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Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Aug 2022

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CDC Drops Quarantine Recommendation After Covid-19 Exposure

Federal health officials scaled back guidance for quarantining and testing to screen for Covid-19 in settings including schools, a relaxation of pandemic precautions that reflects higher protection from vaccines, treatments and prior infection. The Centers for Disease Control and Prevention on Thursday said it no longer recommends that people quarantine after being exposed to the virus, as long as they don’t feel sick, get tested after five days and wear a high-quality mask around others for 10 days. People should still isolate from others for at least five days if they test positive, the CDC said.
11th Aug 2022 - The Wall Street Journal

U.S. CDC no longer recommends students quarantine for COVID-19 exposure

The U.S. Centers for Disease Control and Prevention will no longer recommend quarantines or test-to-stay programs at schools or daycare centers for people exposed to COVID-19, the agency said in updated guidelines on Thursday. The agency also said it was no longer recommending unvaccinated people quarantine after exposure as around 95% of the U.S. population has either been vaccinated, had COVID-19 already, or both.
11th Aug 2022 - Reuters

South Korea’s 1st domestic COVID-19 vaccine ready

Hundreds of vials were lined up on the belt of a packaging machine at L House, SK Bioscience’s vaccine manufacturing facility in Andong, North Gyeongsang Province on Wednesday afternoon, as the developer of South Korea’s first homegrown COVID-19 vaccine SKYCovione is poised to roll out the vaccine’s first batch by the end of August. A few researchers, who were covered from head to toe with sterilized gear — protective shoes, clothing and hair caps — oversaw the automatic process while others put finishing touches on the packages. On the surface of the packaged products, which were stacked one by one in a yellow plastic box, it read: “SKYCovione Multi-Inj.”
11th Aug 2022 - INQUIRER.net

Universal vaccine needed to tackle future Covid waves, study suggests

A universal Covid jab is “urgently needed,” scientists have warned after a study confirmed prior infection or vaccination offers only limited protection against new variants.
11th Aug 2022 - The Independent

Moderna CEO says Covid vaccines will evolve like 'an iPhone'

Forget taking two to three Covid shots a year. Moderna hopes to roll out a single-dose annual booster to cover the coronavirus, the flu and another common respiratory virus within the next five years. As Covid-19 continues to mutate, Moderna will need to keep updating the vaccines that turned it into a global household name while trying to make it more convenient for consumers, CEO Stéphane Bancel said in an interview with CNN Business Wednesday. He estimated a timeline of "three to five years" for the new combined product, and likened the development of the life-saving jab to that of a smartphone. "You don't get the amazing camera, amazing everything the first time you get an iPhone, but you get a lot of things," he said. "A lot of us buy a new iPhone every September, and you get new apps and you get refreshed apps. And that's exactly the same idea, which is you'll get Covid and flu and RSV [respiratory syncytial virus] in your single dose."
11th Aug 2022 - CNN

Does Covid Vaccine Protect Against Omicron? Scientists Seek Pan-Coronavirus Shot

Scientists fear the omicron shots coming this fall won’t be much better at keeping people from getting Covid-19 than what’s come before. That’s pushing drugmakers to start working on next-generation vaccines that don’t have to be updated that often, if at all. Testing shows that omicron-specific vaccines under development at Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE will be “little or no better” than the currently available boosters, according to John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “The benefit of switching composition is barely detectable,” Moore said.
11th Aug 2022 - Bloomberg

COVID rebound is surprisingly common — even without Paxlovid

After the game-changing COVID-19 antiviral Paxlovid began to be used in late 2021, researchers noticed a perplexing trend. In some people taking the drug, symptoms and detectable virus vanish, only to mysteriously return days later. After months of grasping at straws, scientists are beginning to make some headway in understanding ‘Paxlovid rebound’. Two recent studies suggest that it is surprisingly common for SARS-CoV-2 to return in untreated cases of COVID-191, while hinting that the virus’s comeback is fiercer and more common in people who take Paxlovid
11th Aug 2022 - Nature.com

Ensovibep no better than placebo for hospitalised COVID-19 patients

A trial of a novel designed ankyrin repeat protein, ensovibep, for the treatment of patients hospitalised with COVID-19 proved no better than placebo. Ensovibep treatment for patients hospitalised with COVID-19 was no better than placebo and, in fact, the trial was terminated early because of futility, according to the findings of randomised trial by researchers from the ACTIV-3/TICO group. The early treatment of patients infected with COVID-19 using anti-virals such as molnupiravir reduces the risk of hospitalisation or death in at-risk, unvaccinated adults. However, to date, there are no effective anti-viral agents for those who have been hospitalised due to virus. One new class of treatment is designed ankyrin repeat proteins (DARPins), which represent a novel class of specific binding molecules, that can recognise targets with specificities and affinities that equal or surpass those of antibodies.
11th Aug 2022 - Hospital Healthcare Europe

COVID-19 infection in pregnant women linked to increased risk of adverse outcomes

COVID-19 infection in pregnant women is associated with increased risk of adverse outcomes compared to women who are not pregnant, according to a review published in JACC: Advances from the American College of Cardiology Cardiovascular Disease in Women Committee. Cardiovascular complications include heart attack, arrythmias, heart failure and long-haul symptoms that may be difficult to distinguish from other cardiac complications of pregnancy and require the cardiovascular care team to be vigilant when assessing pregnant women with COVID-19. As COVID-19 cases increased globally, awareness of cardiovascular complications also increased, especially in certain high-risk populations. Heart attacks is estimated in up to 12% of patients.
11th Aug 2022 - News-Medical.Net

Key blood clotting protein could be 'warning light' for COVID-19 cases

University of Aberdeen team suggest results indicate that protein PAI-1 could be an early indicator of severe COVID-19 A protein that could be an early indicator of severe COVID-19 has been identified by scientists at the University of Aberdeen. Patients who get seriously ill following a COVID-19 infection frequently show evidence of a severe form of lung disease and in around 30% of patients blood clots are evident. Blood clots arise due to deposits of fibrin within the lung contributing to pneumonia and respiratory distress. These fibrin deposits restrict the amount of oxygen absorbed into the lung.
11th Aug 2022 - PharmaTimes

Valneva cuts full-year outlook on lower COVID-19 vaccine sales

French vaccine developer Valneva on Thursday cut its full-year revenue outlook citing lower demand for its anti-COVID shot from European Union member states. The European Commission in July slashed its order for VLA2001 to just 1.25 million doses from a previously targeted 60 million, pointing to European countries being well supplied with other vaccines and a slowdown in vaccination programmes.
11th Aug 2022 - Reuters

Africa CDC hopeful Aspen will get COVID vaccine orders

Africa's top public health body said on Thursday it was hopeful South African pharmaceutical firm Aspen Pharmacare would get orders for its own brand COVID-19 vaccine. Africa Centers for Disease Control and Prevention (CDC) said last month that it is in detailed discussions with buyers to generate demand for Aspen's COVID-19 vaccine Aspenovax. Just one fifth of adults in Africa are fully vaccinated against COVID-19, but demand has fallen across the continent which already receives donated vaccines from Western countries and has supplies to hand from earlier purchases.
11th Aug 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Aug 2022

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UK health data collaboration paves the way to study long Covid symptoms

If the last two years have taught us anything, it’s that healthcare challenges transcend nations. As research teams across the world rapidly sought ways to collaborate and share information on Covid-19, a spotlight was shone on the importance of data in understanding viruses, diseases and other issues that affect people’s health and wellbeing. This complex, cooperative work allowed our colleagues to develop effective vaccines in record time, giving people the confidence to attend large events such as the Commonwealth Games that took place in Birmingham.
11th Aug 2022 - Pharmaceutical Technology

Queensland researchers find overlap in pathology of long COVID and chronic fatigue syndrome

Griffith University researchers say their findings could help to treat those suffering from long COVID. A woman with chronic fatigue syndrome says she suffered a relapse in symptoms after contracting COVID earlier this year. AMA Queensland says the findings should be independently verified and that more funding for such research should be made available
11th Aug 2022 - Australian Broadcasting Corporation

Vaccines are now approved for children aged six months to five years, but what about newborn babies?

COVID-19 vaccines are now approved for children aged from six months up to five years of age, and are already being rolled out to about 70,000 at-risk youngsters. But what about babies even younger than that? Will there be a vaccine for them? And what role does the vaccination of pregnant people play in the process? Children of all ages can get COVID-19 and experience its complications. However, as noted by an infectious diseases physician at Monash and Melbourne universities, Michelle Giles, young infants aren't at risk of the severe disease that has been seen with older Australians.
11th Aug 2022 - ABC News

Vaccine and drug development boosted by new CSIRO lab

Australia’s national science agency will open the doors of a new $23.1 million national vaccine and drug laboratory in Melbourne on Thursday, after six years of planning and delays. The CSIRO National Vaccine and Therapeutics Lab, based in the south-eastern Melbourne suburb of Clayton, is designed to help turn vaccine and drug candidates into products that can be manufactured onshore in large quantities for clinical trials and will be available for use by companies and researchers around the country.
11th Aug 2022 - Australian Financial Review

Science Is Still in a Race Against the Coronavirus

The Covid-19 pandemic has been a lesson in speed — the speed at which a novel virus among humans can spread, the speed at which it can rack up fatalities and cripple economies, the speed at which vaccines can be designed and produced, the speed at which misinformation can undermine public health. Amid all that rapidity is a different kind of speed, which drives the rest, like an engine spinning the cars on a nauseating carnival ride: the speed of viral evolution. The coronavirus, like many other viruses of its ilk (RNA viruses with highly changeable genomes), evolves fast. It has adapted quickly to us. Now arises the crucial question of whether humans and human ingenuity can adapt faster. Unless the answer is yes, we face a long, doleful future of continued suffering.
10th Aug 2022 - The New York Times

Pfizer readies 'robust' manufacturing capabilities to deliver 2 COVID-19 variant vaccines

Pfizer is planning to deliver COVID-19 vaccines against two sets of omicron subvariants in the autumn in the belief its “robust manufacturing capabilities” are up to the task.
10th Aug 2022 - BioPharma-Reporter.com

MIT researchers develop an easy-to-use test to predict Covid-19 immunity

Most people in the United States have some degree of immune protection against Covid-19, either from vaccination, infection, or a combination of the two. But, just how much protection does any individual person have? MIT researchers have now developed an easy-to-use test that may be able to answer that question. Their test, which uses the same type of "lateral flow" technology as most rapid antigen tests for Covid-19, measures the level of neutralizing antibodies that target the SARS-CoV-2 virus in a blood sample. Easy access to this kind of test could help people determine what kind of precautions they should take against Covid infection, such as getting an additional booster shot, the researchers say. They have filed for a patent on the technology and are now hoping to partner with a diagnostic company that could manufacture the devices and seek FDA approval.
10th Aug 2022 - News-Medical.Net

Covid-19 vaccination in pregnancy

Pregnancy is an independent risk factor for severe covid-19. Vaccination is the best way to reduce the risk for SARS-CoV-2 infection and limit its morbidity and mortality. The current recommendations from the World Health Organization, Centers for Disease Control and Prevention, and professional organizations are for pregnant, postpartum, and lactating women to receive covid-19 vaccination. Pregnancy specific considerations involve potential effects of vaccination on fetal development, placental transfer of antibodies, and safety of maternal vaccination. Although pregnancy was an exclusion criterion in initial clinical trials of covid-19 vaccines, observational data have been rapidly accumulating and thus far confirm that the benefits of vaccination outweigh the potential risks. This review examines the evidence supporting the effectiveness, immunogenicity, placental transfer, side effects, and perinatal outcomes of maternal covid-19 vaccination. Additionally, it describes factors associated with vaccine hesitancy in pregnancy. Overall, studies monitoring people who have received covid-19 vaccines during pregnancy have not identified any pregnancy specific safety concerns. Additional information on non-mRNA vaccines, vaccination early in pregnancy, and longer term outcomes in infants are needed. To collect this information, vaccination during pregnancy must be prioritized in vaccine research.
10th Aug 2022 - The BMJ

Novavax tumbles 30% as waning COVID-19 vaccine demand hits outlook

Shares of U.S. vaccine maker Novavax fell about 30% on Tuesday after it cut its annual revenue forecast by half over falling demand for its COVID-19 shot from low- and middle-income nations. Demand for its vaccine is also waning in the United States, where it was authorized for use among adults last month and was expected to be preferred by the skeptics of messenger RNA-based shots from Moderna Inc and Pfizer Inc
10th Aug 2022 - Reuters

S.Africa's Aspen to halt COVID vaccine output as J&J orders dry up

South Africa's Aspen Pharmacare will stop making COVID-19 vaccines from the end of this month due to a lack of orders, a senior executive said, further undermining Africa's already meager capacity to produce doses. Aspen currently produces vaccines for Johnson & Johnson. In March, it struck a deal to produce, price, and sell its own-brand version of the shot for African markets.
10th Aug 2022 - Reuters

Long-COVID treatments: why the world is still waiting

Bhasha Mewar has had it with doctors. Over the past two years, Mewar has spent nearly all of her life savings seeing heart and respiratory specialists, haematologists, urologists, dermatologists and more, in a desperate bid to tame her long-COVID symptoms. She has taken a slew of drugs: beta blockers to calm her racing heart, steroid inhalers to ease her laboured breathing and an antimalarial drug prescribed to her for reasons she never fully understood. And when Mewar — a curator at an art museum in Ahmedabad, India, who has been sick since what was probably a bout of COVID-19 in March 2020 — would visit her lung doctor twice a month, he always told her the same thing: you need to exercise. “I can’t even walk to the bathroom,” she would reply.
10th Aug 2022 - Nature.com

Covid symptoms sufferers still have four months after catching virus revealed

Covid sufferers are still reporting common symptoms an average of four months after having caught the virus, a new study has found. Two hundred patients enrolled in the Covid-19 Neurological and Molecular Prospective Cohort Study in Georgia, or CONGA, to investigate the longer term impacts of the illness. Fatigue and headache were the two symptoms most participants reported having some four months after first testing positive. Muscle aches, cough, changes in smell and taste, fever, chills and nasal congestion were the next most frequently cited symptoms.
10th Aug 2022 - The Independent

Immunity for common cold coronaviruses may ward off severe covid-19

People with a stronger immune response to the coronaviruses that cause common cold-like symptoms may be better protected against covid-19, raising hopes that a pan-coronavirus vaccine could be achieved. Ricardo da Silva Antunes at La Jolla Institute for Immunology in California and his colleagues analysed blood samples collected from 32 people between 2016 and 2019, before covid-19 emerged. Multiple samples were taken from each person over six months to three years. The team wanted to see how the immune cells in these samples responded to four coronaviruses that cause common cold-like symptoms as well as the original SARS-CoV-2 strain, which emerged in Wuhan, China, at the end of 2019.
10th Aug 2022 - New Scientists

Bat coronaviruses silently infect tens of thousands of people each year, posing pandemic risk, study warns

There may be an average of over 65,000 cases of bat coronaviruses silently infecting people every year in Southeast Asia, according to a new study that could lead to new tools for improving preparedness against future pandemics. The flying mammals are known to host coronaviruses that may be transmitted to people, including SARS-related coronaviruses. Previous studies have suggested that transmission of these viruses to humans may be relatively common in some parts of the world. However, human-bat interactions are also known to vary across regions, influenced by a variety of social, ecological, and economic factors at individual and community scales. The research, published on Tuesday in the journal Nature Communications, used a new framework to estimate and map the risk of potential SARS-related coronaviruses spreading from bats to humans in Southeast Asia.
10th Aug 2022 - The Independent

Study: Pfizer COVID vaccine efficacy wanes 27 days after dose 2 in teens

Article reports that a new study finds waning Pfizer/BioNTech COVID-19 vaccine protection against symptomatic infection in Brazilian and Scottish teens starting 27 days after the second dose amid the Delta and Omicron variant waves, but protection against severe illness was still strong at 98 days in Brazil. The study, published yesterday in The Lancet Infectious Diseases, analyzed nationwide data from 503,776 COVID-19 tests of 2,948,538 adolescents aged 12 to 17 years from Sep 2, 2021, to Apr 19, 2022, in Brazil, and 127,168 tests of 404,673 adolescents from Aug 6, 2021, to Apr 19, 2022, in Scotland. Protection against severe illness, defined as hospitalization or death within 28 days, was estimated only in Brazil owing to the small number of such cases in Scotland.
9th Aug 2022 - CIDRAP

Covid-19: What we know about the BA.4 and BA.5 omicron variants

The number of covid patients admitted to hospital rose steadily from around 550 a day at the end of May to more than 2200 in the second week of July. However, this has since begun to drop, to around 1700 in late July. Daily deaths with covid-19 recorded on the death certificate also rose from the beginning of June, from around 30 to a high of 134 in mid-July. The US Centers for Disease Control and Prevention reported on 22 July that cases, deaths, and hospital admissions were all rising, fuelled by BA.5, which accounted for an estimated 78% of cases. The seven day daily average of new hospital admissions was 6180 (13-19 July), a 4.7% increase from the previous week (5902).5 It has since started to drop. In China, reports suggest that the country is bracing for yet more lockdowns as the omicron subvariants continue to spread
9th Aug 2022 - BMJ.com


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Aug 2022

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Pfizer readies ‘robust’ manufacturing capabilities to deliver 2 COVID-19 variant vaccines

Pfizer is planning to deliver COVID-19 vaccines against two sets of omicron subvariants in the autumn in the belief its “robust manufacturing capabilities” are up to the task.
9th Aug 2022 - BioPharma-Reporter

Five Thoughts on the State of COVID-19 Vaccination and the Road Ahead

This is a confusing time in the public health emergency. Americans are thinking less about COVID-19 on a daily basis and many are eager to move on. But COVID-19 hasn’t gone away, as evidenced by quick spread of the new variant, and it will continue to be part of our lives for the foreseeable future. Getting more Americans vaccinated against the virus will help to move us out of the pandemic stage. We can do this by sharing the right message and using trusted messengers on multiple platforms. This is the focus of the AHA’s vaccine confidence initiative, supported by $3 million in grant funding from the Centers for Disease Control and Prevention (CDC). One of us is president of a hospital in North Carolina and has a background in family medicine and rural health. The other is chief marketing and experience officer for a health system in Louisiana. At the AHA Leadership Summit last month we offered our thoughts on the vaccine and the road ahead. Here are five highlights:
9th Aug 2022 - American Hospital Association

COVID in California: Vaccines, masks cut coronavirus transmission by 99.9% in classrooms, study finds

The alarming spread of omicron subvariants has again put a spotlight on how well COVID-19 rapid antigen tests work at this stage in the pandemic. Many ultra-wealthy people who left San Francisco in the early days of the pandemic decamped to ritzy ski towns. Coronavirus case rates and positive tests rates are steadily declining in California and the Bay Area, signaling that the region is finally on the downside of this summer’s record-long COVID-19 surge
9th Aug 2022 - San Francisco Chronicle

Study details post-COVID-19 symptoms and conditions among children and adolescents in the US

In a recent article published as part of the Morbidity and Mortality Weekly Report (MMWR), researchers assessed the incidence of post-coronavirus disease 2019 (COVID-19) symptoms and conditions among children and adolescents. The researchers found some previously unreported post-COVID conditions and symptoms, including acute pulmonary embolism, blood coagulation, hemorrhagic disorders, acute renal failure, venous thromboembolic event, and cardiac dysrhythmias, in the study participants.
9th Aug 2022 - News-Medical.Net

COVID-19 vaccination reduces infection-related myocardial infarction and stroke risk

COVID-19 vaccination significantly reduces the risk of both an acute myocardial infarction and stroke among those infected with the virus. COVID-19 vaccination provides individuals with a reduced risk of experiencing an acute myocardial infarction or ischaemic stroke after becoming infected with the virus according to the findings of a study by Korean researchers. It has now become recognised that following an acute infection with COVID-19, beyond the first 30 days, individuals with COVID-19 have an increased risk of cardiovascular disease and which includes cerebrovascular disorders, dysrhythmias, ischaemic and non-ischaemic heart disease, pericarditis, myocarditis, heart failure and thromboembolic disease. While it is clear that a COVID-19 vaccination is safe and offers protection against severe COVID-19, hospitalisation and death against all current variants of concern, what is less clear is whether vaccination is able to reduce the post-infection cardiovascular sequelae.
9th Aug 2022 - Hospital Healthcare Europe

With Innovation, We Can Keep Reducing the Toll of COVID-19

Scrolling through social media these days, you’ll see that loud extremists continue to dominate COVID-19 discourse. At one pole are the denialists who argue—incorrectly—that COVID is “just a cold.” At the other are those who suggest that no meaningful progress has been made in controlling its devastation. The truth, of course, is somewhere in the middle. We have not yet extricated ourselves from the peril of SARS-CoV-2, and wishing COVID-19 gone does not make it so. Surging case numbers provide opportunities to produce the next variant as the virus evolves to escape antibodies accumulated from vaccination and prior infection. (There is no way to predict the severity of disease caused by a future variant, though immunity undeniably helps.) Some portion of these cases will be severe, fatal, or result in disabling long COVID.
9th Aug 2022 - TIME

Covid-19: What we know about the BA.4 and BA.5 omicron variants

When and where were these subvariants detected? - BA.4 and BA.5 were first detected in South Africa in January and February 2022, respectively.1 They are offshoots of the omicron variant BA.2, though their additional mutations seem to have given them a transmission advantage. - What’s the difference between BA.4 and BA.5? - The World Health Organization has said that BA.5 now accounts for more than half of the world’s cases, while BA.4 accounts for just over one in 10.3 Why BA.5 has overtaken BA.4 is a mystery, because they’re so similar. Speaking at a Royal Society of Medicine event, Thomas Peacock, a virologist at Imperial College London, said, “They have identical spikes, more or less. So that means it has to be something outside the spike. And really our understanding of that from a virological perspective is very poor.”
9th Aug 2022 - The BMJ

The long reach of long Covid

A recent Kaiser Family Foundation report says that anywhere from 10 million to 35 million working-age adults — as many as a third of all infections — are experiencing long Covid, a hazily defined ailment with symptoms that can include “brain fog,” shortness of breath, heart palpitations and neurological changes. Those symptoms can last anywhere from a few weeks to more than a year. Sen. Tim Kaine (D-Va.) told POLITICO’s Alice Miranda Ollstein that he has felt “as if every nerve ending in my body has had five cups of coffee” since his initial infection subsided in early 2020.
9th Aug 2022 - Politico

EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot

The European Medicines Agency (EMA) has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, it said on Tuesday. The so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID - the original strain first identified in China, and the Omicron offshoots BA.4/5 that are currently behind most cases in Europe. A rolling review means the EMA assesses the data as it becomes available, and the process continues until there is enough data for a formal marketing application.
9th Aug 2022 - Reuters

Novavax tumbles 31% as waning COVID vaccine demand hits revenue forecast

Shares of U.S. vaccine maker Novavax fell about 30% on Tuesday after it cut its annual revenue forecast by half over falling demand for its COVID-19 shot from low- and middle-income nations. Demand for its vaccine is also waning in the United States, where it was authorized for use among adults last month and was expected to be preferred by the skeptics of messenger RNA-based shots from Moderna Inc and Pfizer Inc
9th Aug 2022 - Reuters

Covid Vaccine Maker Novavax Drops After Cutting Sales Outlook 50% (NVAX)

Novavax Inc. shares had their biggest loss in more than three years as the drugmaker slashed its 2022 revenue forecast late Monday on disappointing demand for its Covid-19 vaccine that trailed competitors getting to market. Sales for the year will be as much as $2.3 billion, less than half the previous expected peak of $5 billion, the company said in a statement. Novavax also reported a second-quarter loss of $6.53 a share, wider than analysts’ average estimate of $5.24.
9th Aug 2022 - Bloomberg

Loss Of Smell Linked To Long Term Covid Cognitive Impairment

The Argentinian research team investigated the long term Covid-19 cognitive impairment in older adults through a one-year prospective study design. All 766 participants were randomly invited from the health registry in Jujuy, Argentina, which holds all Covid-19 testing information for its region. Investigators split the group by polymerase chain reaction (PCR) testing status: 88.4% who had Covid-19 and 11.6% without—in other words, the control group.
9th Aug 2022 - Forbes


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Aug 2022

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Immunity for common cold coronaviruses may ward off severe covid-19

People with a stronger immune response to the coronaviruses that cause common cold-like symptoms may be better protected against covid-19, raising hopes that a pan-coronavirus vaccine could be achieved. Ricardo da Silva Antunes at La Jolla Institute for Immunology in California and his colleagues analysed blood samples collected from 32 people between 2016 and 2019, before covid-19 emerged. Multiple samples were taken from each person over six months to three years. The team wanted to see how the immune cells in these samples responded to four coronaviruses that cause common cold-like symptoms as well as the original SARS-CoV-2 strain, which emerged in Wuhan, China, at the end of 2019.
9th Aug 2022 - New Scientist

Study: COVID campus vaccine mandates saved lives. Are they still in place?

