregnant Women Delayed by Slow Enrollment

Changing guidelines and the possibility of being given a placebo made the trial unappealing to some expectant mothers. fizer closed enrollment at many U.S. sites this summer, after fewer than expected numbers of subjects entered the study, researchers say. The slow enrollment was driven by revised guidelines from government and physician groups that recommend pregnant women receive the shots based on new real-world research, according to trial-site researchers. They also say increased vaccine supply made a trial that included the possibility of being given a placebo instead of a vaccine unappealing to expectant mothers and raised questions about the ethics of seeking volunteers.
22nd Sep 2021 - The Wall Street Journal

Coronavirus: China seeks to develop next-gen vaccines amid trial complications

A lack of international cooperation to compare vaccines will make it more difficult for China to come up with convincing data for future vaccines using new technologies or targeting new variants of Covid-19, although China is not alone, experts said. China is developing several second generation vaccines using either inactivated vaccine technology, mRNA or protein subunit technologies. It is also developing first generation vaccines using mRNA technology. China needed to conduct phase 3 clinical trials for its early first generation vaccines overseas because there were not enough Covid-19 cases domestically. However, finding places for clinical trials for second generation vaccines, which target specific variants or a broad spectrum of variants, has become increasingly difficult because it would be considered unethical to deliver placebos in controlled trials where transmissions are high, particularly as other vaccines are available.
22nd Sep 2021 - South China Morning Post

Covishield: UK recognises Covid jab after India outcry

The UK government has amended its foreign travel guidance to clarify that the Indian-made version of the AstraZeneca vaccine is an approved jab. But it is not clear whether people from India can travel to the UK without having to self-isolate for 10 days. The UK's refusal to recognise Covishield had triggered a firestorm of protests in India. With more than 721 million doses administered so far, Covishield is India's primary vaccine. On Tuesday, India described the rule as "discriminatory" and asked the UK to stop requiring fully-vaccinated Indians to self-isolate on arrival. At present, India is not listed as a country where people are recognised as fully vaccinated even if they've had both doses of an approved jab.
22nd Sep 2021 - BBC News

Llama antibodies have 'significant potential' for Covid-19 treatment

Tiny antibodies produced by llamas could provide a new frontline treatment against coronavirus in the form of a nasal spray, research suggests. Scientists at the Rosalind Franklin Institute have found that the nanobodies – a smaller, simple form of antibody generated by llamas and camels – can effectively target the Sars-CoV-2 virus that causes Covid-19. Short chains of the molecules, which can be produced in large quantities in the laboratory, significantly reduced signs of Covid-19 when given to infected animal models, according to the study. The nanobodies bind tightly to the virus, neutralising it in the laboratory, and could provide a cheaper and easier alternative to human antibodies taken from recovered from Covid-19 patients.
22nd Sep 2021 - Metro.co.uk

Between Covid-19 and the flu, health care professionals are bracing themselves for the winter ahead, expert says

The current pace in Covid-19 vaccinations is the slowest it has been since July, according to data released Wednesday from the Centers for Disease Control and Prevention. The latest data comes as flu season is around the corner, which could increase death tolls and put more of a strain on hospitals that are already struggling with an influx of patients and depleted resources. More than 312,000 people have initiated the vaccination process -- or getting their first shot -- over the last week, CDC data shows. That's a 7% drop from last week and a 35% drop from the previous month. An average of 742,703 doses are being administered each day and about 182 million people, or 54.9%, of the US population, are fully vaccinated, the data shows. That leaves 71 million people, or 25.1% of the population, who are not vaccinated
22nd Sep 2021 - CNN

Covid-19 vaccines for teenagers: conversations and consent

On 13 September, the UK chief medical officers recommended that all 12-15 year olds be offered a single dose of Pfizer-BioNTech covid-19 vaccine.1 This followed a previous recommendation by the Joint Committee on Vaccination and Immunisation2 not to offer covid-19 vaccines to healthy 12-15 year olds. The UK now joins a growing list of countries offering vaccination to those aged 12 and over, but it is providing only one dose rather than the two given in other countries because of concerns about rare side effects such as heart inflammation. The health benefits of covid-19 vaccination are small in this age group since covid-19 infection is not a serious threat to their health.5 However, the chief medical officers’ decision was influenced by the wider benefit of reducing further disruption to education. Parents are understandably concerned about vaccine safety. It’s not yet clear how schools and healthcare professionals will cope with delivering up to 2.6 million covid-19 vaccines, answering parents’ questions,6 and supporting teenagers to make informed decisions.
22nd Sep 2021 - The BMJ

CDC panel tackles who needs booster shot of COVID vaccine

An influential panel of advisers to the Centers for the Disease Control and Prevention grappled Wednesday with the question of which Americans should get COVID-19 booster shots, with some members wondering if the decision should be put off for a month in hopes of more evidence. The doubts and uncertainties suggested yet again that the matter of whether to dispense extra doses to shore up Americans’ protection against the coronavirus is more complicated scientifically than the Biden administration may have realized when it outlined plans a month ago for an across-the-board rollout of boosters. The rollout was supposed to have begun this week.
22nd Sep 2021 - The Associated Press

Has the Delta variant changed the symptoms of COVID-19?

It has been said many times that the arrival of the Delta variant of the coronavirus has changed the course of the pandemic. It is more transmissible than previous variants and has quickly become the dominant variant across the world. And because the vaccines are less effective against it, although still effective enough, it has brought the need for booster shots to the forefront of the debate. A new study has shown that the symptoms that the infection presents have also changed. According to the World Health Organization, the most common symptoms of COVID are...
22nd Sep 2021 - AlJazeera

Trials begin on Covid booster jab hoped to protect against new variants

The first trials have begun of a Covid booster jab that it is hoped will offer good protection against a wide range of variants, researchers have revealed. Covid jabs currently used in the UK trigger an immune response towards the coronavirus spike protein, which helps the virus get into human cells. However, different variants of the coronavirus have different mutations in this protein, meaning a vaccine that works well against one variant may not be as effective against another. The team behind the new booster jab hope to get around this problem by triggering an immune response towards the spike and non-spike proteins of the coronavirus.
21st Sep 2021 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Sep 2021

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J&J Says Covid-19 Vaccine Booster Two Months After First Shot Increases Protection

Johnson & Johnson said a booster dose of its Covid-19 vaccine administered two months after the first shot increased protection against symptomatic illness in trial participants, as federal regulators evaluate data for the country’s strategy for rolling out boosters. Data released Tuesday from a late-stage clinical trial showed that study participants in 10 countries including the U.S. who received a second dose of the company’s vaccine two months after the first had 75% protection against symptomatic Covid-19. Participants in the U.S. had 94% protection against the illness. J&J didn’t explain the reason for the difference in efficacy rates.
21st Sep 2021 - The Wall Street Journal

J&J says second shot boosts protection for moderate-severe COVID-19 to 94%

Johnson & Johnson said Tuesday a second shot of its COVID-19 vaccine given about two months after the first increased its effectiveness to 94% in the United States against moderate to severe forms of the disease.
21st Sep 2021 - Reuters on MSN.com

Johnson & Johnson Says Its Booster Shot Provides Increased Protection From COVID-19

People who receive a Johnson & Johnson COVID-19 vaccine booster shot are better protected against the coronavirus for a longer period of time, according to the pharmaceutical company's latest trial results. The one-dose Johnson & Johnson vaccine has been found to be 66% protective against moderate and severe disease overall worldwide and 72% protective against such cases in the U.S. But when a person receives a booster shot two months after getting the pharmaceutical company's one-dose vaccine, the protection against COVID-19 increased to 94%. A booster shot at six months provided a 12-fold increase in antibodies.
21st Sep 2021 - NPR

Covid-19: Monoclonal antibody treatment to be rolled out to hospital patients with no antibody response

Eligible patients with covid-19 in UK hospitals who have not mounted an antibody response against SARS-CoV-2 will be offered the monoclonal antibody treatment ronapreve from this week, the government has announced. The drug is a combination of two monoclonal antibodies (casirivimab and imdevimab), which work by binding to two different sites on the SARS-CoV-2 spike protein and neutralising the virus’s ability to infect cells. It was the first neutralising antibody drug specifically designed to treat covid-19 approved by the Medicines and Healthcare Products Regulatory Agency (in August 2021). Ronapreve will be administered to patients without antibodies—who must be either aged 50 or over, or aged 12 to 49 and considered to be immunocompromised—through a drip. The government said it had secured enough supply for NHS patients across the four nations and that antibody testing will be used to determine which patients are eligible.
21st Sep 2021 - The BMJ

Trials begin on new vaccine to fight Covid-19 variants

Trials are under way in Manchester of a new jab to fight Covid-19 variants in the hope it can offer longer-lasting immunity than current vaccines. Initially involving participants aged 60 and over, its creators hope the new drug – GRT-R910 – can boost the immune response of first-generation Covid-19 vaccines to a wide array of variants of Sars-Cov-2, which cause Covid-19. First to receive the trial jabs were retired NHS nurse Helen Clarke, 64, and her husband Andrew, 63, from Bolton, Greater Manchester. Mrs Clarke said: “I used to work in the NHS and had been involved in research as a nurse in the past.
21st Sep 2021 - Evening Standard

Covid-19: How is vaccination affecting hospital admissions and deaths?

An analysis of UK data from the National Immunisation Management Service (NIMS) and the Coronavirus Clinical Information Network (CO-CIN),1 endorsed by the UK Scientific and Advisory Group for Emergencies (SAGE),2 shows that of 40 000 patients with covid-19 who were admitted to hospital between December 2020 and July 2021 a total of 33 496 (84%) had not been vaccinated. It found that 5198 (13%) of these patients had received their first vaccine and 1274 (3%) their second. A total of 611 patients with previous covid-19 (reinfection) were not included in the analysis.
21st Sep 2021 - The BMJ

HSJ Patient Safety Awards 2021: Covid-19 Infection Prevention and Control Award

Northern Care Alliance Group: Covid-19 Rapid Antigen Testing Using LFDs in Emergency Departments to Aid Infection Prevention & Control – Northern Care Alliance at the Vanguard. During the second wave of the pandemic, demand for PCR testing exceeded capacity and adversely affected patient management. At that time (November 2020), UK policy did not support deployment of lateral flow devices for covid. Northern Care Alliance NHS Group introduced LFD for patients needing admission through emergency departments. An LFD (SD Biosensor) was introduced in the ED by pathology. Significant improvement in patient flow and reduction in nosocomial transmissions was a testimony to its clinical utility. The alliance presented at the National Virology Cell meeting and by late December 2020, the government launched its use for all ED admissions.
21st Sep 2021 - Health Service Journal

Brazil and Argentina tapped to make mRNA vaccines in Latin America

The Pan American Health Organization has selected two biomedical centers in Argentina and Brazil as regional hubs to develop and produce mRNA-based vaccines to fight COVID-19 in Latin America, the regional health agency said on Tuesday. The idea is to tap existing manufacturing capacities to help transfer vaccine technology developed by Moderna in the United States to a region badly hit by the coronavirus and still without access to enough vaccines.
21st Sep 2021 - Reuters

J&J: Booster dose of its COVID shot prompts strong response

J&J said in statement that an extra dose — given either two months or six months after the initial shot — revved up protection. The results haven’t yet been published or vetted by other scientists. The J&J vaccine was considered an important tool in fighting the pandemic because it requires only one shot. But even as rollout began in the U.S. and elsewhere, the company already was running a global test of whether a two-dose course might be more effective — the second dose given 56 days after the first. That two-dose approach was 75% effective globally at preventing moderate to severe COVID-19, and 95% effective in the U.S. alone, the company reported — a difference likely due to which variants were circulating in different countries during the months long study.
21st Sep 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Sep 2021

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Regulators could OK Pfizer boosters for older Americans this week

U.S. regulators could authorize a booster shot of the Pfizer Inc/BioNTech SE COVID-19 vaccine for older and some high-risk Americans early this week in time for the government to roll them out by Friday. The Food and Drug Administration is expected to give the nod to the third shots for at least this group before advisers to the U.S. Centers for Disease Control and Prevention are due to meet on Wednesday. The CDC panel will discuss more precise recommendations for how to administer the shots.
20th Sep 2021 - Reuters

Pfizer, BioNTech Say Covid-19 Vaccine Is Safe for Children Aged 5 to 11

The companies said the Covid-19 vaccine generated levels of antibodies that were similar to those of younger adults. Pfizer will seek emergency use authorization in the U.S. as early as the end of the month.
20th Sep 2021 - The Wall Street Journal

Covid Vaccine for Kids Age 5-11 Likely Available by Halloween, Fauci Says

The U.S. death toll from the Covid-19 pandemic surpassed the number of fatalities in the 1918 influenza pandemic, a milestone many experts say was avoidable after the arrival of vaccines. The White House announced the most sweeping change to U.S. travel policies in months, widening the gap in rules between vaccinated people -- who will see curbs relaxed -- and the unvaccinated. Ther regulations will replace existing bans on foreigners’ travel to the U.S. from certain regions, including Europe. Pfizer Inc. and partner BioNTech SE said their vaccine was safe and produced strong antibody responses in younger children in a large-scale trial. The shot may be available by the end of next month, Anthony Fauci said.
20th Sep 2021 - Bloomberg

Pfizer Vaccine Safe for 5 to 11 Year Olds, Large Trial Finds

Pfizer Inc. and partner BioNTech SE said their Covid-19 vaccine was safe and produced strong antibody responses in children ages 5 to 11 in a large-scale trial, findings that could pave the way to begin vaccinating grade-school kids within months. The long-awaited results offer one of the first looks at how well a Covid vaccine could work for younger children. Pressure to immunize kids has been on the climb in the U.S., where a new school year has started just as the delta variant is fueling a surge in cases.
20th Sep 2021 - Bloomberg

Though lagging behind, Israel’s COVID-19 jab hopes to ‘find its place in market’

Nearly two years after the emergence of the COVID-19 pandemic, Israel may soon finally see its own homegrown vaccine become commercially available. The jab will be a very late newcomer — lagging behind the first wave of COVID vaccines by almost a year — but its backers believe that it will find its rightful place in the global vaccine market, and may even prove in the long run to be more effective than existing jabs against coronavirus variants. These beliefs were offered this month by Dr. Jonathan Javitt, chairman of NRx Pharmaceuticals, the American-Israeli clinical-stage pharmaceutical company tapped two months ago by the Israeli Defense Ministry to manufacture and market the country’s vaccine developed by the government-run Israel Institute for Biological Research (IIBR) in Ness Ziona.
20th Sep 2021 - The Times of Israel

COVID-19: Pfizer-BioNTech vaccine trial for children aged under 12 shows 'robust immune response'

A Pfizer-BioNTech COVID-19 vaccine trial for children aged between five and 11 has produced "positive results" and has shown a "robust immune response", the two firms have said. They said the results are the first to emerge from any vaccine trial for children aged below 12 and would "provide a strong foundation" for seeking the authorisation of its potential rollout across the world. Pfizer and BioNTech said the data will be submitted to health regulatory bodies and that they believe the trial provides a "great opportunity" to prevent COVID-19 in younger age groups.
20th Sep 2021 - Sky News

Cambodia bat researchers on mission to track origin of COVID-19

Researchers are collecting samples from bats in northern Cambodia in a bid to understand the coronavirus pandemic, returning to a region where a very similar virus was found in the animals a decade ago. Two samples from horseshoe bats were collected in 2010 in Stung Treng province near Laos and kept in freezers at the Institut Pasteur du Cambodge (IPC) in Phnom Penh. Tests done on them last year revealed a close relative to the coronavirus that has killed more than 4.6 million people worldwide.
20th Sep 2021 - Reuters

COVID-19 antibody drug Ronapreve rolled out to vulnerable patients

Thousands of vulnerable NHS patients in hospital due to COVID-19 are set to benefit from a ground-breaking new antibody treatment Ronapreve. The drug is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK. Ronapreve, a combination of two monoclonal antibodies, will be targeted initially at those in hospital who have not mounted an antibody response against COVID-19. This includes people who are immunocompromised, for example those with certain cancers or autoimmune diseases, and therefore have difficulty building up an antibody response to the virus, either through being exposed to COVID-19 or from vaccination.
20th Sep 2021 - Pharmafield

Key data on U.S. J&J, Moderna COVID-19 boosters weeks away, Fauci says

Data needed to determine the advisability of booster shots of the Moderna Inc and Johnson & Johnson COVID-19 vaccines is just weeks away, President Joe Biden's chief medical adviser, Dr. Anthony Fauci, said on Sunday. Health officials signaled they expected boosters would ultimately be recommended for a broad swath of the population, but urged Americans not to seek booster doses until they have FDA approval. "We recommend that people wait until you get to the point where you fall into the category where it's recommended," he told CNN.
20th Sep 2021 - Reuters

Winter is coming, again: What to expect from Covid-19 in the new season

“We’re experiencing a new virus, a newly emerged pathogen, and we’re trying to fight it with new tools that we don’t have a lot of experience with,” he said. “And we’re dealing with unpredictable human behavior … which is a very important factor as well, and environmental factors that may influence the severity of Covid outbreaks and how well it transmits.” “There’s a lot of moving parts,” said Duchin, who is also an infectious diseases professor at the University of Washington. Among them: the questions of when Covid vaccines will be approved for use in children and what percentage of parents will agree to vaccinate their kids. While the crystal ball may be cloudy, who can resist taking a peek? Let’s talk about some things we might face in the months ahead.
20th Sep 2021 - STAT News

The search for antivirals for covid-19

Antivirals are one of the most sought after, yet missing, tools to control SARS-COV-2. Chris Stokel-Walker asks what was learnt from a similar search nearly 20 years ago Antiviral drugs are among the most researched tools for treating covid-19. They either prevent a virus entering a host cell or prevent it from being able to replicate once it is inside. And yet, over 18 months into the pandemic, finding ones that are effective against SARS-CoV-2 has proved challenging. Remdesivir was an early frontrunner—and many governments were desperate enough to grant it emergency use approval despite limited evidence. Those early hopes were ultimately dashed when major studies, notably the World Health Organization’s Solidarity trial, found it to be ineffective at preventing death (although it did help patients already recovering do so marginally faster). Doctors in Japan have treated covid-19 patients with favipiravir, an influenza antiviral, but the drug has previously been linked to birth defects
20th Sep 2021 - The BMJ

Pfizer Covid-19 vaccine generates robust antibody response in children, without serious safety issues, company says

Pfizer and its partner BioNTech said Monday that they would file for authorization of their Covid-19 vaccine for use in children after clinical trial results showed encouraging antibody levels in volunteers and side effects similar to those in teens and young adults. The pediatric study, in children ages 5 to 11, is the first to disclose results in young children. It used a lower dose of the vaccine than the one currently being administered, because earlier studies showed that the adult dose could cause more side effects. Adults receive two 30 microgram doses of the vaccine three weeks apart. In school-aged children, this was lowered to 10 micrograms.
20th Sep 2021 - STAT News

‘I felt this huge relief’: how antibody injections could free the immunosuppressed under Covid

But as with so many other simple pleasures in the age of Covid-19, nothing is that simple for Brown. The 47-year-old Missouri resident takes immunosuppressant medication for lupus. Consequently, her body has mounted virtually no antibody response to the coronavirus vaccine – leaving her in persistent peril. Brown is among the estimated 3% of American adults who have immunosuppression, including transplant recipients and people with cancer and autoimmune disorders such as lupus.
19th Sep 2021 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Sep 2021

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Fauci Says More Data Likely to Support Broader U.S. Booster Plan

President Joe Biden’s chief medical adviser said booster shots for more of the U.S. population remain a possibility soon, as additional data on the still-widening outbreak come in. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, spoke two days after an advisory panel to the U.S. Food and Drug Administration rejected a national rollout of boosters for all ages, approving them only for people 65 and older and those who are medically vulnerable. “The story is not over because more and more data is coming in and will be coming in,” Fauci said Sunday on ABC’s “This Week.”
19th Sep 2021 - Bloomberg

COVID-19: Top scientist says ministers should have improved PCR testing system rather than 'abandoning it entirely'

A top scientist who advises the government says ministers should have improved the COVID testing system for international travel rather than "abandoning it entirely". Professor Stephen Reicher, a member of the Scientific Pandemic Insights Group on Behaviours, which feeds into the Scientific Advisory Group for Emergencies (SAGE), said the removal of the need for a PCR COVID test will impact on the UK's ability to spot dangerous infections coming into the UK.
19th Sep 2021 - Sky News

Fauci: FDA vote against Covid booster shots ‘not the end of the story’

A decision not to recommend third-shot booster vaccinations for most Americans is “not the end of the story”, White House chief medical adviser Dr Anthony Fauci insisted on Sunday, two days after a scientific panel appeared to turn the Biden administration’s plan for combating coronavirus on its head. Fauci also said he did not believe a million coronavirus deaths in the US was an inevitability, despite the Delta variant-fuelled surge that last week brought the grim milestone of one in 500 Americans having fallen victim to the pandemic. The near-unanimous vote on Friday by scientific advisers to the US Food and Drug Administration (FDA) to recommend against a routine third shot of the Pfizer vaccine was seen as a rebuke to Joe Biden, who announced the “third jab strategy” as a main plank of his six-pronged anti-Covid plan.
19th Sep 2021 - The Guardian

Bats in Laos Caves Harbor Closest Relatives to Covid-19 Virus

Bats dwelling in limestone caves in northern Laos were found to carry coronaviruses that share a key feature with SARS-CoV-2, moving scientists closer to pinpointing the cause of Covid-19. Researchers at France’s Pasteur Institute and the University of Laos looked for viruses similar to the one that causes Covid among hundreds of horseshoe bats. They found three with closely matched receptor binding domains -- the part of the coronavirus’s spike protein used to bind to human ACE-2, the enzyme it targets to cause an infection. The finding, reported in a paper released Friday that’s under consideration for publication by a Nature journal, shows that viruses closely related to SARS-CoV-2 exist in nature, including in several Rhinolophus, or horseshoe bat, species.
19th Sep 2021 - Bloomberg

Vietnam approves Abdala vaccine as president visits Cuba

Vietnam has approved Cuba's Abdala vaccine for use against the new coronavirus, the government said, as the Southeast Asian country is battling its worst outbreak. Abdala becomes the eighth COVID-19 vaccine approved for use in Vietnam, which has one of the lowest vaccination rates in the region, with only 6.3% of its 98 million people having received at least two shots. The announcement came hours after President Nguyen Xuan Phuc left Hanoi for an official visit to Havana.
18th Sep 2021 - Reuters

Children should know about tiny risk from Covid vaccine, insist experts

Children need to understand the tiny potential risk of life-threatening heart problems before having a coronavirus vaccine, key government advisers are urging. Professor Adam Finn, a member of the Joint Committee on Vaccination and Immunisation, says that in normal times, the vaccine would not have been recommended for widespread use in children until the long-term consequences of rare side effects had been fully investigated. Parents are justified in waiting until the risks are clearer before getting their teenagers vaccinated and the NHS needs to spell out the uncertainty over long-term effects better, he argues. He fears that if some children eventually suffer lifelong health risks without being told of known concerns, trust in other vaccination programmes and wider government health advice will suffer
18th Sep 2021 - The Times

FDA advisers recommend COVID boosters for 65 and older after rejecting broad approval

Advisers to the U.S. Food and Drug Administration voted to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval. The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers. Despite the narrowed scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the U.S. vaccination campaign.
18th Sep 2021 - Reuters

COVID-19: QCovid tool's new algorithm identifies those most at-risk from coronavirus after vaccination

A tool to calculate a person's risk from COVID-19 has been updated to include who could be susceptible to serious complications, even if they have been fully vaccinated. It found that the elderly, men and people from certain ethnic minorities were most likely to end up in hospital or die due to the coronavirus. Last year, the team behind the QCovid tool used data from more than 6 million people to design an algorithm which could predict COVID outcomes. Now, the analysis of 6.9 million people who received two shots of the vaccine allows for a prediction of who may be more susceptible even after their inoculations.
18th Sep 2021 - Sky News

COVID-19: Trial will see if children need second jab - with 12 to 16-year-olds getting different combinations in study

Youngsters aged 12-16 are to be offered a mix of coronavirus vaccines in a new trial to determine whether children need a second jab and if so which type would be most effective. It comes after health leaders approved first doses of the Pfizer vaccine for over-12s on Monday. Researchers from the University of Oxford are carrying out the trial which will analyse how the participants respond to various combinations. Those involved in the study will all receive a full dose of the Pfizer jab initially.
17th Sep 2021 - Sky News

South Korea approves Celltrion's COVID-19 treatment for use

South Korea approved Celltrion's antibody COVID-19 treatment for infected adults in high-risk groups or those with severe symptoms. Phase III clinical trials showed that the treatment significantly reduced deterioration of COVID-19 symptoms to severe levels and shortened recovery, the Ministry of Food and Drug Safety said in a statement. The treatment lowered the rate of high-risk patients developing severe symptoms by 72% and shortened recovery by 4.12 days, the ministry said.
17th Sep 2021 - Reuters

How COVID-19 hybrid immunity could be a potential pandemic game-changer

With the FDA gearing up to decide if all Americans need booster shots, some researchers are pointing to preliminary data suggesting that mixing different vaccines could offer an even stronger immune boost. For now, data is too sparse to support a mix-and-match strategy, experts say. But scientists are learning more about just how strong the immune response can be for someone who has previously been infected with COVID-19 then gets the vaccine -- a phenomenon called "hybrid immunity." "The best thing we can hope for is that three vaccine doses will emulate the super immune response, found among those previously infected with the virus," said Dr. Paul Goepfert, an infectious disease physician and director of the Alabama Vaccine Research Clinic. "This [type of immunity] will protect against variants in the future."
17th Sep 2021 - ABC news

Investigating COVID-19's hidden death toll

The official COVID-19 mortality count in the United States has surpassed 660,000, but inaccuracies in cause of death reports hide the true impact of the pandemic. Researchers at Boston University and the University of Pennsylvania recently explored healthcare factors at the county level that explained why 20% of excess deaths in 2020 were due to COVID-19. Their study found that most of these excess deaths occurred in areas affected by racial and social injustices.
17th Sep 2021 - Medical News Today

Covid-19: How Native Americans led the way in the US vaccination effort

Data from the US CDC show that Native American groups—American Indians and Alaska Natives—have consistently had the best vaccination records since covid-19 vaccination in the US began in early 2021. The CDC’s daily tracker for 13 September showed that 47.5% of American Indians and Alaska Natives were fully vaccinated.1 This compared with 41.8% of Asians, 37.8% of white Americans, and 29.9% of African Americans. The American Indian/Alaska Native group has maintained its lead since the beginning of vaccination in the first dose category as well. Community leaders ascribe this success to two things: first, the US government’s decision to allow Native American communities to control vaccine distribution; and second, traditional ethnic values including respect for elders, “community first” philosophies, and a willingness to trust science—so long as it’s presented by community members themselves.
17th Sep 2021 - The BMJ

Experts, COVID vaccine firms detail ways to scale up fair distribution

After a meeting with vaccine company executives, a multilateral group dedicated to improving global access to COVID-19 vaccines called on countries and manufacturers to urgently take several steps to ensure that 40% of the population in all countries is vaccinated by the end of the year. In other global developments, UNICEF urged countries to reopen schools as soon as possible to avoid further impacts on kids and economies.
16th Sep 2021 - CIDRAP

Studies show good COVID booster effect, waning 2nd-dose protection

Several new studies on the Pfizer/BioNTech mRNA COVID-19 vaccine describe good effectiveness against the Delta (B1617.2) variant after a booster dose and high but waning protection against infection and severe illness 6 months after the second dose. Other, much smaller, studies demonstrated the safety of third mRNA vaccine doses. And a new British study on waning two-dose effectiveness coincides with the recent decision by UK officials to recommend booster doses.
16th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Sep 2021

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British study to test mixed COVID-19 vaccine dose schedules in children

A British study will look into the immune responses of children to mixed schedules of different COVID-19 vaccines as officials try to determine the best approach to second doses in adolescents given a small risk of heart inflammation. Children aged 12-15 in Britain will be vaccinated from next week, while those aged 16-17 have been eligible for shots since August.
17th Sep 2021 - Reuters UK

COVID-19 booster vaccine campaign begins in England

England launched its COVID-19 booster vaccination campaign on Thursday, the National Health Service (NHS) said, after officials and the government gave the go-ahead for the programme earlier in the week. British Prime Minister Boris Johnson on Tuesday outlined how the booster programme for over-50s and other priority groups will form a key plank of his plan to navigate the winter without further coronavirus lockdowns
16th Sep 2021 - Reuters

Pfizer and Moderna say Covid-19 vaccine protection wanes over time

Pfizer and Moderna said protection from their Covid-19 vaccines can wane over time, as the US drug regulator prepares to consider whether to approve a booster programme. Ahead of a crucial meeting of the Food and Drug Administration vaccines advisory committee on Friday to discuss its booster proposal, Pfizer on Wednesday submitted a study by Kaiser Permanente Southern California suggesting that vaccine efficacy wanes over time naturally, “irrespective of variant”, rather than as a consequence of the Delta coronavirus strain evading its jab.
16th Sep 2021 - The Financial Times

WHO Suspends Sputnik V Approval Process Over Manufacturing Breaches

The World Health Organization (WHO) has suspended its approval process for Russia’s Sputnik V coronavirus vaccine, pending a fresh inspection of at least one Russian factory manufacturing the shot. Speaking at a press briefing of the Pan American Health Organization, a regional branch of the WHO, Assistant Director Jarbas Barbosa said Russia’s bid for emergency authorization had been put on hold after a number of manufacturing infringements were uncovered during a WHO inspection in Russia in May.
16th Sep 2021 - The Moscow Times

Indonesia aims to become a global vaccine manufacturing hub

Health Minister Budi Gunadi Sadikin said the country is well placed to join South. Africa in being one of the WHO’s vaccine ‘technology transfer hubs.’ He said Indonesian pharmaceutical companies are also in talks with vaccine manufacturers and developers
16th Sep 2021 - South China Morning Post

US to buy additional doses of Lilly’s Covid-19 antibody therapies

The US Government is to purchase additional doses of Eli Lilly’s neutralising antibody therapies authorised for emergency use to treat Covid-19. As per the deal, Lilly will deliver 388,000 doses of etesevimab to complement doses of bamlanivimab already purchased by the US government.
16th Sep 2021 - Pharmaceutical Technology

Researchers examine the persistent effects of COVID-19 on vascular function of young adults

In a first-of-its-kind study, researchers have examined the persistent effects of SARS-CoV-2 infection on the vascular function of otherwise healthy young adults. The research, published in the American Journal of Physiology-Heart and Circulatory Physiology, was chosen as an APSselect article for September. “It is intriguing that those with persistent [COVID-19] symptoms exhibited peripheral vascular dysfunction, whereas those who were asymptomatic at the time of testing had similar macrovascular and microvascular vasodilation to controls.”
16th Sep 2021 - News Medical

Menstrual changes after covid-19 vaccination

Common side effects of covid-19 vaccination listed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) include a sore arm, fever, fatigue, and myalgia. Changes to periods and unexpected vaginal bleeding are not listed, but primary care clinicians and those working in reproductive health are increasingly approached by people who have experienced these events shortly after vaccination. More than 30 000 reports of these events had been made to MHRA’s yellow card surveillance scheme for adverse drug reactions by 2 September 2021, across all covid-19 vaccines currently offered.
16th Sep 2021 - The BMJ

Analysis: Hospital strain to test UK's vaccine-based winter COVID plan

British Prime Minister Boris Johnson is hoping to get through winter without any more coronavirus lockdowns, but doctors and scientists warn that relying largely on vaccines without other measures could put unsustainable pressure on hospitals. Britain has recorded one of the highest COVID death tolls in the world for its population size and one of the deepest recessions of wealthy nations as a result of the pandemic, but also has one of the world's highest vaccination rates.
16th Sep 2021 - Reuters UK

Can kids be harmed wearing masks to protect against COVID?

Can kids be harmed wearing masks to protect against COVID? No, there is no scientific evidence showing masks cause harm to kids’ health despite baseless claims suggesting otherwise. The claims are circulating on social media and elsewhere just as virus outbreaks are hitting many reopened U.S. schools — particularly those without mask mandates. Among the unfounded arguments: Masks can foster germs if they become moist or cause unhealthy levels of carbon dioxide. But experts say washing masks routinely keeps them safe and clean.
16th Sep 2021 - The Associated Press

FDA strikes cautious tone ahead of vaccine booster meeting

Influential government advisers will debate Friday if there’s enough proof that a booster dose of Pfizer’s COVID-19 vaccine is safe and effective — the first step toward deciding which Americans need one and when. The Food and Drug Administration on Wednesday posted much of the evidence its advisory panel will consider. The agency struck a decidedly neutral tone on the rationale for boosters — an unusual and careful approach that’s all the more striking after President Joe Biden and his top health advisers trumpeted a booster campaign they hoped to begin next week.
16th Sep 2021 - The Associated Press

As Pfizer's booster AdComm nears, FDA staffers say COVID vaccines are already working as intended

Ahead of the FDA's advisory meeting to review Pfizer's COVID-19 booster application, agency staffers voiced skepticism about the need to quickly roll out follow-up shots. As it stands, authorized vaccines are doing their job, the staffers said. In briefing documents ahead of Friday's meeting, FDA reviewers said that while "some observational studies" suggest the efficacy of Pfizer two-dose vaccine wanes over time, overall data "indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States." The FDA's Vaccines and Related Biological Products Advisory Committee plans to review the data Friday and make recommendations to the agency. The White House has said it plans to start giving COVID-19 booster doses during the week of Sept. 20, pending regulatory nods.
16th Sep 2021 - FiercePharma

Study: Farmworkers at 4 times risk of COVID-19

A study today in JAMA Network Open that found quadruple the risk of COVID-19 in California farmworkers reveals risk factors for current or previous SARS-CoV-2 infection in the group, including outdoor work exposures, crowded living conditions, and high body mass index (BMI). A team led by University of California at Berkeley researchers analyzed the data of 1,107 adult farmworkers undergoing testing for COVID-19 infection and immunoglobulin G (IgG) antibodies at federally qualified community clinics and community sites in the Salinas Valley from Jul 16 to Nov 30, 2020.
16th Sep 2021 - CIDRAP

Almost 90% of all 16-24 year olds now have Covid antibodies, official data suggests

Between 87 and 89 per cent of youngsters across the UK have Covid antibodies This suggests they have some protection against the virus from infection or jab Antibody positivity is 'increasing steadily across all four UK countries', ONS said
16th Sep 2021 - Daily Mail

No-fridge coronavirus vaccine looks promising: study

A team based at University of California, San Diego is working on a coronavirus vaccine that doesn’t need to be refrigerated. They grew plant and bacteria viruses and attached a piece of the spike protein from the SARS-CoV-2 virus. In tests with mice, the vaccine led to high levels of neutralizing antibodies.
15th Sep 2021 - The Hill

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Sep 2021

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CDC Advisers Set Meeting for Next Week on Covid Booster Shots

Advisers to the Centers for Disease Control and Prevention will hold a two-day meeting next week to discuss booster shots for Covid-19 vaccines. The Advisory Committee on Immunization Practices posted notice of the meeting, which will be held Sept. 22-23, on its website on Wednesday. The panel of outside experts advises the CDC on how best to administer new vaccines.
15th Sep 2021 - Bloomberg

Why the Delta Variant Is Giving More Children Covid

Covid-19 cases among children are surging across the world amid delta-fueled outbreaks, spurring hospitalizations and raising concern about the risk of severe illness and persistent “long hauler” symptoms. It’s also prompted questions about the safety of schools.
15th Sep 2021 - Bloomberg

Booster Dose Slashes Rates of Covid Infection in Israeli Study

A third dose of the Pfizer Inc.-BioNTech SE Covid vaccine can dramatically reduce rates of Covid-related illness in people 60 and older, according to data from a short-term study in Israel. Starting 12 days after the extra dose, confirmed infection rates were 11 times lower in the booster group compared with a group that got the standard two doses, the analysis released Wednesday by the New England Journal of Medicine found. Rates of severe illness were almost 20 times lower in the booster group.
15th Sep 2021 - Bloomberg

Pfizer (PFE) Says Covid-19 Vaccine Efficacy Erodes Over Time

Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots.
15th Sep 2021 - Bloomberg

FDA Says Covid-19 Vaccines Remain Effective Without Boosters

The Food and Drug Administration said vaccines cleared in the U.S. currently provide sufficient protection against severe disease and death from Covid-19 without additional doses, potentially complicating the Biden administration’s deliberations over the need for booster shots. The FDA released the findings Wednesday in a report analyzing data submitted by Pfizer Inc. and BioNTech SE as part of their request for authorization for their vaccine to be given as a booster shot in people 16 years and older. An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when.
15th Sep 2021 - Wall Street Journal

Russia's Sputnik V vaccine shows 97.2% COVID-19 efficacy in Belarus - RDIF

Russia's Sputnik V vaccine has demonstrated 97.2% efficacy against COVID-19 during the vaccination campaign in Belarus, Russia's RDIF sovereign wealth fund said on Wednesday.
15th Sep 2021 - Reuters

Single-Dose Sputnik Light Approved For Phase 3 Bridging Trials In India

The single-dose COVID-19 vaccine Sputnik Light received approval from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) today to conduct phase 3 bridging trials in India.Last year, Hyderabad-based Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of the vaccine. After the company submitted safety, immunogenicity and efficacy data, the SEC granted permission for conducting the trials in India, a statement by the Central Drugs Standard Control Organisation said.
15th Sep 2021 - NDTV

CureVac scales back mRNA manufacturing for coronavirus vaccine

CureVac, the German biotech once seen as a leading mRNA vaccine developer alongside Moderna and Pfizer, on Tuesday said it will scale back manufacturing plans for its coronavirus shot in Europe. The company attributed the downsizing to "reduced short-term peak demand for vaccines following the first wave of the pandemic vaccination efforts" as well as "corresponding changes in the demand of its first-generation COVID-19 vaccine candidate." As a result, manufacturing contracts with Wacker and Celonic will be terminated. Other manufacturing agreements with Rentschler Biopharma and Novartis are not affected. CureVac is still awaiting a decision from the European Medicines Agency on approval of its first-generation vaccine. Last month, the company reportedly dropped plans to seek a clearance in the U.S. from the Food and Drug Administration.
15th Sep 2021 - BioPharma Dive

U.S. buys additional doses of Eli Lilly, Regeneron COVID-19 therapy

Eli Lilly and Company said on Wednesday the U.S. government bought 388,000 additional doses of its COVID-19 antibody therapy, as infections surge due to the fast-spreading Delta variant. The news comes after Regeneron Pharmaceuticals Inc said late on Tuesday the U.S. government was buying 1.4 million additional doses of its COVID-19 antibody cocktail, REGEN-COV.
15th Sep 2021 - Reuters

Covid-19: Boys are more at risk of myocarditis after vaccination than of hospital admission for covid

The risk of 12-15 year old healthy boys experiencing cardiac adverse events such as myocarditis after their second dose of the Pfizer and BioNTech vaccine is around four times adolescents’ risk of being admitted to hospital as a result of infection with SARS-CoV-2, a preprint study has found. The retrospective study, which has not yet been peer reviewed, used the US vaccine adverse reporting system (VAERS) to identify the rate of post-vaccination myocarditis among 12-15 and 16-17 year olds between January and June 2021 after the second dose of the Pfizer-BioNTech vaccine. The researchers concluded that the rate of cardiac adverse events after the second dose exceeded the expected rate of 120 day covid-19 hospital admission at both a moderate (August 2021) and a high (January 2021) incidence of SARS-CoV-2 infection.
15th Sep 2021 - The BMJ

U.K. Sidelines Homegrown Astra Vaccine in mRNA Booster Push

Britain will roll out a Covid vaccine booster campaign next week in which the homegrown shot from AstraZeneca Plc and the University of Oxford will hardly feature at all. Instead, the U.K. government is relying on shots from Pfizer Inc. and Moderna Inc., both based on messenger RNA technology, and only offering Astra in cases where people can’t have an mRNA vaccine. AstraZeneca’s vaccine, one of the first to be developed, has grappled with safety concerns over potential side effects, including blood clotting. Though the U.S. has not cleared it for use, it’s been widely employed in Britain and many other countries, often to inoculate older adults.
14th Sep 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Sep 2021

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Emergent to make Providence Therapeutics' potential COVID-19 vaccine

Emergent BioSolutions Inc signed a five-year agreement with Canadian biotechnology company Providence Therapeutics to develop and manufacture its COVID-19 vaccine candidate for about $90 million.
14th Sep 2021 - Reuters

CureVac slashes COVID-19 vaccine production plans

German biotech firm CureVac said on Tuesday it cancelled contract manufacturing deals for its experimental COVID-19 vaccine with two prospective partners, after rivals with approved shots have boosted production. Agreements with Celonic Group of Switzerland and Germany's Wacker would be terminated but existing production deals with Rentschler Biopharma and Novartis would remain unchanged, CureVac said in a statement. CureVac fell far behind rivals BioNTech, a partner of Pfizer, and Moderna, in trying to develop an mRNA-based COVID-19 vaccine.
14th Sep 2021 - Reuters on MSN.com

COVID-19: Deputy Chief Medical Officer says winter could be ‘bumpy at times’

Deputy Chief Medical Officer, Professor Jonathan Van-Tam says booster vaccines will be offered to people aged 50 and over, those in care homes, and frontline health and social care workers in order to manage what could be a ‘bumpy winter’ for the UK
14th Sep 2021 - Sky News

83% of stem cell recipients produce antibodies after 2 COVID-19 vaccine doses

Stem cell transplant recipients with cancers like leukemia had an antibody response rate of 83% to the second dose of the Pfizer/BioNTech mRNA COVID-19 vaccine, with almost two-thirds having very strong responses, an observational, single-center study today in JAMA Network Open finds. Researchers from Nantes University Hospital in France studied 117 coronavirus-naïve adults who received a donor stem cell transplant for the treatment of hematologic cancer and were given two doses of the Pfizer COVID-19 vaccine from Jan 20 to Apr 17. The median interval between the two doses was 22 days.
14th Sep 2021 - CIDRAP

A conversation with Bill Gates on how public health has fared in the midst of the pandemic

The foundation’s 2021 Goalkeepers report, published late Monday, shows an additional 10 million children around the globe didn’t get key childhood vaccines this past year, because of public health service disruptions. Another 31 million people were pushed into extreme poverty by the pandemic. And employment among women is expected to remain 13 million jobs lower around the world this year than it was in 2019.
14th Sep 2021 - CIDRAP

WHO-backed vaccine hub for Africa to copy Moderna COVID-19 shot

Efforts to develop an African base for COVID-19 vaccine production will focus on trying to replicate Moderna’s shot, but a lack of progress in talks with the US company mean the project will take time, a senior World Health Organization (WHO) official has said. The drive to produce vaccines in Africa is designed to help more developing countries access COVID-19 shots after rich nations bought up most of this year’s supply.
14th Sep 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Sep 2021

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UK Canceling $1.7 Billion Vaccine Contract With Valneva Is a Bizarre Rug-Pull

The U.K. had poured millions of pounds into Valneva’s Scottish factory, secured an extra 40 million vaccine doses on top of the 60 million it had already agreed to buy, and boasted about the vaccine’s potential as a booster in the autumn. The fact that Valneva was headquartered in France, whose vaccine rollout was off to a dire start and where zero doses had been procured, was the ultimate punchline. Now the U.K. seems to have shot itself in the foot, rather than in the arm. The government is abruptly canceling its supply contract, having found Valneva in breach of its obligations without specifying how — something Valneva is contesting, though without giving more details.
13th Sep 2021 - Bloomberg

Covid-19: Single Pfizer jab recommended for 12 to 15-year-olds

The UK’s four Chief Medical Officers have recommended all children aged 12-15 should be vaccinated against Covid. They have agreed that children of those ages should be given one dose of the Pfizer vaccine to help prevent education being disrupted. A final decision on rollout will be taken by ministers in the four nations of the UK.
13th Sep 2021 - BBC News

UK scraps Covid-19 vaccine deal with French firm Valneva

French vaccine maker Valneva says the UK government has scrapped a deal for its Covid-19 vaccine. The UK had about 100 million doses on order, after it increased its request by 40 million in February. The firm said that the UK government served notice over allegations of a breach of the agreement, which it "strenuously denies". The government said the decision would have no impact on vaccine supply in the UK. "The comments from the company will not have any impact on our vaccine supply and did not form any part of our vaccine rollout in autumn and winter," a spokesperson for Prime Minister Boris Johnson said.
13th Sep 2021 - BBC News

Fully vaccinated people account for 1.2% of England’s Covid-19 deaths

People who were fully vaccinated accounted for just 1.2% of all deaths involving Covid-19 in England in the first seven months of this year. The figures, published by the Office for National Statistics (ONS), have been seized on as proof of the success of the vaccine programme. The figures show a total of 51,281 deaths involving Covid-19 in England between 2 January and 2 July, of which 38,964 were of unvaccinated people.
13th Sep 2021 - The Guardian

Departing FDA officials say it's too soon for COVID-19 boosters as White House plans rollout next week

Does the general U.S. population need COVID-19 boosters? A group of renowned global health experts, including two key departing vaccine authorities at the FDA, don't think so. Even with the wave of delta variant-driven coronavirus cases in the U.S., the authorized vaccines appear to be staving off severe infections, according to a paper published in The Lancet. The group of authors includes top officials with the World Health Organization. The paper stands in stark contrast to the Biden administration’s own booster shot plan, which some have criticized for jumping ahead of federal regulators. The White House has been planning to roll out the extra doses to the general population as early as next week following the FDA’s meeting on Friday to discuss Pfizer’s application for an extra shot.
13th Sep 2021 - FiercePharma

FDA vaccine regulators argue against Covid-19 vaccine boosters in new international review

A group of international experts — including, notably, two outgoing Food and Drug Administration vaccine regulators — argues in a new paper against offering Covid-19 vaccine boosters to the general population. The paper, published Monday in the Lancet, is based on a review of available data about the durability of vaccine protection. That it was co-authored by Marion Gruber and Phil Krause, two veteran FDA officials who have been leading the agency’s review of Covid-19 vaccine applications, amounts to a strikingly direct rebuff to the Biden administration as it lays plans for booster shots. Gruber and Krause announced last month they would be leaving the agency this fall.
13th Sep 2021 - STAT News

Most People Don’t Need Covid Vaccine Booster, Scientists Say

Governments would be better served to focus on immunizing the unvaccinated and to wait for more data on which boosters would be most effective and at what doses, the authors, who included two prominent U.S. Food and Drug Administration experts, argued in the medical journal The Lancet. They based their assessment on a wide range of real-world observational studies as well as data from clinical trials.
13th Sep 2021 - Bloomberg

Australia buys additional 1 mln doses of Moderna's COVID-19 vaccine

Australia has purchased an additional 1 million doses of Moderna's COVID-19 vaccine from the European Union, Prime Minister Scott Morrison said, as the country accelerates its inoculation programme to fight record high infections. The purchase is a boost for Australia's A$2 trillion ($1.5 trillion) economy, which is at risk of slipping into its second recession in as many years as a result of lockdowns of the country's two most populous cities, Sydney and Melbourne
12th Sep 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Sep 2021

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Israel Is Preparing for Possible Fourth Covid Vaccine Dose

Israel is making preparations to ensure it has sufficient vaccine supply in case a fourth round of Covid-19 shots is needed, the country’s top health official said on Sunday. “We don’t know when it will happen; I hope very much that it won’t be within six months, like this time, and that the third dose will last for longer,” Health Ministry Director General Nachman Ash said in an interview with Radio 103FM. Israel, which has mainly used the Pfizer Inc.-BioNTech SE vaccine, has so far inoculated about 2.8 million people with a third dose after beginning a drive to administer booster shots in August. Health officials have said the effects of the initial Covid-19 shots weaken five months after inoculation, making boosters necessary.
12th Sep 2021 - Bloomberg

Oxford Covid jab faces effectively being withdrawn from Britain's vaccine rollout

Research suggests combining two different vaccines provides better protection Medical regulator ruled AstraZeneca cannot be used for third doses in this way Majority of third doses given out this autumn and winter are likely to be Pfizer
11th Sep 2021 - Daily Mail

Unvaccinated People 11 Times as Likely to Die From Covid-19

As the Delta variant became dominant in the U.S. this summer, data showed that unvaccinated Americans were 4.6 times as likely to be infected, 10 times as likely to be hospitalized and 11 times as likely to die from Covid-19 than vaccinated people. In a trio of studies released Friday underscoring the effectiveness of Covid-19 vaccines even against the highly contagious Delta variant, the Centers for Disease Control and Prevention examined Covid-19 outcomes among patients who visited emergency departments, urgent care centers and veterans’ hospitals. One study that tracked patients at five Veterans Affairs Medical Centers across the country between Feb. 1 and Aug. 6 found that mRNA vaccines were 87% effective at preventing Covid-19 associated hospitalization, including during the Delta surge. The study found that effectiveness dropped to 80% for patients over the age of 65, while for younger patients, the vaccines were 95% effective.
11th Sep 2021 - The Wall Street Journal

CDC study: Unvaccinated 11 times more likely to die from Covid-19

People who are not vaccinated against Covid-19 were 11 times more likely to die of the disease and 10 times more likely to be hospitalized with the disease, a study published on Friday by the US Centers for Disease Control and Prevention shows. The study looked at 600,000 Covid-19 cases in 13 states from April through mid-July. "The bottom line is this: We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of Covid-19," CDC Director Dr. Rochelle Walensky said Friday.
10th Sep 2021 - CNN

Brazil Moves Away from Chinese Covid-19 Vaccine

Brazil, a major buyer of China’s CoronaVac shot and a poster child for Beijing’s efforts at vaccine diplomacy, is making a speedy retreat from the Covid-19 vaccine as concerns grow over its efficacy against the Delta variant and other vaccines become more readily available. Brazil’s federal government has halted negotiations over additional doses of Sinovac’s vaccine, CoronaVac, spokespeople for the government and its local producer, the Butantan Institute, told The Wall Street Journal. The government has also said it won’t recommend use of CoronaVac for a third booster shot.
11th Sep 2021 - The Wall Street Journal

FDA Again Warns Parents Not to Get Children Under 12 Vaccinated Yet

The U.S. Food and Drug Administration is “working around the clock” to make Covid vaccines available to young children, it said in a statement on Friday. In the meantime, however, the agency urged parents not to seek out the shots for children who are under 12, and therefore not yet eligible for vaccination. The agency said that it hoped vaccines would be available for young children “in the coming months,” but that it could not offer a more specific timeline. However, once it has applications from the vaccine manufacturers in hand, it will “be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” Dr. Janet Woodcock, the acting F.D.A. commissioner, and Dr. Peter Marks, of the agency’s Center for Biologics Research and Evaluation, said in the statement.
11th Sep 2021 - The New York Times

Vietnam approves Hayat-Vax coronavirus vaccine for emergency use

Vietnam has approved the Hayat-Vax coronavirus vaccine for emergency use, the seventh to be endorsed in the country.
11th Sep 2021 - Reuters

S.Africa's regulator approves Pfizer COVID-19 shot for children 12 and up

South Africa's health regulator has approved Pfizer's COVID-19 vaccine for use by children aged 12 and older, paving the way for the government to offer vaccinations to teenagers. The South African Health Products Authority (SAPHRA) said the decision came after a review of updated safety and efficacy information submitted in March this year. After a bumpy start, South Africa's vaccination campaign has ramped up in recent months with a solid supply of shots secured and just over 12% of its more than 60 million people vaccinated. That puts the country well ahead of others on the continent.
11th Sep 2021 - Reuters

South Africa vaccinates children in test of China’s Sinovac jab

The global study is to enroll 2,000 participants in South Africa while 12,000 others will be taking part in Kenya, the Philippines, Chile and Malaysia.
11th Sep 2021 - Al Jazeera English

Some Vaccines Last a Lifetime. Here’s Why Covid-19 Shots Don’t.