A new study of coronavirus vaccine mandates for students at U.S. colleges and universities suggests the mandates saved about 7,300 lives last fall. "I thought the study that came out (last month) was telling," said Daniel Hurley, CEO of the Michigan Association of State Universities, which represents all 15 public universities in Michigan. "Likely those policies, collectively, saved thousands of lives in this country ... When you put it in those terms, that's significant." A Free Press spot check showed that many Michigan colleges and universities plan to keep their vaccine policies in place for the new school year.
8th Aug 2022 - Detroit Free Press

EU regulator awaits trial data before decision on Covid jab targeting Omicron

The European drugs regulator is holding firm with plans to review Covid-19 vaccines designed to tackle the original coronavirus
8th Aug 2022 - Financial Times

BioNTech and Pfizer to begin clinical trial of vaccine for new Covid variants

BioNTech and Pfizer will start a clinical trial of a Covid-19 vaccine adapted to the BA.4 and BA.5 variants of Omicron this month
8th Aug 2022 - Financial Times

COVID-19 Vaccines Induce Better Long-Term Immunity than Infection

To answer these questions, Shane Crotty and his group at the La Jolla Institute for Immunology performed a head-to-head comparison of four currently used COVID-19 vaccines that target the SARS-CoV-2 spike protein: Pfizer/BioNtech (mRNA), Moderna (mRNA), Janssen/J&J (adenovirus), and Novavax (recombinant protein). In a six-month longitudinal study published in Cell, the researchers examined blood samples from vaccinated and recently infected people for SARS-CoV-2 spike-specific immune responses.
8th Aug 2022 - The Scientist

Covid becomes equal leading cause of death in New Zealand for first time

Covid-19 became the equal leading cause of death in New Zealand for the first time in July, overtaking stroke and drawing even with ischaemic heart disease as the country’s No 1 killer. Michael Baker, an epidemiologist and public health professor, said that for a period in July-August Covid appeared to be causing at least as many deaths as heart disease. Baker said that in mid-July, Covid deaths made up almost 15% of deaths overall, referring to data analysis by the New Zealand Herald that compared confirmed Covid deaths against overall deaths in July. Baker said those deaths were likely a slight undercount, as some people would have died of Covid-19 without being tested.
8th Aug 2022 - The Guardian

SyneuRx reveals results of COVID-19 candidate trial

Positive data show Pentarlandir is safe and effective in patients with mild-to-moderate COVID-19. SyneuRx – a company focused on the development of drugs for COVID-19 and multiple central nervous system disorders – has announced results from its phase 2 clinical trial evaluating the efficacy and safety of SNB01, a novel COVID-19 oral antiviral candidate. 89 participants suffering from breakthrough or unvaccinated cases of COVID-19 were randomised evenly into high-dose, low-dose and placebo groups. The phase 2 study showed that SNB01 – also known as Pentarlandir – can reduce the inflammation caused by COVID and improve overall health
8th Aug 2022 - PharmaTimes

Cellex drops patent case over Siemens COVID-19 tests

North Carolina biotech company Cellex Inc has dropped a patent lawsuit against Siemens Healthineers AG over the design of its rapid COVID-19 self-tests less than a week after bringing the case in Delaware, according to a court filing. Cellex told the Delaware federal court Thursday that it would dismiss the case without prejudice, which means it could be refiled in Delaware or elsewhere. The filing did not provide further details. A spokesperson for Siemens said on Saturday that the companies had not settled.
8th Aug 2022 - Reuters

BioNTech expects Omicron-adapted vaccine deliveries as soon as October

BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October, which will help spur demand in the fourth quarter, the German biotech firm said on Monday as it reaffirmed its vaccine-revenue forecast for the year. Demand for the vaccine, 3.6 billion doses of which have been shipped globally, is waning as most people in the Western world have received three or four shots already.
8th Aug 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Aug 2022

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Quebec records 14 new COVID-19 deaths as hospitalizations drop slightly

As of Friday, there were 2,109 COVID-19 hospitalizations — 716 of them specifically due to the disease — a decrease of 27 compared with Thursday’s total. Of those patients, 57 were in intensive care, a drop of 10 from a day earlier; 27 were in the ICU specifically because of COVID-19. The number of health-care workers absent because of COVID-19 — either due to being in isolation or as a precaution — stood at 4,910. Quebec’s COVID-19 death toll is now 16,024.
7th Aug 2022 - Montreal Gazette

80 fresh COVID-19 cases in Sikkim

Sikkim now has 559 active cases, while 40,863 people have recovered from the disease and 778 patients have migrated to other states so far
7th Aug 2022 - EastMojo

Thailand records 2,432 confirmed Covid-19 cases, 32 deaths on Wednesday

The Public Health Ministry reported on Wednesday (August 3) that over the past 24 hours, 2,432 Covid-19 patients have been admitted to hospitals, one of whom has arrived in Thailand from abroad. The death toll has risen by 32, while 2,472 patients have recovered and discharged from hospitals. The number of cumulative cases in the country since January 1, 2022, stands at 2,373,124 with 9,765 deaths.
7th Aug 2022 - Nation Thailand

Covid cases rise sharply, 446 infections recorded

After witnessing the flattening of the Covid-19 pandemic curve for nearly a month for the last four days, Mumbai is witnessing a sudden surge in the number of infections with the city registering 446 cases on Friday, which is the highest single-day count recorded in the past 18 days. In the past two weeks, the average daily Covid-19 cases were hovering around 200 in Mumbai. But since August 2, when the city reported 329 cases, the numbers are witnessing an upward spiral. The next day, the cases further climbed to 434 cases and one death was also reported. On August 4, the cases saw a slight dip with 410 infections and two deaths. On Friday, the daily caseload again surged to 446.
6th Aug 2022 - The Indian Express

Hospitalizations, deaths tied to COVID-19 up slightly, latest report says

The latest provincial report on COVID-19 in Manitoba suggests an uptick in some severe outcomes for the second week in a row, including more people landing in hospital due to the coronavirus. The report says 53 COVID-19 patients were hospitalized during the week ending July 30, compared to 45 one week earlier. Slightly fewer people ended up in intensive care units: there were seven ICU admissions, down from eight ICU admissions during the week ending July 23. There were six deaths associated with coronavirus, up from five the week before. So far, 2,067 people have died due to COVID-19 since the beginning of the pandemic.
5th Aug 2022 - CBC.ca

UK Covid-19 infections fall for second week in a row

Covid-19 infections in the UK have fallen for the second week in a row, in a fresh sign that the current wave of the virus has peaked, new figures show. The number of patients in hospital with the virus is also on a clear downwards trend. A total of 2.6 million people in private households are estimated to have had Covid-19 in the week to July 25/26, down 19% from 3.2 million in the previous week, according to the Office for National Statistics (ONS). Infections have now dropped by more than a million in the space of a fortnight.
5th Aug 2022 - The Independent

Russia's official toll of COVID-related deaths exceeds 820000

Russia has registered a total of 820,307 COVID-related deaths since the start of the pandemic in the country in April 2020, the state statistics service Rosstat said on Friday. It said 4,991 people had died of COVID-19 or related causes in June, down from 7,098 in May. Russia recorded more than 965,000 excess deaths between April 2020 and June 2022 compared with the average mortality in 2015-2019, Reuters calculations showed.
5th Aug 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Aug 2022

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Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong

Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China for usage in children of the age six months to three years. The consensus interim recommendations on Covid-19 vaccine use in children aged six months or above in Hong Kong were released by the Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zoonotic Diseases under the Centre for Health Protection of the Department of Health. The approval is based on clinical trials and studies of Covid-19 inoculation in children and adolescents in the region.
4th Aug 2022 - Pharmaceutical Technology

Studies: 3 or 4 COVID vaccine doses protective against Omicron

In the first study, published yesterday in JAMA Network Open, researchers in Israel studied the effectiveness of a fourth dose of Pfizer/BioNTech mRNA COVID-19 vaccine against infection in 29,611 healthcare workers (HCWs) at 11 general hospitals who had received three vaccine doses in August or September 2021. The Omicron surge in Israel began in December 2021. The researchers tested workers for COVID-19 using polymerase chain reaction (PCR) only after symptoms emerged or they were exposed to the virus. Of all participants, 5,331 (18%) received a fourth dose in January 2022, the start of a fourth-dose vaccination campaign for Israeli HCWs, and were not infected in the first week after vaccination. Average participant age was 44 years, and 65% were women. Participants were followed until Jan 31, 2022.
4th Aug 2022 - CIDRAP

Eli Lilly Revenue Falls as Sales of Covid-19 Treatment Wanes

Eli Lilly posted a 4% decline in second-quarter revenue, as a drop in sales of the company’s Covid-19 antibody treatment and some older drugs offset gains in sales for newer drugs. The pharmaceutical company Thursday reiterated its sales forecast for the year but cut its profit outlook as the stronger U.S. dollar hurts results. Lilly said lower prices and currency translation also contributed to the declining sales, which came in below Wall Street expectations. Lilly is hoping to boost future revenue with sales of newer drugs, including Mounjaro, recently introduced to treat diabetes. Lilly is studying the same drug, also known by its generic name tirzepatide, to treat obesity, and recently reported positive clinical-trial data.
4th Aug 2022 - The Wall Street Journal

Lilly Plans to Sell Covid-19 Antibody Directly to Health-Care Providers

Eli Lilly & Co. plans to sell its Covid-19 antibody directly to health providers, states and territories in a bid to keep the drug available even as US government funding and purchases dry up. The US is working with Lilly to allow it to sell the antibody, bebtelovimab, through commercial channels, representatives for the Indianapolis-based drugmaker and the Health and Human Services Department said Wednesday. The government’s supply of the therapy will run out as early as the week of Aug. 22, according to Lilly spokeswoman Dani Barnhizer. Concern about the pandemic has ebbed as vaccines have prevented high numbers of severe cases and deaths that accompanied the outbreak’s early stages. Meanwhile, the Biden administration has been frustrated by unwillingness in Congress to provide more funds to continue buying Covid drugs and shots.
4th Aug 2022 - Bloomberg

Long COVID-19 and other chronic respiratory conditions after viral infections may stem from an overactive immune response in the lungs

Viruses that cause respiratory diseases like the flu and COVID-19 can lead to mild to severe symptoms within the first few weeks of infection. These symptoms typically resolve within a few more weeks, sometimes with the help of treatment if severe. However, some people go on to experience persistent symptoms that last several months to years. Why and how respiratory diseases can develop into chronic conditions like long COVID-19 are still unclear.
4th Aug 2022 - The Conversation

A first update on mapping the human genetic architecture of COVID-19

The COVID-19 pandemic continues to pose a major public health threat, especially in countries with low vaccination rates. To better understand the biological underpinnings of SARS-CoV-2 infection and COVID-19 severity, we formed the COVID-19 Host Genetics Initiative1. Here we present a genome-wide association study meta-analysis of up to 125,584 cases and over 2.5 million control individuals across 60 studies from 25 countries, adding 11 genome-wide significant loci compared with those previously identified2. Genes at new loci, including SFTPD, MUC5B and ACE2, reveal compelling insights regarding disease susceptibility and severity.
4th Aug 2022 - Nature.com

The Origins of Covid-19 Are More Complicated Than Once Thought

To trace the pandemic in the other direction, toward its source, the researchers turned to swab samples collected by Chinese scientists from around the Huanan market just before it was shut down by the authorities in January 2020. Those swabs returned a cluster of positives in the south-western corner of the market—on a glove found on one of the stalls, from a grate under one of the cages. Five of the positive samples came from a single stall—a stall that was known to be selling live animals in late 2019, and the same stall where Holmes had taken his photograph of the raccoon dogs five years earlier. This layering of indirect evidence has helped to settle the question of where Covid jumped into humans, but the question of timing has also been a subject of fierce debate.
4th Aug 2022 - Wired.co.uk

Moderna COVID vaccine sales forecast unchanged even as COVAX program cuts orders

Moderna Inc on Wednesday maintained its full-year COVID-19 vaccine sales forecast of $21 billion as canceled orders from low- and middle-income nations through the COVAX program offset gains from new booster dose orders. Moderna shares jumped nearly 17% in morning trading after the company also announced a $3 billion share buyback plan. Moderna has begun producing a redesigned booster shot targeting both the original coronavirus as well as the BA.4 and BA.5 Omicron subvariants.
4th Aug 2022 - Reuters

Eli Lilly to make COVID-19 antibody drug commercially available from August

Eli Lilly and Co said on Wednesday it plans to make its COVID-19 antibody drug commercially available to U.S. states as well as hospitals and other healthcare providers from August. The drug, bebtelovimab, had received authorization in the United States in February for the treatment of mild-to-moderate COVID-19 among adults and children. Eli Lilly entered an agreement in June to supply an additional 150,000 doses of the drug to the U.S. government.
4th Aug 2022 - Reuters

South Africa reports first death causally linked to COVID vaccine

South Africa's health regulator reported on Thursday a causal link between the death of an individual and Johnson & Johnson's (J&J) (JNJ.N) COVID-19 vaccine, the first time such a direct link has been made in the country. The person presented with rare neurological disorder Guillain-Barre Syndrome soon after being given J&J's Janssen vaccine, after which the person was put on a ventilator and later died, senior scientists told a news conference.
4th Aug 2022 - Reuters

Eli Lilly’s Covid-19 Antibody Treatment to Be Sold Commercially

Eli Lilly & Co. said it plans to begin commercial sales of its Covid-19 monoclonal antibody treatment to states, hospitals and other healthcare providers this month, as the federal government’s supply of the drug is nearly depleted. The move marks a shift away from the way Lilly’s drug and most other Covid-19 treatments and vaccines have been distributed in the U.S. It will likely be the first test of whether the vaccines and treatments would remain accessible if shifted to a commercial market. Previously, Lilly sold all of its Covid-19 antibody doses for use in the U.S. via contracts with the federal government. The government has made doses available for free to patients and has overseen allocation to states and pharmacies. But the government will exhaust its supply of Lilly’s Covid-19 antibody treatment, bebtelovimab, as early as the week of Aug. 22, a spokeswoman for the Indianapolis-based company said in a statement. Without new appropriations from Congress, the government lacks funds to purchase more doses from Lilly, she said.
4th Aug 2022 - The Wall Street Journal

People vaccinated against Covid share common symptom after testing positive

“It usually lasts for an average of two to three days, but can last up to seven days in adults,” the ZOE team said. The data found this symptom has become less prevalent with each variant, as nearly a third of adults aged over 35 reported having diarrhoea during the Alpha wave, while just one in five said they experienced it during the Omicron and Delta waves. The people who experienced it during the latter two waves had been vaccinated either twice or had also received their booster jab.
4th Aug 2022 - The Independent


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Aug 2022

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Novavax Covid-19 vaccine should carry warning for possible heart side-effects

The European Medicines Agency (EMA) is recommending that Novavax’s Covid-19 vaccine carry a warning of the possibility of two types of heart inflammation that could be triggered as a side effect. The EMA confirmed that the heart conditions – myocarditis and pericarditis – should be listed as new side effects in the product information for the vaccine, Reuters confirmed on Wednesday, August 3. When discussing the Novavax Covid vaccine the American Medical Association’s (AMA) Doctor Sandra Fryhofer who is the liaison to the Advisory Committee on Immunisation Practices said: “We now have a third type of vaccine in the fight against COVID.”
4th Aug 2022 - Euro Weekly News

Moderna Profit Falls Amid Charges for Unused Covid-19 Vaccines

Moderna Inc. sales rose 9% in the second quarter, but costs tied to a surplus of Covid-19 vaccine doses contributed to a profit decline. The Cambridge, Mass.-based biotechnology company’s revenue came in at $4.75 billion for the period ended June 30, topping Wall Street analyst expectations, driven almost entirely by sales of Moderna’s messenger RNA-based vaccine, branded as Spikevax. But the pace of Moderna’s year-over-year sales growth slowed significantly in the second quarter. The company’s first-quarter revenue was more than triple the year-earlier period. Moderna first introduced its Covid-19 vaccine in late 2020 and it is the company’s only product. At the same time, Moderna’s profit fell 21% to $2.2 billion because of charges tied to expired vaccine doses and changes to purchase commitments.
3rd Aug 2022 - The Wall Street Journal

EU says Novavax Covid-19 vaccine should carry heart side-effect warning

The European Medicines Agency (EMA) is recommending Novavax's Covid-19 vaccine carry a warning of two inflammatory conditions of the heart, based on a small number of reported cases. The conditions - myocarditis and pericarditis - should be listed as new side effects in the product information for the vaccine, Nuvaxovid, the EMA said on Wednesday. The agency has also requested that the US drugmaker provide additional data on the risk of these side effects occurring.
3rd Aug 2022 - Independent.ie

Moderna's COVID vaccine approved for vulnerable young children

The ATAGI experts have recommended children aged between six months and five years, who have a higher risk of developing severe illness from COVID, will be able to receive the Moderna vaccine from September 5.
3rd Aug 2022 - ABC News

Pfizer, BioNTech Initiate Phase 2 Study of Enhanced COVID-19 mRNA-Based Vaccine

Pfizer and BioNTech have initiated an active-controlled, observer-blind, phase 2, randomized study to evaluate the immune response, safety, and tolerability of an enhanced COVID-19 mRNA-based vaccine candidate at a 30-µg dose level, Pfizer said in a statement. The enhanced vaccine, BNT162b5, will consist of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain and an Omicron variant. The enhanced spike protein encoded from the mRNAs in the vaccine has been modified with the aim of increasing the breadth and magnitude of the immune response that could better protect against COVID-19. This is the first of multiple vaccine candidates with an enhanced design that the companies plan to evaluate, according to the statement.
3rd Aug 2022 - Pharmacy Times

Moderna's 2Q earnings beat expectations, but it writes off $500 million in expiring Covid shots

Moderna beat Wall Street’s quarterly earnings and revenue expectations. The Boston biotech company generated $4.7 billion in sales for the quarter, a 9% increase over the same period last year. Moderna posted adjusted earnings of $5.24 per share, an 18% drop from the second quarter of 2021. But the company took a nearly $500 million hit on write-downs for vaccine inventory that has expired or is expected to expire before it can be used.
3rd Aug 2022 - CNBC

How much do face masks protect you against COVID-19?

Health authorities no longer force people in Australia to wear face masks except in certain situations, but previous studies show how effective wearing a mask can be in stopping you from getting COVID-19. From around February this year, most states and territories gradually removed requirements for people to wear face masks except in limited circumstances. Current mandates vary slightly across jurisdictions but masks are generally still required while travelling on public transport and planes, and when in hospitals and aged care centres. The requirement for people to wear masks in airport terminals was removed after the Australian Health Protection Principal Committee (AHPPC) said in June it was no longer appropriate. The decision whether or not to wear a mask in most public indoor spaces such as shopping centres and in offices is now down to individual choice.
3rd Aug 2022 - SBS News

Moderna Sales Climb on Strong Demand for Covid-19 Vaccine

Moderna Inc. sales rose 9% in the second quarter, but costs tied to a surplus of Covid-19 vaccine doses contributed to a profit decline. The Cambridge, Mass.-based biotechnology company’s revenue came in at $4.75 billion for the period ended June 30, topping Wall Street analyst expectations, driven almost entirely by sales of Moderna’s messenger RNA-based vaccine, branded as Spikevax. But the pace of Moderna’s year-over-year sales growth slowed significantly in the second quarter. The company’s first-quarter revenue was more than triple the year-earlier period. Moderna first introduced its Covid-19 vaccine in late 2020 and it is the company’s only product
3rd Aug 2022 - The Wall Street Journal

Gilead Boosts Sales Forecast on Demand for Covid-19 Drug

Gilead Sciences Inc. raised its sales forecast for the year, mostly due to anticipated demand for the Covid treatment Veklury. The drugmaker said Tuesday that it now sees total product sales between $24.5 billion and $25 billion this year, up from its April forecast of $23.8 billion to $24.3 billion. That includes about $2.5 billion in Veklury sales, compared with a prior forecast of about $2 billion. In the second quarter, sales of Veklury, also known as remdesivir, fell to $445 million from $1.5 billion in the first quarter, reflecting the increased availability of other treatments and a drop in Covid-19 hospitalizations in the US. Analysts had expected Veklury sales of $376.4 million in the second quarter.
3rd Aug 2022 - Bloomberg

Covid-19: Memory problems are more common in people who lose the sense of smell

Persistent loss of smell is a better predictor of lingering cognitive symptoms after covid-19 infection than disease severity. A common symptom of covid-19 is a sudden loss of smell. Previous research has found that smell loss can be an early warning sign of Alzheimer’s disease and other conditions. Evidence suggests that covid-19 can also lead to long-lasting neurological problems like difficulty concentrating and memory loss. To see if loss of smell due to covid-19 is associated with persistent cognitive symptoms, Gabriela Gonzalez-Alemán at the Pontifical Catholic University of Argentina in Buenos Aires and her colleagues analysed data from 766 adults aged 60 years or older who had no history of cognitive impairment. Each had taken a PCR test at a covid-19 testing clinic in Argentina, and nearly 90 per cent tested positive.
3rd Aug 2022 - New Scientist

The curious case of the Covid-19 rebound

If we've learned anything over the past two and a half years, it's that Covid-19 is one strange disease. The latest case in point: the coronavirus rebound. The condition grabbed international attention last week when US President Joe Biden tested positive for the virus six days after testing negative following his first bout of the illness. The White House said Biden, who is back in isolation, was experiencing a bit of a "loose cough" but did not have a fever and his lungs were "clear." The President tested positive again after being treated with the antiviral Paxlovid. White House officials had previously suggested a rebound case of Covid was unlikely, based on reports of cases around the country, but Biden's doctors continued to monitor his health and test him.
3rd Aug 2022 - CNN

Moderna maintains vaccine sales view on lower COVAX orders

Moderna Inc on Wednesday maintained its full-year COVID-19 vaccine sales forecast of $21 billion as canceled orders from low- and middle-income nations through the COVAX program offset gains from new booster dose orders. Moderna shares jumped nearly 17% in morning trading after the company also announced a $3 billion share buyback plan. Moderna has begun producing a redesigned booster shot targeting both the original coronavirus as well as the BA.4 and BA.5 Omicron subvariants.
3rd Aug 2022 - Reuters

Omicron better at invading young noses than other variants; smell loss may predict memory issues

The Omicron variant may be more efficient at infecting children through the nose than previous versions of the coronavirus, a small study suggests. Earlier in the pandemic, children's noses had been less welcoming to the virus that causes COVID-19 than adults' noses. Studies of the original SARS-CoV-2 and some of its variants found the virus was met with stronger immune responses in the cells lining young noses than in adults' nasal-lining cells, and it was less efficient at making copies of itself in children's noses. But recent test-tube experiments mixing the virus with nasal cells from 23 healthy children and 15 healthy adults found the antiviral defenses in kids' noses "was markedly less pronounced in the case of Omicron," researchers reported on Monday in PLOS Biology.
3rd Aug 2022 - Reuters

COVID-19 tracker: EU recommends heart inflammation warning for Novavax shot

Regulators are Europe recommend that Novavax's vaccine be tagged with warnings about the risk of myocarditis and pericarditis after a small number of cases were recorded, Reuters reports. The U.S. FDA reached a similar decision back in June, according to the news service. So far, just 250,000 doses of the shot have been administered in Europe. While around 7 million people in the United States who have weaker immune systems are eligible for AstraZeneca's COVID-19 antibody Evusheld, few are actually receiving it, Bloomberg reports. The treatment is intended to help protect people who do not produce a strong response to vaccination. So far, health care providers have ordered just 800,000 courses of the treatment, the news service reports, citing federal data.
3rd Aug 2022 - FiercePharma

Regeneron puts kibosh on 4 antibody studies as Pfizer's Paxlovid dominates the COVID treatment scene

In a sign of the times, Regeneron Pharmaceuticals—whose antibody cocktail REGEN-COV once helped form the vanguard of COVID-19 therapeutics—has axed a clutch of trials weighing the med across a range of patients and clinical stages. The move comes about half a year after the FDA pulled the cocktail from the market after data suggested its efficacy had waned in the face of the surging omicron variant. It’s a fate shared by a number of early-pandemic therapeutics, which have largely fallen by the wayside in the U.S. as the virus swiftly evolves. Now, Regeneron has terminated four clinical trials of REGEN-COV, comprising the monoclonal antibodies casirivimab and imdevimab.
3rd Aug 2022 - FiercePharma