Why don’t Covid-19 vaccinations last longer? Measles shots are good for life, chickenpox immunizations protect for 10 to 20 years, and tetanus jabs last a decade or more. But U.S. officials are weighing whether to authorize Covid-19 boosters for vaccinated adults as soon as six months after the initial inoculation. The goal of a vaccine is to provide the protection afforded by natural infection, but without the risk of serious illness or death. “A really good vaccine makes it so someone does not get infected even if they are exposed to the virus,” said Rustom Antia, a biology professor at Emory University who studies immune responses. “But not all vaccines are ideal.”
11th Sep 2021 - The Wall Street Journal

Covid-19: Hospital may cease giving patient ivermectin, US court rules, as prescriptions soar

An Ohio judge has overturned an earlier court order that forced a hospital to treat a covid-19 patient with the antiparasitic drug ivermectin, popularised by US conservative media. West Chester Hospital was ordered to administer the unproved drug by a county judge on 23 August, after Julie Smith sued on behalf of her husband, Jeffrey Smith, who has been in intensive care since 15 July and on a ventilator since 1 August. Julie Smith launched her lawsuit after the hospital declined to fill a prescription she had obtained from Fred Wagshul, one of three doctors who last year founded the Front Line COVID-19 Critical Care Alliance (FLCCCA), a group that has spread claims of ivermectin’s efficacy against the coronavirus.
11th Sep 2021 - The BMJ

More US studies show COVID vaccines protect from serious illness

The United States Centers for Disease Control and Prevention (CDC) has presented data showing unvaccinated people are four-and-a-half times more likely to contract COVID-19 and 11 times more likely to die from it than those fully vaccinated. In a White House COVID-19 briefing on Friday, CDC Director Dr Rochelle Walensky said the data shows “vaccination works and will protect us from the severe complications of COVID-19”.
11th Sep 2021 - Al Jazeera English

Pfizer to seek approval for vaccine in children 5 and over

Pfizer and BioNTech announced this week that it will soon seek approval from global regulators for use of its coronavirus vaccine in children ages 5 and over. The vaccine makers said in an interview published on Friday that they are looking to produce smaller doses of the vaccine for younger children. “We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told German news outlet Der Spiegel.
11th Sep 2021 - The Hill

Unvaccinated Americans Are 11 Times More Likely to Die of Covid, C.D.C. Reports

Three studies that drew data from different U.S. regions evaluated the protective power of the vaccines. One looked at more than 600,000 virus cases in 13 states, representing about one quarter of the U.S. population, between April and July, and concluded that individuals who were not fully vaccinated were far more susceptible to infection and death from the virus. They were 4.5 times more likely than vaccinated individuals to become infected, 10 times more likely to be hospitalized, and 11 times more likely to die from the coronavirus, the study found.
10th Sep 2021 - The New York Times

Scientists' egos are key barrier to progress, says Covid vaccine pioneer

Scientists would make swifter progress in solving the world’s problems if they learned to put their egos aside and collaborate better, according to the leading researcher behind the Pfizer/BioNTech Covid vaccine. Prof Katalin Karikó, the senior vice-president for RNA protein replacement therapies at BioNTech in Germany, endured decades of scepticism over her work and was demoted and finally kicked out of her lab while developing the technology that made the Pfizer and Moderna vaccines possible.
10th Sep 2021 - The Guardian

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Massive numbers of new COVID–19 infections, not vaccines, are the main driver of new coronavirus variants

It’s natural to wonder if highly effective COVID-19 vaccines are leading to the emergence of variants that evade the vaccine – like dark peppered moths evaded birds that hunted them. But with just under 40% of people in the world having received a dose of a vaccine – only 2% in low-income countries – and nearly a million new infections occurring globally every day, the emergence of new, more contagious variants, like delta, is being driven by uncontrolled transmission, not vaccines.
9th Sep 2021 - The Conversation

Novavax developing joint COVID/flu vaccine

Vaccine manufacturer Novavax has announced it is developing a joint COVID-19/flu shot that is currently in the trial stage. Novavax already manufactures flu shots and a COVID-19 vaccine, which has not yet been approved for public use in Australia. However, the government has placed an order for 51 million doses.
9th Sep 2021 - 9News

Co-inventor of mRNA shots sets sights on pan-coronavirus vaccine

Drew Weissman's decades of research helped pave the way for mRNA Covid-19 vaccines, but the scientist isn't resting on his laurels. The University of Pennsylvania immunologist, who on Thursday shared the $3 million 2022 Breakthrough Prize in Life Sciences with his longtime collaborator Katalin Kariko, is now spearheading efforts to design a new vaccine against all coronaviruses. The Silicon Valley-backed award honors major discoveries with the highest cash amounts in science.
9th Sep 2021 - FRANCE 24

Risk of severe breakthrough Covid-19 higher for seniors and people with underlying conditions

For fully vaccinated Americans, the risk of being hospitalized or dying from Covid-19 is low -- much lower than the risk for unvaccinated people. But in those rare cases when a fully vaccinated person gets infected, data suggests it's older adults and those with multiple underlying medical conditions who are most at risk of serious illness. As of August 30, the US Centers for Disease Control and Prevention has received reports of 12,908 severe breakthrough cases of Covid-19 among fully vaccinated people that resulted in hospitalization or death. For the more than 173 million people who were fully vaccinated by that date, that represents a less than a 1 in 13,000 chance of experiencing a severe breakthrough case of Covid-19.
9th Sep 2021 - CNN

U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug

The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization (EUA) of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the company said on Thursday. "In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19," the company said in a statement.
9th Sep 2021 - Reuters

Trial of Covid-19 vaccine and flu jab combined to begin in Australia on 640 healthy residents

Vaccine developer Novavax will trial a combined flu and Covid-19 vaccination. The tests in Australia will include 640 healthy adults aged between 50-70. Who have previously been infected or received a Covid jab at least 8 weeks prior. Novavax said that flu and Covid combination vaccines will combat new variants
9th Sep 2021 - Daily Mail

Moderna developing single-dose booster shot for COVID-19 and flu

Moderna Inc said on Thursday it is developing a single vaccine that combines a booster dose against COVID-19 with its experimental flu shot. The company hopes to eventually add vaccines it is working on for respiratory syncytial virus (RSV) and other respiratory diseases as an annual shot. "We believe this is a very large opportunity that is ahead of us, if we could bring to market a high efficacy pan-respiratory annual booster," Moderna Chief Executive Officer Stéphane Bancel said during a presentation to update investors on its drugs in development.
9th Sep 2021 - Reuters

Covid-19: More than 60 frontline UK healthcare workers took their own life at the beginning of the pandemic

The Laura Hyde Foundation is calling for 999 workers to sound their sirens at 9am on 9 September in remembrance of their colleagues. More than 60 frontline healthcare workers died of suicide at the beginning of the Covid-19 pandemic, i can reveal. Among the 64 deaths in the first six months of 2020, which included nurses, midwives and paramedics, more than a quarter were newly-qualified workers. The Laura Hyde Foundation (LHF) – a mental health charity for the emergency services – which requested the statistics from the Office for National Statistics (ONS), said the figures were “deeply disturbing”.
9th Sep 2021 - iNews

Risk of contracting Covid-19 on flights is 0.1%, claims new research

The risk of exposure to Covid-19 on a flight where every passenger has tested negative is less than 0.1 per cent, according to new research. The new peer-reviewed study used data from nearly 10,000 air travellers on Delta’s Covid-tested flight corridors between New York’s JFK, Atlanta and Italy’s Fiumicino airports to conclude that a single molecular test performed within 72 hours of departure could significantly decrease the rate of people infected onboard a commercial aircraft. The research, conducted by the Georgia Department of Health and Mayo Clinic in conjunction with Delta airlines, states that infection rates on Covid-19 tested flights constituted 0.5 per cent, or five in 10,000 passengers, compared with 1.1 percent, or one in 100 people, in the community.
9th Sep 2021 - The Independent

Can kids get ‘long COVID’ after coronavirus infections?

Can kids get “long COVID” after coronavirus infections? Yes, but studies indicate they’re less likely than adults to be affected by symptoms that persist, recur or begin a month or more after infection. Estimates vary on how often the symptoms known as long COVID-19 occur in kids. A recently published U.K. study found about 4% of young children and teens had symptoms more than a month after getting infected. Fatigue, headaches and loss of smell were among the most common complaints and most were gone by two months. Coughing, chest pain and brain fog are among other long-term symptoms sometimes found in kids, and can occur even after mild infections or no initial symptoms.
9th Sep 2021 - The Conversation

AstraZeneca's COVID-19 shot joins the list of vaccines flagged for rare Guillain-Barre syndrome

Two months after the FDA flagged Johnson & Johnson’s COVID-19 vaccine for the rare nerve disorder Guillain-Barre syndrome (GBS) Europe’s drug regulator has done the same for AstraZeneca’s COVID shot. The European Medicines Agency will now list GBS as a possible and “very rare” side effect of Vaxzevria, which is administered as a two-dose regimen. Of the 592 million doses of the vaccine administered worldwide through the end of July, 833 cases of the nerve-damaging condition were reported. Both are adenovirus-based vaccines, as opposed to the mRNA shots offered by Moderna and Pfizer/BioNTech. The J&J and AZ vaccines also have been linked to very rare cases of blood clots that occur alongside bleeding.
9th Sep 2021 - FiercePharma

How the Delta variant’s remarkable ability to replicate threw new twists into the Covid-19 pandemic

One of the key reasons the Delta variant has ignited new surges of Covid-19 infections across the United States is its remarkable ability to make copies of itself. That skill has helped make Delta far more transmissible than any other iteration of the coronavirus seen thus far. But its replication prowess could also be at the heart of the other twists Delta has thrown into the pandemic, including the increase in breakthrough infections with the variant and why it potentially causes severe Covid-19 more often. Delta’s breakneck proliferation isn’t its only trick tied to the increase in infections — and symptomatic infections — in people who’ve been vaccinated.
9th Sep 2021 - STAT News

Study says Alpha variant doubled COVID cases in Israeli kids

The SARS-CoV-2 Alpha (B117) variant spread faster and more efficiently than previous strains among children 9 years and younger in Israel in late 2020 and early 2021, even amid the concurrent immunization of adults against COVID-19, according to an observational study yesterday in JAMA Network Open. A team led by a researcher at Schneider Children's Medical Center of Israel in Petah Tikva compared the publicly available daily data of 21,615 children who tested positive for COVID-19 from Aug 1 to Oct 2, 2020, with those of 50,811 children who tested positive from Dec 3, 2020, to Feb 3, 2021. The researchers adjusted weekly incidence rates according to the number of COVID-19 tests performed.
8th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Sep 2021

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W.H.O. Warns of Dire Threat of Covid During Pregnancy in Latin America

The coronavirus pandemic could “wipe away 20 years of hard-fought gains” in reducing maternal mortality in Latin America and the Caribbean, and countries in the region should prioritize those who are pregnant and those who have recently given birth in their vaccination campaigns, officials at the World Health Organization warned on Wednesday. “So far, more than 270,000 pregnant women have become sick with Covid in the Americas and more than 2,600 of them — or 1 percent of those infected — have died from the virus,” Dr. Carissa F. Etienne, the director of the Pan American Health Organization, a division of the W.H.O., said at a news conference.
9th Sep 2021 - The New York Times

Novavax begins early-stage trial for flu-Covid combo vaccine

Vaccine developer Novavax Inc said today it has initiated an early-stage study to test its combined flu and Covid-19 vaccine. The trial, to be conducted in Australia, will enrol 640 healthy adults between the ages of 50 and 70 years and who have either been previously infected with the coronavirus or given an authorized Covid-19 vaccine at least eight weeks prior to the study.
8th Sep 2021 - Free Malaysia Today

Countries should prioritize pregnant, breastfeeding women for COVID-19 shots -PAHO

Countries in the Americas should prioritize pregnant and lactating women in distribution of COVID-19 shots, the Pan American Health Organization (PAHO) said on Wednesday, hailing the ability of the vaccines to protect women and their babies. "PAHO recommends that all pregnant women after their first trimester, as well as those who are breastfeeding, receive the COVID-19 vaccine," PAHO Director Dr. Carissa Etienne said during the organization's weekly virtual briefing.
8th Sep 2021 - Reuters

EU lists rare nerve disorder as possible side-effect of AstraZeneca COVID-19 vaccine

Europe's medicines regulator has added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome, as a possible side-effect of AstraZeneca's COVID-19 vaccine, regular safety updates from the watchdog showed on Wednesday. The European Medicines Agency said a causal relationship between GBS and the AstraZeneca shot, known as Vaxzevria, was a "at least a reasonable possibility" after 833 cases of GBS were reported out of 592 million doses of the vaccine given worldwide by July 31.
8th Sep 2021 - Reuters

Ireland to give COVID-19 vaccine booster shot to over-80s

Ireland will give COVID-19 vaccine booster shots to elderly people who were fully vaccinated at least six months ago, the health ministry said on Wednesday. People over the age of 80 and those over 65 living in long-term residential care facilities will receive a booster dose of a vaccine such as those made by Pfizer or Moderna, irrespective of what vaccine they received initially, the ministry said in a statement.
8th Sep 2021 - Reuters

Covid booster vaccines to be approved in 'next few days' as work is 'almost done'

A Covid booster vaccine rollout is set to be recommended by the government's advisors in the 'next few days' as the work is 'almost done', the Health Secretary has declared. Sajid Javid said he expected the Joint Committee on Vaccination and Immunisation to imminently spell out exactly who should get a third dose of the vaccine, how, and in what order. JCVI experts have spent months studying how boosters should be rolled out - including whether different vaccine brands can be 'mixed and matched', and whether the flu jab should be given at the same time.
8th Sep 2021 - The Mirror

Vietnam to mix Moderna and Pfizer-BioNTech COVID-19 vaccines - media

Vietnam's health ministry will offer the coronavirus vaccine jointly developed by Pfizer and BioNTech as a second dose option for people first inoculated with the Moderna vaccine, state media reported on Wednesday. The ministry had approved the mixed regimen, which is due to low supplies of the Moderna vaccine. Both vaccines are of the Messenger RNA (mRNA) type.
8th Sep 2021 - Reuters

Takeda to deliver Novavax’s Covid-19 vaccine doses to Japan

Takeda plans to supply the vaccine doses earlier next year on obtaining approval from the country’s MHLW. The Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) has agreed to procure 150 million doses of Novavax’s Covid-19 vaccine candidate produced by Takeda Pharmaceutical in the country on obtaining approval.
8th Sep 2021 - Pharmaceutical Technology

Schools don't need to see a big uptick in Covid-19 cases if they follow these measures, Fauci says

Surging Covid-19 cases -- and the increasing proportion reported in children -- are causing many health experts to worry about the outlook as the school year gets underway across the entire country. But Dr. Anthony Fauci said there shouldn't be a big uptick "if we do it right." "We've gotta get the school system masked in addition to surrounding the children with vaccinated people," said the director of the National Institute of Allergy and Infectious Diseases. "That's the solution."
8th Sep 2021 - CNN

Novavax begins early-stage trial for combined influenza/COVID-19 vaccine

Vaccine developer Novavax Inc said on Wednesday it has initiated an early-stage study to test its combined flu and COVID-19 vaccine. The trial, to be conducted in Australia, will enroll 640 healthy adults between the ages of 50 and 70 years and who have either been previously infected with the coronavirus or given an authorized COVID-19 vaccine at least eight weeks prior to the study.
8th Sep 2021 - Reuters

UK's Exscientia, Gates Foundation partner to develop variant-resistant COVID-19 drugs

The Bill & Melinda Gates Foundation would make a $35 million equity investment in privately owned Exscientia Ltd to fund the development of antiviral drugs including for the coronavirus, the Oxford-based drug developer said on Wednesday. Exscientia will make a matching contribution and lead the development of up to five therapeutics, which are ready to enter human trials. The program will initially focus on agents against the SARS-CoV-2 and its variants as well as other coronaviruses.
8th Sep 2021 - Reuters

Moderna taps National Resilience's new Canadian manufacturing site for COVID-19 vaccine production duties

Fresh off National Resilience's acquisition of a new, state-of-the-art manufacturing site in Ontario, the fledgling CDMO is putting it to the test with a high-profile partnership. Moderna has tapped National Resilience, founded in November last year, to manufacture mRNA vaccine substance at Resilience’s newly acquired facility in Mississauga, Canada. While sparse on details, Moderna said the substance made at the plant will be delivered globally. The partnership marks Moderna’s most recent foray into Canada and comes as the biotech faces a vaccine contamination scandal in Japan. In late August, Japanese pharma Takeda, which distributes Moderna’s shot in the country, said it suspended three lots—or about 1.63 million doses—after finding tiny black specks in the vials.
8th Sep 2021 - FiercePharma

Moderna turns to biotech startup to ramp up Covid vaccine manufacturing

Moderna will turn to a biotech startup, National Resilience, to manufacture additional doses of its Covid-19 vaccine. Moderna had previously said it would manufacture 800 million to 1 billion doses of its Covid-19 vaccine in 2021, ramping up to 3 billion doses in 2022. A person familiar with the company said the collaboration might result in hundreds of millions more doses. Currently, the vaccine is given as a two-dose series, though Moderna has said at least some patients may need a third dose given many months later. National Resilience will manufacture mRNA to produce the Moderna Covid-19 vaccine at its facility in Mississauga, Ontario, for worldwide distribution. The company is headquartered in San Diego and Cambridge, Mass.
8th Sep 2021 - STAT News

Efforts grow to stamp out use of parasite drug for COVID-19

Health experts and medical groups are pushing to stamp out the growing use of a decades-old parasite drug to treat COVID-19, warning that it can cause harmful side effects and that there’s little evidence it helps. With a fourth wave of infections, more Americans are turning to ivermectin, a cheap drug used to kill worms and other parasites in humans and animals.
7th Sep 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Sep 2021

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Covid in Scotland: 'I'm double-vaccinated but can't show the proof'

A woman who was vaccinated in England and Scotland says she cannot get an accurate vaccination certificate because of issues with data-sharing across health services. Maura McGoldrick, 21, received her first dose in London and her second in Glasgow, where she lives. However, her vaccination record only shows her having received one dose. The fourth-year student at the University of Edinburgh is concerned others may be similarly affected.
7th Sep 2021 - BBC News

Vaccine makers should supply shots for trials to help spur sector -CEPI

New vaccine trials need established shots for control group-CEPI. Warns against development "standstill" amid lack of vaccines. Companies, countries need to spare 10s of thousands of doses
7th Sep 2021 - Reuters

Third person dies in Japan after taking contaminated Moderna coronavirus vaccine

A third man has died in Japan after receiving an injection from one of three batches of Moderna vaccines since identified as contaminated, though authorities say no causal link has yet been found. The 49-year-old man had his second shot on 11 August and died the following day. His only known health issue was an allergy to buckwheat, the health ministry said on Monday. As with the previous two deaths, the ministry said it had yet to establish if the latest fatality was linked to the vaccine.
7th Sep 2021 - The Guardian

EMA begins analysis of Pfizer-BioNTech’s Covid-19 booster shot data

The European Medicines Agency (EMA) has commenced evaluation of an application submitted by Pfizer and BioNTech seeking an update to conditional marketing authorization (CMA) for the use of a booster shot of their Covid-19 vaccine, Comirnaty. A messenger ribonucleic acid (mRNA) vaccine, Comirnaty was granted a CMA by the European Commission in December last year. The third or booster shot is intended to be administered six months after the second dose in individuals aged 16 years or above, Pfizer noted.
7th Sep 2021 - Pharmaceutical Technology

Japan picks three COVID-19 drug candidates to get research funds

Japan has selected three candidates for COVID-19 treatments to receive subsidies for clinical trials, the health ministry said on Tuesday. The drugs are AstraZeneca Plc's antibody treatment AZD7442, Shionogi & Co's protease inhibitor S-217622, and Fujifilm Holding Corp's antiviral favipiravir, known commercially as Avigan.
7th Sep 2021 - Reuters

Indonesia approves J&J, Cansino COVID-19 vaccines for emergency use

Indonesia has approved the single-dose COVID-19 vaccines produced by Janssen Pharmaceutical Companies, part of Johnson & Johnson, and China's CanSino Biological Inc for emergency use, the country's food and drug agency said in a statement on Tuesday.
7th Sep 2021 - Reuters

New Studies Find Evidence Of 'Superhuman' Immunity To COVID-19 In Some Individuals

Some scientists have called it "superhuman immunity" or "bulletproof." But immunologist Shane Crotty prefers "hybrid immunity." "Overall, hybrid immunity to SARS-CoV-2 appears to be impressively potent," Crotty wrote in commentary in Science back in June. No matter what you call it, this type of immunity offers much-needed good news in what seems like an endless array of bad news regarding COVID-19. Over the past several months, a series of studies has found that some people mount an extraordinarily powerful immune response against SARS-CoV-2, the coronavirus that causes the disease COVID-19.
7th Sep 2021 - NPR

COVID-19: release approved vaccines for trials of new ones

Scientists must develop the next generation of COVID-19 vaccines now, if the world is to meet the challenge of SARS-CoV-2 variants and reduce vaccine inequity by increasing global supply. This can be done only if comparator COVID-19 vaccines — those that have already been approved — are available to support clinical trials. Such comparator vaccines are almost impossible to secure; governments, developers and manufacturers must find a solution to unlock supplies. So far, COVID-19 vaccines have received approval on the basis of data from unvaccinated participants in placebo-controlled efficacy trials. These trials become increasingly difficult to carry out as the number of people who are immunized rises. Comparator vaccines, essentially replacing placebos, are therefore needed for trials that assess whether new candidate vaccines provide comparable levels of protection, including against emerging variants.
7th Sep 2021 - Nature.com

How the risk of side effects could change with Covid-19 vaccine boosters

Additional doses of Covid-19 vaccines are likely rolling out in the United States later this year. It raises the question: What will the side effects from a booster shot look like? Is there a higher or lower risk of an adverse event, compared to the earlier regimens? Overall, the Covid-19 vaccines are overwhelmingly safe and remarkably effective. But as the shots went into millions of arms starting late last year, researchers uncovered a handful of sometimes serious side effects, which were so exceedingly rare that the clinical trials that led to the shots’ authorizations — even with tens of thousands of participants — couldn’t capture them.
7th Sep 2021 - STAT News

What we know about the new C.1.2 coronavirus variant

While much of the world’s focus has been on the Delta variant of coronavirus, a new variant has been identified in South Africa. Currently referred to as the C.1.2 variant, it is yet to be called a variant of interest or concern by the World Health Organization (WHO), but is drawing the attention of scientists due to the number and types of mutations it contains and the speed at which the mutations have occurred.
7th Sep 2021 - AlJazeera

After Moderna contamination mess, Takeda strikes deal with Japan to supply Novavax COVID-19 vaccines

As Moderna faces questions about contaminants found in its COVID-19 vaccines in Japan, the company’s distribution partner in the country, Takeda, is moving forward on its plans with another COVID vaccine developer. On Monday, Takeda said the Japanese government has agreed to purchase 150 million doses of the Novavax shot that it will produce. Takeda and Novavax previously struck a licensing and production deal covering the country. The Novavax shot remains in development, and the partners aim to start the rollout in Japan early next year. The government's purchasing agreement is subject to regulatory approvals.
7th Sep 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Sep 2021

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Why a Covid-19 Vaccine for Children Is Taking So Long

Researchers testing shots in children face serious challenges, starting with making the lower dose under study
6th Sep 2021 - The Wall Street Journal

South African Scientists Say New Covid Variant Slows Its Spread

South African scientists said a new variant, with a concerning number of mutations, spread at a slower rate last month than in July. The so-called C.1.2 variant accounted for just 1.5% of all virus samples sequenced in the country in August compared with 2.2% in July, according to the Network for Genomic Surveillance South Africa. The variant, first identified in South Africa, has been found in a number of countries including the Democratic Republic of Congo, Mauritius, Portugal, New Zealand and Switzerland.
6th Sep 2021 - Bloomberg

Chilean health regulator approves CoronaVac use among children over age 6

The Chilean health regulator on Monday approved the COVID-19 vaccine produced by China's Sinovac Biotech Ltd for use in children over 6 years of age, allowing more people to be included in the country's rapid inoculation campaign.
6th Sep 2021 - Reuters

Sinovac booster shot reverses drop in antibody activities against Delta-study

A booster dose of Sinovac Biotech's COVID-19 vaccine reversed a decline in antibody activities against the Delta variant, a study showed, easing some concerns about its longer-term immune response to the highly contagious strain of the virus. The study comes amid concerns about the Chinese vaccine's efficacy against Delta, which has become the dominant variant globally and is driving a surge in new infections even in the most vaccinated countries.
6th Sep 2021 - Reuters

Brazil suspends use of millions of doses of China's Sinovac coronavirus vaccine

Brazil’s health regulator suspended the use of just over 12.1 million doses of the coronavirus vaccine manufactured by China’s Sinovac after learning that vials containing the shots were filled at an unauthorized production base. The suspension is for 90 days as an investigation is carried out, said Anvisa, the regulator, which announced the decision in a statement Saturday. The Butantan Institute, a Sao Paulo biomedical center that has partnered with Sinovac to fill the vaccine for local usage, notified Anvisa about the irregularity the prior day, the agency said.
6th Sep 2021 - The Washington Post

Denmark cancels tender for domestic coronavirus vaccine production

Denmark has cancelled its previously announced plans for a public tender to establish a national COVID-19 vaccine production facility as it bets on a vaccine already under development by a Danish firm, the Business Ministry said on Monday. Prime Minister Mette Frederiksen announced in April that Denmark aimed to produce COVID-19 mRNA-vaccines by 2022, and that a tendering process would be initiated within a few weeks.
6th Sep 2021 - Reuters

China’s Sinopharm seeks to develop its own mRNA Covid vaccine

Sinopharm is developing a homegrown messenger RNA inoculation for Covid-19, becoming one of the first big Chinese pharmaceutical groups to pursue the technology to combat the disease. The state-owned pharma group’s move comes as concerns grow over the efficacy of conventional inactivated virus vaccines, which have dominated the rollout in China. Certain studies have shown the jabs produce fewer antibodies compared with mRNA shots. Inactivated vaccines, such as Sinopharm’s existing Covid vaccine, use dead viral particles to produce an immune response, while mRNA jabs contain genetic instructions that tell cells to make viral proteins that prime the immune system.
6th Sep 2021 - Financial Times

NHS ‘ready to go’ with Covid jab booster programme, says vaccines minister

The NHS’s vaccine booster programme is “ready to go” and only waiting for scientists to sign off on plans for third jabs, the vaccines minister has said. Speaking in the House of Commons, Nadhim Zahawi, said getting booster vaccines into people’s arms would be a major part of ending the pandemic for good.
6th Sep 2021 - The Independent

Spread of Delta variant driven by immune escape and greater infectivity – study

The coronavirus Delta variant, which has become dominant in a number of countries including the UK, most likely spreads through its ability to evade antibodies and its increased infectivity, researchers have said. As the virus replicates, errors in its genetic make-up cause it to mutate. Some mutations make it more transmissible or more infectious, some help it evade the immune response, potentially making vaccines less effective, while others have little effect.
6th Sep 2021 - Evening Standard

EU watchdog studying data on Pfizer COVID-19 vaccine booster dose

Europe's medicines regulator said on Monday it was evaluating data on a booster dose for Pfizer/BioNTech's COVID-19 vaccine, to be given six months after the second dose in people 16 years of age and older.
6th Sep 2021 - Reuters

Sinovac booster shot reverses drop in antibody activities against Delta-study

A booster dose of Sinovac Biotech's COVID-19 vaccine reversed a decline in antibody activities against the Delta variant, a study showed, easing some concerns about its longer-term immune response to the highly contagious strain of the virus. The study comes amid concerns about the Chinese vaccine's efficacy against Delta, which has become the dominant variant globally and is driving a surge in new infections even in the most vaccinated countries.
6th Sep 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Sep 2021