Paxlovid rebound happens, though why and to whom are still a mystery

As an emergency department physician in New York, I often field calls about medical issues from family members, friends, and even friends of friends. Since the Covid-19 pandemic began, the number of these calls has dramatically increased. The latest slew of these, about Paxlovid and rebound Covid-19 — which President Biden now apparently has — has revealed the confusion surrounding this phenomenon for me, my physician colleagues, and at least one Nobel laureate. I recently got a call from my friend Joachim Frank, who shared the Nobel Prize in Chemistry in 2017, about his rebound Covid after doing what he was supposed to do: taking Paxlovid as his doctor had prescribed.
2nd Aug 2022 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Aug 2022

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for mRNA Covid-19 vaccine.
2nd Aug 2022 - Pharmaceutical Technology

Bharat Biotech expects regulator’s nod for intranasal Covid-19 vaccine in August

Bharat Biotech, which is working on an intranasal Covid-19 vaccine, is hopeful of getting regulatory licenses this month, Chairman and Managing Director of BBIL, Krishna Ella said.
2nd Aug 2022 - Deccan Herald

Fewer pregnant women had severe COVID amid Omicron, after vaccination

Fewer pregnant women had severe COVID-19 in the Omicron variant-era than during periods dominated by previous strains, and vaccinated patients were better protected than their unvaccinated peers, according to research published yesterday in the American Journal of Infection Control. Investigators from South Korea retrospectively examined the electronic medical records of 224 pregnant women who tested positive for COVID-19 and 82 quarantine deliveries from Nov 1, 2020, to Mar 7, 2022, at a single hospital. Average maternal age was 32 years. Pregnant women admitted to the hospital before Jan 17, 2022 were considered to be infected with the Delta variant, while those after that date were considered infected with Omicron. Of the 224 women, 39 (17%) were vaccinated, and 185 (83%) were unvaccinated against COVID-19.
2nd Aug 2022 - CIDRAP

Analysis | What Experts Know About 'Long Covid' and Who Gets It

Most people who suffer from Covid-19 fully recover. Millions of others find complete healing to be frustratingly elusive, in what’s often referred to as long Covid. Symptoms range from pulmonary, cardiovascular, gastrointestinal or neurological problems to cognitive issues such as so-called brain fog. No single explanation, diagnosis or treatment can be applied to them. Colloquially known as long-haulers, these patients reflect the pandemic’s lasting burden on society and the economy.
2nd Aug 2022 - The Washington Post

People vaccinated against Covid share common symptom after testing positive

While it may be widely known that common symptoms of Covid include fatigue, a sore throat, and headaches, there is another widespread symptom being cited among sufferers. According to data gathered by the ZOE Health Study app, diarrhoea is a common symptom of Covid for vaccinated Britons. Data shows that there was a rise in people reporting this symptom in January 2022, and that some of this was related to the Omicron variant of Covid-19. However, the ZOE team pointed out that there seemed to be a “wave of other non-Covid tummy bugs going around too”. The team said that diarrhoea can be an early symptom of the virus, starting on the first day of infection and getting worse throughout the week.
2nd Aug 2022 - The Independent

Vaccine patch offers more robust protection against omicron, delta COVID-19 variants

A COVID-19 vaccine patch is more effective at fighting variants such as delta and omicron than a traditional needle shot, a new study has found. The research, conducted by Australia’s University of Queensland and in partnership with Brisbane-based biotech company Vaxxas, deduced that the needle-free COVID-19 vaccine patch could offer more robust protection against the virus, which has so far claimed over 6.4 million lives since the outbreak in December 2019. The researchers analyzed the Hexapro SARS-CoV-2 spike vaccine using Vaxxas high-density microarray patch (HD-MAP) technology. “The high-density microarray patch is a vaccine delivery platform that precisely delivers the vaccine into the layers of the skin which are rich in immune cells,” said Christopher McMillan of Queensland University in a statement.
2nd Aug 2022 - Al Arabiya English

COVID-19 rebounds like Biden's 'should not dissuade' patients from taking Paxlovid

President Joe Biden tested positive for SARS-CoV-2 again on Monday, the White House announced — the third day in a row he tested positive after testing negative for 3 days last week. Biden, who is fully vaccinated and has received two boosters, has a case of so-called “rebound” COVID-19, which has been reported in some patients after being treated with Paxlovid. He first tested positive on July 21 and experienced “very mild” symptoms, according to the White House.
2nd Aug 2022 - Healio

Life expectancy drops for Native Americans due to COVID-19

Native Americans experienced disproportionately high rates of deaths from COVID-19 due to poverty, crowded housing, high rates of chronic disease, employment in frontline jobs, and limited access to quality health care. Less is known about the pandemic's effects on life expectancy for this population, which makes up 2% of the U.S. population. Noreen Goldman of Princeton University and Theresa Andrasfay, Ph.D. '20 of the University of Southern California investigated life expectancy at birth in 2020 and 2021 -- when COVID-19 rates were surging -- compared to 2019. Life expectancy is a metric of population-level mortality in a given year, and it is sensitive to deaths at younger ages.
2nd Aug 2022 - Science Daily

FDA reauthorizes Meridian's COVID-19 test after changes to enable omicron detection

The Food and Drug Administration reauthorized Meridian Bioscience’s Revogene SARS-CoV-2 molecular assay for emergency use. U.S. regulatory officials warned late last year that the previous version of the test was unable to detect the omicron COVID-19 variant, leading Meridian to modify the design of the assay. The work led Meridian, which is the subject of a pending $1.53 billion takeover, to submit initial data on the revised assay in March and ultimately to win renewed emergency use authorization (EUA).
2nd Aug 2022 - MedTech Dive

Testing negative to COVID-19 but still have symptoms? Here's what you need to know

You have the telltale signs of COVID — fever, headache, dry cough and exhaustion — but your rapid antigen test is returning a negative result. You're not alone. So, if you're testing negative on a RAT but still have symptoms, or if you need to record a positive RAT test result — here's a refresh on what to do.
2nd Aug 2022 - ABC News

GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

GreenLight Biosciences and Samsung Biologics have completed the first commercial-scale engineering run under the companies’ mRNA production partnership: ahead of a COVID-19 vaccine booster clinical trial due to start later this year.
2nd Aug 2022 - BioPharma-Reporter

Reduced severity of COVID-19 in pregnant women during the Omicron wave

In South Korea, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for the coronavirus disease 2019 (COVID-19) pandemic, has infected a considerable number of pregnant women, including those who have delivered by cesarean section. Pregnancy is considered a high-risk factor for severe COVID-19, particularly among infections due to the SARS-CoV-2 Delta variant. The clinical course of infection with the SARS-CoV-2 Omicron variant remains unknown in pregnant women. Furthermore, due to the low vaccination rate of less than 10% in South Korea, information regarding COVID-19 vaccine efficacy in pregnant women is also insufficient.
2nd Aug 2022 - News-Medical.Net

Covid-19: is omicron less lethal than delta?

Soon after the omicron SARS-CoV-2 variant of concern was first reported to the World Health Organization on 24 November 2021, preliminary observational studies in South Africa suggested this highly transmissible variant was associated with lower hospital admission and mortality rates in people with covid-19 infection.1 However, given omicron’s increased propensity to cause reinfections and vaccine breakthrough,23 it was unclear if this effect was due to previous immunity in the population or an inherent property of the genetically divergent variant. Subsequent analyses further supported a lower risk of severe outcomes in infections with omicron compared with delta, although these data were limited to all cause deaths within 28 days of diagnosis. Additionally, many public health measures previously enacted to curb SARS-CoV-2 transmission were being relaxed in early 2022, potentially resulting in more infections in relatively low risk populations. These limitations complicated efforts to assess the true risk of severe disease and mortality associated with omicron infection.
2nd Aug 2022 - The BMJ

Axcella long COVID treatment helps some patients in small trial

One of the first trials aimed at tackling long COVID helped some patients recover from lingering physical and mental fatigue, although the drug developed by Axcella Health Inc failed on the small study's main goal of restoring the normal function of mitochondria - the energy factories of cells. In the 41-patient pilot study released on Tuesday, for three of 21 patients who received the drug, AXA1125, their physical fatigue scores returned to normal levels after 28 days of treatment, Axcella Chief Medical Officer Margaret Koziel said in a phone interview.
2nd Aug 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Aug 2022

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Polio found in New York wastewater as state urges vaccinations

The polio virus was present in wastewater in a New York City suburb a month before health officials there announced a confirmed case of the disease last month, state health officials said on Monday, urging residents to be sure they have been vaccinated. The discovery of the disease from wastewater samples collected in June means the virus was present in the community before the Rockland County adult's diagnosis was made public July 21.
2nd Aug 2022 - Reuters

Moderna signs contract to supply Covid-19 booster vaccines to US

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA). Spikevax is the company’s Covid-19 vaccine intended for active immunisation for disease prevention in people aged 18 years and above.
1st Aug 2022 - Pharmaceutical Technology

Moderna secures £1.74bn deal to supply US government with updated COVID-19 vaccine

Moderna has announced it has secured a deal with the US government to supply 66 million doses of its COVID-19 vaccine booster updated for the Omicron subvariant for use in an autumn and winter campaign. The company will receive up to £1.74bn for the manufacture and delivery of the doses of mRNA-1273.222, a bivalent booster candidate containing Moderna’s COVID-19 vaccine Spikevax plus the Omicron BA.4/5 string mRNA. The US government will also have the option to purchase up to an additional 234 million doses. Commenting on the deal, Stéphane Bancel, chief executive officer of Moderna, said: "We are pleased to extend our successful collaboration with the US government. Moderna's mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets Omicron subvariants BA.4 and BA.5, the most prevalent variants of concern in the US today
1st Aug 2022 - PMLiVE

SK Bioscience eyes Europe as market for COVID-19 vaccine

SK Bioscience has submitted the application for conditional approval of the COVID-19 vaccine SKY Covione with the European Medicines Agency in efforts to expand its presence in the global market, the South Korean vaccine developer said Monday. Beginning with the European region, SK Bioscience said it will look to showcase the South Korean COVID-19 vaccine on the global stage as the size of the coronavirus vaccine market grows rapidly. South Korea’s Ministry of Food and Drug Ministry gave the green light to SKYCovione at the end of June as the country became the third nation in the world with a homegrown COVID-19 treatment and a domestically-developed vaccine, behind the UK and US.
1st Aug 2022 - The Korea Herald

Pfizer and BioNTech start trial of 'next-gen' COVID vaccine

The two companies h(Pfizer and BioNTech) ave begun a Phase II study on an ‘enhanced’ version of their mRNA vaccine against COVID-19, a so-called 'nextgen' Covid vaccine
1st Aug 2022 - BioPharma-Reporter.com

COVID-19 Pandemic Dramatically Increased Childcare Stress Among Health Care Workers

A September 2021 poll revealed that 1 in 5 health care workers (HCWs) quit their job since March 2020. Pre-existing disparities and issues in the health care workforce and within the current childcare system were exacerbated because of the COVID-19 pandemic, according to the poll. Researchers found that childcare stress (CCS) was associated with anxiety, depression, burnout (occupational stress), intent to reduce (ITR), and intent to leave (ITL) for HCWs, which were experienced at disproportionate levels across different subgroups. The source of the study, called Coping with COVID, is a 14-item survey looking at several demographic items, such as race, ethnicity, gender, years in practice, outpatient vs inpatient practice environment, and work role between April-December 2020.
1st Aug 2022 - Pharmacy Times

'Living with COVID': Where the pandemic could go next

As the third winter of the coronavirus pandemic looms in the northern hemisphere, scientists are warning weary governments and populations alike to brace for more waves of COVID-19. In the United States alone, there could be up to a million infections a day this winter, Chris Murray, head of the Institute of Health Metrics and Evaluation (IHME), an independent modeling group at the University of Washington that has been tracking the pandemic, told Reuters. That would be around double the current daily tally.
1st Aug 2022 - Reuters

Studies investigate impact of COVID-19 pandemic on memory and thinking changes

Researchers present findings at world’s largest dementia research conference Persistent loss of smell after COVID-19 linked to memory and thinking changes associated with diseases like Alzheimer’s. Links between life changes during pandemic, and memory, investigated. Intensive care admissions (not necessarily COVID-19) associated with dementia risk
1st Aug 2022 - Alzheimer's Research UK

Covid warning over symptom of new strain that affects sufferers at night

An immunologist has warned the new strain of Covid-19 could be causing different symptoms – including one that emerges during the night. Omicron BA.5 is a highly-contagious subvariant prompting concern as it contributes to a fresh wave of infections across the globe, including the UK. Scientists have been finding differences with previous strains, including the ability to reinfect people within weeks of having Covid. A leading immunologist has now suggested it could be causing a new symptom among patients. “One extra symptom from BA.5 I saw this morning is night sweats,” Professor Luke O’Neill from Trinity College Dublin told an Irish radio station in mid-July.
1st Aug 2022 - The Independent

Habitual mask-wearing is likely helping Japan, Singapore and South Korea bring daily Omicron deaths down, epidemiologists say

As the mask mandate debate rages on in Australia, epidemiologists and medical specialists suggest looking to countries where citizens are perfectly happy to wear them to see how powerful the simple infection-control measure can be. Nearly two and a half years into the COVID-19 pandemic, countries where mask-wearing is a cultural norm are seeing some signs of success as the persistent Omicron sub-variants spread throughout their communities. University of Otago public health professor and epidemiologist Michael Baker said underlying the widespread acceptance of masks in some countries was a sense of personal responsibility to protect others from COVID-19. "I'm looking at the countries that appear, on paper, to be keeping their mortality very low … despite having lots of circulating virus, and it's basically the Asian countries, particularly Japan, South Korea, Singapore," he said.
1st Aug 2022 - ABC News

An administrative bungle caused Queensland's COVID cases to be under reported

While Saturday's COVID case count appears to show a massive spike of more than 18,000, Queensland Health says this is due to an administrative error and many are historic.
1st Aug 2022 - ABC News

COVID's deadly 'payback period'

We're heading for another peak in infections, and the daily death toll has never been so high, while worldwide we appear to be faring worse than just about anywhere else. But why? And how many more waves will Australia need to endure? Today, epidemiologist Professor Tony Blakely on why Australia's early success at keeping the virus at bay now seems to be working against us. Featured: Professor Tony Blakely, epidemiologist, School of Population and Global Health, University of Melbourne
31st Jul 2022 - ABC News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Aug 2022

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Reinfection, severe outcome more common with BA.5 variant; virus spike protein toxic to heart cells

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Reinfections, severe outcomes may be more common with BA.5. Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests.
30th Jul 2022 - Reuters

Pfizer and BioNTech initiate phase 2 study of ‘enhanced’ COVID-19 vaccine

Pfizer and BioNTech have initiated a phase 2 study evaluating a new version of the COVID-19 vaccine that the companies hope will better protect against the virus. The Pfizer-BioNTech COVID-19 vaccine, BNT162b5, consists of RNAs encoding ‘enhanced’ prefusion spike proteins for the SARS-CoV-2 wild-type strain and an Omicron variant, with the aim of increasing the magnitude and breadth of the immune response. The vaccine candidate will be evaluated in a US-base study, enrolling around 200 participants aged 18 to 55 who have already received one booster dose at least 90 days prior to their enrolment in the study. The participants will be divided into subgroups based on the number of months since their last dose. The study does not include a placebo. BNT162b5 is the first of multiple vaccine candidates with an enhanced design, the companies stated, representing their long-term COVID-19 vaccine strategy to overcome the relatively short-lived immune response seen with their first-generation vaccine, BNT162b2.
29th Jul 2022 - PMLiVE

Serious self-harm in young people jumped during strict COVID-19 lockdowns - study

Serious self-harm among young people jumped during strict COVID-19 lockdowns, new research shows. The study found that boys needing urgent support from emergency services doubled, and then tripled for children in care. Meanwhile, girls continued to be over-represented in self-harm figures, researchers said. It comes after another study suggested that people living in poverty are more likely to suffer with long COVID. Psychiatrists have called for more funding and development of community mental health services due to the findings, which have been published in the Royal College of Psychiatrists' BJPsych Open
29th Jul 2022 - Sky News

Could next-generation vaccines finally end the covid-19 pandemic?

The coronavirus vaccines have been a brilliant success, possibly saving tens of millions of lives. But they haven’t ended the pandemic and their effectiveness has been eroded by the evolution of variants of the SARS-CoV-2 coronavirus. A new generation of covid-19 vaccines is needed – but what exactly should this involve? The US plans to roll out boosters that target the BA.4 and BA.5 omicron subvariants.
29th Jul 2022 - New Scientist

Reinfection, severe outcome more common with BA.5 variant; virus spike protein toxic to heart cells

Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests. From late April through early June, researchers there studied 15,396 adults infected with the BA.2 variant and 12,306 infected with BA.5. Vaccines and boosters were equally effective against both sublineages, according to a report posted on Monday on medRxiv ahead of peer review. However, 10% of BA.5 cases were reinfections, compared to 5.6% of BA.2 cases, which suggests a reduction in protection conferred by previous infection against BA.5 compared to BA.2, the researchers said. Moreover, the vaccines appeared to be less effective in reducing the risk of severe outcomes for BA.5 compared with BA.2.
29th Jul 2022 - Reuters

CanSinoBIO's inhaled COVID booster stronger against BA.1 Omicron subvariant than Sinovac shot

Chinese vaccine firm CanSino Biologic's inhalation-based candidate elicited a better antibody response as a booster against the BA.1 Omicron sub-variant than Sinovac's shot, but the antibody level dropped in months, clinical trial data showed. The result came as top political leaders in China called for proper tracking of virus mutation and developing of new vaccines and treatments in the country's effort to refine its COVID control strategy.
29th Jul 2022 - Reuters

If you're high risk, do not wait for updated COVID vaccines, experts say

People at high risk of severe disease who have yet to get a second COVID-19 booster should not wait for next-generation, Omicron-targeted vaccines expected in the fall, five vaccine experts told Reuters. In many countries, including the United States, the BA.5 Omicron subvariant of the virus is surging, but current vaccines continue to offer protection against hospitalization for severe disease and death.
29th Jul 2022 - Reuters

AstraZeneca lifts revenue guidance on COVID treatment

AstraZeneca (AZN.L) said it expected prescriptions of its COVID therapy to drive sales growth of more than 20% this year, as company reported second-quarter profit that topped analyst estimates. The injection, called Evusheld, which is designed to protect against COVID infection for at least six months, has been deployed in many countries for people with compromised immune systems who see little or no benefit from vaccines.
29th Jul 2022 - Reuters

Covid Leaves Some 5% of People With Faulty Sense of Smell, Taste

Losing the sense of smell and taste has become a hallmark of coronavirus infection. But a new study finds that the problem persists in some 5% of patients, disrupting their everyday lives and providing yet another set of symptoms to chalk up to long Covid. The scientists drew their conclusion after reviewing 18 studies involving more than 3,600 patients. The findings mean that as many as 15 million patients may be affected worldwide, they said in a paper published Thursday in the UK medical journal BMJ. Women were less likely to recover than men, the research found, as were patients whose symptoms were strongest or who had nasal congestion. Overall, most patients regained their sense of smell and taste within three months.
27th Jul 2022 - Bloomberg

How long-term Covid-19 immunity paves the way for universal Covid-19 vaccines

In recent months, scientists have also learned that the immune cells that provide lasting protection — known as memory B cells and T cells — can keep the worst effects of the most recent versions of the virus at bay, even if they were trained to corral older strains of SARS-CoV-2. Vaccine researchers are expanding their focus from antibodies to these memory immune cells as the new discoveries open a path toward universal coronavirus vaccines. Universal vaccines, however, are still a long way off — possibly years — drawing on approaches never used before. “That’s a scientific challenge,” said Anthony Fauci, chief medical adviser to the president, during the summit.
29th Jul 2022 - Vox.com


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Jul 2022

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Air Pollution Likely to Contribute to Diseases Including Dementia, UK Committee Finds

Air pollution is "likely" to increase the risk of developing dementia, a Government research group has said. The Committee on the Medical Effects of Air Pollutants has published its findings after reviewing almost 70 studies which analysed how exposure to emissions affect the brain over time. The 291-page report concludes that air pollution "likely" increases the risk of accelerated "cognitive decline" and of "developing dementia" in older people. Experts believe this is due to the impact of pollutants entering the circulatory system, affecting blood flow to the brain.
28th Jul 2022 - Bloomberg

What the UK is Getting Right in the Fight to Contain Monkeypox

As global concerns mount about the threat of monkeypox, the UK offers a measure of hope that the crisis is controllable. Just days after the World Health Organization declared the outbreak a public health emergency, the UK released data suggesting that transmission is plateauing. That’s giving health experts a dash of optimism. “The figures that we are seeing, certainly with the eye of faith, do look as though they are slowing down,” Jimmy Whitworth, a professor of public health at the London School of Hygiene and Tropical Medicine, said in a phone interview. “It doesn’t mean we’re out of the woods, but it is an encouraging sign.”
28th Jul 2022 - Bloomberg

CityU researchers invents accurate rapid COVID-19 antibody level test

Vaccines have become the most important weapon in the fight against the COVID-19 pandemic, but antibody levels after vaccination decay quickly over time. Therefore, an accurate and affordable antibody rapid test is urgently needed to adjust the revaccination strategy. A research team led by City University of Hong Kong (CityU) recently invented an accurate rapid-testing device that can quantify and display the antibody level as a length of a visual bar, like a mercury thermometer, in as few as 20 minutes, enabling convenient mass screening or individual monitoring of immune protection against COVID-19.
28th Jul 2022 - EurekAlert!

Pfizer and BioNTech speak out against CureVac suit over patents for COVID-19 vaccines

Global clinical-stage biopharmaceutical company, CureVac, filed a lawsuit earlier this month against BioNTech, making the claim that CureVac should be compensated for an apparent infringement of a range of patents. The suit took place in German court and BioNTech has declared that it is contesting CureVac’s allegations, and called upon its partner, Pfizer, in a Massachusetts court filing to counter the claims. Both BioNTech and Pfizer assert that following CureVac’s failed attempts to develop a COVID-19 vaccine, CureVac tried to profit from the partnership, threatening patent infringement and legal action as a means of correcting CureVac’s ‘meritless allegations’.
28th Jul 2022 - PMLiVE

In Rural America, Covid Hits Black and Hispanic People Hardest

At the peak of the Omicron wave, Covid killed Black Americans in rural areas at a rate roughly 34 percent higher than it did white people. The coronavirus pandemic walloped rural America last year, precipitating a surge of deaths among white residents as the virus inflamed longstanding health deficits there. But across the small towns and farmlands, new research has found, Covid killed Black and Hispanic people at considerably higher rates than it did their white neighbors. Even at the end of the pandemic’s second year, in February 2022, overstretched health systems, poverty, chronic illnesses and lower vaccination rates were forcing nonwhite people to bear the burden of the virus. Black and Hispanic people in rural areas suffered an exceptionally high toll, dying at far higher rates than in cities during that second year of the pandemic.
28th Jul 2022 - The New York Times

Fauci calls BA.5 a ‘moving target’ that may subside by the time Omicron boosters are ready. Scientists are pushing for a universal COVID vaccine instead

Vaccines made specifically to tackle the BA.5 subvariant of COVID should be ready by this fall, Dr. Anthony Fauci, U.S. President Joe Biden’s chief medical advisor, told The Hill this week. But the vaccines could suffer from one major flaw—BA.5-specific vaccines may become less effective once the Omicron subvariant is replaced by another strain, a real possibility given that dominant strains have been replaced with more competitive forms of the virus roughly every six months during the course of the pandemic. “You’re dealing with a moving target,” he said on The Hill’s Rising television show. “There’s always the possibility that you’re going to have the evolution of another variant… And hopefully, if that occurs, it will vary off from the BA.5 only slightly—in the sense of being a sub-sublineage of it, and not something entirely different.”
28th Jul 2022 - Fortune

Millions still without sense of smell or taste after Covid-19

Still struggling with your sense of smell after a bout with Covid-19? You’re far from alone. About 5% of patients with confirmed cases of Covid-19 — some 27 million people worldwide — are estimated to have suffered a long-lasting loss of smell or taste, a new analysis suggests. In the analysis published Wednesday in The BMJ (the peer-reviewed medical journal of the British Medical Association), researchers evaluated 18 previous studies of smell and taste loss across several continents and in varying demographic groups. About three quarters of those affected by loss of taste or smell regained those senses within 30 days. Rates of recovery improved over time, but about 5% of people reported “persistent dysfunction” six months after their infection with Covid-19.
28th Jul 2022 - CNBC

EMA task force begins review of Veru's sabizabulin for Covid-19

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the EU. Under this process, the ETF will analyse all available data, including findings from a trial in moderate-to-severe Covid-19 patients admitted to the hospital with increased ARDS and mortality risk. According to the study findings, treatment with sabizabulin lowered the number of deaths in these subjects versus placebo.
28th Jul 2022 - Pharmaceutical Technology

COVID-19 Moderna vaccine induces significant antibody reactions among children

In a recent article published in the Science Translational Medicine journal, researchers illustrated that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccination triggers potent antibody reactions in children.
28th Jul 2022 - News-Medical.Net

COVID-19: Millions could suffer from long-term smell or taste problems after coronavirus infection, study says

Around one in 20 people who have tested positive for COVID-19 worldwide have long-term smell or taste problems for at least 6 months, a new study has found. The survey was put together by a team of international experts, including some from the UK and analysed data from 18 studies comprising 3,699 patients. Published in the BMJ, it used modelling to estimate how many people go on to suffer from altered taste or smell for at least six months after a COVID-19 infection. It found that an estimated 5.6% of patients suffer smell dysfunction for at least six months, while 4.4% have a change in taste
28th Jul 2022 - Sky News

UK scientists take ‘promising’ step towards single Covid and cold vaccine

Scientists have made a “promising” advance towards developing a universal coronavirus vaccine to tackle Covid-19 and the common cold. Researchers at the Francis Crick Institute in London have discovered that a specific area of the spike protein of Sars-CoV-2 – the virus that causes Covid-19 – is a good target for a pan-coronavirus jab that could offer protection against all the Covid-19 variants and common colds. Developing a vaccine that protects against a number of different coronaviruses is a huge challenge, they said, because this family of viruses have many key differences, frequently mutate and generally induce incomplete protection against reinfection. That is why people can repeatedly catch common colds, and why it is possible to be infected multiple times with different variants of Sars-CoV-2.
28th Jul 2022 - The Guardian

Pfizer profit beats estimates on higher demand for COVID products

Pfizer Inc did not raise its 2022 forecast for sales of its COVID-19 vaccine and antiviral treatment on Thursday, and its shares fell nearly 5% before recovering. The U.S. drugmaker maintained its full-year forecast of around $54 billion for its COVID products, even as second-quarter sales of its Paxlovid antiviral pills were much higher-than-expected, raising concerns among some analysts over Pfizer's long-term growth prospects.
28th Jul 2022 - Reuters

COVID-19: People living in poverty more likely to get long COVID, study suggests

According to the Institute for Fiscal Studies (IFS), people with coronavirus symptoms lasting more than four weeks are more likely to have been living in social housing or claiming benefits before they got ill. Previous studies have shown that long COVID patients are more likely to be women, middle-aged and have an underlying health condition.
27th Jul 2022 - Sky News

Persistent brain fog, hair loss highlighted in long-COVID studies

The first study, by University of Oslo researchers in Norway, was published yesterday in Open Forum Infectious Diseases. The team used four computer-based cognitive tests from the Cambridge Neuropsychological Test Automated Battery to assess 75 adult COVID-19 patients' cognitive function 13 months after release from a single hospital. Included patients were, on average, 55.7 years old and were admitted to the hospital up to June 2020. The four tests were delayed matching to sample (DMS) (testing short-term memory, visuospatial processing, learning, and attention), the One-touch Stockings of Cambridge (OTS) test (executive function), rapid visual-information processing (RVP) (sustained attention), and spatial working memory and strategy (SWM).
27th Jul 2022 - CIDRAP

Can we really get better Covid vaccines? There are big hurdles, but some hope

On Tuesday, White House officials gathered scientists, pharmaceutical executives, and experts in public health at a summit to try to lay out a path toward creating better vaccines. What was the upshot? For starters, there was tremendous optimism about the prospects for developing next-generation vaccines. And there were, in fact, glimmers of a tractable path to better products — if Congress will provide billions of dollars to speed things up.
27th Jul 2022 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Jul 2022

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Novavax Covid-19 vaccine gets Australian TGA approval for adolescents

Novavax has received expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. Nuvaxovid is indicated for active immunisation for the prevention of Covid-19 in individuals of this age group. It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years. The approval is based on findings from the paediatric expansion of the Phase III PREVENT-19 clinical trial of 2,247 adolescents of this age group at 73 sites in the US.
27th Jul 2022 - Pharmaceutical Technology

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust,
27th Jul 2022 - The Associated Press

The Future of COVID Vaccines: will you need constant boosters or is a single "forever" shot possible?

Most Australians over 30 are now eligible for their fourth COVID vaccine booster shot. But will there ever be a "forever" vaccine, that removes the need for boosters? Or a vaccine that stops you contracting COVID in the first place? Royal Melbourne Hospital's Dr Kudza Kanhutu specialises in infectious diseases and has a background in immunology. Hear her discuss what the future of COVID vaccines might look like with Nadia on Mornings
27th Jul 2022 - ABC News

Bharat Biotech, ExcellGene consortium to develop variant-proof Covid vax

Switzerland’s ExcellGene SA has announced its role in the recently approved consortium funding through the Coalition for Epidemic Preparedness Innovations (CEPI) for co-developing a variant-proof coronavirus vaccine with India’s Bharat Biotech. The consortium is developing or designing a new vaccine concept that confers highly cross-reactive protection against numerous SARS-CoV-2 variants of concern as well as other betacoronaviruses.
27th Jul 2022 - Business Standard

New studies bolster theory coronavirus emerged from the wild

Two new studies provide more evidence that the coronavirus pandemic originated in a Wuhan, China market where live animals were sold – further bolstering the theory that the virus emerged in the wild rather than escaping from a Chinese lab. The research, published online Tuesday by the journal Science, shows that the Huanan Seafood Wholesale Market was likely the early epicenter of the scourge that has now killed nearly 6.4 million people around the world. Scientists conclude that the virus that causes COVID-19, SARS-CoV-2, likely spilled from animals into people two separate times. “All this evidence tells us the same thing: It points right to this particular market in the middle of Wuhan,” said Kristian Andersen a professor in the Department of Immunology and Microbiology at Scripps Research and coauthor of one of the studies.
27th Jul 2022 - The Independent

How Much Rest Do You Really Need When You Get Covid-19?

Many people feel the urge to power through after testing positive for Covid-19. President Biden recently told Americans he was “getting a lot of work done” after testing positive and tweeted a photo of himself signing a bill at his desk. Doctors say it is important to rest, even for people with mild to moderate cases of the virus. Some doctors worry that as we get more inured to the pandemic, some people with symptoms aren’t taking enough down time. Pushing yourself too hard can lengthen your recovery, they say, adding that the healing trajectory for Covid-19 is less predictable than for other respiratory illnesses.
27th Jul 2022 - The Wall Street Journal

Does the Covid vaccine really affect your period? Here’s what our study found

In January 2021, my colleagues at the hospital were among the first to receive the Covid-19 vaccine. Comparing the side-effects afterwards, most of us had a sore arm, some of us felt feverish and generally under the weather, but one comment stood out. “My period was heavier than usual,” said one of the midwives. “But that happens to me every year after we get our flu vaccines, too. It’s just another of those vaccine side-effects, isn’t it?” Was it? I’m an immunologist working in female reproduction and this was the first time I had heard of such an effect, but it didn’t strike me as implausible. We know that various stressors, physical and psychological, can influence the menstrual cycle and vaccination is certainly a physical stressor; those of us who were complaining of feeling under the weather could attest to that. And yet I wondered why, if this effect was as run of the mill as my colleague seemed to think, it wasn’t something I had heard before.
27th Jul 2022 - The Guardian

Covid-19 antibody levels jump among oldest age groups after spring booster jabs

Covid-19 antibody levels among the oldest age groups have jumped sharply in recent months, following the rollout of spring booster jabs, new figures suggest. Some 94.3% of people aged 80 and over in England were likely to have antibodies at the start of July, up from 65.8% at the end of March. Among 75- to 79-year-olds, the proportion stands at 93.1%, up from 62.8%. The figures have been calculated by the Office for National Statistics (ONS) and use a higher threshold for measuring antibodies than in previous studies, in order to better reflect the proportion of people with the strongest possible antibody response to infection.
27th Jul 2022 - The Independent

The Earliest Known Cases of COVID-19 Have Finally Been Pinpointed

Wild animals sold on the southwestern side of the Huanan Seafood Wholesale Market in Wuhan were the most likely source of the COVID-19 outbreak, a team of 18 international scientists claim. While there's still no 'smoking gun', it seems there is a mountain of circumstantial evidence that would be very statistically unlikely to exist without the Wuhan markets at the epicenter of the outbreak. According to a 2021 World Health Organisation (WHO) mission report, a total of 174 people caught SARS-CoV-2 in the very early days of the outbreak in December 2019. Locations of where 155 of those people lived and worked were able to be extracted from the report. In their study published in Science, the international team of researchers found that the majority of these 155 people lived near the west bank of the Yangtze River, where the Wuhan markets are located. There was a high density of cases surrounding the market.
27th Jul 2022 - Science Alert

Pfizer starts mid-stage trial for vaccine against Omicron subvariant

Pfizer Inc and its German partner BioNTech SE said on Wednesday they had started a mid-stage study of a modified COVID-19 vaccine which targets both the original as well as the BA.2 Omicron subvariant. Pfizer said the vaccine is in an initial proof-of-concept study to gather more data. Together, the BA.4 and BA.5 subvariants are estimated to make up nearly 95% of the circulating coronavirus variants in the United States for the week ended July 23.
27th Jul 2022 - Reuters

FDA Clears Danish Monkeypox Vaccine Plant, Paving Way for Use of Doses in U.S.

The Food and Drug Administration signed off on a Bavarian Nordic A/S monkeypox vaccine plant, a move that allows use in the U.S. of 786,000 doses made at the facility in Denmark. The FDA said Wednesday it had validated the quality of the shots made at the plant and they met the agency’s standards. “This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox,” Health and Human Services Secretary Xavier Becerra said. Health authorities seeking to vaccinate people at high risk of monkeypox have been waiting for the shots. The federal government had allowed the 786,000 doses to be shipped to the U.S. in advance to speed their availability once the FDA cleared the plant.
27th Jul 2022 - The Wall Street Journal

CDC to make monkeypox nationally notifiable condition

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.
27th Jul 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Jul 2022

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U.S. Leads Globally in Known Monkeypox Cases, CDC Says

The U.S. has reported about 3,600 confirmed or suspected monkeypox cases, federal data showed, while vaulting near the top of the list of countries with the most known infections since the onset of the global health emergency. The rise in cases comes as the U.S. expands testing capacity, broadening the ability to spot new infections, but also as the global outbreak continues to grow. Some public-health experts said rising transmission heightens the chances a broader population will face the risk of infections as the opportunity to slow and potentially stop the outbreak is fading. Data have shown the outbreak is heavily concentrated among men who have sex with men, as the virus exploits social networks among people in close contact. This is already a concern, but spreading more broadly means the potential added challenge of trying to educate and protect a broader population, health experts said.
26th Jul 2022 - The Wall Street Journal

Monkeypox Proves Elusive Foe as WHO Sounds Alarm on Global Spread

The Covid-19 outbreak forced governments around the world to revamp their pandemic response programs, invest in drugs and vaccines and establish viral surveillance systems. Now monkeypox is putting those upgrades to the test -- and they’re falling short. Getting out in front of the global flare-up of the monkeypox virus, which has spread to about 16,000 people in more than 70 countries in just a few months, is an achievable goal, according to infectious disease experts. Yet the lack of urgency and coordination in testing and treatment in many parts of the world has prompted the World Health Organization to sound the alarm.
26th Jul 2022 - Bloomberg

Novavax Announces Expanded Approval of Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 through 17 in Japan

Novavax, Inc, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Nuvaxovid™ COVID-19 vaccine received expanded manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for primary immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17. Novavax has partnered with Takeda to develop, manufacture, and distribute Nuvaxovid in Japan.
26th Jul 2022 - The Associated Press

How COVID-19 lockdown measures — and their outcomes — varied in cities around the world

During the COVID-19 pandemic, Chinese cities have repeatedly imposed lockdowns following their central government’s stubborn pursuit of Zero-COVID. But lockdowns weren’t limited to authoritarian regimes such as China. Many democracies also imposed some form of lockdowns to curb the virus transmission. How effective were they? Was it worth it? And who was the most adversely affected? These are meaningful questions to reflect on, especially as drastic COVID-19 measures have been lifted as the severity of the virus’s impact has waned.
26th Jul 2022 - The Conversation Indonesia

COVID-19 antivirals may cut risk of hospitalization, death

McMaster University researchers in Ontario led the systematic review and network meta-analysis of 40 randomized clinical trials that included 17,563 patients comparing the effectiveness of 16 different antiviral drugs or drug combinations, including molnupiravir, nirmatrelvir-ritonavir (Paxlovid), and remdesivir, with standard care or a placebo in adults with non-severe COVID-19 up to Apr 25, 2022. The researchers noted that most antiviral trials to date have included hospitalized patients with severe or critical disease rather than those with milder illnesses. "Furthermore, although efficacy data from trials of molnupiravir, nirmatrelvir–ritonavir and remdesivir are promising, no head-to-head trials have compared these drugs," they wrote. "This is particularly important as health care systems attempt to prioritize access to effective COVID-19 treatments in the early stages of the disease."
26th Jul 2022 - CIDRAP

Diabetes risk remains elevated three months after COVID-19 infection

The risk of diabetes after infection with Covid-19 remains high for at least three months before declining to background levels. The diabetes risk from infection after acute infection also raises the risk on adverse sequlae as shown by increased used of several therapeutic agents such as pain medication, antidepressants, anxiolytics and oral hypoglycaemic agents.
26th Jul 2022 - Hospital Healthcare Europe

Novavax COVID-19 vaccine: When will it be available in the US?

Earlier this month, the Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for the Novavax COVID-19 vaccine. Research shows Novavax to be 100% effective in preventing moderate to severe COVID-19. Novavax uses a traditional vaccine model used previously for influenza and shingles vaccines. The United States Department of Health and Human Services has secured 3.2 million doses of Novavax for distribution in the U.S., with ordering opening to medical professionals in the coming weeks.
26th Jul 2022 - Medical News Today

BioNTech, Pfizer ask U.S. court for clearance over patent dispute with CureVac

COVID-19 vaccine maker BioNTech said on Tuesday that it and partner Pfizer have filed a complaint with the U.S. District Court in Massachusetts, seeking a judgment that they did not infringe U.S. patents held by rival CureVac. Reporting by Ludwig Burger and Blake Brittain Editing by David Bario and Mark Potter
26th Jul 2022 - Reuters

Monkeypox Vaccine Maker Bavarian Nordic Considers 24-Hour Emergency Production

Bavarian Nordic A/S, the only company with a vaccine approved for monkeypox, said it’s preparing to run production through the night to meet surging demand after the virus outbreak was declared a global emergency. The flare-up of monkeypox, which has spread to about 16,000 people in more than 70 countries in just a few months, was declared a public-health emergency of international concern by the head of the World Health Organization over the weekend. This is the highest level of alert that aims to marshal more resources globally to curb the outbreak and is the first such ruling since coronavirus started sweeping around the world.
26th Jul 2022 - Bloomberg

Pandemic Drinking Led to Thousands of UK Hospital Admissions, Deaths

Increased drinking fuelled by the pandemic could lead to thousands of extra hospital admissions, deaths and cases of disease over the next 20 years, experts have warned. A new study commissioned by NHS England from the University of Sheffield found that while lighter drinkers cut their consumption during the pandemic, heavier drinkers drank more and may never return to where they were. Experts found that 25 to 34-year-olds who were drinking at risky levels before the pandemic were the most likely to increase their drinking when Covid-19 hit.
26th Jul 2022 - Bloomberg

Mysterious Hepatitis Cases in Children May Have Complex Cause

An international effort to find the cause of mysterious hepatitis cases among children in dozens of countries yielded a new hypothesis on Monday, with research now suggesting that the cases were caused by a pair of viruses working in concert to trigger the liver inflammation in children with a certain genetic susceptibility. Between last October and July 8, 1,010 probable cases of unexplained hepatitis in children occurred in 35 countries, including the U.S., according to the World Health Organization. The cases can’t be explained by the familiar causes of hepatitis, including hepatitis viruses, excessive alcohol consumption or an overdose of the over-the-counter pain medicine acetaminophen.
26th Jul 2022 - The Wall Street Journal

Getting Around After the Pandemic Will Be a Shared Exercise

The report concludes that consumers’ mobility demands are evolving in seemingly contradictory ways. On one hand, people want inexpensive options, but on the other, the pandemic accelerated a shift away from mass transit, which is the cheapest service available. Ultimately, consumers want agile, on‑demand, and affordable transportation, which creates challenges that are difficult to reconcile. In that environment, new players will struggle to make money as they try to fulfill these demands.
26th Jul 2022 - Bloomberg

Feds look ahead to next-generation COVID vaccines

The White House tomorrow will host a summit on the future of COVID-19 vaccines, which will be streamed online. One of the main topics is speeding development of a more broadly protective COVID-19 vaccine. The Food and Drug Administration (FDA) vaccine advisory group recently recommended a bivalent booster shot that includes the original SARS-CoV-2 strain and an Omicron variant, and at the meeting, several members aired concerns that officials will more frequently face the challenge of tweaking the vaccine to keep up with the quickly evolving virus. At the global level, researchers are working on a roadmap for developing a new coronavirus vaccine to broadly protect against the most dangerous ones.
26th Jul 2022 - CIDRAP

Pfizer, BioNTech rebuff CureVac's 'groundless' patent infringement claims against COVID-19 shot Comirnaty

Pfizer and BioNTech aren’t playing sitting duck in the COVID-19 vaccine patent litigation that German mRNA specialist CureVac has brought. After joining forces to develop the massively successful COVID shot, Comirnaty, Pfizer and BioNTech are now facing what they call “threats of a groundless patent infringement suit by a company, CureVac, who has been unable to bring to market any product to help in the fight against COVID-19,” the partners said in a complaint filed Monday in the U.S. District Court for the District of Massachusetts. Pfizer and BioNTech allege there is “an actual, immediate, substantial and justiciable controversy” at play over whether Comirnaty has infringed or will infringe the trio of patents covered in CureVac’s lawsuit. Now, the partners want the Massachusetts court to rule against the infringement charges and prevent CureVac from pursuing further infringement claims, according to the court filings.
26th Jul 2022 - FiercePharma

‘There’s no one long Covid’: Experts struggle to make sense of the continuing mystery

Robert Gallo apologized for still coughing. The day before President Biden tested positive for Covid-19, the famed HIV researcher said he was still recovering from a Covid infection that had left him unable to walk, put him in the hospital, and made him delusional, he said Wednesday during a roundtable discussion about long Covid. Presented by the Global Virus Network, a coalition of leading virologists, the two-day virtual conference convened experts across disciplines and around the world to ask and answer questions about what causes long Covid, how to predict who gets it, how to treat it, and just possibly how to prevent it. No one has the answers, but Gallo, who co-founded the group and is also director of the Institute of Human Virology at the University of Maryland School of Medicine, puts his money on the amount of virus present right from the start.
26th Jul 2022 - Stat News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Jul 2022

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TGA provisionally approves COVID-19 vaccine, Nuvaxovid, for use in 12-17 year olds

Australia’s Therapeutic Goods Administration (TGA) has provisionally approved the Biocelect - on behalf of US biotech Novavax (Nasdaq: NVAX) - COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years. The decision follows provisional approvals on 19 January 2022 for the use of Nuvaxovid in adults, on June 9, 2022, the Nuvaxovid booster dose for use in adults. As with adults, the vaccine should be administered in adolescents intramuscularly…
25th Jul 2022 - The Pharma Letter

Are We Getting Closer to a Potential Universal Coronavirus Monoclonal Therapeutic?

A research team reports discovering a neutralizing monoclonal antibody that it says has the potential to become a universal coronavirus therapy against SARS-CoV-2 and all its variants of concern, including Beta, Gamma, Delta, Epsilon and Omicron. In multiple animal models, the mAb shows effectiveness against the SARS-CoV, the Severe Acute Respiratory Syndrome that emerged in China in 2002, and MERS-CoV, the Middle East Respiratory Syndrome that appeared in Saudi Arabia in 2012, according to the scientists, who had that it also shows effectiveness against several common cold coronaviruses.
25th Jul 2022 - Genetic Engineering & Biotechnology News

The dominant BA.5 variant of Covid-19 signals we’re still not in the clear

Tracking BA.5’s rise is complicated somewhat because of an increase in at-home rapid testing to confirm infection, rather than testing in a clinical setting, which would make its way to health authorities and paint a fuller picture of the data. While the number of cases is nowhere near the level of infections due to omicron last winter, the week-on-week total of hospital admissions overall has trended up steadily over the past month, according to data from the Centers for Disease Control and Prevention.
25th Jul 2022 - Vox.com

New RT-PCR platform gives results faster than other COVID-19 tests on the market

Researchers at Columbia Engineering and Rover Diagnostics announced today that they have built an RT-PCR platform that gives results in 23 minutes that match the longer laboratory-based tests--faster than other PCR tests on the market. It can be adapted to test for a broad range of infectious diseases including not just COVID-19 but also flu, strep, and other viruses that require fast diagnosis. Its targeted sensitivity is higher than other types of tests such as isothermal, antigen, and CRISPR. And, at just two pounds, the Rover PCR is easy to carry around and can be used by anyone.
25th Jul 2022 - News-Medical.Net

Think You’ve Never Had Covid-19? Think Again.

Charley Ding spent weeks early in the pandemic intubating patients sick with Covid-19. The 42-year-old anesthesiologist in South Barrington, Ill., said he has since watched most of the doctors and nurses he works with get infected at some point. But he has never gotten Covid-19, he said. “It’s probably a combination of being careful, maybe being blessed with a good immune system,” he said. “But also just luck.” Dr. Ding is a member of a shrinking club of people who are pretty sure they have never been infected with SARS-CoV-2, the virus that causes Covid-19. Geneticists and immunologists are studying factors that might protect people from infection, and learning why some are predisposed to more severe Covid-19 disease.
25th Jul 2022 - The Wall Street Journal

China approves Genuine Biotech's HIV drug for COVID patients

China on Monday gave conditional approval to domestic firm Genuine Biotech's Azvudine pill to treat certain adult patients with COVID-19, adding another oral treatment option against the coronavirus. The availability of effective COVID vaccines and treatments is crucial in laying the groundwork for China's potential pivoting from its "dynamic COVID zero" policy, which aims to eliminate every outbreak - however small - and relies on mass testing and strict quarantining.
25th Jul 2022 - Reuters

COVID reinfections appear to be surging in the latest Omicron wave. Here's what we know

When Lyndall Heather caught COVID-19 for a third time this year, she initially didn't believe she had it. Just six weeks on from her second COVID infection, the Darwin nurse was well within the immune period that precluded her from testing. "I just thought it's pretty unlikely, it's probably just the cold," she said. But after becoming seriously unwell, she went for a PCR test and found out she had contracted a separate COVID-19 infection. "Even my manager found it confusing. I guess things are constantly changing," Ms Heather said. Hampered by long COVID symptoms like fatigue and brain fog, Ms Heather said her latest reinfection has left her anxious for the future.
25th Jul 2022 - ABC News

Covid-19: Building immunity against virus will take years - expert

It could take years before our immune systems build up defences against the ever-changing virus that causes Covid-19 – but an immunologist is optimistic we'll soon have a much smarter booster to fight it.
25th Jul 2022 - New Zealand Herald

Commentary: No cause for alarm over 'Centaurus', the new Omicron subvariant BA.2.75

Should we be worried about the new Omicron subvariant BA.2.75? There is no clear evidence "Centaurus" evades the immune system significantly or spreads more quickly for now, but what we do know suggests it would likely fizzle out like Alpha and Delta, says this virologist.
25th Jul 2022 - CNA

Scientists identify how the coronavirus spike protein causes heart damage

The new research has found that the SARS-CoV-2 coronavirus spike protein is capable of causing heart muscle injury through the inflammatory process, setting it apart from previously known coronaviruses. The good news is that the preliminary research suggests the damage caused by the process, which is part of the heart muscle cells' "own natural immune machinery" can be reduced by vaccination. Research published in 2020 discovered abnormal changes to the way the heart was pumping in 55% of hospitalised patients, with around one in seven showing evidence of severe dysfunction.
25th Jul 2022 - Sky News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Jul 2022

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Shanghai districts face mass COVID testing round during July 26-28

Shanghai ordered residents across nine of the city's districts and some smaller areas to do COVID-19 tests over July 26-28, the city government said on Monday, as sporadic local cases kept emerging in the Chinese commercial hub. Shanghai lifted a two-month lockdown in June but has registered double-digits daily cases in recent weeks. Officials rely on repeated mass testing rounds to identify infections they quickly quarantine to prevent further spread, in line with China's "dynamic zero" strategy that demands each flare-up be contained as quickly as possible.
24th Jul 2022 - Reuters

Monkeypox 'Can Be Contained' in US, White House Doctor Says

Monkeypox “can be contained” in the US, with the goal of eventually eliminating the illness as testing and vaccinations ramp up, the White House’s Covid-19 response coordinator said. Ashish Jha repeated that, with more than 2,000 cases nationwide, the US Department of Health and Human Services is weighing whether to declare monkeypox a public health emergency. On Saturday, the head of the World Health Organization declared the global outbreak a public health emergency of international concern. “We think we can get our arms around this thing,” Jha said in an interview with CBS’s “Face the Nation” on Sunday. “But obviously, if we need further tools, we will invoke them as we need them.”
24th Jul 2022 - Bloomberg

WHO Chief Overrules Panel to Declare Monkeypox Global Emergency

The monkeypox outbreak is a public health emergency of international concern, the head of the World Health Organization said, overruling a divided expert panel to issue the group’s highest alert. The move paves the way for stepped-up global cooperation to stop the virus, which has spread to dozens of countries. The last time the WHO made a similar declaration was during the early stages of the Covid-19 outbreak in January 2020. US Health and Human Services Secretary Xavier Becerra called the WHO decision “a call to action for the global health community.” President Joe Biden’s administration has made vaccines, testing and treatments available and is “determined to accelerate our response in the days ahead,” he said in a statement.
24th Jul 2022 - Bloomberg

COVID: Is the virus getting smarter?