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Israel to present COVID-19 booster shot data to FDA experts

Israel this month will present data from an extensive rollout of COVID-19 vaccine booster shots to the U.S. Food and Drug Administration, which is weighing White House plans to begin a booster drive in the United States. Sharon Alroy-Preis, head of public health at Israel's Health Ministry, said the ministry had been asked by the U.S. Food and Drug Administration (FDA) to brief its advisors at a Sept. 17 meeting.
5th Sep 2021 - Reuters

What Vaccinated People Need to Know About Breakthrough Infections

If you’re vaccinated, you should think about a number of variables, including your overall health, where you live and the risks you take.
5th Sep 2021 - The New York Times

FDA Pushes for Moderna Booster Shot Data in Weighing Dose

U.S. health regulators are seeking additional coronavirus booster shot data from Moderna Inc., as the Biden administration expects to begin a widespread booster campaign this month with only the Pfizer Inc.-BioNTech vaccine, people familiar with the matter say. Moderna announced Friday that it had “completed” its submission of data to the Food and Drug Administration for authorization of boosters. The FDA has been seeking more data as Moderna’s submission rolled in, the people added.
4th Sep 2021 - Bloomberg

‘Far too early’ for South African C.1.2 virus variant to cause concern

It is too early to say if the new variant of COVID-19 spotted in South Africa will become a major player in the pandemic – or fizzle out like many variants spotted before. Known as C.1.2, the variant has attracted panicked headlines around Australia and the world due to its collection of mutations, some of which it shares with other variants of concern.
4th Sep 2021 - Sydney Morning Herald

Everything we know about the mu variant, the latest coronavirus mutation

On Monday the World Health Organization (WHO) officially labeled the mu variant as a "variant of interest," a designation that indicates a need for further study about possible dangers while falling short of the more serious classification, "variant of concern." Variants of concern are regarded as a top priority because they are more immunity-resistant, contagious or deadly than other strains. Currently the WHO considers four strains to meet those criteria: alpha, beta, gamma and delta (the variant most prevalent in the United States).
4th Sep 2021 - Salon

AstraZeneca reaches settlement with EU on COVID-19 vaccine delivery

Settlement brings doses delivered to 300 million as agreed. Agreement will also end pending litigation in Brussels. Capped rebates on vaccine will apply if doses are delayed. Doses will go to EU-laggards in uptake ranking, COVAX facility
3rd Sep 2021 - Reuters

EU reviewing risk of rare inflammation after COVID-19 vaccinations

Europe's medicines regulator said on Friday it was reviewing if COVID-19 vaccines caused a risk of a rare inflammatory condition, following a report of a case with Pfizer/BioNTech's shot. The safety panel of the European Medicines Agency is looking into Multisystem Inflammatory Syndrome (MIS) after the condition was reported in a 17-year-old male in Denmark, the agency said.
3rd Sep 2021 - Reuters

Australia approves highly effective Moderna Covid-19 jab for children aged 12 to 17

Australia's medical regulator approves American Moderna jab for all over 12s Medical regulator boss said the jab was 98% effective against severe disease One million doses will arrive in September and 10million by the end of the year In 2022 Australia will receive 15 million of Moderna's 'updated' variant boosters The move helps nation reach 70 per cent vaccination rate to end lockdowns
3rd Sep 2021 - Daily Mail

U.S. COVID-19 booster shot campaign to start with only Pfizer - source

A White House plan to offer COVID-19 booster shots will most likely start this month only with the vaccine made by Pfizer Inc and BioNTech, a narrower initiative than anticipated, a source familiar with the matter said on Friday. President Joe Biden had expected to launch a campaign to administer 100 million booster shots on Sept. 20. But U.S. vaccine makers other than Pfizer have lagged in seeking authorization of an additional dose.
3rd Sep 2021 - Reuters

Moderna seeks EU authorization for COVID-19 vaccine booster dose

Moderna Inc said on Friday it had asked the EU drugs regulator for conditional approval of a booster shot of its COVID-19 vaccine at a 50 microgram dose.
3rd Sep 2021 - Reuters

Analysis: Are COVID boosters needed? FDA vaccine advisers wrestle with a thorny issue

The debate will likely be heated following the Biden Administration's announcement last month - before the experts could weigh in - that the U.S. plans to start booster doses Sept. 20 if regulators approve them. The White House move usurped the normal process in which the FDA and the U.S. Centers for Disease Control and Prevention make these sort of science-based decisions, according to interviews with six current and former FDA scientists and CDC advisory panel members.
3rd Sep 2021 - Reuters on MSN.com

A new COVID-19 variant called Mu that might be able to evade immunity from vaccines has been detected in almost every US state

A new COVID-19 variant called Mu might be able to evade the immunity people get from vaccines, Insider reported. The Mu variant has been detected in 47 US states and the District of Columbia, according to data from Outbreak.info. Only Nebraska, Vermont, and South Dakota are yet to detect a case, the data says.
3rd Sep 2021 - Business Insider on MSN.com

Fauci says he's 'keeping a very close eye on' new COVID-19 variant

The variant, labelled “mu,” has been detected in 39 countries in South America and Europe. “We certainly are aware of the mu variant. We’re keeping a very close eye on it,” Anthony Fauci said. “We don’t consider it an immediate threat right now,” he added.
3rd Sep 2021 - The Hill

One Vaccine Makes More Antibodies Than Another. Does it Matter?

Ten months ago, the results of large clinical trials appeared almost too good to be true: Two messenger RNA vaccines reduced symptomatic Covid-19 cases by more than 90% in almost every group that got them. Now, subtle differences between the Pfizer Inc.-BioNTech SE and Moderna Inc. vaccines are emerging across patient groups over time. One small U.S. study found waning levels of antibodies with Pfizer’s vaccine, particularly in an older group of people. And a larger study from Belgium found that Moderna’s shot may generate more antibodies than Pfizer’s.
3rd Sep 2021 - Bloomberg

No Mu variant detected in Philippines so far — genome center

The Philippines has not yet detected the presence of the new coronavirus variant known as “Mu,” the country’s genome center said on Friday. “We went back to our database, we have sequenced more than 12,000 [samples]…We have not yet detected Mu variant in the Philippines,” Philippine Genome Center Executive Director Cynthia Saloma said in a briefing.
3rd Sep 2021 - Philstar.com

Moderna vaccine approved for children 12 years and older, in line with Pfizer vaccine

Moderna's COVID-19 vaccine has been approved by Australian health authorities for children as young as 12. The vaccine was already approved for adults 18 and over, and the Therapeutic Goods Administration has now extended that approval down to teenagers. It brings the vaccine into line with the extremely similar Pfizer vaccine. Both are based on MRNA technology.
3rd Sep 2021 - ABC News

mRNA COVID vaccines not tied to serious side effects

Ten months ago, the results of large clinical trials appeared almost too good to be true: Two messenger RNA vaccines reduced symptomatic Covid-19 cases by more than 90% in almost every group that got them. Now, subtle differences between the Pfizer Inc.-BioNTech SE and Moderna Inc. vaccines are emerging across patient groups over time. One small U.S. study found waning levels of antibodies with Pfizer’s vaccine, particularly in an older group of people. And a larger study from Belgium found that Moderna’s shot may generate more antibodies than Pfizer’s.
3rd Sep 2021 - CIDRAP

Lilly's COVID-19 antibody combo cleared for nationwide use as feds say it can tackle the dominant delta variant

That didn't take long. Only a few days after Eli Lilly's COVID-19 antibody combo of bamlanivimab and etesevimab made its return to more than 20 states, federal officials are resuming distribution nationwide. In a Thursday alert, officials said Lilly's drug "can be used in all U.S. states, territories, and jurisdictions" based on data about variants circulating nationwide. Since Eli Lilly's combo is expected to be effective against the delta variant—and because that variant is now dominant in the United States—officials are ready to again endorse the drugs.
3rd Sep 2021 - FiercePharma

The White House wants $65 billion for an ‘Apollo’-style pandemic preparedness program

The Biden administration on Friday unveiled a sweeping new biosecurity plan, outlining a $65 billion proposal to remake the nation’s pandemic preparedness infrastructure in the wake of Covid-19. The new spending would represent one of the largest investments in public health in American history: During a press briefing, Eric Lander, the White House science adviser, likened the proposal to the Apollo program of the late 1960s. The immense funding boost would target programs aimed at developing and manufacturing vaccines, treatments, and tests more quickly. It would also provide new money for laboratory capacity, viral detection mechanisms, and early warning systems.
3rd Sep 2021 - STAT News

Crowded U.S. Jails Drove Millions Of COVID-19 Cases, A New Study Says

If the U.S. had done more to reduce its incarceration rate, it could have prevented millions of COVID-19 cases. That's the conclusion of researchers who conducted what they say is the first study to link mass incarceration rates to pandemic vulnerability. Many of those preventable cases, they add, occurred in communities of color. The U.S. jail and prison system acts as an epidemic engine, according to the study from researchers at Northwestern University and the World Bank. That engine is driven by a massive number of people who, despite some counties' efforts to trim jail populations, have been cycling between cramped detention facilities and their home communities.
2nd Sep 2021 - NPR

Covid Survivors More Likely to Have Kidney Problems, Study Finds

Since the beginning of the pandemic, doctors have found that people who become very ill with Covid-19 often experience kidney problems, not just the lung impairments that are the hallmark of the illness. Now, a large study suggests that kidney issues can last for months after patients recover from the initial infection, and may lead to a serious lifelong reduction of kidney function in some patients.
1st Sep 2021 - The New York Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Feb 2021

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China approves two more COVID-19 vaccines for wider use

China approved two more COVID-19 vaccines for wider use Thursday, adding to its growing arsenal of shots. The National Medical Products Administration gave conditional approval to a vaccine from CanSino Biologics and a second one from state-owned Sinopharm. Both are already being used among select groups of people under an emergency use authorization. China now has four vaccines to immunize its population. CanSino said its one-shot vaccine candidate is 65.28% effective 28 days after the dose is given. It can be stored at 2 degrees to 8 degrees Celsius, “making it more accessible especially to the regions with underserved public health,” it said in a statement.
25th Feb 2021 - The Independent

COVID-19: One in seven people now have coronavirus antibodies as vaccine rollout continues

One person in seven has antibodies against COVID-19, with the vaccine starting to add to the population's immunity, according to new research. Blood tests on more than 154,000 people across England showed that between 26 January and 8 February,
25th Feb 2021 - Sky News

Pfizer’s Covid-19 vaccine is 92% effective at preventing serious illness, Israeli study says

Ninety-two per cent of recipients of the Pfizer vaccine have been protected from developing severe symptoms of Covid-19, the most comprehensive study of the jab has found. The study, published in The New England Journal of Medicine, was based on data from 1.2 million patients of Israel’s largest healthcare provider, half of whom had received the Pfizer-BioNTech vaccine. It was conducted by doctors and researchers led by Professor Ran Balicer, of Israel’s Clalit Health Services, along with a team of senior researchers from Harvard University, and is the largest study of its kind.
25th Feb 2021 - The Times

California coronavirus variant is resistant to antibodies, but vaccines should still work

Early studies show the coronavirus variant that’s spreading widely across California is somewhat resistant to antibodies that fight off infection, but the vaccines still should offer plenty of protection, infectious disease experts say. Antibodies generated by the vaccines, or by previous coronavirus infection, were two to four times stronger against earlier versions of the virus compared to the new variant, scientists at UCSF found in laboratory studies. They released preliminary results this week.
25th Feb 2021 - San Francisco Chronicle

First universal coronavirus vaccine will start human trials this year

The coronavirus sweeping around the world isn’t the first to make the leap into humans and it won’t be the last. Vaccines against SARS-CoV-2 were developed in record time and are performing well. But now we urgently need a different kind of vaccine, say scientists: one that will protect us against other coronaviruses, even those we haven’t met yet.
25th Feb 2021 - New Scientist

How would COVID-19 vaccine makers adapt to variants?

How would COVID-19 vaccine makers adapt to variants? By tweaking their vaccines, a process that should be easier than coming up with the original shots. Viruses constantly mutate as they spread, and most changes aren't significant. First-generation COVID-19 vaccines appear to be working against today's variants, but makers already are taking steps to update their recipes if health authorities decide that's needed.
25th Feb 2021 - The Independent

Pfizer and BioNTech Studying Third Covid-19 Vaccine Dose to Fight New Strains

Pfizer Inc. and BioNTech SE have begun a study testing in people whether the companies’ Covid-19 shot can provide protection against emerging strains of the coronavirus. The companies said Thursday they have started the small study to see whether a third dose of their authorized Covid-19 vaccine would increase its effectiveness against new variants, such as the strain first identified in South Africa. The approach differs from that of Moderna Inc., which said Wednesday it had made a new vaccine targeting the strain found in South Africa and shipped doses to U.S. government researchers for human testing.
25th Feb 2021 - Wall Street Journal

GSK narrows focus on elderly in trial to treat pneumonia from COVID-19

GlaxoSmithKline will extend a trial testing an experimental rheumatoid arthritis drug on patients suffering from pneumonia related to COVID-19 to focus on the elderly as it seeks to firm up encouraging findings so far.
25th Feb 2021 - Reuters

Moderna sees $18.4 billion in sales from COVID-19 vaccine in 2021

Moderna Inc said on Thursday it was expecting sales of $18.4 billion from its coronavirus vaccine this year, putting it on the path to post a profit for the first time since its formation in 2010. Moderna and Pfizer Inc are the only drugmakers whose vaccines have been cleared for emergency use against COVID-19 in the United States so far. Pfizer earlier this month forecast $15 billion in its share of sales from the COVID-19 vaccine it developed jointly with partner BioNTech.
25th Feb 2021 - Reuters

England minorities: Higher COVID-19 cases, fewer vaccinated

England’s ethnic minority communities have higher levels of COVID-19 infections and lower levels of vaccine acceptance than other groups, according to a new study that highlights how the pandemic is worsening health inequalities. The study found that 92% of people across England either have received or would accept a vaccine. But that figure dropped to 87.6% for Asians and 72.5% for Blacks, according to the study released Thursday by Imperial College London. Researchers also found that most people of all age groups produced disease-fighting antibodies after two doses of the Pfizer-BioNTech vaccine.
25th Feb 2021 - The Independent

AZ to divert COVID-19 vaccines from global supply chain to meet EU target -

AstraZeneca has said it will be able to meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. The company released a statement saying it will meet the EU’s targets by using its global supply chain to make up for any shortfall in Europe, where it is struggling to get production up to speed. It released the statement following a Reuters report citing a European official, directly involved with talks over vaccine supply, stating less than half of the 180 million doses ordered will be delivered in the second quarter.
25th Feb 2021 - pharmaphorum

Experimental arthritis drug could prevent severe Covid-19 in over 70s, study finds

An experimental drug usually used to treat arthritis could help prevent severe coronavirus symptoms in those most at risk from the disease, a study has suggested. Otilimab was found to have a potential clinical benefit in treating the severe lung disease associated with Covid-19.
25th Feb 2021 - Wales Online

Moderna begins studying potential COVID-19 vaccine booster targeting variant first detected in South Africa

Drug manufacturer Moderna says it will begin testing a variant-specific version of its COVID-19 vaccine that would target the B1351 variant first detected in South Africa. The company has previously reported that its original two-dose vaccine — already approved for use in Canada — appears to provide protection against the B117 variant first detected in the U.K., as well as the B1351 variant, though its own research suggests it may be less effective against the latter. The company says it will study the B1351 variant-specific vaccine both as a potential booster to the original COVID-19 vaccine and as a standalone for people who have not yet received a vaccine at all.
25th Feb 2021 - CBC.ca

Why global Covid infections have plummeted

One explanation for the stubbornly high number of infections in Brazil is the role played by new variants, which can spread quickly across the population without a strict lockdown in place to contain them. Similarly in the UK, the B.1.1.7 variant spread rapidly before the current lockdown. Despite recent success in tackling the virus, scientists emphasised that all countries remained vulnerable to surges in new cases. “Any rapid relaxation of protective measures could produce spikes in infection rates,” said Ted Cohen, professor of infectious disease epidemiology at Yale University. “There are large pools of susceptible individuals still at risk.”
25th Feb 2021 - Financial Times

China approves two COVID-19 vaccines from Sinopharm's affiliate, CanSino

China's medical products regulator said on Thursday that it had approved two more COVID-19 vaccines for public use, raising the number of domestically produced vaccines that can be used in China to four. The two newly cleared vaccines are made by CanSino Biologics Inc (CanSinoBIO) and Wuhan Institute of Biological Products, an affiliate of China National Pharmaceutical Group (Sinopharm). They join a vaccine from Sinovac Biotech approved earlier this month, and another from Sinopharm's Beijing unit approved last year. Prior to formal approval for wider public use by the National Medical Products Administration, millions of doses of the two Sinopharm vaccines and Sinovac shot had been administered in China's vaccination program.
25th Feb 2021 - Reuters on MSN.com

China’s death rates didn’t rise overall at start of pandemic, study finds

In the first three months of 2020, mortality rates in Wuhan were 56 per cent higher than estimates based on average in previous years. But elsewhere they were lower than expected, which researchers said may be related to behavioural changes during lockdown
25th Feb 2021 - South China Morning Post

In boost for COVID-19 battle, Pfizer vaccine found 94% effective in real world

The first big real-world study of the Pfizer/BioNTech vaccine to be independently reviewed shows the shot is highly effective at preventing COVID-19, in a potentially landmark moment for countries desperate to end lockdowns and reopen economies. Up until now, most data on the efficacy of COVID-19 vaccines has come under controlled conditions in clinical trials, leaving an element of uncertainty over how results would translate into the real world with its unpredictable variables. The research in Israel – two months into one of the world’s fastest rollouts, providing a rich source of data – showed two doses of the Pfizer shot cut symptomatic COVID-19 cases by 94% across all age groups, and severe illnesses by nearly as much.
25th Feb 2021 - EURACTIV

Three-shot combo? Pfizer, BioNTech roll COVID-19 booster trial as real world data back first vaccine

As Pfizer and BioNTech start testing whether a third dose of their COVID-19 shot can help fend off new coronavirus variants, a massive real-world study has confirmed that its first, two-dose regimen is 94% effective. The third-dose study now underway will gauge the effects of that follow-up dose on circulating and new COVID-19 virus variants. At the same time, the companies are in talks with the FDA and EMA about studying a new booster specifically designed to tackle new variants. They're hoping to validate "future modified mRNA vaccines with a regulatory pathway similar to what is currently in place for flu vaccines,” according to a press release.
25th Feb 2021 - FiercePharma

Researchers find worrying new coronavirus variant in New York City

Two separate teams of researchers said this week they have found a worrying new coronavirus variant in New York City and elsewhere in the Northeast that carries mutations that help it evade the body's natural immune response -- as well as the effects of monoclonal antibody treatments. Genomics researchers have named the variant B.1.526. It appears in people affected in diverse neighborhoods of New York City, they said, and is "scattered in the Northeast." One of the mutations in this variant is the same concerning change found in the variant first seen in South Africa and known as B.1.351. It appears to evade, somewhat, the body's response to vaccines, as well. And it's becoming more common.
25th Feb 2021 - CNN

BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19–related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan–Meier estimator.
24th Feb 2021 - nejm.org

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Feb 2021

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COVID-19 variant spreading in New York City has mutation that may weaken effect of vaccines

B.1.526 variant first appeared in samples collected in New York City in November It now accounts for about 27 percent of viral sequences in databases used by scientists. Scientists have identified two versions of the B.1.526 variant, which are lumped together for now. One of the B.1.526 variants has the E484K mutation which scientists believe help the virus partially avoid the vaccine effects. The other has the S477N mutation which may optimize the binding process with human cells to possibly increase infection rates
25th Feb 2021 - Daily Mail

FDA says Johnson & Johnson’s single-dose shot protects against COVID-19

Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic. The Food and Drug Administration’s scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J&J’s shot — one that could help speed vaccinations by requiring just one dose instead of two — is safe to use.
24th Feb 2021 - PBS

Covid-19 can survive on clothing for up to THREE DAYS - with polyester garments sustaining the virus the longest, scientists warn

Coronaviruses similar to Covid-19 can survive on clothing for up to three days, according to new research. Research carried out by De Montfort University (DMU) in Leicester looked at how a coronavirus behaves on three fabrics commonly used in the healthcare industry. Polyester enables the virus to survive at infectious levels for up to 72 hours, whereas it dies within 24 hours on 100 per cent cotton.
24th Feb 2021 - Daily Mail

Sanofi and GSK start new study of COVID-19 vaccine

Sanofi and GlaxoSmithKline (GSK) have announced the initiation of a new Phase II study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate. If results of the study are positive, the Phase III study will start this year in Q2, with the vaccine expected to be available later in the year in Q4. In parallel to the new Phase II study and recognising the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants which will be used to inform the next stages of the Sanofi/GSK development programme.
24th Feb 2021 - Pharmafield

Johnson & Johnson’s single-dose vaccine ‘protects against Covid-19’

Johnson & Johnson's single-dose vaccine protects against Covid, according to an analysis by US regulators. The vaccine is about 66 per cent effective overall at preventing moderate to severe Covid-19, a report on Wednesday by the Food and Drug Administration confirmed. It will now go forward to a panel of FDA experts who will debate if the evidence is strong enough to recommend the vaccine. The FDA is expected to make a final decision within days.
24th Feb 2021 - Evening Standard

Covid-19: First doses of vaccines in Scotland led to a substantial fall in hospital admissions

Rollout of the Pfizer BioNTech and Oxford AstraZeneca vaccines has led to a substantial fall in severe covid-19 cases requiring hospital admission in Scotland, suggest the results of the first study to report on the impact of the UK’s vaccination strategy.1 - The results, available as a preprint, showed that four weeks after the first doses of the Pfizer BioNTech and Oxford AstraZeneca vaccines were administered the risk of hospitalisation from covid-19 fell by up to 85% (95% confidence interval 76 to 91) and 94% (95% CI 73 to 99), respectively.
24th Feb 2021 - The BMJ

China's bid to stop Wuhan COVID-19 spread cut deaths from other causes: study

The number of deaths in China - excluding the coronavirus epicentre of Wuhan - fell slightly during the first three months of 2020, suggesting efforts to control the spread of COVID-19 reduced fatalities from other causes, a new study showed. Researchers from the University of Oxford and the Chinese Center for Disease Control and Prevention (CDC) analysed official death registry data from Jan. 1 to March 31 last year for changes in overall and cause-specific deaths. The death rate in Wuhan, the central Chinese city where the SARS-CoV-2 coronavirus was first identified, stood at 1,147 per 100,000 over the period, 56% higher than expected, they found in the study published on Wednesday by BMJ, the journal of the British Medical Association.
24th Feb 2021 - Yahoo News Singapore

Real-world trial of Pfizer COVID vaccine finds high 2-dose, good 1-dose protection

A large observational, real-world study from Israel estimates that the Pfizer/BioNTech COVID-19 vaccine is 46% effective at preventing infection 14 to 20 days after the first dose and 92% 7 days after the second dose, backing the results of an earlier randomized, controlled trial, according to a study today in the New England Journal of Medicine (NEJM). A single dose, however, was 74% effective against COVID-related hospitalization and 72% effective at preventing death.
24th Feb 2021 - CIDRAP

US ready to distribute J&J COVID vaccine, White House says

Today leaders of the White House COVID-19 response team said they are ready to distribute Johnson & Johnson's COVID-19 vaccine when and if the Food and Drug Administration (FDA) issues an emergency use authorization (EUA)—which could come as early as this weekend. "We are doing the work so if the EUA is granted we will waste no time in getting life-saving vaccines into the arms of Americans," said Jeff Zients, the Biden administration's COVID-19 czar during today’s press conference on response efforts.
24th Feb 2021 - CIDRAP

Moderna sends COVID-19 booster shot for NIH testing as it hikes production targets past 2B doses

Moderna on Wednesday said it's now on track to produce 700 million vaccine doses this year, and it's still aiming for 1 billion at the high end. Last year, the company had said 500 million would be its minimum output this year, and it ratcheted up that minimum to 600 million in January. And for 2022, the biotech is planning for 1.4 billion doses—or perhaps even 2 billion, depending on the dose required for booster shots targeting new variants. The company has shipped a booster candidate to the National Institutes of Health for testing, according to Wednesday's statement; it's targeted specifically at the South Africa variant now worrying public health experts.
24th Feb 2021 - FiercePharma

Mission Possible: Pfizer and BioNTech star in their own vaccine discovery movie

The movie-length product placement is a behind-the-scenes look at Comirnaty, the now-authorized coronavirus shot Pfizer developed and produced in concert with its partner BioNTech. Pfizer provided the National Geographic's scientific storytellers “unprecedented access” to the vaccine's development, said Sally Susman, Pfizer executive VP and chief of corporate affairs, said. “This film is riveting and suspenseful,” Susman said in a media backgrounder from Disney Advertising Sales, the Disney group that oversees National Geographic’s CreativeWorks branded content studio, which created the film. “It is a testament to all of our employees and partners across the biopharmaceutical industry who have put in the long hours of tireless dedication and sacrifice, often working away from their families."
24th Feb 2021 - FiercePharma

Moderna ready to test version of Covid-19 vaccine aimed at worrisome variant

Moderna is pressing forward with a modified version of its Covid-19 vaccine meant to protect against an emerging strain of the virus, the company said Wednesday, planning to start a clinical trial as soon as regulators give the green light. Laboratory tests have suggested that Moderna’s authorized vaccine confers less protection against the variant, known as B.1.351, than it does against other strains. Pfizer has reported similar findings with its vaccine, and human trials conducted by Johnson & Johnson and Novavax suggest vaccines designed for the original strain of SARS-CoV-2 are less effective against B.1.351 as well. Moderna said it is seeking to test the novel vaccine on its own and as a combined shot with its current vaccine. It also plans to test whether giving a booster of the current vaccine on its own will give enhanced protection against new variants of the virus that causes Covid-19.
24th Feb 2021 - STAT News

Pfizer-BioNTech vaccine performs as well in the real world as in clinical trials, new study concludes

Pfizer and BioNTech’s Covid-19 vaccine performed as well in the real world as it did in the clinical trial that led to its use, a large study conducted in Israel concluded. The study, published Wednesday in the New England Journal of Medicine, is the largest to date assessing the effectiveness of the vaccine, comparing all illness, severe illness, and hospitalizations as well as deaths between 600,000 pairs of vaccinated and unvaccinated people. That a vaccine will perform as well in the real world as it does in the highly controlled setting of a clinical trial is not a given, noted senior author Ran Balicer, director of the Clalit Research Institute of Israel.
24th Feb 2021 - STAT News

FDA scientists endorse J&J’s Covid vaccine, as new data shed light on efficacy

Scientists at the Food and Drug Administration said Wednesday that the single-shot Covid-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease. Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.
24th Feb 2021 - STAT News

Moderna to begin clinical trials of a booster shot to protect against the South African variant

Moderna says it has shipped boosters shots of its COVID-19 vaccine, designed to protect against the South African variant, to the NIH for clinical trials. A study found Moderna's two-dose regimen had a six-fold decrease in antibody response against the variant that other common versions of the virus. Several studies suggest have suggested the variant, known as B.1.351, is more resistant to existing vaccines than other variants of the coronavirus. In the U.S., there are 46 confirmed cases of the variant across 14 states. It comes as Moderna announced it is raising its expected global vaccine production for 2021 from 600 million to 700 million
24th Feb 2021 - Daily Mail

Brits could get their Covid vaccine in a PILL in future, Oxford University says

Professor Sarah Gilbert said team were exploring new ways to deliver vaccine Also looking at whether it could be given via a nasal spray, like flu sometimes is It could help alleviate supply issues that have hindered rollouts internationally
24th Feb 2021 - Daily Mail

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Feb 2021

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Drug supply chain issues aren't going away, report says

The first chapter of the ninth edition of ASHP's pharmacy forecast, which was released earlier this month, is called, "The Certainty of Uncertainty for a Global Supply Chain." Written by Erin Fox, PharmD, and Aaron Kesselheim, MD, JD, MPH, the section reflects on responses to an ASHP survey from 272 experts in health-system pharmacy. Allocation guides, a push for domestic supply chains, manufacturing quality scrutiny, and more were all topics the panelists thought would be highly relevant for the next 5 years, and the authors agree. "With a global pandemic and continuing uncertainty regarding the stability and quality of the medication supply chain, health-system pharmacists must be prepared for significant disruptions to 'normal' healthcare delivery, including disruption of medication procurement," they write.
24th Feb 2021 - CIDRAP

Sanofi and GSK begin new study of their COVID-19 vaccine

The new Phase II study will involve 720 volunteers aged 18 years and over, and will include equal numbers of adults aged 18 to 59 years and those 60 years and above. The study will test three different antigen doses with a fixed dose of adjuvant in the total study population, at sites in the US, Honduras and Panama. Sanofi/GSK said in a statement that results of the Phase II trial will inform the Phase III protocol, adding that if data from the new trial is positive, a global late-stage trial could begin in the second quarter of 2021. Depending on the outcome of the potential Phase III trial, regulatory submissions for the vaccine could be expected in the second half of 2021, with the vaccine likely to then be available in Q4 2021 if approved.
23rd Feb 2021 - PharmaTimes

Sanofi to provide manufacturing support to Johnson & Johnson for their COVID-19 vaccine to help address global supply demands

Sanofi has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen´s COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs. Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization for its single-dose Janssen COVID-19 vaccine candidate and an application for conditional marketing authorisation to the European Medicines Agency.
23rd Feb 2021 - PharmiWeb

Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints

Sanofi and GlaxoSmithKline on Monday announced the start of a Phase 2 study testing a new version of the experimental coronavirus vaccine the two partners have been developing. The 720-volunteer mid-stage study begins roughly two months after the partners disclosed weaker than expected results for their first vaccine candidate. Sanofi and GSK are evaluating a "refined antigen formulation" in the new trial, and could start Phase 3 testing in the second quarter if results are positive, they said in a statement. If all goes well, Sanofi and GSK hope to bring a vaccine to market by the fourth quarter of 2021. But that outcome would still represent a six-to-nine month delay from previous estimates, a significant setback for a program that was promised up to $2.1 billion in funding from the U.S. government. Multiple coronavirus vaccines are already available, and others could arrive later this year.
23rd Feb 2021 - BioPharma Dive

Covid-19 could become disease of the poor and persist in some areas of UK, expert warns

Dr Mike Tildesley, reader in mathematical modelling of infectious diseases at the University of Warwick and member of the Government advisory group SPI-M, said that he was "concerned" that the virus might persist particular parts of the country. Asked on BBC Radio 4's Today programme whether Covid-19 could remain a "disease of the deprived", he said: "This is a real concern actually for me and I know a number of other scientists have raised this, that we may end up in a situation where we have the 'vaccine rich' and as it were, who are able to access the vaccine who have taken up the vaccine and are at much lower risk.
23rd Feb 2021 - Mirror Online

Fauci: Vaccinated people shouldn't dine indoors or go to the theater quite yet

Dr. Anthony Fauci cautions against indoor dining and theatergoing even for those fully vaccinated. The number of coronavirus cases in the US remains high. He said it'd be safer to gather indoors again as more people get vaccinated and COVID-19 cases drop.
23rd Feb 2021 - Business Insider

Covid-19: Vaccine success drives England's lockdown exit

Siren study - The Pfizer and BioNTech covid-19 vaccine is at least 70% effective against symptomatic and asymptomatic infection 21 days after the first dose and at least 85% seven days after the second dose, shows a UK study of healthcare workers. The Siren study previously investigated the effect of prior infection on protection against reinfection but has now been amended to investigate vaccine effectiveness. The first results following this update have looked at the eight weeks after the first Pfizer-BioNTech vaccine dose.
23rd Feb 2021 - The BMJ

Italy 'misled WHO on pandemic readiness' weeks before Covid outbreak

Italy allegedly misled the World Health Organization (WHO) on its readiness to face a pandemic less than three weeks before the country’s first locally transmitted coronavirus case was confirmed. Each year, countries bound by the International Health Regulations (IHR) – an international treaty to combat the global spread of disease – are required to file a self-assessment report to the WHO on the status of their preparedness for a health emergency.
23rd Feb 2021 - The Guardian

Heads of COVID vaccine firms promise dose ramp-up

Today during a House Committee on Energy & Commerce hearing, chief executives from Pfizer, Moderna, Johnson & Johnson, AstraZeneca, and Novovax addressed US lawmakers for the first time since July 2020 on the production of vaccines and when Americans could expect more doses. According to Richard Nettles, MD, vice president of US medical affairs for Johnson & Johnson's Janssen division, his company will be able to immediately ship vaccine doses upon a Food and Drug Administration (FDA) emergency use authorization (EUA). An FDA advisory board meets on Feb 26 to consider granting an EUA to Johnson & Johnson.
23rd Feb 2021 - CIDRAP

Adults with Down syndrome 3 times more likely to die of COVID, study finds

Adults older than 40 with Down syndrome are about three times more likely to die of COVID-19 than the rest of the population, pointing to the need to prioritize coronavirus vaccination to this group, a study published yesterday in the Lancet's EClinicalMedicine has found. A team led by Emory University researchers conducted the international online survey of the clinicians or caregivers of 1,046 patients with Down syndrome diagnosed as having COVID-19 from April to November 2020.
23rd Feb 2021 - CIDRAP

COVAX vaccine begins shipping from India facility

The World Health Organization's (WHO's) South East Asia office said on Twitter today that the first batches rolled out from India's Serum Institute in Pune. The move comes a week after the WHO listed versions of the AstraZeneca-Oxford vaccine made in India and South Korea for emergency use, which paves the way for the vaccine to be distributed by the COVAX program. The vaccines required two separate reviews and approvals, because they are made in two different facilities.
23rd Feb 2021 - CIDRAP

Pfizer, Moderna and J&J tout supercharged COVID-19 vaccine output, eyeing nearly 140 million new doses by March

Pfizer, which has been shipping 4 million to 5 million doses per week, plans to increase that to 13 million a week by mid-March, according to executive testimony planned for Tuesday morning's hearing before the House Energy and Commerce Committee's oversight arm. J&J, which reportedly had just 2 million doses in stock last week, should be able to ship 20 million by March 31—provided it wins FDA authorization as expected, Richard Nettles, M.D., vice president of U.S. medical affairs at Janssen’s infectious diseases and vaccines unit, said in his testimony. The shot is up for an FDA panel review later this week. And Moderna, which already doubled its monthly deliveries to the feds this year and has so far supplied 45 million doses of its mRNA vaccine, aims to double monthly deliveries again by April, president Stephen Hoge's testimony states.
23rd Feb 2021 - FiercePharma

Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes: exec, analyst

Amid the high-stakes fight against COVID-19, a company at the forefront of the vaccine effort is laying plans to hike prices after the crisis. A top Pfizer exec said the drugmaker aims to charge more after the "pandemic pricing environment," and an influential analyst says the company could be eying prices 3 to 4 times higher. On an earnings call earlier this month, CFO Frank D’Amelio said that “obviously,” the company is “going to get more on price” after the “pandemic pricing environment." He was speaking in response to Bank of America Merrill Lynch analyst Jason Zemansky, who asked the management team about how profit margins for the program could change over time.
23rd Feb 2021 - FiercePharma

UK, US to achieve herd immunity in 2021, but not EU: Report

The United States and the United Kingdom are on course to achieve herd immunity against COVID-19 by the end of 2021 given the speed of their mass vaccination programmes, but key European Union nations are not, according to a new report. The German database firm Statista studied the number of COVID-19 vaccines that were given on a daily basis, using recent data from local health authorities of each country.
23rd Feb 2021 - FiercePharma

Not to be sniffed at: Agony of post-COVID-19 loss of smell

The doctor slid a miniature camera into the patient’s right nostril, making her whole nose glow red with its bright miniature light. “Tickles a bit, eh?” he asked as he rummaged around her nasal passages, the discomfort causing tears to well in her eyes and roll down her cheeks. The patient, Gabriella Forgione, wasn’t complaining. The 25-year-old pharmacy worker was happy to be prodded and poked at the hospital in Nice, in southern France, to advance her increasingly pressing quest to recover her sense of smell. Along with her sense of taste, it suddenly vanished when she fell ill with COVID-19 in November, and neither has returned.
23rd Feb 2021 - The Associated Press

UK data: COVID-19 vaccines sharply cut hospitalizations

Two U.K. studies released Monday showed that COVID-19 vaccination programs are contributing to a sharp drop in hospitalizations, boosting hopes that the shots will work as well in the real world as they have in carefully controlled studies. Preliminary results from a study in Scotland found that the Pfizer-BioNTech vaccine reduced hospital admissions by up to 85% four weeks after the first dose, while the Oxford-AstraZeneca shot cut admissions by up to 94%. In England, preliminary data from a study of health care workers showed that the Pfizer vaccine reduced the risk of catching COVID-19 by 70% after one dose, a figure that rose to 85% after the second.
22nd Feb 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Feb 2021

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‘Extremely promising’: 1st dose of COVID vaccine cuts illness

Data from two separate studies published in the UK, one in England and another in Scotland, have shown vaccines against COVID-19 are effective in cutting disease transmission and hospitalisations starting from the first dose. Analysis from Public Health England (PHE) published on Monday shows that the vaccine manufactured by Pfizer-BioNTech reduces the risk of catching infection by more than 70 percent after the first dose. That risk is reduced by 85 percent after a second dose.
23rd Feb 2021 - Al Jazeera English

Novavax vaccine could be approved by JUNE - bringing another 100 million doses of COVID-19 vaccine to the US after drug company announced its final stage clinical trial in ...

Novavax has now enrolled 30,000 people in the US and Mexico to its shot trial Its CEO told Reuters last month it could deliver doses to the US by June if all goes well in its trials. The vaccine was shown to be 89.3% effective and works nearly as well against the UK variant in tests in Britain. But the shot is about 50% less effective against the South African variant. US has a contract for 100 million doses of Novavax's COVID-19 vaccine. It would likely be the fourth shot authorized in the US, assuming Johnson & Johnson's vaccine gets greenlit by the FDA this week
22nd Feb 2021 - Daily Mail

Covid-19 Pfizer vaccine cuts chance of hospitalisation for elderly by 75% after one jab, research finds

One dose of the Pfizer vaccine slashes the chances of being admitted to hospital with Covid by at least 75 per cent among over-80s, real-world data from Public Health England (PHE) has found.Dr Mary Ramsay, head of immunisation at PHE, said this was at the “lower end of the estimate” and the drop in hospital admissions and deaths was thought to be even more profound. Another study found that the Pfizer/BioNTech jab also offered a high degree of protection for younger age groups.
22nd Feb 2021 - i on MSN.com

COVID-19: Vaccine rollout linked to 85% and 94% drop in coronavirus hospital admissions in Scotland, study shows

The COVID-19 vaccines being used in the UK could reduce a person's risk of being admitted to hospital by as much as 94% four weeks after the first dose, new data suggests. Experts examined coronavirus hospital admissions in Scotland among people who have had their first jab and compared them to those who had not yet received a vaccine.
22nd Feb 2021 - Sky News

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

This Friday, a group of vaccine and infectious disease experts will assemble virtually to discuss whether the Food and Drug Administration should clear Johnson & Johnson's coronavirus vaccine for emergency use. The meeting, convened by the FDA, is likely one of the last steps in the agency's review of J&J's shot. The regulator held similar meetings to review study results from Pfizer and Moderna and, each time, authorized the companies' vaccines the very next day. The advisers are expected to support emergency use of J&J's vaccine, as they did for Pfizer's and Moderna's. But Friday's meeting will be important viewing nonetheless, as the experts are likely to debate emerging issues like protection against new virus variants. The meeting will be broadcast through an FDA conference system as well as on Youtube. BioPharma Dive will be covering live.
22nd Feb 2021 - BioPharma Dive

Sanofi and GSK start test of upgraded coronavirus vaccine after first version disappoints

Sanofi and GlaxoSmithKline on Monday announced the start of a Phase 2 study testing a new version of the experimental coronavirus vaccine the two partners have been developing. The 720-volunteer mid-stage study begins roughly two months after the partners disclosed weaker than expected results for their first vaccine candidate. Sanofi and GSK are evaluating a "refined antigen formulation" in the new trial, and could start Phase 3 testing in the second quarter if results are positive, they said in a statement. If all goes well, Sanofi and GSK hope to bring a vaccine to market by the fourth quarter of 2021. But that outcome would still represent a six-to-nine month delay from previous estimates, a significant setback for a program that was promised up to $2.1 billion in funding from the U.S. government. Multiple coronavirus vaccines are already available, and others could arrive later this year.
22nd Feb 2021 - BioPharma Dive

U.K. Data Trove Shows Vaccine Program Cuts Covid-19 Hospitalizations, Deaths

A single shot of the vaccine produced by Pfizer led to a 57% reduction in cases of Covid-19 in people of age 80 and over, rising to 88% after a second dose, according to preliminary data from the U.K.
22nd Feb 2021 - Wall Street Journal

Clinical trials offer new hope for Covid-19 treatment

Clinical trials are taking place at the Great Western Hospital with the aim of finding more effective ways to treat patients with coronavirus. Operating department practitioner Helen Langton explains how her team approaches patients and families to get their consent.
22nd Feb 2021 - BBC News

COVID-19 survivors may only need one vaccine dose, study finds

Researchers looked at blood samples of 10 people previously infected with coronavirus who received one shot of the Pfizer-BioNTech or Moderna vaccine COVID-19 survivors had boosted levels of immune system cells and a 1,000-fold increase in levels of neutralizing antibodies. The levels were enough to neutralize both the original strain of the virus and the South African variant that is more highly contagious. Dr Anthony Fauci said the data is 'impressive' and that - if it holds up - health officials may consider letting survivors get one dose
22nd Feb 2021 - Daily Mail

Blood thinners may protect against COVID-19 complications

A new study has found that administering heparin-based blood thinners to patients with COVID-19 in the first 24 hours of hospital admission reduced the risk of death. The researchers observed a 27% reduced risk of 30-day mortality among patients who received blood thinners. Severe bleeding that required a blood transfusion occurred in 4.6% of patients and was not significantly linked with early intervention to prevent coagulation.
22nd Feb 2021 - Medical News Today

This UK lockdown must be the last. Here's how we can achieve that

As the UK has yo-yoed in and out of multiple lockdowns, restrictions have harmed people’s livelihoods, businesses, mental and physical health, and their quality of life. In the first and second lockdowns, these restrictions proved insufficient to permanently drive down the prevalence of Covid-19. This time, we have been promised that all adults will have received their first vaccine dose by July – but its level of effectiveness, coupled with the potential emergence of new strains of the virus, means the vaccine rollout will not be a complete solution to the pandemic.
22nd Feb 2021 - The Guardian

Delaying 2nd AstraZeneca COVID shot may boost efficacy

A single dose of the AstraZeneca/Oxford vaccine offered 76% protection against COVID-19 for 3 months, at which time administering the second dose resulted in up to 47% greater protection than giving it at 6 weeks, according to a study published late last week in the Lancet. The pooled post-hoc exploratory analysis of four randomized, controlled trials led by researchers from Oxford University involved 17,178 adults in the United Kingdom, Brazil, and South Africa from Apr 23 to Dec 6, 2020. The study also examined the effect of one versus two doses of the vaccine in reducing community spread of COVID-19 and the protection conferred by a low dose followed by a standard dose versus two standard doses.
22nd Feb 2021 - CIDRAP

AstraZeneca's Indian COVID-19 vaccine partner told to prioritize local supplies: CEO

Low- and middle-income countries banking on doses of AstraZeneca’s COVID-19 vaccine from Serum Institute of India may have to wait a bit longer, the Indian shot maker’s CEO said over the weekend. The same goes for Europe, where officials have reportedly considered importing supplies from the world's largest vaccine maker by doses. Serum Institute has been told to prioritize supplies for India first as the country hustles to vaccinate 300 million people, or a fifth of its population, by August. The move could signal delays for other countries waiting on orders of AstraZeneca’s adenovirus shot, which Serum Institute is cranking out on license under the name Covishield.
22nd Feb 2021 - FiercePharma

After Pfizer deal, Sanofi offers a hand to Johnson & Johnson for COVID-19 vaccine production

Sanofi hasn't abandoned its COVID-19 vaccine hopes despite a setback in the high-stakes race, but as it moves two different shots forward, it's also pitching in to make doses for its usual rivals. The drugmaker on Monday inked a manufacturing tie-up with Johnson & Johnson to help produce that company’s vaccine in Europe. The deal follows a separate agreement for Sanofi to turn out 100 million doses of the Pfizer-BioNTech vaccine for Europe this year. When J&J's one-dose-and-done vaccine scores an authorization, Sanofi will give the company access to its plant in Marcy l’Etoile, France. Workers there will formulate the J&J vaccine and fill vials, and the site will turn out around 12 million doses per month, Sanofi said. The deal “demonstrates Sanofi’s ongoing commitment to the collective effort to ending this crisis as quickly as possible,” CEO Paul Hudson said in a statement.
22nd Feb 2021 - FiercePharma

US: South African COVID strain found in New York state resident

The first case of a fast-spreading coronavirus variant from South Africa has been discovered in a resident of the US state of New York, Governor Andrew Cuomo said. Cuomo said on Sunday the case, a person from Nassau County, was detected at the Opentrons Labworks Inc’s Pandemic Response Lab. The mutated strain of the coronavirus, which was first detected in South Africa, was first discovered in the US last month.
22nd Feb 2021 - Al Jazeera English

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Feb 2021

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Pfizer vaccine ‘highly effective’ in reducing coronavirus transmission, study suggests

New data from Israel suggests vaccine is 89.4 per cent effective at preventing infections, whether symptomatic or not
21st Feb 2021 - The Independent

Continent’s medics boycott Oxford jab as Europe talks down efficacy

Europe’s faltering immunisation programme has been hit by a boycott of the Oxford-AstraZeneca vaccine by medical staff concerned about its side effects and doubtful of its efficacy against new variants of Covid-19. Health workers in France and elsewhere in the EU are declining the Anglo-Swedish vaccine, increasingly portrayed in European media as a cheap and inferior alternative to the mRNA jabs made by Pfizer-BioNTech and Moderna.
22nd Feb 2021 - The Times

Pfizer-BioNTech Shot Stops Covid Spread, Israeli Study Shows

The Pfizer Inc. and BioNTech SE Covid-19 vaccine appeared to stop the vast majority of recipients in Israel becoming infected, providing the first real-world indication that the immunization will curb transmission of the coronavirus. The vaccine, which was rolled out in a national immunization program that began Dec. 20, was 89.4% effective at preventing laboratory-confirmed infections, according to a copy of a draft publication that was posted on Twitter and confirmed by a person familiar with the work. The companies and Israel’s Health Ministry worked together on the preliminary observational analysis, which has not yet been peer-reviewed.
22nd Feb 2021 - Bloomberg

The ticket to a return of clubs, gigs and football matches? Five-minute coronavirus test made in the UK is touted as 'game-changer' in unlocking live events

Yorkshire firm Avacta have developed a new super-fast lateral flow Covid test Understood to be in last test stage at Government top-secret Porton Down lab The test's developers say it is more accurate and faster than the US devices It is hoped that 5-minute rapid testing will be used on admission to large events
21st Feb 2021 - The Times

Sage expert calls for children to get Covid jab as schools set to reopen

Pressure is mounting on the government to prove it is safe for children to return to the classroom before it reopens schools, as one of the UK government’s scientific advisers warned that the plan could lead to a resurgence of coronavirus. In a last-minute plea before Boris Johnson announces on Monday details of plans to reopen schools in England on 8 March, unions, experts and some opposition MPs, have demanded the publication of scientific evidence informing the government’s decision.
21st Feb 2021 - The Guardian

The inside story of how the Oxford vaccine was made and the team behind it

How an email to a scientist in her pyjamas began an astonishing story — the creation of a groundbreaking vaccine in less than 12 months. Over the past year Andrew Pollard, director of the Oxford Vaccine Group, has been tackling a daunting a mission: to develop a life-saving vaccine against Covid-19. It involved “logistics, teamwork and resilience”, he says. Approval of the vaccine for use in the UK, which was granted on December 30, was in some ways the summit denied him on Everest in 1994 when hw was part of the group that just fell short.
21st Feb 2021 - The Times

Pfizer, Moderna vaccines have reduced effectiveness against South African variant, studies show

President Biden hesitated in giving a specific timeline for when every American will be able to get a vaccine and when the country will be able to return to normalcy. During a visit to the Pfizer vaccine manufacturing facility in Michigan on Friday, the president said he wanted to be “straight” with the American people and explained that issues such as weather events, emerging virus mutations and manufacturing delays could pose significant challenges to the vaccination process.
20th Feb 2021 - The Washington Post

Pfizer and BioNTech Coronavirus Vaccine Effective After 1 Dose, Can Last 2 Weeks in Standard Freezer, Separate Research Shows

On Friday, Pfizer and BioNTech announced that they have submitted new data about their BNT162b2 vaccine to the Food and Drug Administration. With this submission, the two companies hope that the FDA will update the emergency use authorization (EUA) it has granted the vaccine. The new data indicates that Pfizer and BioNTech's BNT162b2 can be kept for as long as two weeks at temperatures common to pharmaceutical freezers and refrigerators, as opposed to the constant ultra-low temperature storage it initially seemed to necessitate.
20th Feb 2021 - The Motley Fool

Russia approves 3rd coronavirus vaccine before late-stage trials begin, PM says

Russia on Saturday approved a third coronavirus vaccine for domestic use, Prime Minister Mikhail Mishustin said on state TV, though large-scale clinical trials of the shot, labeled CoviVac and produced by the Chumakov Centre, have yet to begin. Russia has already approved two COVID-19 vaccines, including the Sputnik V shot, developed by Moscow’s Gamaleya Institute, following a similar approach of granting approval before seeing any late-stage trial results.
20th Feb 2021 - Global News

How Google search data can predict COVID-19 outbreaks

New research finds that online searches can accurately predict regional increases and decreases in COVID-19 cases. Certain types of searches reveal the activities in which people plan to engage. The search volume for outside-the-home vs. stay-at-home activities forecasts the number of COVID-19 diagnoses 10–14 days later.
20th Feb 2021 - Medical News Today

Association between mental illness and COVID-19 in South Korea

In their nationwide cohort study, Seung Won Lee and colleagues suggest that patients with a severe mental illness had a slightly higher risk for severe clinical outcomes of COVID-19.1 Although the authors classified region of residence into urban and rural categories to adjust for potential confounding, the high number of COVID-19 cases in Daegu (the fourth most populous city in South Korea) indicates that bias could remain due to uncontrolled confounding as a result of regional differences.
20th Feb 2021 - The Lancet

Italian doctors remember night that ushered in Europe's first COVID-19 lockdown

A year ago, Laura Ricevuti and Annalisa Malara, both doctors at Codogno hospital in Italy, had a hunch that something was different about a patient in the intensive care ward. Their decision to take matters into their own hands wound up triggering a national emergency - they had identified the first case of COVID-19 in the area that would become Europe’s first lockdown zone. A previously healthy 38-year-old man, now known as Mattia, his first name, or “patient one”, had gone to the hospital with a high fever, cough and shortness of breath on Feb. 18, 2020. He refused to be admitted so was given antibiotics and went home.
20th Feb 2021 - Reuters

Elon Musk Got 4,000 SpaceX Workers to Join a Covid-19 Study. Here’s What He Learned.