Coronavirus infections are surging as the virus evolves, becoming "too clever", according to the World Health Organisation's special envoy on COVID-19, David Nabarro. With figures suggesting nearly three million people in the UK are still unvaccinated, what can be done to encourage those people to get their jabs, and is the virus becoming too smart for our vaccines to keep up? On the Sky News Daily with Niall Paterson, the WHO's Mr Nabarro explains why it's still important to keep protected from coronavirus, and vaccination champion Wendy Francis-White shares her experience helping to get jabs in the arms of those who are vaccine hesitant.
24th Jul 2022 - Sky News

Two symptoms that mean you should 'assume you have Covid', professor says

Article reports that a professor has warned people over two symptoms that probably mean they have Covid. With free tests stopped for the majority in April, it is harder for people to spot they have the virus. Omicron BA.5 is now the dominant Covid strain, accounting for approximately 79% of UK cases as of July 18. Professor Tim Spector, who heads up the ZOE Health Study, said people should assume they do have coronavirus if they wake up with a sore throat and fatigue, despite getting a good night's sleep, The Mirror reports. Professor Spector tweeted: "Twice as many covid cases as common colds currently- the ratio has never been so high. Symptoms much the same except generally more fatigue and sore throat - so best to assume it’s Covid!
23rd Jul 2022 - Birmingham Live

COVID Virus May Tunnel through Nanotubes from Nose to Brain

SARS-CoV-2, though, may have come up with an ingenious work-around. It may completely do away with the molecular maneuverings needed to attach to and unlock a cell membrane. Instead it wields a blunt instrument in the form of nanotube “bridges”—cylinders constructed of the common protein actin that are no more than a few tens of nanometers in diameter. These tunneling nanotubes extend across cell-to-cell gaps to penetrate a neighbor and give viral particles a direct route into COVID-impervious tissue. Researchers at the Pasteur Institute in Paris demonstrated the prospects for a nanotube-mediated cell crossing in a study in a lab dish that now needs to be confirmed in infected human patients.
23rd Jul 2022 - Scientific American

Children who suffer four symptoms could develop Long Covid, study finds

Children who show at least four symptoms are most at risk of suffering from Long Covid, according to new research. The international study found the most common symptoms to be fatigue or weakness, cough, difficulty breathing or shortness of breath. Researchers also found hospitalisations for 48 or more hours and being aged 14 or older are other aggravating factors. These findings could help identify vulnerable individuals who are more susceptible to Long Covid. Lead author Professor Stephen Freedman of the University of Calgary, Alberta, Canada, explained: "We found in some children, illness with Covid-19 is associated with reporting persistent symptoms after three months. Our results suggest appropriate guidance and follow-up are needed, especially for children at high risk for Long Covid."
23rd Jul 2022 - Daily Record

There's a new COVID-19 Omicron subvariant, so what is BA.2.75 and why are some people calling it 'Centaurus'?

Since the COVID-19 pandemic first began, many have become desensitised to these next few words: There's a new Omicron subvariant. BA.2.75 was first detected in India in early May. Since then, it's been found in Europe and the United States. The chief scientist with the World Health Organization (WHO), Soumya Swaminathan, said BA.2.75 appeared to have mutated in a way that could indicate "major immune escape". However, Dr Swaminathan says there isn't enough data to know how severe its impact will be. Here's what we know so far:
23rd Jul 2022 - ABC News

WHO Declares Monkeypox a Global Health Emergency

The World Health Organization has declared that monkeypox is a public-health emergency of international concern as global case numbers surpass 16,000. This is the first time the WHO has declared a global health emergency since the start of the Covid-19 pandemic in January 2020. The WHO’s director-general, Dr. Tedros Adhanom Ghebreyesus, said the emergency committee believes the risk is moderate globally, except in the European region where it assesses the risk as high.
23rd Jul 2022 - The Wall Street Journal

‘Covid is not going to go away’: Australia will require public health measures for foreseeable future, say experts

In May 2021, Australia’s chief medical officer, Prof Paul Kelly, described how Covid vaccines were our “ticket out of the pandemic”. Vaccination, he said, would give Australians “a life with more certainty”. More than one year later, Australia’s Covid-19 vaccination rate is among the highest in the world. Yet daily deaths from the virus remain in the double-digits. Hospitals are overwhelmed, aged care homes and the most vulnerable are struggling with outbreaks, and there is again debate about whether more social restrictions, including mask mandates, are needed to curb virus spread. Infectious diseases expert and director of the Doherty Institute, Prof Sharon Lewin, said: “Last year, I definitely did not think we would be in this position.”
22nd Jul 2022 - The Guardian

New study estimates how many children will get long Covid

An international study estimates the prevalence of long Covid in children to be anywhere from 5% to 10% — a figure that's far lower than estimates of long Covid in more than a third of adults. The findings, published Friday in the journal JAMA Network Open, also suggested that several factors could predict which children with Covid may have ongoing symptoms or develop new ones in the 90 days following infection. Those include having seven or more symptoms during the initial phase of illness and hospitalization for more than two days. Age was also a factor: Long-term symptoms were more prevalent in children 14 years and older.
22nd Jul 2022 - NBC News

WHO Prioritizes Health Care Workers And Older Populations in Latest COVID-19 Vaccination Strategy Update

After missing the target to vaccinate 70% of people in every country against COVID by July 2022, WHO’s new vaccine strategy prioritises 100% coverage for health workers and older people – but admits that every country will have to decide for itself. The World Health Organization has published an update to the Global COVID-19 Vaccination Strategy that preserves its 70% global vaccination target and 100% vaccination targets for health care workers and older populations, but acknowledges that countries will still need to determine their ‘context-specific targets’ for their own COVID-19 national vaccination programmes.
22nd Jul 2022 - Health Policy Watch


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Jul 2022

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Antigen tests show more than 20,000 new Covid infections per day

The country registered 23 more Covid-19 fatalities and 2,607 new cases admitted to hospital during the previous 24 hours, the Public Health Ministry announced on Thursday morning, but government data showed an average of more than 20,000 positive antigen tests over the past week.
21st Jul 2022 - Bangkok Post on MSN.com

COVID-19 Vaccine Linked to Short-Term Changes in Menstrual Cycle Length, Study Suggests

A new study shows that women may experience short-term changes in their menstrual cycles after COVID-19 vaccination. The researchers found that these changes were associated with all COVID-19 vaccine types.
21st Jul 2022 - Prevention

CDC endorses more traditional Novavax COVID shot for adults

U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax -- a more traditional kind of vaccine, health officials said Tuesday. Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.
21st Jul 2022 - Associated Press

COVID-19 tied to new-onset, short-term heart disease, diabetes

COVID-19 patients are six times more likely than uninfected people to develop cardiovascular disease (CVD) and nearly twice as likely to receive a new diabetes diagnosis, but the risk begins to recede at 5 weeks and 12 weeks, respectively, concludes a UK study published yesterday in PLOS Medicine.
20th Jul 2022 - CIDRAP

BLOOM Shionogi Covid Pill Xocova Fails to Win Japan Panel Backing

Shionogi & Co.’s experimental Covid-19 treatment Xocova failed to win the backing of health experts in Japan who said there wasn’t enough data to show the medicine’s efficacy. The panel members didn’t recommend that Japan’s health ministry authorize emergency use of the therapy as there was a need to continue discussion on it, Hiroshi Kiyota, chairman of the expert committee said in a briefing Wednesday. The health ministry relies on the panel’s decision to give the approval.
20th Jul 2022 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Jul 2022

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With COVID and influenza on the rise, how worried should pregnant women be?

When Alix Mellor fell ill with COVID, she cycled through the full gambit of symptoms: coughing throughout the night, soaring temperatures and unforgiving physical fatigue. But it was the thing she couldn't feel that really made her worry. Days into the infection and 34 weeks pregnant, she noticed her baby was uncharacteristically still. "I called the midwives and they said to come into the hospital and they did some fetal monitoring to make sure the baby is OK," the Melbourne mother says. "It was in my mind that it's not just about me, it's about the baby." It was the second time in three weeks the Melbourne mother had found herself at the hospital with a respiratory illness. The first was with a nasty bout of influenza which saw her hospitalised for four days with a "really high pulse rate". Women who test positive for COVID while pregnant have a higher risk of hospitalisation and ventilation than those who aren't pregnant and are also at greater risk of premature birth and stillbirth. It's a similar situation for the flu, which can be deadly for expectant mothers.
20th Jul 2022 - ABC News

CDC endorses more traditional Novavax COVID shot for adults

U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax -- a more traditional kind of vaccine, health officials said Tuesday. Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.
20th Jul 2022 - The Associated Press

Weekly tests dropped for unvaccinated state employees

Minnesota state government employees who are unvaccinated for COVID-19 are no longer required to take weekly tests for the virus in order to stay in the workplace. The requirement that went into effect in September 2021 meant thousands of employees took tests each week. Those that didn’t comply were subjected to suspensions or other discipline. A state official said the requirement was rescinded because of the evolving nature of the virus. “Whereas it was common to have broad, uniform precautionary measures earlier in the pandemic, the pandemic is at a point where public health COVID-19 risk assessments and precautions are now more dependent upon the specific circumstances of individuals and communities,” said Patrick Hogan, Department of Minnesota Management and Budget spokesman.
20th Jul 2022 - The Associated Press

As BA.5 Spreads, How Long Will a Prior Covid-19 Infection Protect You?

If you have had Covid-19, how long can you expect to be protected from another infection? Doctors say the window between infections might be shrinking, fueled in part by the immune-evading Omicron BA.5 subvariant, although researchers are still gathering data. The U.S. Centers for Disease Control and Prevention has long set 90 days as its window for what counts as a new Covid-19 infection—meaning that symptoms or positive Covid tests within 90 days of a prior infection have been considered the same infection. Getting reinfected sooner has always been possible but uncommon. Now, reinfections are happening more often and can occur closer in time, say infectious-disease specialists and epidemiologists. They cite the march of new subvariants emerging and circulating simultaneously as well as BA.5’s ability to evade immune protections. In addition, doctors note, people are taking fewer precautions, such as masking indoors or avoiding large gatherings.
20th Jul 2022 - The Wall Street Journal

Novavax Covid Shot for Adults Gains CDC Advisers' Backing

Novavax Inc.’s shares surged after its Covid-19 vaccine won backing from a panel of US public health advisers, a crucial step in providing officials with another tool against the virus as cases start to rise again. The 12-member panel of outside experts convened by the Centers for Disease Control and Prevention voted unanimously to recommend the shots for adults. CDC Director Rochelle Walensky signed off on the advice from the Advisory Committee on Immunization Practices, which allows the shot to finally go into arms. The stock gained 12% at the close of New York trading Tuesday.
20th Jul 2022 - Bloomberg

Shionogi Covid Pill Xocova Fails to Win Japan's Panel Backing

Shionogi & Co.’s experimental Covid-19 treatment Xocova failed to win the backing of health experts in Japan who said there wasn’t enough data to show the medicine’s efficacy. The panel members didn’t recommend that Japan’s health ministry authorize emergency use of the therapy as there was a need to continue discussion on it, Hiroshi Kiyota, chairman of the expert committee said in a briefing Wednesday. The health ministry relies on the panel’s decision to give the approval.
20th Jul 2022 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Jul 2022

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More (mostly mild) side effects when flu vaccine given with COVID booster

Self-reported data from nearly 1 million Americans show an 8% to 11% higher rate of mostly mild systemic adverse events after simultaneous seasonal flu vaccine and mRNA COVID-19 booster (third) doses than with the COVID-19 booster alone. In the study, published today in JAMA Network Open, the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team and Emory University analyzed rates of systemic adverse events among 981,099 Americans aged 12 years and older in the week after either simultaneous flu and COVID-19 booster doses or the booster alone from Sep 22, 2021, to May 1, 2022. Volunteers responded to at least one health survey through the CDC's smartphone-based v-safe monitoring system during the study period.
17th Jul 2022 - Cidrap.umn.edu

A riskier approach to new vaccines will pay off

The UK has been hit by three consecutive waves of Omicron variants, each one appearing in a matter of weeks. If a future variant proves much more dangerous, we will not have much time to brace for impact. So what can be done? The answer: develop better vaccines. The simplest approach is, as with flu, to try to predict where the virus will be four to six months ahead, and to make booster doses accordingly. That looks feasible. After scaling up to meet demand for vaccines in 2021, the world has “unprecedented production capacity”, says Rasmus Bech Hansen, founder of Airfinity, a health analytics company — enough to produce another 8bn doses this year. But better, if we can figure out how to do it, is to make a vaccine that targets all Sars-Cov-2 variants, or a wider family of coronaviruses including Sars or, even more ambitiously, all coronaviruses.
15th Jul 2022 - Financial Times

COVID-19 has become 'too clever for us' and can 'break past' our protection, WHO official says

WHO special envoy David Nabarro told Sky News on Thursday that the reason for a surge in new COVID-19 cases globally is because the virus "changed yet again, and it's become too clever for us." "This virus is capable of constantly evolving and changing," he told the outlet. "It can break past our immune defenses, and that's why the numbers are going up." Nabarro told Sky that taking precautions against the virus, like ensuring people are up to date on their COVID-19 vaccination shots, is still important to keep others safe.
15th Jul 2022 - Business Insider on MSN.com

FDA delays decision on BeiGene's cancer drug on China COVID curbs

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections. The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said. The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd , as well as U.S.-based Coherus BioSciences Inc (CHRS.O) and its Chinese partner Shanghai Junshi Biosciences Co Ltd
15th Jul 2022 - Reuters

Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children

Pfizer Inc and BioNTech SE have sought approval from Japan's health ministry for use of their COVID-19 vaccine for use in children aged six months to four years, the companies said in a statement on Thursday. The filing follows approval last month by U.S. regulators for Moderna Inc's two-dose vaccine and the Pfizer-BioNTech three-shot regimen for children in the same age group.
15th Jul 2022 - Reuters

Canada clears Moderna's COVID vaccine for children under 5

Canada on Thursday authorized Moderna Inc's COVID-19 vaccine for babies as young as 6 months old, making it the country's first vaccine against coronavirus for children under 5, Health Canada said. Canada had been offering Moderna's Spikevax vaccine to children above 5 since March, and the latest authorization means some 1.7 million more children are now eligible for inoculation against COVID, according to Health Canada.
15th Jul 2022 - Reuters

EU adds severe allergies as side effect of Novavax COVID vaccine

The European Medicines Agency on Thursday identified severe allergic reactions as potential side effects of Novavax Inc's (NVAX.O) COVID-19 vaccine. The vaccine was authorized by U.S. regulators on Wednesday, and its product label in the United States warns against administering the shot to people with a history of allergic reactions to any components of the shot. Shares of Novavax fell 20.3% to $55.72 in morning trading, along with the broader market and other COVID-19 vaccine makers. Novavax shares are usually volatile.
15th Jul 2022 - Reuters

From AstraZeneca to Novavax: Serum Institute wins FDA nod to supply new COVID shot to US from India

With an FDA authorization for Novavax’s Nuvaxovid, Serum Institute of India (SII) has scored the go-ahead to finally supply a COVID-19 vaccine to the U.S. Wednesday’s emergency use authorization for Novavax’s recombinant protein-based vaccine means SII is able to supply the shot, also known as Covovax, to the U.S. from India. SII has been producing AstraZeneca’s Vaxzevria, but that adenovirus-vectored vaccine isn’t available in the U.S. The Novavax green light now makes SII the first Indian drugmaker to produce a COVID shot for the U.S. market.
15th Jul 2022 - FiercePharma

UK weekly COVID-19 infections rise, booster jab programme announced

An estimated 3.5 million people in Britain had COVID-19 in the latest week of available data, the Office for National Statistics (ONS) said on Friday, up nearly 30% on the 2.7 million recorded in the previous week. Separately, the government announced that a new COVID booster jab programme would begin later this year. "The percentage of people testing positive for coronavirus (COVID-19) continued to increase across the UK," the ONS said. "These increases were likely caused by increases in infections compatible with Omicron variants BA.4 and BA.5."
15th Jul 2022 - Reuters

FDA green-lights Novavax vaccine as COVID-19 levels rise

The FDA's approval allows distribution of the vaccine to begin, but before health providers can administer it, the Centers for Disease Control and Prevention (CDC) must recommend it. The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to discuss the topic on Jul 19. In its announcement, the FDA said the vaccine is approved for use as a two-dose primary series in adults (ages 18 and older). The vaccine is made on a more traditional platform, which officials hope will sway more people to become immunized. The vaccine contains the SARS-CoV-2 spike protein produced in insect calls and contains the Matrix-M adjuvant as an immune booster. The FDA's announcement yesterday came more than a month after its vaccine advisory board recommended EUA approval. Earlier this week, the Biden administration announced the purchase of 3.2 million Novavax doses.
14th Jul 2022 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Jul 2022

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Health Canada approves first COVID-19 vaccine for youngest kids

Canada's drug regulator approved Moderna's COVID-19 vaccine for infants and preschoolers Thursday, making it the first vaccine approved for that age group in the country. Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years old in doses one-quarter the size of that approved for adults. “After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective at preventing COVID-19 in children between 6 months and 5 years of age,” the department said in a statement.
14th Jul 2022 - CTV News

Alnylam accuses Pfizer, Moderna of infringing a second patent

Alnylam is adding more fuel to the fire in its infringement lawsuits against Pfizer and Moderna, claiming both companies violated a patent that was just granted to the company on Tuesday. The fight is over mRNA technology Pfizer and Moderna used in developing their respective COVID-19 vaccines, Alnylam says. Alnylam originally filed lawsuits against each in March. On Tuesday in lawsuits filed in U.S. district court in Delaware, Alnylam said that its newly granted patent covers a specific class of lipid nanoparticles (LNPs) and how they are manufactured. LPLs deliver genetic material into cells.
14th Jul 2022 - FiercePharma

FDA delays decision on BeiGene's cancer drug on China COVID curbs

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration (FDA) has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections. The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said. The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd , as well as U.S.-based Coherus BioSciences Inc and its Chinese partner Shanghai Junshi Biosciences Co Ltd
14th Jul 2022 - Reuters

AstraZeneca says COVID vaccine as effective as mRNA shots in review

AstraZeneca said on Wednesday a review of real-world data showed its COVID-19 vaccine provided equally effective protection against hospitalisation and death after two doses as with current mRNA shots from Pfizer and Moderna
14th Jul 2022 - Reuters

Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children

Pfizer Inc and BioNTech SE have sought approval from Japan's health ministry for use of their COVID-19 vaccine for use in children aged six months to four years, the companies said in a statement on Thursday. The filing follows approval last month by U.S. regulators for Moderna Inc's two-dose vaccine and the Pfizer-BioNTech three-shot regimen for children in the same age group. The majority of COVID vaccinations in Japan have used the Pfizer vaccine, authorised by regulators for children aged five to 11 in January
14th Jul 2022 - Reuters

WHO Panel Advises Against Generic Antidepressant to Treat Covid

A generic antidepressant and a gout medicine that garnered some popularity as Covid-19 treatments shouldn’t be used for mild infection because there’s no evidence they help, according to a panel of experts advising the World Health Organization. The drugs, fluvoxamine and colchicine, could potentially cause harm, the group of experts said in the BMJ medical journal Thursday. The panel didn’t give advice for severe illness, saying there was a lack of data.
14th Jul 2022 - Bloomberg

How long after exposure you can test positive and early signs to look for

Covid rates are continuing to increase, and more and more people are testing positive across the UK. The Zoe Health Study produced data this week showing that there were over 350,000 daily Covid cases – a new record for the UK. Professor Tim Spector, Zoe scientific co-founder and lead scientist on the Zoe Health Study, said: “Covid is still rampant in the population. “So much so that if you have any cold-like symptoms at the moment it’s nearly twice as likely to be Covid as a cold. “Even if people have had a past infection and are fully vaccinated, people are still catching it.” Here’s everything you need to know about how quickly you will show symptoms.
14th Jul 2022 - iNews

Study: Kids have stronger COVID-19 antibody response than adults

A new prospective study of 252 families with members diagnosed as having mild COVID-19 in Italy finds that, while all age-groups had detectable SARS-CoV-2 antibodies up to 1 year after infection, children—especially those younger than 3 years—had higher antibody levels than adults at all intervals tested. In the study, published today in JAMA Network Open, a team led by University of Padua researchers enrolled 902 unvaccinated patients at a COVID follow-up clinic from Apr 1, 2020, to Aug 31, 2021. Families were included in the study if they had children younger than 15 years and at least one member who had tested positive for COVID-19 at least 4 weeks earlier.
13th Jul 2022 - CIDRAP

Novavax, at long last, clinches FDA emergency nod for protein-based COVID shot

The U.S. FDA gave the all-clear to Novavax’s adjuvanted, protein-based shot, teeing up the nation’s fourth pandemic prophylactic behind those from Pfizer-BioNTech, Moderna and Johnson & Johnson. The FDA’s emergency use authorization covers the prevention of COVID-19 caused by SARS-CoV-2 among adults ages 18 and up. The company aims to file a full biologics license application by year-end and figures it will be the last COVID vaccine player blessed with an emergency nod, Novavax’s John Trizzino, executive vice president, chief commercial officer and chief business officer, told Fierce Biotech at this year’s BIO International Convention.
13th Jul 2022 - Fierce Pharma


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FDA Authorizes Novavax’s Covid-19 Vaccine

U.S. health regulators have authorized the use of Novavax Inc.’s Covid-19 vaccine, providing a new option that works differently than the two leading vaccines, but at a time when overall demand for vaccines and boosters is low. The Food and Drug Administration said Wednesday that adults 18 years and older may receive Novavax’s vaccine. The Novavax vaccine, given as two doses three weeks apart, could become available soon if the Centers for Disease Control and Prevention signs off in the coming days. The authorization gives adults “another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency-use authorization,” FDA Commissioner Robert M. Califf said.
14th Jul 2022 - The Wall Street Journal

Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines

AstraZeneca’s (AZ) COVID-19 vaccine, Vaxzevria, and the available mRNA COVID-19 vaccines provide ‘equally effective’ protection against hospitalisation and death, an expert review of data from 79 real-world studies has revealed. Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public Health and the International Vaccine Access Center. The findings from the study were reported by Expert Review of Vaccines. The findings shows that Vaxzevria and the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines offer an ‘equivalent degree’ of protection against hospitalisation (91-93%) and death (91-93%) following two doses, regardless of age.
13th Jul 2022 - PMLiVE

Covid vaccine 66 per cent less effective at preventing infection than it was just two months ago, expert says

Covid cases have hit record levels in the UK, yet the vaccine is less effective at preventing infection than at any time since it was introduced, according to a leading virus modeller. The degree of protection a jab gives against getting a Covid infection has tumbled from about 30 per cent two months ago to about 10 per cent today, according to Professor Karl Friston, of University College London. This is largely because the new dominant Omicron subvariants, BA.4 and BA.5, are much better at evading immunity built up by vaccinations than their predecessor, BA.2, he says.
13th Jul 2022 - iNews

How long after catching Covid can you become reinfected and when should you get your booster?