To monitor the prevalence of the virus among SpaceX workers nationwide, Mr. Musk and the rocket company’s top medical executive worked with doctors and academic researchers to build an antibody-testing program. More than 4,000 SpaceX workers volunteered for monthly blood tests. This week the group published its findings, which suggest that a certain threshold of antibodies might provide people lasting protection against the virus. Mr. Musk is listed as a co-author of the peer-reviewed study, which appears in the journal Nature Communications. “People can have antibodies, but it doesn’t mean they are going to be immune” to Covid-19, said Galit Alter, a co-author of the study who is a member of the Ragon Institute of MGH, MIT and Harvard. Individuals who experienced fewer, milder Covid-19 symptoms generated fewer antibodies and were therefore less likely to meet the threshold for longer-term immunity, the study found.
20th Feb 2021 - The Wall Street Journal

Mental anguish in COVID-19 survivors, young US adults

A research letter by Italian investigators published yesterday in JAMA Psychiatry details a study of 381 patients in Rome who had sought emergency care for COVID-19 and were given a psychiatric assessment 1 to 4 months after recovery, from Apr 21 to Oct 15, 2020. One-hundred-fifteen of 381 patients (30.2%) were diagnosed as having PTSD, while 17.3% had depression, 7.0% had generalized anxiety disorder, 0.7% were hypomanic, and 0.2% were psychotic. Women made up 55.7% of the PTSD diagnoses, and patients with PTSD reported higher rates of a history of psychiatric disorders (34.8%) and delirium or agitation when ill (16.5%) and the persistence of more than three coronavirus-related symptoms after recovery from infection (62.6%).
19th Feb 2021 - CIDRAP

To get ahead of variants, Covid-19 drug makers use evolutionary biology as a guide

Before becoming a Covid-19 drug, each candidate was just a tiny fragment of someone’s immune system, part of a swarm of Y-shaped proteins unleashed to try to keep the coronavirus from invading more cells. If the person recovered, these antibodies might end up in a blood sample in a lab. Some proved more effective than others. Yet even as researchers pinpointed the best of the bunch as possible medications, they knew their power could wane: What worked against the coronavirus as it was last year could falter as the pathogen evolved.
19th Feb 2021 - Stat News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Feb 2021

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Zambia study casts doubt on the assumption that COVID-19 skipped Africa

A new study concluding out of Lusaka, Zambia last summer has found that as many as 19% (almost 1 in 5) of recently-deceased people tested positive for COVID-19. A new Boston University School of Public Health (BUSPH) study in Lusaka, Zambia's capital, challenges the common belief that Africa somehow "dodged" the COVID-19 pandemic. The findings indicate that low numbers of reported infections and deaths across Africa may simply be from lack of testing, with the coronavirus taking a terrible but invisible toll on the continent. Published in The BMJ, the study found that at least 15% and as many as 19% of recently-deceased people arriving at Lusaka's main morgue over the summer had the coronavirus, peaking at 31% in July. Despite most having had COVID symptoms, few were tested before death.
19th Feb 2021 - News-Medical.net

Japan finds more than 90 cases of new COVID-19 virus strain: media

Japanese health authorities have found more than 90 cases of a new strain of the COVID-19 virus, the Mainichi newspaper reported on Friday. The variant is believed to have come from overseas but is different from strains that originated in Britain and South Africa, according to the report which cited Japan’s National Institute of Infectious Diseases. Japan has reported 151 cases of variants from Britain, South Africa and Brazil, according to the health ministry. The nation has had more than 400,000 cases of COVID-19 with 7,194 fatalities.
19th Feb 2021 - Reuters

Pfizer to test COVID-19 vaccine engineered for South African variant

A top Pfizer Inc scientist said on Thursday the company is in intensive discussions with regulators to test a booster shot version of its coronavirus vaccine specifically targeted for a highly contagious variant that is spreading widely in South Africa and elsewhere. A laboratory study released on Wednesday suggested that the South African virus variant may reduce protective antibodies elicited by the Pfizer/BioNTech vaccine by two-thirds, but it is not clear how much that reduces the shot's effectiveness against this version of the pathogen. Phil Dormitzer, one of Pfizer's top viral vaccine scientists and a co-author of the study, said in an interview he believes the current vaccine is highly likely to still protect against the concerning variant first discovered in South Africa. "A level of neutralizing antibodies that may be on the order of between a third and a half the level of neutralizing antibodies you see against the original virus does not mean you have only a third to half of the protection level, you may well have full protection," he said.
18th Feb 2021 - The Jerusalem Post

Pfizer says South African coronavirus variant could reduce efficacy of vaccine by two-thirds

The South African coronavirus variant may reduce protection from the Pfizer vaccine by two-thirds, according to a new laboratory study from Pfizer and BioNTech. Though it is not clear if the shot is effective against the mutation, the study did find the vaccine is still able to neutralise the virus – and there isn’t real-world evidence from human trials yet that the vaccine is ineffective against the variant. But the companies are still making investments and talking to regulators about developing an updated version of their mRNA vaccine or a booster shot, if needed.
18th Feb 2021 - Metro

Zambia study casts doubt on the assumption that COVID-19 skipped Africa

A new study concluding out of Lusaka, Zambia last summer has found that as many as 19% (almost 1 in 5) of recently-deceased people tested positive for COVID-19. A new Boston University School of Public Health (BUSPH) study in Lusaka, Zambia's capital, challenges the common belief that Africa somehow "dodged" the COVID-19 pandemic. The findings indicate that low numbers of reported infections and deaths across Africa may simply be from lack of testing, with the coronavirus taking a terrible but invisible toll on the continent. Published in The BMJ, the study found that at least 15% and as many as 19% of recently-deceased people arriving at Lusaka's main morgue over the summer had the coronavirus, peaking at 31% in July. Despite most having had COVID symptoms, few were tested before death.
18th Feb 2021 - The New York Times

Covid: Johnson & Johnson's vaccine may actually be TWO doses

Johnson & Johnson's one-dose COVID-19 vaccine was hailed as a way to increase supply and more quickly vaccinate the U.S. population But on Thursday, Andy Slavitt, the White House senior advisor on COVID-19 response, said the company is testing the effectiveness of its shot with a booster It's unclear whether this will delay the vaccine being approved by the U.S. Food and Drug Administration for emergency use authorization Worldwide, J&J's was 66% effective at preventing COVID-19 illness, including 72% effective in the U.S., but just 57% effective in South Africa
18th Feb 2021 - Daily Mail

Pfizer coronavirus vaccine may be less likely to protect against South African variant

The Pfizer vaccine may be less likely to protect against infection from the South African variant than other strains, a laboratory study has found, although experts believe that it should still stop severe illness. Blood taken from people who received the vaccine produced two thirds fewer neutralising antibodies against a virus with the key South African mutations compared with the previous variant.
18th Feb 2021 - The Times

These Doctors Want to Pick Their Covid-19 Vaccine, Fearing Reactions, Lower Efficacy

Health-worker unions in Europe say thousands of their members refuse to take one of the three Covid-19 vaccines available in the region because of concerns over efficacy and reports of side effects, the latest setback for the continent’s slow vaccine rollout. Organizations representing health professionals across Europe said this week that doctors and nurses shouldn’t be forced to take the vaccine developed by AstraZeneca PLC because it was shown to offer less robust protection against Covid-19 than the other two currently authorized in the European Union. They also expressed concern over reports that the AstraZeneca vaccine appeared to cause stronger reactions in recipients.
18th Feb 2021 - Wall Street Journal

Covid: Ethnicity vaccine gaps in over-70s

Black and mixed heritage people in their 70s are being vaccinated against Covid-19 at much lower rates than white people, GP records suggest. And fewer Bangladeshi and Pakistani people had been jabbed by 11 February. This follows data from earlier in the vaccination programme showing similar gaps among the over-80s. A discrepancy was not seen in the over-70s at that point, but this is most likely because very few were being vaccinated at that stage. The findings come from a study called OpenSafely, run by the University of Oxford and the London School of Hygiene and Tropical Medicine. The team has access to completely anonymised medical records covering 40% of GP practices in England.
18th Feb 2021 - BBC News

More than half of South Africans infected by Covid-19, says insurer

More than half the population of South Africa may have been infected by Covid-19, the head of the country’s largest health insurer has said. The nation of 58 million people has been hit by a huge second wave of infections after a new and more contagious variant raced through the population. South Africa has recorded nearly half of the Covid-19 deaths and a third of cases in Africa, although rates of testing are limited in many countries.
18th Feb 2021 - The Times

Delayed Second Dose versus Standard Regimen for Covid-19 Vaccination

Case Vignette - You chair the Governor’s task force on rollout of the Covid-19 vaccine. Given concerns about the limited availability of the two-dose mRNA vaccine, you have been asked to weigh in on the debate regarding the most effective use of the currently available doses. Should people who have already received a first dose of vaccine have their second dose delayed by a number of months until there is a greater supply, so that more people can receive a first dose? Or should those who have gotten the first dose receive the second dose according to the standard schedule, 3 to 4 weeks after the first dose, as recommended by the Food and Drug Administration (FDA)? You must consider the benefits and risks of the two approaches, on both individual and population levels, and decide what to recommend to the task force.
18th Feb 2021 - nejm.org

How have COVID-19 pandemic school closures impacted the health of children globally?

As the current coronavirus disease 2019 (COVID-19) continues to challenge public health, most recently by the emergence of new variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), schools in many regions of the world continue to be largely closed. It has been estimated that from March to May 2020, this affected up to 1.5 billion children and young people (CYP). A new study by researchers in the US and the UK explores the damage caused by school closures to educational progress, health, and well-being in CYP globally. Surprisingly, the damage appears to be far less than was originally thought. The team has released their findings on the medRxiv* preprint server.
18th Feb 2021 - News-Medical.Net

Associations between feelings/behaviors during COVID-19 pandemic lockdown and depression/anxiety after lockdown in a sample of Chinese children and adolescents.

Children and adolescents may be more susceptible to mental disorders due to COVID-19 pandemic than adults. This study aimed to identify correlated factors for depression/anxiety among children and adolescents after COVID-19 pandemic lockdown. An online survey by cluster sampling was conducted after lockdown in 5175 Chinese children and adolescents with informed consents from their parents. The 9-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder scales with 10-point cutoff were used to measure depression and anxiety, separately. Stepwise logistic regression was conducted. Stata 15.1 Version was used.
18th Feb 2021 - Physician's Weekly

English lockdown reducing COVID-19 infections but prevalence still high, study finds

England’s third national COVID-19 lockdown is helping to reduce infections, a study found on Thursday, but the prevalence of cases remains high as Prime Minister Boris Johnson eyes a cautious route to re-opening the economy. Johnson is due to set out a roadmap out of the lockdown, which began on January 5, on Monday, and has said that it will be a cautious and prudent approach. The study, known as REACT-1 and led by researchers at Imperial College London, found that national prevalence was two thirds lower between Feb 4 and 13 than it had been in the previous survey that covered Jan 6-22.
18th Feb 2021 - Reuters

Thai-developed COVID vaccine to proceed to human trials

Thailand’s second domestically developed vaccine will soon undergo human trials, officials say, adding that the plan was to produce up to five million doses by the end of the year. The vaccine, developed by Thailand’s Chulalongkorn University, had been successful in trials on mice and monkeys and is due to be tested on humans in late April or early May, Kiat Ruxrungtham of the Chula Vaccine Research Center said on Thursday. “By year-end, we should have a production capacity of one to five million doses annually,” Kiat told a news conference, adding this could later rise to about 20 million doses per year. The announcement comes amid criticism that Thailand’s vaccine strategy has been slow and overly reliant on AstraZeneca shots being produced by local manufacturer Siam Bioscience, which owned by the country’s king. The Thai-developed “ChulaCov19” vaccines are initially being produced in California, but will be produced locally in later stages by Thai company Bionet Asia, Kiat said.
18th Feb 2021 - AlJazeera

Pfizer, Moderna vaccines may be less effective against B1351 variant

Both the Pfizer/BioNTech and the Moderna COVID-19 vaccines may be less effective against the B1351 variant first identified in South Africa, although the latter vaccine could offer good protection against the B117 variant first seen in the United Kingdom, according to two letters published yesterday in the New England Journal of Medicine. In the letter on the Pfizer/BioNTech BNT162b2 coronavirus vaccine, a team led by scientists from the University of Texas Medical Branch in Galveston made three recombinant viruses with different mutations using a SARS-CoV-2 isolate from January 2020. Using 20 serum samples collected from 15 participants in a 2020 trial of the vaccine 2 to 4 weeks after their second dose, they tested the samples' ability to neutralize the 2020 strain and all variants, including B1351 and B117.
18th Feb 2021 - CIDRAP

Vitamin D not effective in moderate to severe COVID, study finds

Less than a week after JAMA Network Open published a small study showing zinc and vitamin C were not associated with improved mild COVID-19 infections, a 240-person JAMA study also found that a single dose of vitamin D did not have any significant effect on moderate to severe COVID-19 infections. The study, published yesterday by Igor Murai, PhD, a Sao Paul rheumatologist, and colleagues, reported that hospital stay was a median 7.0 days for both those in the intervention and the placebo group, and while there were differences up to 8.4 percentage points across in-hospital mortality, intensive care unit (ICU) admission, and mechanical ventilation needs, they were all statistically not significant.
18th Feb 2021 - CIDRAP

UK COVID-19 swab study highlights lockdown impact

The latest results from an ongoing study from Imperial College London to track COVID-19 patterns in Britain show that infections have fallen by more than two-thirds since January, likely due to lockdowns. In other global developments, the World Health Organization announced a new battle plan against COVID-19. The research team based at Imperial College London, part of the REACT program, has been using home-based swab tests to tracking virus spread, and their latest results from a preprint study include 85,000 people who were tested between Feb 4 and Feb 13. Infections fell across the country, with steeper drops in London and the South East, and more modest declines in Yorkshire and Humber. Prevalence dipped across all ages at a similar level, suggesting that the pattern is due to the lockdown, rather than vaccination. However, they warned that infections are still high, at about 1 in 200 people, with the highest levels seen in young people ages 5 to 12 and those ages 18 to 24 years old.
18th Feb 2021 - CIDRAP

Novavax, coronavirus shot data in hand, strikes an eye-popping supply deal with global vaccine consortium

COVID-19 vaccine maker Novavax has at times flown under the radar as some of the world's leading drugmakers dominated headlines and raced toward rollouts. But an eye-popping new supply deal with international players is sure to turn heads. Novavax on Thursday unveiled a memorandum of understanding with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of its coronavirus vaccine candidate to COVAX, a global effort to ensure equitable vaccine distribution. The Serum Institute of India will help produce doses under a prior deal between that company and Gavi. The deal will support work by Gavi, the Coalition for Epidemic Preparedness Innovations and the World Health Organization to distribute doses in every country worldwide.
18th Feb 2021 - Fierce Pharma

Bring on the boosters: Studies show Pfizer, Moderna COVID vaccines are less potent against aggressive variant

In early January, researchers from the University of Texas and Pfizer published a preprint study suggesting that Pfizer’s COVID-19 vaccine could protect against a mutation discovered in the U.K. and South Africa. Two weeks later, though, news emerged that Pfizer and its partner BioNTech were working on booster shots to protect against new variants. Now there’s more evidence that Pfizer’s vaccine—as well as the other authorized mRNA vaccine from Moderna—will need to be updated to fend off aggressive new variants of COVID-19. The data are raising concerns among some analysts of "breakthrough" cases of COVID-19, even in vaccinated people, and the potential for more lockdowns this summer. In a letter published in the New England Journal of Medicine Wednesday, Pfizer and the University of Texas said a lab study showed the vaccine was about two-thirds less potent against the South African variant of COVID-19 than it was against the original virus.
18th Feb 2021 - Fierce Pharma

Pfizer study another worry for South Africa's vaccine rollout

Scientists will meet on Thursday to advise South Africa’s government on its next steps after a study suggested the dominant local coronavirus variant may reduce protective antibodies from Pfizer’s COVID-19 vaccine by two-thirds. The laboratory study, published in the New England Journal of Medicine, is another worry for the country hardest-hit by the pandemic on the African continent after it placed AstraZeneca vaccinations on hold earlier this month. Although its implications on the real-world efficacy of Pfizer’s vaccine are not yet clear, the study comes after clinical trial data on the AstraZeneca, Johnson & Johnson (J&J) and Novavax vaccines showed reduced efficacy against the more contagious 501Y.V2 variant, first identified late last year.
18th Feb 2021 - Reuters

How covid-19 testing is developing and its future

An HSJ and Siemens Healthineers roundtable discussed how the covid-19 testing regime has developed to date, how it will need to evolve further to consistently reach the right person with the right test at the right time, and what its likely legacy will be for the diagnostics sphere as a whole. The words “testing” and “game changer” have frequently been seen together in the months since the pandemic began. Boris Johnson initially applied the phrase to antibody testing and then in September to rapid mass testing of asymptomatic individuals, which he suggested could offer a route to renewed social gatherings even pre-widespread vaccination. But away from such high profile proclamations, how has covid-19 testing actually developed? And how could and should it develop in the longer term?
17th Feb 2021 - Health Service Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Feb 2021

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Pfizer says South African variant could significantly reduce vaccine protection

A laboratory study suggests that the South African variant of the coronavirus may reduce antibody protection from the Pfizer Inc/BioNTech SE vaccine by two-thirds, and it is not clear if the shot will be effective against the mutation, the companies said on Wednesday.
18th Feb 2021 - Reuters

Senate panel endorses bill seeking P500M indemnification fund for COVID-19 vaccine side effects

The Senate Finance Committee has endorsed for plenary approval a measure that would ensure availability of national funds to compensate Filipinos in case they die or experience serious side effects after receiving COVID-19 shots. Senator Sonny Angara, who serves as the chair of the panel, sponsored Bill No. 2057 or the proposed COVID-19 Vaccination Program Act of 2021 on Tuesday. It consolidated the bills related to COVID-19 vaccines filed by other lawmakers. Under the bill, ₱500 million will be provided for the COVID-19 National Indemnity Fund. The money will be sourced from the contingent fund of the national budget. State insurance agency PhilHealth was tasked to oversee its administration. A special task group composed of medical and vaccine experts will conduct post-vaccination monitoring of patients.
17th Feb 2021 - CNN Philippines

Study Investigates COVID-19 in Pregnant Patients with Rheumatologic Disease

A new study has found that among patients with rheumatologic disease, pregnancy is not associated with increased self-reported COVID-19, but is associated with a shorter duration of COVID-19 symptoms and a higher prevalence of loss of smell or taste. The study, by researchers from Hospital for Special Surgery (HSS), in New York City, appears online first in the journal Arthritis Care & Research.
17th Feb 2021 - Associated Press

Experts say India's Covid-19 'human barricade' to keep cases under control

With falling rates of Covid-19 infection in India and surveys suggesting nearly 300 million people may already have antibodies, some experts believe the worst of the disease has passed, despite a recent uptick in two hard-hit states. "There is a human barricade for the virus," said Bhramar Mukherjee, an epidemiologist at the University of Michigan, who with a team of researchers, has been modeling the trajectory of the outbreak in India. "By the end of March, we should see a very slow, steady decline (in cases)," she added. Cases that were rising by nearly 100,000 a day in September are now growing at just 10,000 a day. And India's official number of total infections, which was projected to surpass that of the United States in late 2020, now stands at 11 million, well behind the US tally of about 28 million.
17th Feb 2021 - Hindustan Times

‘India’s COVID-19 infections grossly underestimated’

India’s southern state of Karnataka alone may have had 31.5 million cases of COVID-19 or nearly 95 times greater than have been reported, says a new study that puts a question mark on the 10 million plus cases reported for the whole country so far. Published this month in the Journal of the American Medical Association, the study is based on data collected from a representative sample of households in 20 districts of Karnataka, home to 70 million of India’s 1.3 billion people. As of Monday, 15 February, according to Worldometers, India had recorded 10,916,589 cases of COVID-19, second only to the US with 28,261,470 cases. Brazil came in third with 9,834,513 cases.
17th Feb 2021 - SciDev

Lockdown may have boosted well-being for some

A study of people who care for children finds that COVID-19 lockdowns have provided some unexpected benefits. Survey respondents report four areas of personal growth that have been given an opportunity to flourish when busy lives were interrupted. People reported positive changes in their family relationships, spiritual well-being, and more. The study suggests ways we may emerge from the pandemic strengthened by the experience.
17th Feb 2021 - Medical News Today

Covid-19: World's first human trials given green light in UK

Healthy, young volunteers will be infected with coronavirus to test vaccines and treatments in the world's first Covid-19 "human challenge" study, which will take place in the UK. The study, which has received ethics approval, will start in the next few weeks and recruit 90 people aged 18-30. They will be exposed to the virus in a safe and controlled environment while medics monitor their health. The UK has given doses of a Covid vaccine to more than 15 million people. Human challenge studies have played a vital role in pushing the development of treatments for a number of diseases, including malaria, typhoid, cholera and flu.
17th Feb 2021 - BBC News

‘NHS workers will need help to manage the trauma of the pandemic’

There’s no doubt some occupational groups have had a particularly tough time, especially NHS workers. Many NHS staff have dealt with inordinate numbers of critically ill patients. Some have been trying to provide care in a far from ideal situation, knowing that doing so will lead to poor outcomes for their patients. This is having an impact on their mental health. My recent study of staff working in critical care during the pandemic showed they report more than twice the rate of probable post-traumatic stress disorder (PTSD) found in military veterans who’ve recently experienced combat. While the situations may be different, there might be some lessons we can learn from studied of PTSD in military veterans to help NHS workers cope during the pandemic.
17th Feb 2021 - Nursing Notes

Contact tracing alone has little impact on curbing Covid spread, report finds

Contact tracing alone has a marginal impact on Covid transmission, curbing the spread of the disease by just 2% to 5%, official estimates show. The figures come after Dido Harding, who heads the government’s £22bn test-and-trace programme in England, suggested it was set to substantially reduce the spread of coronavirus this spring. Newly published data behind that assertion shows the vast majority of the impact of test and trace is down to people self-isolating. An army of contact tracers has been hired to track down close contacts of those who test positive for Covid, and ask them to self-isolate. The contact tracers also remind people of the need to quarantine after a positive test.
17th Feb 2021 - The Guardian

Pregnancy tied to estimated 70% higher COVID-19 rate

Pregnant women in Washington state were infected with COVID-19 at a 70% higher rate than others of similar ages, with nonwhite women shouldering a disproportionate burden, according to a study published yesterday in the American Journal of Obstetrics & Gynecology. Noting that population-based estimates of coronavirus infections in pregnancy are unreliable due to incomplete recording of pregnancy status or inclusion of only hospitalized patients, a team led by researchers from the University of Washington in Seattle analyzed data from 240 pregnant COVID-19 patients at 35 healthcare systems, capturing 61% of the state's annual births, from Mar 1 to Jun 30, 2020.
17th Feb 2021 - CIDRAP

FDA could reject AstraZeneca’s COVID vaccine on efficacy and manufacturing shortfalls: analyst

It was bad enough when a study released last week concluded that AstraZeneca’s COVID-19 vaccine was largely ineffective against the aggressive B.1.351 variant that recently emerged in South Africa. Now, analysts are wondering whether inconsistent manufacturing of the vaccine for the clinical trials may have muddied the results—concerns that could give the FDA pause when considering the vaccine for emergency use. That was the conclusion of a note SVB Leerink analysts sent to clients Wednesday, in which they laid out both the bear and bull cases for FDA authorization of AstraZeneca’s COVID vaccine. The bottom line? The bear case is worrisome, they said. One major concern SVB Leerink cited is that AstraZeneca is manufacturing its vaccine on a “distributed” basis, meaning it’s not centralized, but spread over multiple sites and contract partners. The material used to make the vaccine for the South Africa trial came from a company in India, and it’s not clear where it was manufactured or whether the results from that trial truly reflect the properties of the vaccine that’s being developed for the U.S.
17th Feb 2021 - FiercePharma

Pfizer, Moderna pledge more mRNA vaccine doses to Europe after AZ supply concerns

After a coronavirus vaccine supply feud between top officials in Europe and COVID-19 vaccine player AstraZeneca, officials there are doubling down on their purchase of an alternative technology. This week, the bloc finalized the purchase of 350 million additional mRNA vaccine doses. Pfizer and BioNTech struck a deal with the European Commission to supply 200 million more doses of their mRNA-based COVID-19 vaccine, Corminaty, to the European Union, with the option to sell an additional 100 million doses at a later date. The move comes after a factory upgrade in Belgium prompted the companies to temporarily reduce shipments with an eye on delivering "significantly more" doses in the second quarter. The sale comes on top of 300 million Comirnaty doses the partners sold to the EU in November, bringing the bloc's total order up to 500 million shots. The new 200-million-dose tranche will be rolled out in 2021, with some 75 million doses pegged for delivery in the second quarter.
17th Feb 2021 - Scientific Viewpoint

In lab experiment, Pfizer-BioNTech vaccine less potent against coronavirus variant

The Pfizer-BioNTech Covid-19 vaccine loses some potency against the coronavirus variant that first appeared in South Africa, researchers reported Wednesday, based on lab experiments. What the findings mean for how well the vaccine will protect real people from the variant, called B.1.351, is hard to tell. But clinical data from three other vaccines — those from AstraZeneca, Novavax, and Johnson & Johnson — have already shown the shots are not as powerful at blocking symptomatic Covid-19 cases caused by B.1.351 as by other forms of the virus. In the new study, which was published Wednesday in the New England Journal of Medicine, researchers from Pfizer, BioNTech, and the University of Texas Medical Branch examined how well blood taken from people who had received the companies’ shot fought off a virus engineered to have the key mutations found in B.1.351. They reported that there was about a two-thirds drop in neutralization power against the variant compared to other forms of the SARS-CoV-2 coronavirus.
17th Feb 2021 - STAT News

The myth of ‘good’ and ‘bad’ Covid vaccines: Why false perceptions overlook facts, and could breed resentment

Mike Ryan, the World Health Organization’s health emergencies director, had a conversation recently with his mother, the kind that lots of public health people are having these days, much to their dismay. Ryan’s mother was concerned about one of the Covid-19 vaccines in use in Ireland, where she lives. The one made by AstraZeneca. Clinical trials had shown the vaccine offered protection against the disease, but less than the vaccine made by Moderna or the one made by Pfizer and BioNTech. Ryan’s mother was worried the vaccine might not be good enough.
17th Feb 2021 - STAT News

Lab studies suggest Pfizer, Moderna vaccines can protect against coronavirus variant

A new report published in the New England Journal of Medicine on Wednesday suggests that Pfizer-BioNTech's Covid-19 vaccine can protect people against concerning new coronavirus variants, including one first seen in South Africa called B.1.351. For the study, researchers at Pfizer and the University of Texas Medical Branch genetically engineered versions of the virus to carry some of the mutations found in B.1.351. They tested them against blood samples taken from 15 people who had received two doses of the Pfizer/BioNTech vaccine as part of a clinical trial. While the blood serum samples produced less neutralizing antibody activity, it was still enough to neutralize the virus, they wrote in a letter to the journal. This is in line with other studies. And it's well within what is seen with other viruses, one of the researchers said.
17th Feb 2021 - CNN

South Africa launches vaccine roll-out with Johnson & Johnson jab

South Africa has kicked off its vaccination campaign against COVID-19 by injecting healthcare workers with the shot developed by Johnson & Johnson as part of an observational study. The first healthcare worker was inoculated at 1pm (11:00 GMT) on Wednesday at the Khayelitsha District Hospital in Cape Town, following the arrival of 80,000 vaccine doses at Johannesburg’s international airport the night before. President Cyril Ramaphosa, along with Health Minister Zweli Mkhize and Deputy Health Minister Joe Phaahla, were also among the first to be vaccinated. “This day marks a milestone for South Africa. Finally, the vaccines are here, and they are being administered,” Ramaphosa told reporters as he sought to allay any fears among South Africans sceptical about an inoculation drive that has been hit by delays and the spread of misinformation. “I’d like to invite South Africans to take this up so that we can all be safe and we can all be healthy.”
17th Feb 2021 - Al Jazeera English

Exclusive: Two variants have merged into heavily mutated coronavirus

Two variants of the SARS-CoV-2 coronavirus that causes covid-19 have combined their genomes to form a heavily mutated hybrid version of the virus. The “recombination” event was discovered in a virus sample in California, provoking warnings that we may be poised to enter a new phase of the pandemic. The hybrid virus is the result of recombination of the highly transmissible B.1.1.7 variant discovered in the UK and the B.1.429 variant that originated in California and which may be responsible for a recent wave of cases in Los Angeles because it carries a mutation making it resistant to some antibodies. The recombinant was discovered by Bette Korber at the Los Alamos National Laboratory in New Mexico, who told a meeting organised by the New York Academy of Sciences on 2 February that she had seen “pretty clear” evidence of it in her database of US viral genomes.
16th Feb 2021 - New Scientist

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Feb 2021

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Call for nurses to join Covid-19 vaccine side effects study

Nurses and other health professionals from the UK are being encouraged to take part in a safety study of the Oxford/AstraZeneca Covid-19 vaccine in order to tackle possible side effects. They are also being asked to urge patients to sign up to the study,
16th Feb 2021 - Nursing Times

Bristol children as young as six can take part in Oxford University coronavirus vaccine trial

Bristol has been selected as one of four locations to take part in a world-first coronavirus vaccine trial for children. The University of Oxford study will recruit up to 300 child volunteers nationally, aged between six and 17 years old, to investigate if the current Oxford-AstraZeneca vaccine is effective in protecting children. As well as the Oxford site, three partner sites in London, Southampton and at Bristol Royal Hospital for Children will run the trial. It launched today (Monday, February 15) and the first vaccinations are expected to commence later this month. Recruitment for Bristol's is open to all BS postcodes via the trial website, which states that participants from Black, Asian and minority ethnic groups are "particularly welcome" to take part. The length of the study is one year and participants will be asked to attend five visits, with anyone under the age of 16 requiring parental consent.
16th Feb 2021 - Bristol Live

My Teens Are Coronavirus Vaccine Guinea Pigs

The day after my teenagers got their first shots in the Moderna Covid vaccine trial, I found my 13-year-old daughter, Zoe, sprawled out in bed during a distance-learning art class. Under a pile of blankets, she said she had chills. My heart skipped a beat. Any other time I would have worried about her missing school or Nordic ski practice, but this time I was elated when her temperature peaked at 100.5 degrees. A fever meant she was probably reacting to a real mRNA vaccine, and not a placebo. Maybe she’d won the vaccine lottery! When Pfizer and Moderna were granted emergency authorization to license their vaccines in December, the shots were approved for people as young as 16 and 18, respectively. But in order to end the pandemic, many experts said that younger children will need to be vaccinated.
16th Feb 2021 - The New York Times

North Korean hackers attempted to steal Pfizer coronavirus vaccine

South Korea's National Intelligence Service claim North Korea tried stealing data The NIS claim hackers targeted vaccine manufacturer Pfizer to steal information North Korea has continuously claimed it has not had a single Covid-19 case Last month it was reported North Korea was starting to develop its own vaccine
16th Feb 2021 - Daily Mail

Covid vaccine impact revealed in over-80s blood tests

England's vaccination programme is starting to pay off, with the over-80s age group now the most likely to test positive for coronavirus antibodies, Office for National Statistics testing suggests. Blood tests reveal more over-80s than any other age group in England are showing signs of some immunity against Covid infection. This comes as Covid deaths have fallen. But overall, deaths are still 40% above the five-year average.
16th Feb 2021 - BBC News

Why the three biggest vaccine makers failed on Covid-19

As pharmaceutical companies raced to develop Covid-19 vaccines, crossing the finishing line in record time, the world’s three biggest vaccine makers were also-rans. GlaxoSmithKline, Merck and Sanofi are now left playing catch-up, after upstarts including Moderna and BioNTech demonstrated their mastery of new technologies that will shape the industry for years to come. New Jersey-based Merck recently dropped its vaccine development programme completely, while Paris-based Sanofi and the UK’s GSK are having to redo an early-stage trial of the jab they are jointly developing, after a dosing mistake.
16th Feb 2021 - The Financial Times

Covid-19 could cause potentially dangerous 'nodules' on patients' EYEBALLS due to inflammation triggered by the virus, scientists warn

From a dry cough to a high fever, coronavirus is known to be linked to a range of unpleasant symptoms. Now, a new study has revealed another potential side effect - nodules on the eyeballs. Researchers have warned that coronavirus infection may trigger inflammation of the eyeballs and lead to the formation of mysterious nodules at the back of the organ. Experts do not yet know what causes these nodules or the impact they have on a patient's long-term health. However, a study of 129 French patients who had severe Covid-19 and underwent MRI scans revealed nine of them (seven per cent) suffered abnormalities.
16th Feb 2021 - Daily Mail on MSN.com

GPs could offer common asthma drug as early Covid-19 intervention

A common asthma drug, Budesonide, which could be given by GP surgeries as an early community intervention, has been found to reduce Covid-19 symptoms. In a small trial at the University of Oxford, the steroid inhaler was given seven days after the onset of Covid-19 symptoms and appeared to significantly reduce the need for critical care. The researchers also reported persistent symptoms, seen after 28 days, were reduced with the asthma drug. The study, which has yet to be peer-reviewed, involved 146 people who had tested positive for Covid-19, half of whom were given 800 mg of Budesonide twice a day and the other half received the usual care.
16th Feb 2021 - Pulse Today

SA asks Serum Institute to take back 1 million vaccine doses — report

SA has asked the Serum Institute of India to take back the one million Covid-19 vaccine doses the company had sent in early February, The Economic Times reported on Tuesday, a week after the country said it will put on hold use of AstraZeneca's shot in its vaccination programme. Serum Institute of India, which is producing AstraZeneca's shot, has emerged as a key vaccine supplier. One million doses of the Covid-19 vaccine landed in SA last week and another 500,000 were due to arrive in the next few weeks. The company did not immediately respond to a Reuters request for comment.
16th Feb 2021 - TimesLIVE

Novavax signs deal with SK Bioscience for 40 mln vaccine doses for S. Korea

U.S. drug developer Novavax Inc said on Monday it has signed a license agreement with South Korea manufacturer SK Bioscience to produce 40 million doses of its COVID-19 vaccine for South Korea. “Concurrently, SK Bioscience has finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021,” Novavax said in a statement https://bit.ly/37eMKB2.
16th Feb 2021 - Financial Post

WHO authorizes AstraZeneca's COVID vaccine for emergency use

The World Health Organization has granted an emergency authorization to AstraZeneca’s coronavirus vaccine, a move that should allow the U.N. agency’s partners to ship millions of doses to countries as part of a U.N.-backed program to tame the pandemic. In a statement Monday, the WHO said it was clearing the AstraZeneca vaccines made by the Serum Institute of India and South Korea’s AstraZeneca-SKBio. The WHO’s green light for the AstraZeneca vaccine is only the second one the U.N. health agency has issued after authorizing the Pfizer-BioNTech vaccine in December. Monday’s announcement should trigger the delivery of hundreds of millions of doses to countries that have signed up for the U.N.-backed COVAX effort, which aims to deliver vaccines to the world’s most vulnerable people.
16th Feb 2021 - Associated Press

Another new coronavirus variant seen in the UK

Scientists have identified another new variant of coronavirus in the UK with some potentially troubling mutations. B.1.525 appears similar to the South African variant which prompted door-to-door tests in areas where it has been found. Researchers from Edinburgh University have found 38 cases so far - 2 in Wales and 36 in England - in samples dating back to December. It has been seen in other countries, including Denmark, Nigeria and the US. UK experts are studying it to understand what risk it poses. It is too soon to say if it should be added to the UK's list of "variants of concern" and whether mass testing for it should happen. So, for now, it is a "variant under investigation".
16th Feb 2021 - BBC News

Brazil says Amazon COVID-19 variant three times more contagious

A coronavirus variant identified in the Brazilian Amazon may be three times more contagious but early analysis suggests vaccines are still effective against it, the country’s health minister said on Thursday, without providing evidence for the claims. Under pressure as the variant hammers the jungle city of Manaus with a devastating second wave of infections, Health Minister Eduardo Pazuello sought to reassure legislators that the surge of recent months was unexpected but coming under control.
12th Feb 2021 - Al Jazeera English

COVID-19: Scientists identify new coronavirus variant with potentially concerning mutations

Scientists have identified another new coronavirus variant in the UK which has potentially concerning mutations. B.1.525, the new variant, contains a genetic change called E484K which is also found in the Brazilian and South African variants. Public Health England (PHE) has said there is no evidence that the mutations in the new variant make the virus more transmissible or cause severe disease. Laboratory studies have shown that viruses with the E484K mutation can escape human defences, making them more efficient at evading natural and vaccine-triggered immunity
16th Feb 2021 - BBC News

Fauci wins $1 million Israeli prize for 'defending science'

The Dan David Foundation, which is based at Tel Aviv University, said on Monday that Fauci has won the prize for “courageously defending science in the face of uninformed opposition during the challenging COVID crisis,” the Seattle Times reported. “As the COVID-19 pandemic unraveled, [Fauci] leveraged his considerable communication skills to address people gripped by fear and anxiety and worked relentlessly to inform individuals in the United States and elsewhere about the public health measures essential for containing the pandemic’s spread,” the foundation’s awards committee said.
16th Feb 2021 - The Hill

Initial sky-high UK in-hospital COVID death rate fell sharply

The in-hospital death rate among adult COVID-19 patients in England early in the pandemic was 31% but declined significantly over time, with older age, male sex, low socioeconomic status, Asian or mixed ethnicity, and underlying conditions signaling poor outcomes, according to a retrospective, observational study published yesterday in The Lancet Respiratory Medicine. A team led by a researcher from University College London used the National Health Service Hospital Episode Statistics administrative dataset to estimate in-hospital deaths and contributing factors among 91,541 COVID-19 patients at 500 hospitals from Mar 1 to May 31, 2020.
16th Feb 2021 - CIDRAP

U.K. inspects AstraZeneca vaccine partner's India manufacturing, setting stage for supply boost

AstraZeneca set up a globetrotting supply network for its COVID-19 vaccine to deliver doses around the world, but it hasn't tapped regional producers to ease delivery shortfalls elsewhere. But that could change—and soon. British regulators are inspecting one of the drugmaker's biggest production partners, Serum Institute of India, which signed on to manufacture AstraZeneca's shot for its home country and other global markets. Sources close to the matter told Reuters about the manufacturing audit. A green light from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) could clear the way for AstraZeneca to import the India-made shots to the U.K. and EU, which has struggled to beef up vaccine supplies after AZ said it would cut first-quarter deliveries last month.
16th Feb 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Feb 2021

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Next coronavirus vaccines may be drops, pills or printed on demand

The race to develop vaccines against covid-19 got off to a flyer, but with dangerous new virus variants, stark inequalities in access to vaccines and few vaccination options for children, the world still needs all hands on deck. Last week, a virtual meeting run by the New York Academy of Sciences called The Quest for a COVID-19 Vaccine showcased the most promising new candidates. So far, all approved covid-19 vaccines have been injectable. Another option is a nose drop, says Robert Coleman, CEO of biotech company Codagenix, in Farmingdale, New York.
15th Feb 2021 - New Scientist

Countries already using Pfizer coronavirus vaccine include UK, US, Canada and Singapore

As Australia takes delivery of its first shipment of coronavirus vaccines, at least 44 countries have already begun inoculating their citizens using the Pfizer-BioNTech shot, World Health Organization data shows. Dozens of other countries have also begun mass inoculations, but they have started early without WHO approval. The Pfizer shot is the only vaccine with WHO emergency approval so far. The countries using the vaccine are mostly located in Europe, with Canada, the United States, Chile, Singapore and some Middle Eastern countries also securing doses.
15th Feb 2021 - ABC News

Pan-European consortium seeks big pharma partner for COVID-19 shot

A pan-European consortium developing a COVID-19 vaccine is in talks with big pharma to support the late-stage development of its shot and ramp up manufacturing, the head of German biotech firm Leukocare told Reuters. Leukocare is working with Italy’s ReiThera and Belgium’s Univercells on a vaccine based on a so-called non-replicating adenoviral vector, the same technology that AstraZeneca and Johnson & Johnson have used. Chief Executive Michael Scholl said the companies were talking to potential big pharma partners about whether they could provide additional manufacturing capacity, as well as help to advance their candidate through Phase III clinical trials.
15th Feb 2021 - Reuters

Wearing a face mask can reduce your risk of severe Covid-19: Humidity inside coverings limits the spread of the virus to the lungs leading to milder infection, study shows

NIH researchers assessed humidity of a space before and after wearing a mask. Masks increase humidity by between 38 and 90 per cent compared to maskless. This leads to hydrated air being inhaled by the person wearing the mask. This helps the respiratory tract to clear out the virus in the mucus and prevent it reaching the lungs
15th Feb 2021 - Daily Mail

COVID-19 shots might be tweaked if variants get worse

The makers of COVID-19 vaccines are figuring out how to tweak their recipes against worrisome virus mutations — and regulators are looking to flu as a blueprint if and when the shots need an update. “It’s not really something you can sort of flip a switch, do overnight,” cautioned Richard Webby, who directs a World Health Organization flu center from St. Jude Children’s Research Hospital. Viruses mutate constantly and it takes just the right combination of particular mutations to escape vaccination. But studies are raising concern that first-generation COVID-19 vaccines don’t work as well against a mutant that first emerged in South Africa as they do against other versions circulating around the world.
15th Feb 2021 - The Independent

Covid-19: Vaccine as good in 'real world' as in trial in Israel

More data from Israel's vaccination programme is suggesting the Pfizer jab prevents 94% of symptomatic infections. This indicates the vaccine is performing just as well in a larger population as it did in the clinical trials. It is proving highly effective at preventing illness and severe disease among all age groups, according to public health doctor Prof Hagai Levine. "High vaccination coverage of the most susceptible groups" was key, he said. Israel's largest health fund Clalit looked at positive tests in 600,000 vaccinated people and the same number of unvaccinated people, matched by age and health status. It found 94% fewer infections among the vaccinated group. This was based on test results in people's medical records, usually taken if they had symptoms or were a close contact of someone who had tested positive. And the vaccine prevented almost all cases of serious illness. This pattern was the same in all age groups - including the over-70s, who may have been under-represented in clinical trials.
15th Feb 2021 - BBC News

The search for new Covid drugs — and a researcher’s reason for optimism

David Fajgenbaum is a physician and scientist at the University of Pennsylvania. He is best known for his personal battle against Castleman Disease, which nearly killed him before he discovered a treatment that saved his life. Now, however, Fajgenbaum’s research lab at Penn is now working to catalog and analyze drugs that might prove effective against Covid-19. He recently joined STAT’s podcast, “The Readout LOUD,” to discuss that work and more. Excerpts of the conversation are below, lightly edited for clarity.
15th Feb 2021 - Stat News

WHO approves AstraZeneca/Oxford COVID-19 vaccine for emergency use

The World Health Organization (WHO) on Monday listed AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use, widening access to the relatively inexpensive shot in the developing world. “We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production,” Tedros Adhanom Ghebreyesus, WHO Director-General, told a news briefing. “We continue to call for COVID19 vaccine developers to submit their dossiers to WHO for review at the same time as they submit them to regulators in high-income countries,” he said. A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
15th Feb 2021 - Reuters

How effective is a single vaccine dose against Covid-19?

The cases are already beginning to emerge. When 85-year-old Colin Horseman was admitted to Doncaster Royal Infirmary in late December, it was for a suspected kidney infection. But not long afterwards he caught Covid-19 – at the time, roughly one in four people in hospital with the virus had acquired it there. He developed severe symptoms and was eventually put on a ventilator. A few days later, he died. At first glance, Horseman's situation may seem fairly typical, though no less tragic for it. After all, at least 84,767 people have now succumbed to the disease in the UK alone at the time of writing. But, as his son recently explained in a local newspaper, less than three weeks earlier he had been among the first people in the world to receive the initial dose of a Covid-19 vaccine – the Pfizer-BioNTech version. He was due to receive the second dose two days prior to his death.
15th Feb 2021 - BBC News

Is it safe for pregnant women to have a COVID-19 vaccine?

Last week, my sister who is an NHS dentist, told me she was going to get her first dose of the COVID-19 vaccine. While we spoke on the phone, she said she was a little apprehensive about getting it. When I asked her why she said two of the dental nurses at her surgery were not getting theirs as they both saw messages on WhatsApp that said the vaccine would make them infertile. I told my sister it was complete nonsense and that there was no evidence to suggest this was true; she subsequently went to get vaccinated, but the nurses did not. Sadly, I am hearing from many young people who are hesitant to take the COVID vaccine due to misinformation they have come across around fertility – so let me address this issue head-on.
15th Feb 2021 - Al Jazeera English

COVID-19: Oxford vaccine creator calls for donations to help people in poorer countries receive a jab

The co-creator of the Oxford vaccine has called on people to give money to support coronavirus vaccination in poorer countries. Professor Sarah Gilbert is backing a new campaign launching today, which asks people in the UK to give money to the World Health Organisation COVID-19 relief fund when they receive the date for their coronavirus vaccination. "We produced and developed the Oxford vaccine as a vaccine for the world," Professor Gilbert said about the campaign, which is called Arm in Arm. "We are happy to support a new initiative to get COVID vaccines to as many people as possible."
14th Feb 2021 - Sky News

WHO green-lights AstraZeneca COVID vaccine for urgent use

The World Health Organization (WHO) today announced that the AstraZeneca-Oxford COVID-19 vaccine made in two different countries is listed for emergency use, clearing the final hurdle for doses to be distributed by the COVAX program. In other developments, WHO officials said multiple factors are probably responsible for a drop in global cases, and the European Centre for Disease Prevention and Control (ECDC) said in its latest risk assessment that countries are seeing an increase in the number and proportion of SARS-CoV-2 variants.
14th Feb 2021 - CIDRAP

Coronavirus China: WHO scientist says virus was 'widespread' in December

Peter Embarek, lead WHO researcher in Wuhan, has revealed virus was circulating 'widely' in December 2019. He also revealed 13 variants were found among early cases, suggesting disease was in humans for some time. Embarek stopped short of saying disease was circulating before December, but called for further research Comes less than a week after Embarek told a press conference in China that there is no evidence the virus was circulating 'in Wuhan or elsewhere' before December
14th Feb 2021 - Daily Mail

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Feb 2021

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Lifelong immunity hope for Covid-19 vaccine

Trials of coronavirus vaccines for children as young as five are set to begin within days, laying the groundwork for a childhood immunisation programme that could protect people from Covid-19 for most of their lives. AstraZeneca started recruiting British children for a paediatric trial, with the first vaccines to be given by the end of the month. Pfizer is close to beginning a similar global trial. If successful they could pave the way for a vaccine programme on the model of measles or polio, in which a series of jabs early in life provide immunity lasting decades. A booster programme might be needed for the elderly. Professor Sarah Gilbert, chief investigator on the Oxford team behind the AstraZeneca vaccine, believes such a programme could reduce the consequence of Covid infection for most healthy adults to those of a cold
14th Feb 2021 - The Times

China hits back after US expresses 'deep concerns' over WHO Covid-19 report

China has fired back at the US over allegations from the White House that Beijing withheld some information about the coronavirus outbreak from World Health Organization investigators. The White House on Saturday called on China to make data from the earliest days of the Covid-19 outbreak available, saying it had “deep concerns” about the way the findings of the WHO’s Covid-19 report were communicated. China responded with a statement from its Washington embassy on Sunday, saying the US had already gravely damaged international cooperation on Covid-19 and was now “pointing fingers at other countries who have been faithfully supporting the WHO and at the WHO itself”.
14th Feb 2021 - The Guardian

Covid-19 may not have started in China, says WHO expert

The virus which causes Covid-19 may not have emerged in China, a World Health Organisation (WHO) scientist has suggested. Professor John Watson, who was part of the WHO team that travelled to China to investigate the origins of the pandemic, said the virus’s leap from animals to humans may have occurred outside the country’s borders. He told BBC One’s The Andrew Marr Show that the pandemic most likely started with an infection in an “animal reservoir” which was then passed on to humans through an “intermediate host”. Asked if he was sure the virus emerged in China, Prof Watson, who previously served as England’s deputy chief medical officer until 2017, said “no”.
14th Feb 2021 - Wales Online

COVID-19: Vaccines giving 67% protection after three weeks, large-scale research shows

One dose of a COVID-19 vaccine gives 67% protection after three weeks, a leading epidemiologist has said. Professor Tim Spector of King's College London, who runs the ZOE COVID-19 surveillance app, said data collected from 50,000 users vaccinated with either the Pfizer or Oxford/AstraZeneca jab showed one dose gave 46% protection after two weeks, rising to 67% after three to six weeks. The app uses information submitted by more than four million users across the world to predict and track coronavirus infections across the UK and other countries
14th Feb 2021 - Sky News

Double masking can block 92% of infectious particles, CDC says

Double masking can significantly improve protection, new data from the US Centers for Disease Control and Prevention shows. Researchers found that layering a cloth mask over a medical procedural mask, such as a disposable blue surgical mask, can block 92.5% of potentially infectious particles from escaping by creating a tighter fit and eliminating leakage. "These experimental data reinforce CDC's prior guidance that everyone 2 years of age or older should wear a mask when in public and around others in the home not living with you," CDC Director Dr. Rochelle Walensky, told a White House briefing.
14th Feb 2021 - CNN

UK’s ‘Professor Lockdown’ hopeful there will be no further lockdowns

Britain's "Professor Lockdown" says the U.K. is on track to start loosening restrictions next month — and that he's optimistic there will be no need for further lockdowns in the year ahead. Professor Neil Ferguson of Imperial College London said the spread of the so-called U.K.-variant "has set us back a lot" but that he is hopeful following weeks of tough restrictions that primary schools at least will be able to reopen in early March. "We're in a better place than I might have anticipated a month ago," he told POLITICO's Westminster Insider podcast. "The lockdown has really driven down cases quite fast. They’re basically halving about every 17 days at the moment or so, and that means in a month's time — the prime minister's talked about potentially reopening schools, we might have some bandwidth to do that, at least primary schools. And if we continue to see then a continued decline without large outbreaks, then perhaps starting to relax other aspects of society the following month."
14th Feb 2021 - POLITICO.eu

7 Virus Variants Found in U.S. Carrying the Same Mutation

In a study posted on Sunday, a team of researchers reported seven growing lineages of the novel coronavirus, spotted in states across the country. All of them have evolved a mutation in the same genetic letter. “There’s clearly something going on with this mutation,” said Jeremy Kamil, a virologist at Louisiana State University Health Sciences Center Shreveport and a co-author of the new study. It’s unclear whether it makes the variants more contagious. But because the mutation appears in a gene that influences how the virus enters human cells, the scientists are highly suspicious. “I think there’s a clear signature of an evolutionary benefit,” Dr. Kamil said.
14th Feb 2021 - The New York Times

COVID-19: Previously-infected people only need one vaccine shot, say French experts

France's top health authority has recommended that people who've had coronavirus only get one vaccine dose. Those who have recovered from the virus have built an immune response similar to that brought on by a vaccine, said the High Authority of Health (HAS). It said a single shot would "play the role of reminding" the person's body how to fight the infection. The vaccines approved by the European Union - made by Moderna, Pfizer and AstraZeneca - all stipulate two doses with a gap inbetween to achieve maximum protection.
13th Feb 2021 - Sky News

Coronavirus: Oxford-AstraZeneca vaccine trial to begin in February for children

A trial to test how well the Oxford-AstraZeneca coronavirus vaccine works in children is set to begin. Around 300 volunteers will take part in the trial, which will start at the end of February. The scientists want to see how well the vaccine works in children aged between six and 17 years old. Currently there are no plans to vaccinate children in the UK, but so far more than 14 million people have received one of the approved vaccines for coronavirus.
13th Feb 2021 - BBC News

AstraZeneca teams with IDT Biologika to speed coronavirus vaccine output in EU

AstraZeneca is teaming up with German CDMO IDT Biologika to quickly speed output of finished COVID-19 vaccine doses. And their pact doesn't stop with this pandemic. To address Europe's "immediate vaccination needs during the pandemic," the companies agreed to work together to speed output of finished AZ doses by the second quarter of this year, AstraZeneca said Wednesday. Their newly expanded deal has a broader goal as well—helping secure "Europe’s future vaccine supply independence" through combined investments in new capacity at IDT Biologika's Dessau, Germany, manufacturing site.
13th Feb 2021 - FiercePharma

After failing to deliver, AstraZeneca rethinks EU coronavirus vaccine supply chain

AstraZeneca is scrambling to find more manufacturers to produce its coronavirus vaccine in Europe after the drugmaker’s bet on a limited number of sites fell short. By the end of January, only one continental plant — located in Seneffe in Belgium — was authorized to manufacture the drug substance for the vaccine coveted by governments across Europe, alongside two sites in the U.K. and U.S. After announcing the company would be unable to deliver nearly two-thirds of the 100 million doses it promised the EU by the end of March, AstraZeneca CEO Pascal Soriot initially pointed the finger at the Belgian plant, now owned by U.S. company Thermo Fisher Scientific.
13th Feb 2021 - POLITICO.eu

White House cites ‘deep concerns’ about WHO COVID-19 report, demands early data from China

The White House on Saturday called on China to make available data from the earliest days of the COVID-19 outbreak, saying it has “deep concerns” about the way the findings of the World Health Organization’s COVID-19 report were communicated. White House national security adviser Jake Sullivan said in a statement that it is imperative that the report be independent and free from “alteration by the Chinese government”, echoing concerns raised by the administration of former President Donald Trump, who also moved to quit the WHO over the issue.
13th Feb 2021 - The Globe and Mail

Covid-19 pandemic: China 'refused to give data' to WHO team

China refused to hand over key data to the World Health Organization (WHO) team investigating the origins of Covid-19, one of its members has said. Microbiologist Dominic Dwyer told Reuters, the Wall St Journal and the New York Times the team requested raw patient data from early cases, what he called "standard practice". He said they only received a summary. China has not responded to the allegation but has previously insisted it was transparent with the WHO. The US has urged China to make available data from the earliest stages of the outbreak, saying it has "deep concerns" about the WHO report.
13th Feb 2021 - BBC News

Zinc, vitamin C show no effect for COVID-19 in small study

Consuming high doses of zinc and ascorbic acid (vitamin C) was not associated with improvement in COVID-19 infections, according to a small study published today in JAMA Network Open. In a 214-person, open-label experiment with COVID outpatients in Ohio and Florida, those who received one or both supplements had similar symptom-reduction periods as those who received standard of care. Over the years, scientific studies have not conclusively shown that either supplement can help overcome illnesses such as the common cold. Since the pandemic began, however, both supplements have seen an increased market owing to people's belief that they can give the immune system a boost. The New York Times reported zinc sales of $134 million, and USA Today found that vitamin C sales reached $209 million during the first half of 2020, up 76% compared with 2019.
13th Feb 2021 - CIDRAP