People may become reinfected with Covid-19 as early as 28 days after recovering from the virus, according to the latest advice from the Australian Health Protection Principal Committee. Previously, reinfection was defined as a case occurring more than 12 weeks after an initial infection. The committee said the Omicron subvariants BA.4 and BA.5 “are associated with increased immune escape and we are likely to see rates of reinfection rise among those who have previously been infected with an earlier Covid-19 variant, and those who are up to date with their vaccinations”.
13th Jul 2022 - The Guardian

Covid-19: Researchers face wait for patient level data from Pfizer and Moderna vaccine trials

Independent researchers looking to obtain patient level data from the Pfizer and Moderna covid-19 vaccine trials may have to wait longer. In status reports filed recently with the US federal trials registry (clinicaltrials.gov) between February and May, both companies extended the dates by which the trials will be completed, Pfizer by nine months, from 15 May 2023 to 8 February 2024. Moderna’s expected completion date is delayed from 27 October to 29 December 2022. Pfizer indicated in its trial protocol that individual participant data would be made available two years after study completion.1 Now that the date has been pushed back, Pfizer will entertain and review requests “when the study is complete and all planned analyses have been performed,” said the company’s senior director of global media relations, Jerica Pitts. Luis Carlos Saiz, a researcher at the Innovation and Organisation Unit of the Navarre Regional Health Service, Spain, said that access to raw patient data was important for researchers because “it is key to build trust in health policies and to protect citizens from potential vested interests.”
13th Jul 2022 - The BMJ

Pfizer, Moderna COVID-19 vaccines infringe new Alnylam patent, lawsuits say

Alnylam Pharmaceuticals Inc escalated its patent fight with Pfizer Inc and Moderna Inc over their COVID-19 vaccines on Tuesday, accusing the companies in Delaware federal court of infringing a newly obtained patent. The lawsuits said the vaccines' messenger-RNA delivery systems violate an Alnylam patent on lipid nanoparticle (LNP) technology for delivering genetic material into human cells. The U.S. Patent and Trademark Office issued the patent the same day Alnylam filed the complaints.
13th Jul 2022 - Reuters

Adapted, two-strain vaccines to lift COVID protection - EU official

Adapted versions of established mRNA COVID-19 vaccines that address two variants in one shot will soon offer people better protection than vaccines that are now available, a European health official said on Wednesday. Moderna and the BioNTech-Pfizer alliance are working on vaccines based on a combination of the original Wuhan virus and an Omicron subvariant. Referred to as bivalent shots, these are planned for use in the autumn vaccination campaign.
13th Jul 2022 - Reuters


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What is the long-term protection against COVID-19?

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is known to cause many clinical manifestations. The protection conferred by prior infection or vaccination against infection over the long term is poorly understood. A new paper in Immunological Reviews describes the immunologic parameters associated with protection from COVID-19.
12th Jul 2022 - News-Medical.Net

Australia's CSIRO develops machine learning tool that spots emerging COVID-19 variants

CSIRO did not mention how they developed the AI tool called VariantSpark but it was used to analyse around 10,000 COVID-19 samples in a new study, whose findings were published in the peer-reviewed journal Computational and Structural Biotechnology Journal. The researchers worked with both Intel and ACT-based cloud system provider RONIN on the said study. According to a media release, VariantSpark can provide hourly updates, enabling the quick sharing of information with public health decision-makers and helping hospitals prepare for potential increases in admissions.
12th Jul 2022 - Healthcare IT News

Nitric oxide boosts oxygen in pregnant women with COVID-19 pneumonia

Inhaled high-dose nitric oxide (INO200) safely shortened time on supplemental oxygen and hospital stays among pregnant women diagnosed as having severe bilateral COVID-19 pneumonia, suggests a new study led by Massachusetts General Hospital (MGH) researchers. COVID-19 pneumonia is an especially dire diagnosis for pregnant women because it can rapidly lower oxygen in the blood and body tissues, requiring hospital admission and cardiopulmonary support, first author Carlo Valsecchi, MD, said in an MGH news release. "Pregnant women are three times more likely to need intensive care unit admission, mechanical ventilation, or advanced life support, and four times more likely to die," he said. "They also face a greater risk of obstetric complications such as preeclampsia, preterm delivery, and stillbirth."
12th Jul 2022 - CIDRAP

Development of a multiomics model for identification of predictive biomarkers for COVID-19 severity: a retrospective cohort study

COVID-19 is a multi-system disorder with high variability in clinical outcomes among patients who are admitted to hospital. Although some cytokines such as interleukin (IL)-6 are believed to be associated with severity, there are no early biomarkers that can reliably predict patients who are more likely to have adverse outcomes. Thus, it is crucial to discover predictive markers of serious complications.
12th Jul 2022 - The Lancet

White House urges COVID boosters to protect against spreading BA.5 subvariant

BA.5 is estimated to account for 65% of the coronavirus variants circulating in the United States as of last week, said Rochelle Walensky, the director of the U.S. Centers for Disease Control and Prevention (CDC). Officials urged people who are 50 years old or older to get a booster shot and said that would not prevent them from getting another "bivalent" booster designed to fend off Omicron more specifically later this year.
12th Jul 2022 - Reuters

Moderna unveils positive data on new booster candidate

Just a few weeks after the FDA recommended that COVID-19 vaccine manufactures tweak their boosters to zero in on the omicron BA.4 and BA.5 subvariants, Moderna has unveiled promising new data for its prospect. On Monday, the mRNA specialist said its omicron-containing bivalent booster elicited higher neutralizing antibody responses compared with the current booster. After one month, trial participants who received the bivalent booster had BA.4 and BA.5 neutralizing antibodies that were 1.69 times higher than those who received the original booster, the company said.
11th Jul 2022 - FiercePharma


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Moderna Is Developing Two Different Omicron-Targeting Booster Shots

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries. The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week. In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.
11th Jul 2022 - The Wall Street Journal

Future Covid Variants Can Be Predicted by AI, Startup Claims

As pharmaceutical companies struggle to keep up with the rapidly mutating coronavirus, a startup in Cambridge, Mass., says it can help them by using artificial intelligence to predict future variants. Apriori Bio models the ways a virus might change and predicts how it will behave. The company says it’s harnessing that information to design “variant-proof” vaccines and treatments that can fight current and future strains—and provide an early warning to governments, sort of like a hurricane alert, to guide the public-health response. After honing its technology, called Octavia, for more than two years, the fledgling company is formally launching with $50 million in funding from Flagship Pioneering Inc., the incubator behind Moderna Inc.
11th Jul 2022 - Bloomberg

Italy to start administering second COVID booster to over-60s

Italy will soon start its campaign to administer a second COVID-19 booster to everyone aged over 60, the health minister said on Monday, after receiving a green light from European Union health agencies.
11th Jul 2022 - Reuters

Moderna to advance two Omicron vaccine candidates against newer variants

Moderna Inc said on Monday it was advancing two Omicron vaccine candidates for the fall, one designed against the BA.1 variant and another against the BA.4 and BA.5. Vaccine makers including Moderna and rival Pfizer Inc are developing updated vaccines to target the fast-spreading Omicron subvariants BA.4 and BA.5, which have gained a foothold in the United States over recent weeks. Moderna said its decision to develop the bivalent vaccines was based on different market preferences for shots against the subvariants.
11th Jul 2022 - Reuters

US FDA approves Pfizer-BioNTech’s Covid-19 vaccine for adolescents

The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s Supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years. Earlier, the regulatory agency granted emergency use authorization (EUA) for the use of the vaccine in this age group and so far over nine million adolescents of this age have received the initial vaccine regimen. Comirnaty is the first Covid-19 vaccine to obtain FDA approval for use in adolescents. The FDA granted approval based on findings from a Phase III clinical trial in 2,260 subjects aged 12 to 15 years.
11th Jul 2022 - Pharmaceutical Technology

BioNTech, Pfizer ask EU to authorize 3-dose COVID-19 vaccine for kids over 6 months

BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than 5 years. The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest kids on June 17. The three-dose regimen includes a much lower dose than what's given to adults. BioNTech and Pfizer say that the data from the trial, which enrolled over 10,000 children, indicates the three doses in young children elicited a strong immune response and has a favorable safety profile. Adverse reactions were generally less frequent in this age group compared to children aged between 5 and 12. As such, the companies want the EU to expand its conditional marketing authorization to include the youngest children.
11th Jul 2022 - POLITICO

Scared of needles? Inhalable COVID-19 vaccine shows promise in new study

An inhalable COVID-19 vaccine has shown great promise in protecting the lungs against the coronavirus in a new study. Researchers from the US’ North Carolina State University created the inhalable vaccine that is shelf-stable at room temperature for up to three months and specifically works to target the lungs and can be self-administrated through an inhaler.
11th Jul 2022 - Al Arabiya English

4th COVID-19 vaccine effectively protects elderly against Omicron -study

The fourth dose of the coronavirus vaccine is effective in protecting the elderly against the Omicron variant and lowers their risk of death by 72% compared to those who received only three doses, according to a new study conducted by Tel Aviv University and Ben-Gurion University of the Negev in collaboration with the Health Ministry. The study, published in the peer-reviewed JAMA Internal Medicine journal, found that elderly recipients of the fourth dose were 34% more protected against infection than those who received only the third dose at four months previously. Recipients of the fourth dose were also 64-67% less likely to be hospitalized for mild to moderate and severe illness.
11th Jul 2022 - The Jerusalem Post

Moderna's Noubar Afeyan on the race to create a Covid vaccine

Moderna's Noubar Afeyan on the race to create a Covid vaccine with the Financial Times health team
11th Jul 2022 - Financial Times

Could a universal coronavirus vaccine be the silver bullet that ends this pandemic—and the next?

First-generation vaccines were not the panacea hoped for in COVID-19’s early days. Nor did herd immunity swoop in and save the day. Could a so-called “pan-coronavirus” vaccine be the long-awaited silver bullet that ends the COVID pandemic—and the next one, too? Answer: It’s complicated. “The term pan-coronavirus vaccine needs an asterisk next to it,” Dr. Stuart Ray, vice chair of medicine for data integrity and analytics at Johns Hopkins’ Department of Medicine, told Fortune.
11th Jul 2022 - Fortune

CEPI provides $30m to advance novel coronavirus vaccine

The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with a consortium of research and technological institutions to fund the development of a novel vaccine to provide protection against COVID-19, as well other SARS-like Betacoronaviruses.
11th Jul 2022 - European Pharmaceutical Review

Hologic Announces Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV

Hologic, Inc. announced that it is now offering its Panther Fusion ® SARS-CoV-2/Flu A/B/RSV assay and its Novodiag ® RESP-4 molecular diagnostic test for sale in the European Union in time for the northern hemisphere’s respiratory viral season. Both assays detect and differentiate four of the most prevalent respiratory viruses that can present with similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus (RSV). The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that runs on the fully automated high-throughput Panther Fusion system. The test uses nasopharyngeal swab samples.
11th Jul 2022 - The Associated Press

Study reveals sex-based differences in the clinical outcomes of COVID-19 in the US

In a recent study posted to the Research Square* preprint server, researchers investigated sex-based differences among coronavirus disease 2019 (COVID-19) patients in the United States (US). Studies have reported greater severity and fatality associated with COVID-19 among men compared to women across the globe; however, the mechanisms for sex-based differences in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are not clear. Previous research observations indicate that researchers must consider the patients’ sex as an important variable for COVID-19 data interpretation.
11th Jul 2022 - News-Medical.Net

BioNTech, Pfizer ask EU to authorize 3-dose COVID-19 vaccine for kids over 6 months

BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than 5 years. The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest kids on June 17. The three-dose regimen includes a much lower dose than what's given to adults. BioNTech and Pfizer say that the data from the trial, which enrolled over 10,000 children, indicates the three doses in young children elicited a strong immune response and has a favorable safety profile. Adverse reactions were generally less frequent in this age group compared to children aged between 5 and 12. As such, the companies want the EU to expand its conditional marketing authorization to include the youngest children.
11th Jul 2022 - POLITICO Europe

ECDC and EMA update recommendations on additional booster doses of COVID-19 vaccines

The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are recommending that second booster doses of COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease.
11th Jul 2022 - ECDC.Europa.eu


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Pfizer, BioNTech Get Full FDA Approval for Covid Vaccine for Teens

Pfizer Inc. and BioNTech SE gained full US regulatory approval for their Covid-19 vaccine for teens 12 to 15 years old, a milestone that will allow the companies to continue to market it to adolescents after the pandemic. The vaccine partners earlier got formal approval for their Covid vaccine for teens 16 and older. In a statement on Friday, the companies said the US Food and Drug Administration approved their supplemental application to extend that approval to younger adolescents. The shot first went into play when it received emergency use authorization, a temporary clearance for use during the pandemic, for the age group. For full approval, the companies submitted additional information to the FDA, including six months of follow-up data after the two-dose regimen was complete in recipients.
10th Jul 2022 - Bloomberg

South Africa’s Afrigen to collaborate with US researchers on mRNA vaccines

South African biotech company Afrigen will collaborate with researchers from the US National Institutes of Health on the development of the next generation of mRNA vaccines and drugs as part of an attempt to expand global access to innovative medicines.
8th Jul 2022 - The Financial Times

Covid-19: FDA authorises pharmacists to prescribe Paxlovid

The US Food and Drug Administration (FDA) has authorised licensed pharmacists to prescribe Pfizer’s oral antiviral drug Paxlovid (nirmatrelvir and ritonavir) to eligible patients who have tested positive for covid-19, subject to some limitations. The FDA’s action on 6 July, a revision of the emergency use authorisation, will make the drug more widely available to people with covid-19, particularly in rural and poor areas. About 90% of the US population lives within five miles of a pharmacy, according to the American Pharmacists Association. Until now, only doctors, nurses, and physician assistants could prescribe Paxlovid. The drug is approved for treatment of mild to moderate covid-19 in adults and children aged 12 or older who weigh at least 40 kg and are at high risk for progression to severe covid-19, including hospital admission or death. Those who report a positive home test on either a rapid antigen diagnostic test or a polymerase chain reaction test are eligible for Paxlovid without further testing.
8th Jul 2022 - The BMJ

South Africa's Afrigen partners with U.S. on mRNA vaccine research

South Africa's Afrigen Biologics Limited said on Friday that it will collaborate with U.S. government researchers to develop mRNA vaccines and therapeutics. The agreement will enable the sharing of scientific expertise, technical skills and materials with the U.S. National Institutes of Health (NIH) to help Afrigen produce mRNA vaccines against COVID-19 and other diseases, said the Cape Town-based biotech start-up.
8th Jul 2022 - Reuters

EU drugs regulator open to COVID boosters that target older Omicron offshoots

The European Medicines Agency (EMA) is open to using next generation COVID-19 vaccines that target older offshoots of the Omicron variant this fall, an official said on Thursday, amid a rise in cases due to new Omicron subvariants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved. The EMA expects new COVID vaccine boosters to be approved by September.
8th Jul 2022 - Reuters


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'All-in-one' coronavirus vaccine gets backing from CEPI

A new type of vaccine - which could provide broad protection against a variety of SARS-like betacoronaviruses, including SARS-CoV-2 variants - has received backing of up to $30m from CEPI.
7th Jul 2022 - BioPharma-Reporter.com

COVID-19 vaccination with bacterial peptide conjugated to receptor-binding domain elicits potent immune response

In a recent study published in the iScience journal, researchers assessed the efficiency of immunization with a bacterial peptide conjugated to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain against SARS-CoV-2 infection. Overall, the study findings showed that the CPD-RBD vaccination elicited a potent immune response and also protected against the severe symptoms associated with COVID-19.
7th Jul 2022 - News-Medical.Net

Brii Bio introduces Covid-19 combination therapy in China

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.
7th Jul 2022 - Pharmaceutical Technology

Exothera to support process development of Turkish company's COVID-19 vaccine

Turkey based Vaccizone has chosen Belgian CDMO, Exothera, to fast-track process development of its COVID-19 vaccine for European clinical trials.
7th Jul 2022 - BioPharma-Reporter.com

COVID-19 and brain damage explained

The authors suggested that antibody-triggered cytotoxicity targeting the endothelial cells probably led to neuroinflammation, vascular leakage, platelet aggregation, and neuronal damage. Overall, the study findings illustrated that immune complexes accompanying complement activation damaging the microvasculature were the primary cause of blood-brain barrier collapse, microthromboses, perivascular inflammation, and neuronal damage in SARS-CoV-2 patients. The authors proposed that these events largely influenced the neurological symptoms found in acute COVID-19 and probably in long-COVID. Importantly, the current findings indicated the need for therapeutic modalities targeting the development of the immune complex.
7th Jul 2022 - News-Medical.Net

Africa CDC says it has signed MOU with Pfizer for COVID pill

Africa's top public health body said on Thursday it had signed a memorandum of understanding with Pfizer for countries on the continent to receive supplies of the Paxlovid pill to treat COVID-19. Data from a mid-to-late stage study in November last year showed the antiviral medication was nearly 90% effective in preventing hospitalisations and deaths compared to a placebo, in adults at high risk of severe illness.
7th Jul 2022 - Reuters

Wastewater study technique finds virus variants sooner; many patients are using meds affected by Paxlovid

With just a very small amount of raw sewage and a new analysis technique, researchers can determine the genetic mixture of SARS-CoV-2 variants in the community and detect new variants up to 14 days before they start showing up on patients' nasal swabs, according to a new report. Tests of a new method for wastewater genomic surveillance at the University of California, San Diego campus from November 2020 to September 2021 detected the Epsilon, Alpha and Delta variants "earlier and more consistently than clinical samples, and identified multiple instances of virus spread" that were not detected with traditional monitoring, researchers reported on Thursday in Nature.
7th Jul 2022 - Reuters

New Covid variants threaten China’s mRNA vaccine hopes

China is making progress in efforts to develop a homegrown messenger RNA Covid-19 vaccine, but experts warn that it risks being outpaced by rapid mutations of the Omicron coronavirus variant. Beijing’s refusal to approve foreign jabs, and the limited effectiveness of the more traditional inactivated vaccines available from domestic companies, mean an mRNA vaccine is widely seen as essential to any shift away from President Xi Jinping’s economically costly zero-Covid policy.
7th Jul 2022 - Financial Times


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Study: COVID would have killed 58% more Americans without vaccines

A new study estimates that COVID-19 vaccinations averted 58% of U.S. deaths that could have occurred in a hypothetical scenario in which no inoculations existed. Published Wednesday in JAMA Network Open, the modeling study concludes that COVID-19 vaccinations prevented 27 million infections, 1.6 million hospitalizations and 235,000 deaths among U.S. adults from December 2020 to September 2021. However, the study cautions that it relied on “incomplete national data” from multiple health records due to the lack of a national database and the “limitations of current methods” for measuring vaccine effectiveness.
6th Jul 2022 - Washington Times

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in June this year.
6th Jul 2022 - Pharmaceutical Technology

COVID in California: Reinfection heightens risk of other health problems, study finds

A new type of vaccine protects against a variety of betacoronaviruses including the one that caused the COVID-19 pandemic and COVID’s variants, in mice and monkeys, a Caltech study found. Betacoronaviruses are a subset of coronaviruses that infect humans and animals. The study, published in the journal Science on Tuesday, from researchers in the laboratory of Caltech’s Pamela Bjorkman, professor of biology and bioengineering, found that the new vaccine is broadly protective. It works by presenting the immune system with spike protein pieces from SARS-CoV-2 and seven other SARS-like betacoronaviruses, attached to a protein nanoparticle structure, to induce production of cross-reactive antibodies, Caltech said.
6th Jul 2022 - San Francisco Chronicle

COVID-19 vaccination activates antibodies targeting parts of virus spike protein shared between coronaviruses

"Our theory is that there is actually memory from previous common cold coronavirus encounters, and when you get the vaccine for SARS-CoV-2, the vaccine reawakens some of those memories. Then you see this early response which is basically just a rapid memory response to what you've already seen," Altin said. "With time, the immune system can reshape those responses more in the direction of the pandemic virus."
6th Jul 2022 - Medical Xpress

Research highlights importance of designing effective COVID vaccine allocation strategies

In a recent study posted to the medRxiv* pre-print server, researchers at the University of Melbourne used a modified Susceptible, Exposed, Infectious, and Recovered (SEIR) mathematical model to examine the impact of different vaccine mechanisms and disease characteristics on a population comprised of individuals at high and low risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The study highlighted the significance of devising effective coronavirus disease 2019 (COVID-19) vaccine allocation strategies before the onset of the pandemic or the beginning of viral transmission at the community level.
6th Jul 2022 - News-Medical.Net

Two or 3 vaccine doses may cut risk of long COVID

An observational study of Italian healthcare workers infected with SARS-CoV-2 who didn't require hospitalization suggests a link between two or three doses of vaccine and a lower prevalence of long COVID. In the modeling study, published late last week in JAMA, researchers in Milan studied 2,560 workers at nine healthcare facilities from March 2020 to April 2022. All healthcare workers were mandated to receive three doses of the Pfizer/BioNTech mRNA COVID-19 vaccine in 2021. And all were screened for COVID-19 once a week or every 2 weeks and when they developed symptoms or were exposed to the virus.
6th Jul 2022 - CIDRAP

Estimates of long Covid are startlingly high. Here’s how to understand them

It’s important to remember that long Covid is an evolving umbrella term for an array of symptoms that vary in both number and degree. Some housebound people are assailed by brain fog that completely robs them of concentration, while others find memory aids help them get through their workdays. Some former athletes can’t complete a 6-minute walk test, while others can gradually return to activity if they monitor their heart rate. Long Covid clinics that adapt techniques from rehabilitation medicine see people eventually get better. In a world transitioning away from bustling downtowns to hybrid work-from-home status, we may not see who’s missing.
6th Jul 2022 - STAT News

Pharmacists Can Prescribe Pfizer's Covid Pill Under FDA Order

Pharmacists will be permitted to prescribe Pfizer Inc.’s Paxlovid under a move by US regulators aimed at providing prompt access to the widely used Covid treatment. State-licensed pharmacists can prescribe Paxlovid to eligible patients, subject to certain limitations to assure appropriate treatment, the Food and Drug Administration said Wednesday in a statement. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients,” Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said in the statement.
6th Jul 2022 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Jul 2022

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The Health Risks of Getting Covid-19 a Second (or Third) Time

Covid-19 reinfections can bring some new risks of serious medical problems, hospitalization and death, a new study has found. Protection provided by vaccines and prior infection has greatly improved Covid outcomes since the pandemic’s early days, and reinfections are typically less severe than initial ones. Yet each new infection carries a risk of medical problems, including hospitalization, death and long Covid, according to preliminary data from a study of patients in the Veterans Affairs health system. This is a timely finding, doctors say, as more-infectious Omicron subvariants BA.4 and BA.5 proliferate and are expected to make reinfections more common.
5th Jul 2022 - The Wall Street Journal

Health Ministry approves COVID-19 vaccine for infants

Health Ministry Director General Professor Nachman Ash has approved the administration of Moderna's Pfizer-BioNTech's COVID-19 vaccines for infants and children ages six months to five years. Though the approval applies to all children in the above age group, the Health Ministry has not issued a general recommendation for the vaccine. The vaccines were approved last month by the US Food and Drug Administration (FDA), and later the same month by the Israeli Health Ministry's Staff for the Management of Pandemics.
5th Jul 2022 - Arutz Sheva

Oxford University Takes Aim at Future Pandemics After Covid Vaccine

The University of Oxford, one of the first to cross the finish line with a Covid-19 vaccine, is shifting its focus to health threats that could trigger the next pandemic. Oxford’s Pandemic Sciences Institute, launched Tuesday, aims to reduce the risks posed by infectious diseases by improving data collection, strengthening surveillance and helping to create vaccines and other countermeasures. Oxford said the organization will seek to learn from the response to Covid and take advantage of the university’s research and global partnerships. But it will have to bring in additional funds to carry out its mission.
5th Jul 2022 - Bloomberg

Spectacular success of mRNA COVID-19 vaccines just a glimpse of their full potential

The "spectacular" success of mRNA (messenger ribonucleic acid) vaccine technology against SARS-CoV-2 provides "just a glimpse of their full potential", according to the authors of a Perspective published by the Medical Journal of Australia today. Asymptomatic individuals constitute 16–38% of the SARS-CoV-2 infected population which increases the difficulty of identifying infected individuals. The lack of convenient and sensitive tests to detect the virus in all individuals is continuing to limit global response to the pandemic. Predominantly, SARS-CoV-2 is detected through RT-PCR (real-time reverse transcription polymerase chain reaction) on swab samples collected from the nose and throat. However, these tests require long detection times, high costs, specialized equipment and medical personnel, and are not feasible in areas where resources are limited.
5th Jul 2022 - Medical Xpress

Skin Patch Test Detects COVID-19 in Under Three Minutes

A rapid and reliable skin-patch test can now detect the COVID-19 virus, and potentially other infectious agents in under three minutes, without the need to draw blood. This convenience overcomes a current challenge in identifying infected individuals who are averse to blood tests and could help restrict the spread of the pandemic. The details of the new test were published on July 1, 2022, in an article in the journal Scientific Reports titled, “Anti‑SARS‑CoV‑2 IgM/IgG antibodies detection using a patch sensor containing porous microneedles and a paper‑based immunoassay.”
5th Jul 2022 - Genetic Engineering & Biotechnology News

The Health Risks of Getting Covid-19 a Second (or Third) Time

Covid-19 reinfections can bring some new risks of serious medical problems, hospitalization and death, a new study has found. Protection provided by vaccines and prior infection has greatly improved Covid outcomes since the pandemic’s early days, and reinfections are typically less severe than initial ones. Yet each new infection carries a risk of medical problems, including hospitalization, death and long Covid, according to preliminary data from a study of patients in the Veterans Affairs health system. This is a timely finding, doctors say, as more-infectious Omicron subvariants BA.4 and BA.5 proliferate and are expected to make reinfections more common.
5th Jul 2022 - The Wall Street Journal

CureVac files patent lawsuit in Germany against BioNTech

CureVac has filed a patent lawsuit in Germany against BioNTech over its use of mRNA technology, marking one of the first known cases of a company going to court amid the fierce competition to develop a vaccine against the coronavirus. The German-based biotech company is seeking "fair compensation" from BioNTech and two subsidiaries for infringement of its intellectual property rights, it said on Tuesday.
5th Jul 2022 - Reuters

New Covid subvariants BA.4 and BA.5 are the most contagious yet – and driving Australia’s third Omicron wave

Australia is heading for its third Omicron wave in the coming weeks, as BA.4 and BA.5 become the dominant Covid strains. BA.4 and BA.5 are more infectious than previous Covid variants and subvariants, and are better able to evade immunity from vaccines and previous infections. So we’re likely to see a rise in case numbers. So what are BA.4 and BA.5? And what can we expect in this next phase of the pandemic?
5th Jul 2022 - The Guardian

BA.5 Subvariant Drives Majority of Recent Covid-19 Cases

The highly contagious Omicron BA.5 subvariant has taken over as the dominant version of the virus causing new Covid-19 cases in the U.S., the latest federal data show. BA.5 represented nearly 54% of U.S. cases in the week ended July 2, the Centers for Disease Control and Prevention estimated Tuesday. It surpassed BA.2.12.1, the version of Omicron partly responsible for a persistent springtime surge in cases, which is now estimated to represent closer to one in four cases. Another version known as BA.4, which is closely related to BA.5, and also ramped up recently, represents nearly 17% of cases, the CDC estimates.
5th Jul 2022 - The Wall Street Journal


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Jul 2022

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Long COVID: 'Viral reservoir' of spike protein may explain long-term symptoms

Researchers investigated the antigens of SARS-CoV-2—the virus that causes COVID-19—present in blood plasma samples collected from individuals with long COVID and typical COVID-19 infection. They found that one particular SARS-CoV-2 antigen—the spike protein—was present in the blood of a majority of long COVID patients, up to a year after they were first diagnosed with COVID-19. In patients with typical COVID-19 infection, however, the spike protein was not detected. This finding provides evidence for the hypothesis that SARS-CoV-2 can persist in the body through viral reservoirs, where it continues to release spike protein and trigger inflammation.
4th Jul 2022 - Medical News Today

Hong Kong's Lee Sees No Immediate Need for Mass Covid Testing

Hong Kong’s new Chief Executive John Lee said there is no immediate need for a universal compulsory Covid testing campaign in the city but stressed that there needs to be a reduction in the number of daily infections, which are at the highest level since April. Lee, appearing on a program broadcast by TVB on Sunday, shed more light on his Covid agenda for the first time since being sworn in as chief executive on Friday by Chinese President Xi Jinping, who was also in the city to celebrate the 25th anniversary of its return to Chinese rule. Hong Kong should carry out more laboratory nucleic acid testing for Covid because it’s a reliable way to detect infections, but this would not expand into a universal compulsory testing campaign for now,
4th Jul 2022 - Bloomberg

Covid Shots Are Coming. Will They Be Too Late?

Roseann Renouf, 77, has grown tired of the current generation of coronavirus shots. Having “never been one for a lot of vaccination,” she decided to forgo the latest round of boosters after watching vaccinated friends contract Covid-19, even though the doses offer a critical extra layer of protection. “It’s just taking another same booster,” Ms. Renouf, a retired nurse anesthetist from Fort Worth, said. “They haven’t done anything different with them to cover new variants.” But her gripe about the Covid vaccines may soon be settled. American regulators committed last week to updating the 2020 vaccine recipes for this fall’s booster campaign with new formulas meant to defend against the ultra-contagious Omicron subvariants, offering Ms. Renouf and other holdouts a fresh reason to change their minds.
4th Jul 2022 - The New York Times

Oxford Biomedica, AstraZeneca enter new deal for Covid-19 vaccine

Oxford Biomedica has entered a new three-year Master Services & Development Agreement to potentially manufacture AstraZeneca UK’s Covid-19 vaccines in the future. The latest deal is an extension of an original Master Supply and Development Agreement signed by the parties in September 2020. Under the initial deal, the production of Covid-19 vaccines at the Oxbox facility of Oxford Biomedica is anticipated to conclude in the last quarter of this year. As per this agreement, AstraZeneca had agreed to make an upfront payment of $18.1m (£15m) to Oxford Biomedica as a capacity reservation fee.
4th Jul 2022 - Pharmaceutical Technology

Paxlovid remains effective in those vaccinated against COVID-19

Israeli researchers have found that paxlovid use in those at risk of COVID-19 progression remains effective even in fully vaccinated patients. The effectiveness of the anti-viral drug paxlovid in preventing the progression of COVID-19 remains even in those who have been adequately vaccinated against the virus according to the results of a real-world study by Israeli researchers. Paxlovid consists of nirmatrelivir, a protease inhibitor against COVID-19 and ritonavir, which reduces the in vivo metabolism of nirmatrelivir. The published data for the drug (the EPIC-HR trial) suggested that treatment of symptomatic COVID-19 in patients at risk of progression to severe disease, results in an 89% lower risk compared to placebo. Nevertheless, the study was undertaken before omicron became the main circulating variant and therefore the generalisability of the study’s findings are potentially limited.
4th Jul 2022 - Hospital Healthcare Europe

Omicron-specific COVID shots could increase protection as boosters, European Medicines Agency says

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
4th Jul 2022 - Reuters

'Two doses are no longer enough': Canadians required to get COVID shot every nine months

Canadians will be required to get a booster shot every nine months for the foreseeable future, Health Minister Jean-Yves Duclos told reporters. So if you thought you were fully vaccinated, think again. Duclos said that the previous definitions of “fully vaccinated” makes no sense, explaining that it’s more important that shots are “up to date” and whether or not a person has “received a vaccination in the last nine months.” He added, “We will never be fully vaccinated against COVID-19,” according to Blacklock’s Reporter. Duclos was asked if he was preparing Canadians for the return of vaccine mandates in the fall, he reportedly replied, “We must continue to fight against COVID.”
4th Jul 2022 - Toronto Sun

COVID vaccines prevented poor outcomes in people of all sizes

COVID-19 vaccination protected people of all body sizes from hospitalization and death—although vaccinated people with a low or high body mass index (BMI) were at greater risk, according to a study of adults in England published yesterday in The Lancet Diabetes & Endocrinology. University of Oxford researchers led the study, which involved 9,171,524 adult primary care patients in England with available body mass index (BMI) data from Dec 8, 2020 (when the COVID-19 vaccine first became available in the United Kingdom), to Nov 17, 2021. Average patient age was 52 years, and average BMI was 26.7 kilograms per meter squared (kg/m2) (overweight).
1st Jul 2022 - CIDRAP

Oxford Biomedica signs up for 3 more years of making AstraZeneca COVID shots⁠—on an 'as needed basis'

There was a time—not so long ago—when COVID-19 vaccine manufacturers couldn’t produce doses fast enough. But that was then, and this is now: Friday, when Oxford Biomedica revealed an extension of its contract with AstraZeneca through 2025, the deal was to make shots on an “as needed basis,” the company said. This comes just nine months after Oxford announced a 50 million pound sterling ($68 million) investment from the over-strapped Serum Institute of India to increase its ability to manufacture COVID vaccines for AZ at its Oxbox facility.
1st Jul 2022 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Jul 2022

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Study determines ideal COVID19 vaccine type, timing during pregnancy

Since the COVID-19 vaccine rollout, data has indicated that inoculation during pregnancy can help to protect both the mother and baby. New research collaboratively conducted at Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), published in the peer-reviewed Nature Communications, looked further into the extent of this protection by examining which vaccine is most effective, and when.
1st Jul 2022 - The Jerusalem Post

COVID-19 vaccination for children aged 5–11 years

When considering risks, post-implementation studies have found BNT162b2 to be safe in children aged 5–11 years.17 Importantly, the small but serious risk of vaccine-induced myocarditis appears to be much lower in children aged 5–11 years (reporting rate of 2·2 cases per million doses) than in adolescents or young adults.17 Implementation of a large-scale immunisation programme, however, comes with both financial and opportunity costs—for example, diversion of health-care staff and resources could potentially affect the provision of other crucial health-care services, such as routine childhood immunisation programmes. Clinicians and parents must balance the relatively small risks of severe disease outcomes with the relatively small risks that accompany vaccination in children aged 5–11 years. Although many countries continue to actively recommend COVID-19 vaccination for children aged 5–11 years, some countries, such as Sweden, have advised against vaccinating healthy 5–11 year-olds,18 whereas others, such as Norway, have made the vaccine available should parents wish to vaccinate their children.19 With the US Food and Drug Administration authorisation of use of COVID-19 vaccines in children younger than 5 years,20 the same dilemmas are likely to resurface, although with even more marginal risk–benefit ratios. In particular, considering that the global population has been living through the pandemic for more than 2 years and has been exposed to multiple waves of different SARS-CoV-2 variants, governments, policy makers, and clinicians need to urgently address the added value of vaccination—be it primary or boosters—for protection against severe disease outcomes in children who have already been infected by the virus. Above all, public messaging of the risks and benefits of vaccinating children against COVID-19 needs to be clear to encourage public confidence in vaccines and trust in those advocating for vaccination to prevent other, more serious diseases.
1st Jul 2022 - The Lancet

Pfizer seeks approval from US FDA for Covid-19 treatment

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness. Paxlovid received emergency use authorization to treat mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above who are at increased disease progression risk.
1st Jul 2022 - Pharmaceutical Technology

Two-week break from methotrexate may boost Covid-19 vaccine effect

A two-week break from taking methotrexate after a Covid-19 booster vaccine can help improve its effectiveness, a UK trial has suggested. Analysis of immune responses in 127 participants who were randomly allocated to suspend methotrexate use for two weeks and 127 to continue using it as usual, showed such a difference that researchers stopped the trial early. At four weeks and 12 weeks after the Covid-19 jab, participants’ spike-antibody levels were more than two-fold higher in the paused methotrexate group compared with those who continued to take the drug. Reporting in The Lancet Respiratory Medicine, the researcher also found a worsening of disease control at week four in those who had stopped taking methotrexate but that it had normalised by week 12. Overall, there was no impact on quality of life or general health, suggesting the approach could be useful for more than a million people in the UK who take the immune-suppressing drug for inflammatory conditions.
1st Jul 2022 - Pulse Today

Modified mRNA COVID shots could increase protection as boosters - EMA

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
1st Jul 2022 - Reuters

Oxford Biomedica signs new deal to make AstraZeneca COVID shot

Britain's Oxford Biomedica said on Friday it had signed a new three-year agreement to potentially make AstraZeneca's COVID-19 vaccine beyond 2022, but no volumes were defined in an indication of waning demand for the shot. Cell and gene therapy firm Oxford Biomedica said in April that it had manufactured more than 100 million doses of AstraZeneca's vaccine since their partnership began in September 2020. Commitments under the deal are scheduled to end this year.
1st Jul 2022 - Reuters

US FDA wants COVID boosters targeting Omicron BA.4, BA.5 subvariants

The U.S. Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus. If authorized, the changes would mark the first major retooling of COVID vaccines, but also could slow their rollout as the FDA has recommended a design somewhat different from what the companies had already tested and started producing.
1st Jul 2022 - Reuters

Omicron-specific COVID shots could increase protection as boosters - EMA

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
1st Jul 2022 - Reuters

Oxford Biomedica (LON:OXB) Signs Covid Vaccine Deal With AstraZeneca

Oxford Biomedica Plc has signed a three-year agreement with AstraZeneca Plc to manufacture the UK drug giant’s Covid-19 vaccine on an as-needed basis. The agreement is an extension of the original supply and development agreement signed between the two companies in September 2020, as the coronavirus swept around the world, according to a statement Friday. Oxford Biomedica stock was up more than 3% in early trading in London.
1st Jul 2022 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Jul 2022

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Fair Pharma Scorecard shows industry has a long way to go for COVID-19 products

How has the pharma industry weighed human rights during its marketing of COVID-19 drugs and vaccines? That’s what the Pharmaceutical Accountability Foundation (PAF) sought to answer, and the results might not be what the industry wants to hear. For its Fair Pharma Scorecard project, PAF ranked 26 companies involved in selling COVID-19 drugs, vaccine and diagnostics based on their compliance with 19 human rights principles. Not one company complied with all the criteria, and most "still need to take big steps" to make their products accessible and affordable, PAF said. In general, PAF noticed a weariness toward knowledge sharing, iffy transparency levels and differences between various products at the same companies. For example, Pfizer's compliance with the criteria scored at 65% for its oral antiviral Paxlovid and 50% for its vaccine.
30th Jun 2022 - FiercePharma

Fauci says he believes Paxlovid kept him out of the hospital, even though he tested positive again.

“Paxlovid did what it was supposed to do,” Dr. Fauci, 81, said in an interview, saying that he believed that the treatment, made by Pfizer, kept him out of the hospital when he first tested positive for the virus on June 15. He added that he thought the drug also reduced the severity of his initial symptoms. One thing Paxlovid could not do was keep Dr. Fauci from missing his daughter’s wedding. It went on without him in New Orleans two Saturdays ago, when he was sidelined with his initial infection. He participated remotely. Dr. Fauci has been vaccinated against Covid and has received two booster doses. His experience with Paxlovid adds to a growing body of anecdotal evidence about patients whose Covid symptoms improved after they took Paxlovid, and who even tested negative, only to have symptoms occur again a few days later. That is exactly what happened to him, Dr. Fauci said; he recently tested positive again after three days of negative tests.
30th Jun 2022 - The New York Times

Pfizer Seeks FDA’s Full Approval for Paxlovid Covid-19 Pill

Pfizer Inc. has asked the Food and Drug Administration to grant full approval of its Covid-19 antiviral pill, a step toward allowing the drugmaker to sell the drug commercially. Pfizer said Thursday that it had filed the submission. The FDA typically has 60 days to accept the application and up to 10 months to conduct a review before issuing a decision. To date, Pfizer has been selling the drug, called Paxlovid, to the federal government under an authorization for emergency use. The federal government has then been directing the pills’ distribution.
30th Jun 2022 - The Wall Street Journal

A 14-year-old tiger died after contracting Covid-19 in an Ohio zoo, officials say

A tiger at an Ohio zoo died of health complications caused by Covid-19, officials said Wednesday. The 14-year-old Amur tiger, Jupiter, died Sunday after developing pneumonia caused by the virus, the Columbus Zoo and Aquarium said in a statement. Jupiter was undergoing long-term treatment for chronic underlying illnesses, which made him more susceptible to the virus, the zoo said. Jupiter's care team reported last week that he had been "acting ill." He wasn't interested in eating or interacting with his keepers and was reluctant to move or stand, according to the statement. After Jupiter was anesthetized for examination, results suggested he may have been suffering from an infection, and treatment began.
30th Jun 2022 - CNN

Covid-19: Canada outperformed comparable nations in pandemic response, study reports

Canada performed better than the majority of G10 countries in its response to the first two years of the covid-19 pandemic, a study has concluded. A paper published in the Canadian Medical Association Journal concluded that Canadians were better vaccinated than comparable western countries, with fewer infections, fewer covid deaths, and lower mortality from all causes. Researchers from the University of Toronto, some of whom are members of Ontario’s covid-19 science advisory board, linked the country’s lower death rate to the persistence of its social restrictions and the relative lack of antivaccine sentiment. The study compared responses from the 11 countries in the G10, comprising Canada, Belgium, France, Germany, Italy, Japan, the Netherlands, Sweden, Switzerland, the UK, and the US. Japan was an extreme outlier, with by far the fewest deaths and infections despite having the oldest population and imposing the mildest restrictions.
30th Jun 2022 - The BMJ

S.Korea authorises AstraZeneca COVID therapy Evusheld for vulnerable people

South Korea on Thursday authorised AstraZeneca PLC's antibody-based therapy for preventing COVID-19 infection in people with a poor immune response, increasing its options as it works to ease the pandemic burden on the healthcare system. The Ministry of Food and Drug Safety granted emergency use authorisation for 20,000 doses of Evusheld for individuals aged 12 years and older who have not been exposed to the coronavirus.
30th Jun 2022 - Reuters

Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid

Pfizer Inc said on Thursday it is seeking full U.S. approval for its oral COVID-19 antiviral treatment Paxlovid, which is currently available under an emergency use authorization (EUA). Pfizer said it submitted a New Drug Application for Paxlovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk of progression to severe illness.
30th Jun 2022 - Reuters

NYC to Offer Pfizer's Covid Drug at Mobile Test-to-Treat Sites

New York City will start offering Pfizer Inc.’s Covid antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus. Initially, mobile sites will be stationed outside of pharmacies in Inwood, South Ozone Park and the East Bronx, and will expand to 30 locations by the end of July, Manhattan’s Borough President Mark Levine said on Twitter Thursday. People who test positive for Covid and qualify for Paxlovid will be able to get a prescription on-the-spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.
30th Jun 2022 - Bloomberg

Maternal deaths climbed 33% during COVID-19

Maternal deaths in the first months of the COVID-19 pandemic increased 33%—and even higher in Black and Hispanic women—according to data from the National Center for Health Statistics (NCHS) published yesterday in a study in JAMA Network Open. That rate compares with an overall 22% COVID-related excess death rate during the study period, according to two researchers from the University of Maryland (UMD) and Boston University (BU), who conducted the study. They defined maternal mortality as deaths during pregnancy or just after birth.
29th Jun 2022 - CIDRAP

COVID-19 tracker: Pfizer seeks full approval for Paxlovid

After running six months on an emergency use authorization for Paxlovid, Pfizer is now seeking a full FDA approval for the COVID antiviral in patients who are at high risk for progression to severe illness regardless of their vaccination status. When taken within five days of symptom onset, Paxlovid cut the risk of hospitalization or death from any cause by 86% in non-hospitalized, high-risk patients, according to final results from the phase 2/3 EPIC-HR study. Pfizer's application package also includes data from the EPIC-SR study, which didn't hit its goal in vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID.
29th Jun 2022 - FiercePharma

FDA: Don’t rush a move to change the Covid-19 vaccine composition

On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to approve the use later this year of Covid-19 vaccines based on an Omicron variant sequence. One of us (P.A.O.) was among those voting “no.” It is possible these vaccines will be two-component designs that also include the current version. Will Americans soon be better protected against Covid-19? The Covid-19 vaccines currently authorized for use in the U.S. are all based on the sequence of the original SARS-CoV-2 virus, which was obtained early in 2020. The virus has evolved over the past 30 months, creating variants that are either more infectious, or harder to counter by vaccination, or both
29th Jun 2022 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Jun 2022

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Doctors treat first UK patient in Covid ‘super donor’ blood trial

Doctors have treated the first UK patient in a reopened clinical trial that will explore whether blood plasma from “super donors” can help fight Covid in those with weakened immune systems. Super donors produce exceptionally high levels of antibodies after infection and vaccination, and there are hopes that transfusions of their blood plasma can wipe out the virus in people whose own immune systems are compromised. While two landmark trials known as Recovery and Remap-Cap found that convalescent plasma from people who recovered from Covid did not benefit other patients, a closer look at the Remap-Cap data showed that plasma with the highest levels of antibodies might help the immunosuppressed. The findings prompted doctors to reopen the plasma arm of the Remap-Cap trial to investigate specifically whether donated plasma with extremely high levels of antibodies can save the lives of people with weakened immune systems and reduce the amount of time they spend in intensive care.
30th Jun 2022 - The Guardian

How the UK’s rising Covid cases compare to other countries

The UK is facing its fifth wave of Covid infections, experts have warned, as cases hit 1.8m in the latest weekly figures, a 23 per cent climb week-on-week. More worryingly, hospital admissions have increased 31 per cent, climbing at a higher rate than the last Omicron revival back in March.
30th Jun 2022 - The Independent

Coronavirus vaccines should be updated for fall, FDA advisers say

It’s time to update coronavirus vaccines to better match the variants currently driving the pandemic, outside experts told the Food and Drug Administration on Tuesday. The independent scientists and physicians endorsed an updated omicron vaccine by a 19-2 vote. Despite the overwhelming agreement that it is time to change the vaccine, many experts said they felt frustrated and hamstrung by the need to make a decision quickly to prepare for fall with limited data.
29th Jun 2022 - The Washington Post

BioNTech, Pfizer to start testing universal vaccine for coronaviruses

Germany's BioNTech, Pfizer's partner in COVID-19 vaccines, said the two companies would start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year. Their experimental work on shots that go beyond the current approach include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.
29th Jun 2022 - Reuters

S.Korea approves first domestically developed COVID vaccine

South Korea approved its first domestically developed COVID-19 vaccine, manufactured by SK bioscience Co Ltd, for general public use following positive clinical data, authorities said on Wednesday. The SKYCovione vaccine was authorised for a two-dose regimen on people aged 18 or older, with shots given four weeks apart, according to the Ministry of Food and Drug Safety. In a phase III clinical trial of 4,037 adults, SKYCovione induced neutralizing antibody responses against the SARS-CoV-2 parental strain, SK bioscience said in a statement.
29th Jun 2022 - Reuters

U.S. FDA advisers recommend change to COVID vaccine composition for fall

Advisers to the U.S. Food and Drug Administration on Tuesday recommended a change in the design of COVID-19 booster shots this fall in order to combat more recently circulating variants of the coronavirus. The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next wave of COVID booster shots should include a component that targets the Omicron variant of the coronavirus.
29th Jun 2022 - Reuters

Covid: Face masks brought back at Nottinghamshire hospital sites

Face masks have been reintroduced at some Nottinghamshire hospitals just two weeks after they were dropped. Mask policy had been relaxed in all but high-risk areas of Sherwood Forest Hospitals' three sites as part of a phased return to pre-pandemic policies. But a rise in covid cases among staff and patients at King's Mill, Newark and Mansfield Community hospitals has led to the decision being reversed. Bosses said they would keep face mask and visiting requirements under review.
29th Jun 2022 - BBC News

FDA advisers call for Omicron update for COVID boosters

The Food and Drug Administration (FDA) outside advisory committee today recommended that new booster shot versions include an Omicron variant component, as newer subvariants expand their footprint and the nation faces an uncertain fall and winter with the virus. In its weekly update today, the Centers for Disease Control and Prevention (CDC) said the proportion of BA.4 and BA.5 subvariants increased sharply last week, mainly due to BA.5.
28th Jun 2022 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Jun 2022

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Korea's First Home-Grown COVID-19 Vaccine To Speed Hub Ambitions

Only one last step remains before the approval of South Korea’s first home-grown COVID-19 vaccine as SK Bioscience’s SKYCovione (GBP510) receives positive assessments from review committees. Any nod, which could happen this week, would mark a milestone for the country's ambitions of becoming a global vaccine hub.
28th Jun 2022 - Pink Sheet

Rare heart-related side effects higher with Moderna COVID vaccine

Though both complications were rare, data from Ontario show higher rates of myocarditis and pericarditis with the Moderna COVID-19 vaccine than with the Pfizer-BioNTech vaccine, but the rates were lower for both vaccines if the spacing between receiving two doses was extended, according to a study late last week in JAMA Network Open. Myocarditis is an inflammation of the heart muscle, and pericarditis involves swelling of the thin membrane around the heart.
28th Jun 2022 - CIDRAP

Indias first indigenous mRNA vaccine likely to be available soon

Soon India may have its first indigenous mRNA vaccine that is stable at 2-8 degrees Celsius as the expert panel advising the Central Drugs Standards Control Organisation (CDSCO) has green-signalled Gennova Biopharma's mRNA vaccine candidate for Covid19. The Subject Expert Committee (SEC) has recommended granting the Emergency Use Authorisation (EUA) to the country's first mRNA-based Covid-19 vaccine in a meeting held on Friday, according to reports. Now, the Drugs Controller General of India (DCGI) will take a final call on granting the final approval.
28th Jun 2022 - Business Standard

COVID was twice as deadly in poorer countries

Early in the COVID-19 pandemic, the risk of dying from the disease was roughly twice as high for people living in lower-income countries as for those in rich nations, a study reports. The research, published in BMJ Global Health in May1, is one of a growing number of studies to reveal COVID-19’s massive burden in lower-income countries. Data from early in the pandemic suggested that death and infection rates in poor countries were relatively low compared with those in rich ones. But recent evidence paints a very different picture, says Madhukar Pai, an infectious- disease epidemiologist at McGill University in Montreal, Canada. “This paper is one among many that illustrate that the biggest impact of this pandemic has been on low- and middle-income countries,” says Pai.
28th Jun 2022 - Nature.com

In 1st year of pandemic, COVID vaccines saved 20M lives

Based on official data on COVID-19 deaths, the authors estimated that vaccinations prevented 14.4 million deaths in 185 countries and territories during the one-year study duration. Based on excess mortality estimates, they observed that vaccinations halved the potential global death toll and averted around 19.8 million deaths in a year. The latter represents the true extent of the first year of the pandemic, showing a global reduction of 63% in total deaths due to vaccination.
28th Jun 2022 - News-Medical.Net

Fast-evolving COVID variants complicate vaccine updates

As countries brace for another Omicron wave driven by the variants BA.4 and BA.5, calls to update COVID-19 vaccines are growing louder. Existing vaccines based on the version of the virus SARS-CoV-2 that emerged in Wuhan, China, in late 2019 are a poor match to current Omicron strains. As a result, the vaccines now offer only short-lived protection from infection — although they seem to be holding up against severe disease. This week, an advisory panel to the US Food and Drug Administration (FDA) will meet to discuss whether COVID-19 vaccines should be updated — and what the upgraded vaccines should look like.
28th Jun 2022 - Nature.com

EnGeneIC’s second generation COVID-19 vaccine protects against all variants

The world’s first COVID-19 vaccine to offer immunity against all variants is one step closer. Clinical trials have shown the novel vaccine works by stimulating a completely different immune pathway from other vaccines, producing “high affinity” antibodies that neutralise all COVID-19 variants. Australian Biopharma company EnGeneIC is currently conducting trials of its groundbreaking vaccine in Sydney and Melbourne. Thirty-two healthy participants received two doses, three weeks apart. Of those, 27 have passed the 28-day safety assessment with no side effects. Critically, they all have high affinity antibodies capable of neutralising all COVID-19 mutants, including Omicron.
28th Jun 2022 - The Associated Press

How do I know if I've had COVID-19, and what else can antibody blood tests tell us about past infection?