Oxford University to test COVID-19 vaccine response among children for first time

The University of Oxford has launched a study to assess the safety and immune response of the COVID-19 vaccine it has developed with AstraZeneca Plc in children for the first time, it said on Saturday. The new mid-stage trial will determine whether the vaccine is effective on people between the ages of 6 and 17, according to an emailed statement from the university. Around 300 volunteers will be enrolled and first inoculations are expected this month, Oxford said. The two-dose Oxford/AstraZeneca vaccine has been hailed as a ‘vaccine for the world’ because it is cheaper and easier to distribute than some rivals.
13th Feb 2021 - Reuters

All hypotheses on Covid-19 origins still being investigated, says WHO boss

The World Health Organization says it has not ruled out any theory on the origins of the coronavirus pandemic, despite one top official earlier this week appearing to dismiss the idea it had escaped from a laboratory. Speaking at a briefing on Friday, Dr Tedros Adhanom Ghebreyesus, director-general of the WHO, said a summary report from the organization’s team sent to Wuhan to investigate the origins of the virus should be published next week, with a full report coming soon after. But he confirmed that while the scientists made progress in understanding the circumstances around the outbreak in Wuhan in late 2019, more work was needed on all of the potential routes the virus may have taken into the human population.
13th Feb 2021 - The Guardian

Statins 'cut risk of Covid death': Study finds cholesterol drugs taken by eight million Britons reduce chance of dying to virus by 43% in hospital patients

Statins tackle 'bad' blood cholesterol and they are used by eight million Britons A study has now found giving statins to Covid patients can reduce death risk The study was a review of 12 other studies into the effectiveness of statins in cutting mortality from coronavirus
13th Feb 2021 - Daily Mail

Virus variant first detected in the U.K. has been deadlier, study confirms

Scientists had already determined that the variant of the novel coronavirus first detected in the fall in the United Kingdom — known as B.1.1.7. because of its molecular makeup — was probably 30 to 70 percent more transmissible than the typical version of the virus causing covid-19. They also knew, based on preliminary data, that the variant appeared to be relatively more deadly for the growing number of people catching it. U.K. scientists now say the variant is probably 30 to 70 percent more deadly, based on a follow-up study by the government released Friday that assessed a larger sample size of covid-19 patients and also found a higher rate of hospitalization.
13th Feb 2021 - The Washington Post

England's current lockdown could be the last, says Neil Ferguson

The scientist whose data modelling led to the first UK lockdown has expressed hope that the current lockdown could be the last. Prof Neil Ferguson, who advises the government as part of the New and Emerging Respiratory Virus Threats advisory group (Nervtag), said the nation was “in a better place than I might have anticipated a month ago”. He told Politico’s Westminster Insider podcast: “The lockdown has really driven down cases quite fast. They’re basically halving about every 17 days at the moment or so, and that means in a month’s time – the prime minister’s talked about potentially reopening schools – we might have some bandwidth to do that, at least primary schools. “And if we continue to see then a continued decline without large outbreaks, then perhaps starting to relax other aspects of society the following month.”
12th Feb 2021 - The Guardian

New COVID variant with 5 mutations identified in California

A new SARS-CoV-2 variant, CAL.20C, has been detected in southern California amid a surge in local infections and is spreading through and beyond the United States, according to a research letter published in JAMA. Researchers at Cedars-Sinai Medical Center (CSMC) in Los Angeles analyzed COVID-19 strains before and after the surge in cases in southern California in October 2020. Before October, most coronavirus strains there originated from the 20C clade (group of viruses evolved from the same ancestor), which emerged in New York via Europe in the early stages of the pandemic. "SARS-CoV-2 will be with the global population for some time and has clearly shown its tendency toward rapid antigenic variation, providing a 'wake-up call' that a sustained effort to develop a pan-SARS-CoV-2 vaccine is warranted," the authors said.
12th Feb 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Feb 2021

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Manitoba agrees to purchase 2M doses of Providence Therapeutics coronavirus vaccine

The Manitoba government has committed to buy two million doses of a made-in-Canada COVID-19 vaccine currently under clinical trial. Premier Brian Pallister announced the purchase of the Providence Therapeutics COVID-19 vaccine at a Thursday morning press conference. “With today’s announcement we’re taking a big step … to creating a secure, stable supply of Canadian-made COVID vaccines,” Pallister said. A human trial for the prospective vaccine was started in Toronto in late January. In a release Jan. 26 Providence said the vaccine, dubbed PTX-COVID19-B, is a messenger RNA (mRNA) vaccine, and is the first fully-made in Canada vaccine to reach the human clinical trial stage.
11th Feb 2021 - Global News

Bolivia signs deal with China´s Sinopharm for coronavirus vaccine

Bolivia said on Thursday it had inked an agreement with China´s Sinopharm locking in an initial supply of half a million doses of the company´s vaccine against coronavirus by the end of February. Bolivian President Luis Arce said China’s President Xi Jinping had agreed to sell Bolivia 400,000 doses and had donated another 100,000 doses to the South American nation, among the poorest in the region. Bolivia has been rocked by political and social upheaval since contested elections in 2019 saw longtime president Evo Morales leave office. It has lagged behind wealthier regional neighbors in securing bilateral vaccine supply deals. The Andean nation has since signed agreements with Russia for its Sputnik V vaccine and India’s Serum Institute for AstraZeneca’s COVID-19 shot. It has also signed a deal with the World Health Organization-backed COVAX initiative.
11th Feb 2021 - Reuters

Does the coronavirus vaccine work on Bristol's variant? This is what Public Health England says

Public Health England has shared a reassuring statement about Bristol's coronavirus variant in relation to vaccines. Several experts have raised doubts about the mutation present in this particular 'variant of concern', as experiments suggest it might make antibodies less effective in attacking the infection. Speaking to ITV last night (Wednesday, February 10), a member of the Scientific Advisory Group for Emergencies said the variant "may be able to re-infect people who’ve been previously infected or who’ve been previously vaccinated". However, Public Health England (PHE) remains optimistic about the efficacy of current vaccines - at least in the primary aim of preventing serious illness and death.Speaking to ITV last night (Wednesday, February 10), a member of the Scientific Advisory Group for Emergencies said the variant "may be able to re-infect people who’ve been previously infected or who’ve been previously vaccinated". However, Public Health England (PHE) remains optimistic about the efficacy of current vaccines - at least in the primary aim of preventing serious illness and death.
11th Feb 2021 - Bristol Live

AstraZeneca Plans to Double Covid-19 Vaccine Output

AstraZeneca PLC said it was fixing problems with the manufacturing of its Covid-19 vaccine and expects to roughly double monthly production to 200 million doses by April, as it seeks to move past a rocky start to the shot’s rollout. The Anglo-Swedish drugmaker reported strong full-year earnings and forecast increased 2021 earnings growth. The forecast doesn’t factor in sales of the pandemic vaccine it developed alongside the University of Oxford.
11th Feb 2021 - Wall Street Journal

CDC: people who have received two Covid-19 vaccine doses can skip quarantine

People who have received the full course of Covid-19 vaccines can skip the standard 14-day quarantine after exposure to someone with the infection as long as they remain asymptomatic, US public health officials advised. The Centers for Disease Control and Prevention (CDC) said late on Wednesday the vaccines have been shown to prevent symptomatic Covid-19, thought to play a greater role in the transmission of the virus than asymptomatic disease. “Individual and societal benefits of avoiding unnecessary quarantine may outweigh the potential but unknown risk of transmission (among vaccinated individuals),” the CDC said.
11th Feb 2021 - The Guardian

Roche arthritis drug reduces COVID-19 deaths in trial in hospitalised patients

Roche's arthritis drug tocilizumab cuts the risk of death among patients hospitalised with severe COVID-19, also shortening the time to recovery and reducing the need for mechanical ventilation, results of a large trial showed on Thursday.
11th Feb 2021 - Nasdaq

When will kids be able to get COVID-19 vaccines?

Students as young as first grade might be able to get vaccinated against COVID-19 by September, White House chief medical adviser Dr. Anthony Fauci predicted in an interview published by ProPublica on Thursday. Fauci cited clinical trials now underway in the U.S. from vaccine developers Pfizer and Moderna to test the safety and efficacy of the doses in children. He had said previously that the Food and Drug Administration might allow for vaccinations in American children "by the time we get to the late spring and early summer." So far, except for a handful of errors, the nationwide vaccine rollout has not included children.
11th Feb 2021 - CBS News

Pfizer says it expects data on COVID-19 vaccines for children in 'early part of 2021'

Pfizer says it has completed enrollment of its clinical trial of 12-to-15 year olds and believes it will have data in 'the early part of 2021.' Moderna is still recruiting children for its trial if 12-to-18 year olds and says it expects to have preliminary data 'around mid-year 2021.' Neither company has yet started pediatric trials testing their coronavirus vaccines in those aged 11 and younger Dr Anthony Fauci says he believes children as young as first graders may be able to receive COVID-19 vaccines by the school year start in September. But pediatricians believe studies are moving too slowly and that not immunizing children threatens herd immunity and increases the risk of variants spreading
11th Feb 2021 - Daily Mail

Government ordered to investigate link between PPE shortages and NHS COVID-19 deaths

A report by the House of Commons public accounts committee (PAC) highlighted concerns among frontline staff that guidance did not specify a high enough level of PPE to properly protect them against infection, while some supplies were substandard or insect-infected. Black, Asian and minority ethnic (BAME) staff were more likely to report experiencing PPE shortages or feeling pressured to work without adequate protection - over twice as many BAME doctors reported experiencing PPE shortages compared with white colleagues. The BMA has urged the government to learn from ‘these terrible shortcomings’ and listen to the experiences of frontline workers during the first wave of the pandemic to ensure that healthcare workers are properly protected in the future.
11th Feb 2021 - GP online

COVID-19 linked with new set of symptoms, according to study of over a million people

Chills, loss of appetite, headache and muscle aches could be a sign of COVID-19 infection, according to new findings. Based on swab tests and questionnaires taken from June up until last month as part of Imperial College London's REACT study of over one million people, those with the above symptoms were more likely to test positive for the virus. This is in addition to the "classic" symptoms of COVID-19 already included in NHS guidance, which are: - Fever - New persistent cough - Loss of sense of smell and/or taste
11th Feb 2021 - Sky News

Bristol Covid-19 variant: Experts monitor new mutation

A new coronavirus variant found in Bristol may be able to infect people who have already had Covid-19 or who have been vaccinated. But experts said jabs will still protect against people becoming seriously ill with the disease. The Bristol variant contains the E484K mutation also found in the South African and Brazilian variants. Health officials in the city say getting as many people vaccinated as possible is key. The Bristol variant has been defined by the New and Emerging Respiratory Virus Threats Advisory Group (Nervtag) as the Kent variant with the E484K mutation. Laboratory studies have shown that viruses with that mutation are able to escape human defences, making them more efficient at evading natural and vaccine-triggered immunity.
11th Feb 2021 - BBC News

'More than 40% of people suffer trauma following Covid-19′

Many people suffer trauma with symptoms such as flashbacks after catching Covid-19, even if they did not require clinical assistance or hospitalisation, a study has found. The Imperial College London and University of Southampton study, published on Tuesday, looked at 13,049 people with experience of coronavirus.
11th Feb 2021 - Pulse Today

COVID-19: AstraZeneca on course to roll out jab for new variants by autumn

AstraZeneca has said it is on course to roll out a coronavirus vaccine that is effective against new variants by the autumn. The company, which has produced a COVID-19 vaccine alongside University of Oxford, said clinical trials for the next generation of jab would commence in the spring.
11th Feb 2021 - Sky News

Is It Safe to Delay a Second COVID Vaccine Dose?

Vaccine shortages and distribution delays are hampering efforts to curb the SARS-CoV-2 pandemic. So some scientists have suggested postponing the second shots of two-dose vaccines to make more available for people to get their first doses. The original recommended interval was 21 days between doses for the Pfizer vaccine and 28 days for the Moderna shots, the two currently authorized in the U.S. Now the U.S. Centers for Disease Control and Prevention has updated its guidance to say that people can wait up to 42 days between doses, though the agency still advises individuals to stick to the initial schedule. And developers of the University of Oxford–AstraZeneca vaccine—which is authorized for use in the U.K.—suggest even longer stretches are possible, saying their shot performs better when its doses are spaced 12 weeks apart.
11th Feb 2021 - Scientific American

AstraZeneca working to adapt Covid-19 vaccine to new strains

AstraZeneca said Thursday it's working with the University of Oxford to adapt its COVID-19 vaccine to protect against new strains of the virus as public health officials raise concerns about mutations that may make the virus more resistant to existing vaccines. The Anglo-Swedish drugmaker worked with Oxford to develop one of the first COVID-19 vaccines authorized for widespread use. AstraZeneca said it hopes to cut the time needed to produce large amounts of any new vaccine to between six and nine months.
11th Feb 2021 - Business Standard

C.D.C. Urges Better Masking for Increased Virus Protection

Wearing a mask — any mask — reduces the risk of infection with the coronavirus, but wearing a more tightly fitted surgical mask, or layering a cloth mask atop a surgical mask, can vastly increase protections to the wearer and others, the Centers for Disease Control and Prevention reported on Wednesday. New research by the agency shows that transmission of the virus can be reduced by up to 96.5 percent if both an infected individual and an uninfected individual wear tightly fitted surgical masks or a cloth-and-surgical-mask combination.
11th Feb 2021 - The New York Times

Long Covid: The illness wreaking havoc behind the pandemic

Coronavirus has been dominating the headlines for a year – but behind the grim death statistics and hospital admissions, a related illness has been quietly wreaking havoc on the lives of thousands of Scots. Long Covid, or post-covid syndrome, has been described by some as the “pandemic behind the pandemic”. Research is in its infancy and there is no clear treatment or cure. The post-viral condition affects people who fell ill with coronavirus, but did not make a full recovery within three months.
11th Feb 2021 - STV News

Kent Covid variant mutation must be taken seriously, warns UK scientist

The Kent variant of the coronavirus with a key mutation that enables the South African variant to escape some of the vaccines used against it must be taken very seriously in the UK, according to a leading microbiologist. Prof Ravi Gupta of the Cambridge Institute for Therapeutic Immunology and Infectious Diseases, who is a member of the government’s scientific advisory body Nervtag, warned that the mutated variant, at the moment causing just 21 known cases, should be treated with as much concern as the South African variant. The Kent variant B117, which spreads twice as fast as the original coronavirus, is now dominant in the UK and is present in many countries around the world. But Public Health England has identified 21 cases of B117 that also have the E484K mutation: 14 in the Bristol region, four in Greater Manchester and three elsewhere. E484K is the change to the spike protein in South Africa that scientists believe is chiefly responsible for vaccines triggering a lower antibody response to infection.
11th Feb 2021 - The Guardian

CDC alters COVID-19 quarantine guidance for vaccine recipients

If you have received two doses of the COVID-19 vaccine and are exposed to someone with the virus, you no longer have to quarantine for 14 days as long as you remain free of symptoms, according to new recommendations issued by the Centers for Disease Control and Prevention (CDC). Because the vaccines prevent symptomatic COVID-19 infections, and symptomatic people are thought to be more contagious, the CDC said the risk of unnecessary quarantine outweighs the potential unknown risk of transmission among vaccinated people.
11th Feb 2021 - CIDRAP

Tocilizumab cuts death rate in severe COVID-19, study finds

Hospitalized COVID-19 patients given the anti-inflammatory monoclonal antibody tocilizumab were less likely to die or require invasive mechanical ventilation, according to preliminary results of the UK RECOVERY trial posted today on the medRxiv preprint server. Led by University of Oxford researchers, the ongoing Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial involved assigning 4,116 severely ill coronavirus patients to receive either intravenous tocilizumab, a rheumatoid arthritis drug, or usual care. Most (82%) of the participants also received a systemic corticosteroid such as dexamethasone.
11th Feb 2021 - CIDRAP

Merck canned its own COVID-19 vaccines. Now, it's in talks to manufacture other companies' shots

After Merck & Co. got off to a late start in the COVID-19 vaccine race and made an early exit, the drug giant is in talks to aid the global vaccine manufacturing effort. The drugmaker is “actively involved” in discussions with governments, health agencies and other pharmaceutical companies to “identify the areas of pandemic response where we can play a role, including potential support for production of authorized vaccines," a spokesman said via email. News of the talks comes about two weeks after Merck abandoned both its coronavirus vaccine candidates—one it acquired through its Themis buyout and the other it was studying in partnership with IAVI. Merck said the two shots had produced immune responses weaker than those prompted by natural infections as well as by other COVID-19 vaccines.
11th Feb 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Feb 2021

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Single dose of Pfizer vaccine shows signs of success in UK

Official data from the UK’s vaccination campaign show that a single dose of the BioNTech/Pfizer jab offers good protection against Covid-19, boosting the government’s approach of extending the gap between doses. Although not enough evidence is available to draw definitive conclusions about the impact of the vaccination campaign on deaths and hospitalisations, several people with access to government data said indications showed it was reducing cases in the groups prioritised to receive the jab.
11th Feb 2021 - Financial Times

A lone infection may have changed the course of the pandemic

In each warm body it infects, the virus behind Covid-19 has the potential to change. It can become more deadly, more transmissible or more resistant to the vaccines on which we are all pinning so much hope. Mercifully, the biology of Sars-CoV-2 means that such changes happen slowly and almost always fail to catch on. But mutations, like pandemics, are a numbers game. Every new person infected provides another opportunity for the virus to adopt a new form. So far, Sars-CoV-2 has infected at least 106 million people worldwide and taken on many thousands of mutations. Most of those changes are slow and inconsequential – evolutionary dead ends that nobody will ever realise existed. But, in some people, the virus hits the jackpot.
11th Feb 2021 - Wired.co.uk

Pfizer/BioNTech vaccine could reduce Covid-19 viral load - what it means

New data gathered by researchers in Israel suggests that the Pfizer/BioNTech Covid vaccine is reducing the viral load of the virus. Israel has already vaccinated around one in three residents, after beginning its vaccine deployment program on 20 December. According to a paper which was published on Monday (8 Feb), positive test results of patients aged 60 and over had up to 60 per cent smaller viral loads on the swab, compared to the 40 to 59 age group. The paper explains that this is because, by this point, at least 14 days have passed since more than 75 per cent of the over-60s age group received their first dose, in comparison to the 25 per cent of 40 to 60 year olds.
10th Feb 2021 - The Scotsman on MSN.com

Teva Is in Discussions to Help Make Covid-19 Vaccines, CEO Says

Teva Pharmaceutical Industries Ltd. is in talks with Covid-19 vaccine makers about helping to produce and distribute shots as demand rises for immunizations. The generic drug giant is offering to dedicate its manufacturing capacity in the U.S., Europe and beyond to aid with mass-immunization efforts geared at combating the pandemic, Chief Executive Officer Kare Schultz said Wednesday. “We have a large, worldwide network of manufacturing capabilities,” from creating underlying drug substances to putting solutions into sterile vials, known as the fill-finish process, he said in an interview. “There are a limited number of facilities that can do this kind of manufacturing, and it takes time to build them.”
10th Feb 2021 - Bloomberg on MSN.com

Coronaviruses linked to Covid-19 circulating in bats and pangolins in Southeast Asia, study finds

Coronaviruses similar to that which causes Covid-19 may be circulating in bats and pangolins in Southeast Asia, a study has found. In a breakthrough that provides clues for those investigating the origin of the pandemic, scientists said high levels of neutralising antibodies against coronaviruses were present in the animals in Thailand. A team from Singapore’s Duke-NUS Medical School found SARS-CoV-2 – the virus that causes Covid-19 – neutralising antibodies in Rhinolophus bats in a Thai cave and in a pangolin at a wildlife checkpoint in the south of the country. The findings, published in the journal Nature Communications, indicate more coronaviruses are likely to be discovered across Southeast Asia, which has a large and diverse bat population, the researchers said. Such viruses have now been found across a wide expanse measuring 4,800 km, from Japan and China to Thailand.
10th Feb 2021 - The Independent

Study Links Four New Symptoms To Covid-19 Infection, Including Headaches And Loss Of Appetite

In a study of more than 1 million people in England between June 2020 and January 2021, researchers identified chills, loss of appetite, headaches and muscle aches as additional symptoms linked with having Covid-19. Some symptoms vary by age, with headaches most reported in children and teens (between 5-17 years old), who are less likely to report “classic” Covid-19 symptoms, and adults over 55 reporting appetite loss.
10th Feb 2021 - Forbes

CDC study finds two masks are better than one vs. COVID-19

US government researchers have found wearing two masks was better than one when preventing the spread of Covid-19, according to a Centres for Disease Control and Prevention (CDC) study. In a lab experiment, two artificial heads were placed six feet from each other and studied on how many coronavirus-sized particles were expelled and inhalled while wearing a variety of face coverings. Researchers found that wearing one mask, either cloth or surgical, prevented 40 per cent of incoming droplets from being breathed in. When adding a surgical mask underneath a cloth mask, 80 per cent of incoming droplets were stopped.
10th Feb 2021 - The Independent

AstraZeneca to build new Covid-19 vaccine facility in Germany

AstraZeneca has unveiled plans to build a new Covid-19 vaccine manufacturing facility in partnership with IDT Biologika at the German firm’s Dessau site, in a move aiming to speed up production and defuse a row with the EU over vaccine supply.
10th Feb 2021 - The Guardian on MSN.com

Covid-19: Sports equipment presents 'low risk'

The risk of coronavirus transmission from sharing sports equipment is "lower than once thought", a study suggests. Researchers, led by Liverpool School of Tropical Medicine, applied live virus particles to nine types of sports equipment and a control material. They concluded it "seems unlikely" that sports balls and accessories are a major cause for transmission. Prime Minister Boris Johnson said last June that cricket balls are a "natural vector" of coronavirus. The Strike study found the virus was least transferrable on absorbent materials like cricket gloves and tennis balls, compared with non-porous equipment like racing saddles and rugby balls.
10th Feb 2021 - BBC News

David Oliver: Mistruths and misunderstandings about covid-19 death numbers

I want to set the record straight about some serious misinformation surrounding covid-19 death certification and mortality statistics. I will paraphrase some of the claims that I have heard repeatedly in the media: “People are not dying from, but with, covid-19.” “Deaths classified as from covid-19 result from largely false positive polymerase chain reaction (PCR) test results,” “deaths are mostly from other causes and underlying conditions,” “death numbers are grossly inflated,” “there is no excess mortality compared with other years or months,” and this is “no different from a normal flu season.” Let’s see, shall we? According to the Office for National Statistics (ONS), the total number of deaths with covid-19 recorded on the death certificate in England and Wales has now passed 100 000. The government’s daily press releases, however, report “deaths within 28 days of a positive test result”—a definition repeated faithfully by broadcast and print journalists and on social media. This approach probably under-recognises the real number of deaths from covid-19 by around 20%.
10th Feb 2021 - The BMJ

In Spain, patients with serious conditions left out of AstraZeneca early vaccination

The Covid vaccine made by AstraZeneca will for now only be administered to essential workers in Spain, including teachers, law enforcement officers, firefighters and members of the armed forces – but not supermarket workers. Although the treatment has been approved by European authorities for anyone over the age of 18, the Spanish government is taking a conservative approach: first it ruled out people over 80 years of age, then it further reduced the target group to those under 55. And on Tuesday, a committee of experts advising the National Healthcare System established that individuals under 55 with certain pre-existing medical conditions will also be left out, at least during the initial phase.
10th Feb 2021 - EL PAÍS in English

Japan suffers rise in female suicides during Covid-19 pandemic

A much-anticipated inquiry into the origins of the coronavirus pandemic wrapped up its mission in China on Tuesday with no breakthrough discovery, as investigators ruled out a theory that Covid-19 came from a lab while failing to identify which animal may have passed it to humans. It remains unclear which species first transmitted Covid-19 to humans, said Liang Wannian, who headed up the Chinese contingent of an inquiry carried out jointly with World Health Organization experts. The WHO mission -- which China repeatedly delayed -- was dogged by fears of a whitewash, with the US demanding a "robust" probe into the origins of the pandemic in late 2019, and China firing back with a warning not to "politicise" the investigation. During the closely monitored mission, which included a visit to an exhibition celebrating China's recovery, reporters were largely kept at arm's length from the experts.
10th Feb 2021 - Financial Times

Covid origins still a mystery as WHO-China probe ends

A much-anticipated inquiry into the origins of the coronavirus pandemic wrapped up its mission in China on Tuesday with no breakthrough discovery, as investigators ruled out a theory that Covid-19 came from a lab while failing to identify which animal may have passed it to humans.
10th Feb 2021 - IBTimes UK

Vaccine vs variant: Promising data in Israel's race to defeat pandemic

Israel’s swift vaccination rollout has made it the largest real-world study of Pfizer Inc’s COVID-19 vaccine. Results are trickling in, and they are promising. More than half of eligible Israelis - about 3.5 million people - have now been fully or partially vaccinated. Older and at-risk groups, the first to be inoculated, are seeing a dramatic drop in illnesses. Among the first fully-vaccinated group there was a 53% reduction in new cases, a 39% decline in hospitalizations and a 31% drop in severe illnesses from mid-January until Feb. 6, said Eran Segal, data scientist at the Weizmann Institute of Science in Rehovot, Israel.
10th Feb 2021 - Reuters UK

Ohio underreported as many as 4,000 COVID-19 deaths

Ohio will add as many as 4,000 previously unreported COVID-19 deaths to the state's tally during the next week after the Ohio Department of Health discovered reporting errors dating back to October. Most of these deaths occurred in November and December, the agency said in a news release, already the deadliest two months of the pandemic with 1,574 and 2,859 deaths, respectively. The correction will result in a few days of higher-than-average death totals, the agency warned. The actual date of death will be reflected on the state's coronavirus dashboard.
10th Feb 2021 - Cincinnati Enquirer on MSN.com

WHO recommends use of Oxford/AstraZeneca vaccine for all adults

The World Health Organization has recommended the Oxford/AstraZeneca coronavirus vaccine for use worldwide by all adults, including the elderly, in a boost for the jab after a series of setbacks. The WHO’s Strategic Advisory Group of Experts on Immunization (Sage) said the vaccine could be used by all people over the age of 18 in all countries, including places such as South Africa where the circulation of new variants had raised some concerns over its efficacy. Some countries, such as France and Sweden, have restricted use of the shot to younger adults, citing a lack of sufficient trial data for the elderly, but WHO offi