Antibody blood tests can tell you if you've had COVID-19, but there are some caveats. COVID-19 antibodies naturally dwindle over time, so if they turn up in your blood test, their levels can't tell you exactly how long ago you were infected — just that you were infected sometime in the past few months. "We think now [the test] is a useful marker of fairly recent infection, as opposed to whether you've ever been infected," Dr Machalek says.
28th Jun 2022 - ABC News

Majority of secondary school children have Covid-19 antibodies, says new data

Nearly all secondary school-age children have Covid-19 antibodies, according to new data. Data from the School Infection Survey, which was released on Monday, revealed that numbers of primary school parents who would be "unlikely" to vaccinate their children has increased. The news comes as levels of Covid continue to rise in the UK, with new cases likely due to variants of the Omicron strain. In the last week, an estimated 1.7million people are reported to have had the virus, up 23% from 1.4 million the previous week.
28th Jun 2022 - Daily Record

COVID-19 fattens up our body's cells to help fuel its viral takeover, study suggests

Researchers tried using weight-loss drugs and other fat-targeting compounds to try to stop the virus in cell culture. The new study comes as infections rose in all four UK nations, with about 1.7 million having the virus last week.
28th Jun 2022 - Sky News

Improving COVID-19 vaccine immunogenicity by interrupting methotrexate treatment

In summary, this important study shows that a 2-week interruption of methotrexate after booster COVID-19 vaccination results in increased immunogenicity compared with no interruption among patients with several immune-mediated inflammatory diseases. Although this finding adds to the evidence base to support interruption of methotrexate after vaccination, a shared decision process is needed to weigh the possible benefit of optimising protection from COVID-19 and the possible risk of underlying disease flare.
28th Jun 2022 - The Lancet

U.S. FDA will decide on redesigned COVID vaccines by early July

U.S. regulators plan to decide by early July whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of the coronavirus, with hopes of launching a booster campaign by October, a top Food and Drug Administration official said on Tuesday. "The better the match of the vaccines to the circulating strain we believe may correspond to improve vaccine effectiveness, and potentially to a better durability of protection," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a meeting of outside expert advisers to the agency.
28th Jun 2022 - Reuters

Are Updated Booster Shots Coming?

Tomorrow will be a big day for the future of U.S. coronavirus vaccines: A panel of independent advisers to the F.D.A. will recommend whether to update the existing vaccines to take aim at a version of the virus in the Omicron family. The advisory panel also will probably split between those who believe a fall booster will be broadly necessary and those who would limit additional shots to high-risk individuals. The policy may depend on funding and resources. “It’s very clear we’re not going to have enough vaccines for every adult who wants one,” said Dr. Ashish Jha, the White House coordinator for the pandemic response.
27th Jun 2022 - The New York Times

AstraZeneca launches first Evusheld DTC, but without full approval it comes with a different feel

AstraZeneca launched the first ever COVID drug DTC for its prevention antibody, Evusheld, and it’s one of the most unusual and unique commercials you will see this year. The ad, which is set up more as a public health announcement (though is heavily branded), has a very different feel from most traditional pharma DTCs. There are no bright colors or emotional beats. You won’t find someone roller skating around a park, for instance, or someone running with their dog. What you get instead is just one narrator, standing in a bland, empty, white office space, laying out informatively how Evusheld works, who it’s for and, instead of waiting for the end of the ad, explaining many of the potential side effects in the middle of the video.
24th Jun 2022 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Jun 2022

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Epstein-Barr may play a role in some long COVID; coronavirus can impair blood sugar processing by organs

Among 280 patients with SARS-CoV-2 infections, including 208 with long COVID, researchers found that at four months after diagnosis, fatigue and problems with thinking and reasoning were more common in study participants with immune cells in their blood showing signs of recent EBV reactivation. These signs of reactivation were not linked with other long COVID findings such as gastrointestinal or heart and lung problems, however. And EBV itself was not found in patients' blood, which suggests any reactivation likely is transient and happens during acute COVID-19, Dr. Timothy Henrich of the University of California, San Francisco and colleagues reported on medRxiv ahead of peer review.
28th Jun 2022 - Reuters

Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine

Pfizer and BioNTech have shared positive results from a phase 2/3 trial of two Omicron-adapted COVID-19 vaccine candidates. The data shows that a booster dose of both Omicron-adapted vaccines gave a considerably higher immune response against Omicron BA.1, compared to Pfizer/BioNTech’s current COVID-19 vaccine. The phase 2/3 trial involved 1,234 participants aged 56 and older. One month after receiving a booster dose, the Omicron-adapted monovalent candidates significantly increased protection against Omicron BA.1, showing a 13.5 and 19.6-fold increase above pre-booster dose levels. One vaccine is monovalent and the other is bivalent, made up from a combination of the Pfizer/BioNTech COVID-19 vaccine and a vaccine candidate designed to target the spike protein of the Omicron BA.1 variant.
27th Jun 2022 - PMLiVE

EMA recommends Novavax COVID vaccine for adolescents

EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.
27th Jun 2022 - EU Reporter

China's first mRNA vaccine is close — will that solve its COVID woes?

China is getting closer to approving its first mRNA vaccine to protect people against COVID-19. In a small clinical trial, the Chinese vaccine candidate triggered a stronger antibody response in vaccinated adults when given as a booster shot than did a jab containing inactivated SARS-CoV-2, the vaccine platform that the country has mostly relied on so far. The experimental jab, called ArCoV, is a strong candidate to become China’s first approved mRNA vaccine. But what it would mean for the government’s handling of the pandemic is hard to know, say researchers. A highly effective mRNA vaccine would reduce the chances of widespread serious infections that could overwhelm hospitals. However, it is unlikely to bring an end to the country’s strict ‘zero COVID’ strategy, which uses mass testing and lockdowns to quash all infections.
27th Jun 2022 - Nature.com

F.D.A. May Move Toward Updating Vaccines

A panel of independent experts advising the Food and Drug Administration is set to recommend on Tuesday whether to update existing Covid-19 vaccines to target a newer version of the coronavirus in a booster shot that Americans could get in the fall. The federal government is hoping to improve the vaccine to better boost people’s immunity before a likely resurgence of the virus this winter. But to move that quickly, it may need to abandon the lengthy human trials that have been used to test coronavirus vaccines over the past two years in favor of a faster process that relies more on laboratory tests and animal trials. The most recent trials with human volunteers have taken five months, even using relatively small groups. But the virus is evolving so quickly that new vaccine formulations are out of date before such trials are even finished.
27th Jun 2022 - The New York Times

Long Covid 2: supporting the mental and physical needs of patients

Long Covid is a multi-system condition affecting both the body and the mind that occurs in some people as a lingering consequence of a Covid-19 infection (Maxwell et al, 2022). As described in our first article in this series, symptoms are diverse and many post-Covid-19 sequelae present as undifferentiated symptoms not apparent on routine investigation (Maxwell et al, 2022). This can contribute to patients’ symptoms not always being taken seriously by health professionals. Lack of clarity over the mechanisms for long Covid means opinion can be polarised, with some practitioners believing all symptoms are physical and others that they are purely psychological. In truth, there is ample evidence that long Covid is a combination of physical and mental symptoms, many of which are undifferentiated and common in established physical and psychological conditions. Individual prognosis for individuals is hard to assess, with some people recovering within months but others still having problems after two years.
27th Jun 2022 - Nursing Times

BioNTtech in conflict with regulator over new COVID vaccine approval - WAS

The launch of German drugmaker BioNTech's vaccine adapted to the Omicron coronavirus variant may be delayed due to a disagreement with the regulator over the approval process, the Welt Am Sonntag (WAS) newspaper reported on Saturday. The regulator should still decide by the end of June whether or not to approve the new vaccine but BioNTech Chief Executive Ugur Sahin does not plan to submit any new clinical trials, WAS reported, citing the Financial Times.
27th Jun 2022 - Reuters

Sinovac's COVID-19 vaccine conditionally registered in South Africa

China's Sinovac Biotech said on Saturday that South Africa's health products regulator has granted conditional registration to its coronavirus vaccine CoronaVac for people aged 18 and above.
27th Jun 2022 - Reuters

China's Clover says its COVID booster shot candidate lifts antibody against Omicron

China's Clover Biopharmaceuticals said on Monday a booster shot of its COVID-19 vaccine candidate significantly increased antibody response against the Omicron coronavirus variant from levels seen after two primary shots. A third dose of its vaccine candidate SCB-2019 resulted in a 19-fold increase in neutralising antibody levels against the Omicron BA.2 subvariant from pre-booster levels, Clover said in a filing to the Hong Kong stock exchange.
27th Jun 2022 - Reuters

US grapples with whether to modify COVID vaccine for fall

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match recent changes of the shape-shifting coronavirus. Moderna and Pfizer have tested updated shots against the super-contagious omicron variant, and advisers to the Food and Drug Administration will debate Tuesday if it’s time to make a switch — setting the stage for similar moves by other countries. “This is science at its toughest,” FDA vaccine chief Dr. Peter Marks told The Associated Press, adding that a final decision is expected within days of the advisory panel’s recommendation.
27th Jun 2022 - The Associated Press

FDA panel to advise on whether — and how — Covid vaccines should be updated

The Food and Drug Administration faces an important decision in coming days — whether to instruct companies that make Covid-19 vaccines to update the viral strain or strains of SARS-CoV-2 those products target. It seems almost a given that the FDA will tell manufacturers that it is time to change the composition of Covid vaccines, with an eye to a rollout of updated vaccines to be administered in the autumn. But how and to what are questions that still need answering. The agency is seeking the advice of its independent panel of vaccine experts, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, to help it decide how, in the words of senior FDA official Peter Marks, to predict the future. VRBPAC meets Tuesday to discuss the issue.
27th Jun 2022 - STAT News

Pfizer says its Omicron-containing boosters outperform current vaccine

Pfizer said Saturday that using new versions of its Covid-19 vaccine as boosters led to a superior antibody response against the Omicron variant compared to its current shot. The results in some ways mirror those released by Moderna earlier this month. Data from both companies will be evaluated on Tuesday by a panel of experts convened by the Food and Drug Administration in the hopes of deciding what strains of the SARS-Cov-2 virus should be included in booster shots for the fall. Companies will need lead time to manufacture doses of new vaccines if it is decided they are needed.
26th Jun 2022 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Jun 2022

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Pfizer’s Omicron-Targeting Covid-19 Vaccines Generate Stronger Immune Response

Federal health authorities are trying to decide whether to stick with the current shots for a fall vaccination campaign or use a tweaked version. Studies have found that the current vaccines don’t work as well against Omicron as they did against earlier strains. “Based on these data, we believe we have two very strong Omicron-modified candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” Pfizer Chief Executive Albert Bourla said. The study didn’t measure whether and how well the shots reduced the risk of Covid-19. Pfizer and BioNTech announced the results by news release. The findings haven’t been published in a peer-reviewed medical journal. Omicron is the most recent strain of the virus to come to predominate in the U.S. and many other countries.
26th Jun 2022 - The Wall Street Journal

Australia struggles against vaccine fatigue as it battles flu outbreak

Australia is battling its first serious influenza outbreak since the start of the Covid-19 pandemic, leaving the authorities struggling to persuade a vaccine-weary public to get flu shots. Official data showed there were 65,770 flu cases in May - more than double the month's previous record set during a severe outbreak in 2019. But the numbers have been rapidly increasing. According to the federal government's influenza surveillance system, there were 147,155 cases of flu recorded from Jan 1 to June 19 this year. Of these, 55,101 or more than one third occurred from June 5. There have been 54 flu-related deaths.
26th Jun 2022 - The Straits Times

Expert on why you need your covid booster jab now to keep safe this winter

England’s leading NHS medic is urging those eligible for a spring booster but yet to come forward to take up the offer as soon as possible as a quarter of a million reminders go out before the end of the month. The largest and fastest vaccination programme in NHS history has now invited everyone eligible for a spring booster and more than four in five people have already had their jab. The NHS has invited more than five million people in total to get their spring booster in line with JCVI guidance as part of the world-leading NHS Covid-19 vaccination programme. It is urging anyone yet to come forward for a spring dose to do so as soon as practically possible. More than four million people and around 86% of those aged 75 and over have already had their spring dose. Those who are eligible include older adult care home residents, people aged 75 and over and those who are immunosuppressed.
25th Jun 2022 - Daily Post Wales

GSK announces that COVID-19 vaccine candidate is effective at preventing Omicron infection

The Europen companies GSK and Sanofi have partnered for a COVID-19 vaccine candidate that is 72% effective at preventing infection from the Omicron variant. The companies are hoping their shot can join the Pfizer, Moderna and Novavax vaccines in becoming available for the long-term fight against Covid. It comes as U.S. regulators face widespread criticism after the controversial approval of jabs for children six months to four year old. It comes as Covid case figures have stabilized at 99,984 per day in the U.S., but deaths have jumped 20% over the past week to 385 daily
25th Jun 2022 - Daily Mail

Greece Under Fire for Recommending 2nd COVID-19 Booster for 30+

Greek authorities’ decision to recommend a second COVID-19 booster shot for individuals over thirty was criticized by a leading health specialist on Friday. The current recommendation for a second booster shot for people aged 30 to 59 who do not belong to the vulnerable groups “is not accompanied by the necessary documentation,” Elias Mossialos, Professor of Health Policy at the London School of Economics and Political Science (LSE), has posted on Facebook. Greece’s National Vaccination Committee reiterated a “strong recommendation” that those aged 60 and over get a second booster shot. Appointments for that age category have been available since early April this year.
25th Jun 2022 - Greek Reporter

The next COVID booster shots will likely be updated for Omicron

COVID-19 vaccines this fall are likely to be based on the Omicron variant of the coronavirus rather than the original strain, although some experts suggest they may only offer significant benefits for older and immunocompromised people. Moderna, Pfizer and Novavax have been testing vaccines based on the first BA.1 Omicron variant that became dominant last winter, driving a massive surge in infections. On Wednesday, Moderna said its updated vaccine worked well against more recent Omicron subvariants, and that it was moving forward with plans to ask regulators for approval. Vaccines that can bridge the gap between the original version of coronavirus and the Omicron variant would likely be “far, far better” for the fall, according to Trevor Bedford, a biologist at the University of Washington who has closely tracked mutations of the SARS-coV-2 virus.
25th Jun 2022 - Edmonton Journal

Global impact of the first year of COVID-19 vaccination: a mathematical modelling study

COVID-19 vaccination has substantially altered the course of the pandemic, saving tens of millions of lives globally. However, inadequate access to vaccines in low-income countries has limited the impact in these settings, reinforcing the need for global vaccine equity and coverage.
25th Jun 2022 - The Lancet

Sanofi-GSK Covid vaccine found effective against Omicron

Sanofi and GlaxoSmithKline have reported promising results from trials of their Covid-19 vaccine, which has proved to be particularly effective against the Omicron strain of coronavirus. The vaccine targets the original and the Beta strains of coronavirus but was also tested against the more recent Omicron variant. When used as a first dose, it demonstrated a 64.7 per cent efficacy rate against symptomatic infection overall in adults, and was 72 per cent effective against infections caused by Omicron. The vaccine was safe and well-tolerated in a trial of 13,000 people
25th Jun 2022 - Financial Times

WHO says over 900 probable cases of acute hepatitis reported in children

Thirty-three countries have reported 920 probable cases of severe acute hepatitis in children so far, a jump of 270 from May, the World Health Organization (WHO) said on Friday. The WHO said that the European Region accounted for half the probable cases, including 267 from the United Kingdom, while a third of the probable cases were from the United States. Health authorities globally have been investigating the mysterious rise in severe cases of hepatitis - or liver inflammation – in young children. The outbreak was first reported in April in Britain and has since then hit dozens of other countries.
25th Jun 2022 - Reuters

How Serious is Monkeypox? WHO Says Not Global Emergency

The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern. The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak. “What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.
25th Jun 2022 - Bloomberg

European Commission grants marketing authorisation to Valneva's COVID-19 shot

French drugmaker Valneva's COVID-19 vaccine has received marketing authorisation from the European Commission (EC) for use as a primary vaccination in people from 18 to 50 years of age, the company said on Friday. The marketing authorisation will cover the European Union's member states as well as Iceland, Liechtenstein, and Norway. "Now that we have received this full marketing authorization, we hope that the EC and its member states will place orders that reflect this demand," Valneva CEO Thomas Lingelback said in a statement.
24th Jun 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Jun 2022

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CDC Advisers Endorse Moderna’s Covid-19 Vaccine for Kids 6 to 17 Years

Advisers to the Centers for Disease Control and Prevention backed use of Moderna Inc.’s Covid-19 vaccine in children ages 6 to 17 years. Children in the age group already have access to Covid-19 vaccines made by Pfizer Inc. and its partner BioNTech SE. The advisers recommended on Thursday that Moderna’s shot should also be made available to that age range, in a pair of 15-0 votes. The advisers’ endorsement follows the Food and Drug Administration’s authorization of the shots last week. It is one of the last steps before the Moderna shot would be more broadly available in doctors’ offices, pharmacies and vaccine clinics. Many states and vaccination sites wait for the CDC’s signoff before providing the inoculations. It typically follows the recommendations of its Advisory Committee on Immunization Practices but doesn’t have to. The panel is made up of pediatricians, epidemiologists and other health experts.
24th Jun 2022 - The Wall Street Journal

U.S. CDC confirms evidence of local monkeypox transmission

The U.S. Centers for Disease Control and Prevention (CDC) said there was evidence of local transmission of monkeypox, in addition to reports of cases where people had traveled abroad. The cases are mainly occurring in men who have sex with men, but women are also getting infected, CDC staff member Dr. Agam Rao said at a panel meeting on Thursday. Monkeypox, a viral infection that causes skin lesions, is endemic in certain parts of Africa. But the current outbreak has hit countries where the virus does not usually spread, sparking concern.
24th Jun 2022 - Reuters

South African biotech company to develop first African-owned Covid-19 vaccine

A year after the creation of the mRNA Vaccine Technology Transfer Hub, a South African biotech company has teamed up with a Belgium-based firm to develop an African Covid-19 vaccine. South Africa’s Afrigen Biologics and Belgium’s Univercells will develop the first African-owned Covid-19 shot as part of a broader effort to reduce the continent’s reliance on other regions for vaccines. During the signing of the agreement on Tuesday, Afrigen, based in Cape Town, said it is working to facilitate the production of mRNA vaccines at more than 15 manufacturing sites in low- and middle-income nations worldwide.
23rd Jun 2022 - ZAWYA

Scientists probe Japan's remarkable COVID success in hunt for new vaccine to protect some of the most vulnerable

Japan's notable coronavirus pandemic resilience has generated scores of possible explanations, from the country's preference for going shoeless indoors, to the purportedly low-aerosol-generating nature of Japan's quiet conversation, to its citizens' beneficial gut bacteria. Even irreligiousness — said to have spared the Japanese from exposure to crowded houses of worship — has been touted as a virtue in the age of COVID-19. Despite having the world's oldest population, with almost one in three residents 65 or older, Japan has had fewer COVID fatalities per capita than almost any other developed nation.
23rd Jun 2022 - CBS News

Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age. The European Commission will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly. If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
23rd Jun 2022 - Associated Press

Moderna’s Covid-19 Vaccine for Kids 6 to 17 Years Faces CDC Review

Advisers to the Centers for Disease Control and Prevention are set to decide whether to recommend Moderna’s Covid-19 vaccine for children ages 6 to 17 years. Children in the age group already have access to Covid-19 vaccines made by Pfizer and its partner BioNTech. The advisers are discussing whether Moderna’s shot should also be made available for that age range. The advisers’ meeting follows the Food and Drug Administration’s authorization of the shots last week.
23rd Jun 2022 - Wall Street Journal

EU watchdog backs marketing authorisation for Valneva's COVID-19 shot

Valneva's COVID-19 vaccine was endorsed by the European Medicines Agency (EMA) on Thursday, although the French company's contract with the European Commission to supply the dose hangs in the balance. The original deal was for up to 60 million doses. But due to application delays and countries in Europe already having excess supply, the Commission has signalled that it wants to amend the agreement for a much smaller number of doses
23rd Jun 2022 - Reuters.com

Omicron-specific COVID vaccines on the horizon, Pfizer chief says

COVID-19 vaccines that specifically target the Omicron and other variants are under development, Pfizer Inc's (PFE.N) chief executive said on Wednesday, adding that the company will be able to quickly adapt shots as the novel coronavirus mutates. While the ultimate approval decisions rest with U.S. regulatos, "we are ready for that," the drugmaker's CEO Albert Bourla told MSNBC in an interview, noting that the Food and Drug Administration is convening a meeting later this month.
23rd Jun 2022 - Reuters.com

Nearly 1 in 5 adults who had COVID have lingering symptoms - U.S. study

Nearly 1 in 5 American adults who reported having COVID-19 in the past are still having symptoms of long COVID, according to survey data collected in the first two weeks of June, U.S. health officials said on Wednesday. Overall, 1 in 13 adults in the United States have long COVID symptoms lasting for three months or more after first contracting the disease, and which they did not have before the infection, the data showed.
23rd Jun 2022 - Reuters.com

Monkeypox News: Chelsea Clinic to Offer Vaccines in NYC to Vulnerable Groups

New York health officials will begin offering monkeypox vaccination to vulnerable groups at a temporary clinic in the city, where 28 cases have been identified as of Wednesday. New Yorkers who may have been exposed to monkeypox can get the vaccine, city health officials said Thursday. Eligible groups include “all gay, bisexual, and other men who have sex with men (cisgender or transgender) ages 18 and older who have had multiple or anonymous sex partners in the last 14 days,” the health department said in a statement. While shots were earlier offered to close contacts of confirmed cases, the department is expanding availability to eligible people who may have been exposed.
23rd Jun 2022 - Bloomberg

Paxlovid shown effective against visits for severe COVID-19

Pfizer's antiviral drug Paxlovid was tied to very few COVID-related visits to the emergency department (ED) or hospital, but people in socially vulnerable US regions are less likely to receive it or a similar COVID-19 drug, according to two studies published yesterday in Morbidity and Mortality Weekly Report (MMWR).
22nd Jun 2022 - CIDRAP

Moderna 2-strain booster shows strong subvariant antibody response

Moderna reported that the bivalent (two-strain) mRNA vaccine it developed against Omicron showed a strong neutralizing antibody response against the Omicron BA.4 and BA.5 subvariants and that it will seek regulatory approval in the coming weeks. Moderna's bivalent vaccine contains its original vaccine plus a strain that targets Omicron and its subvariants. The announcement comes amid rising BA.4 and BA.5 levels worldwide
22nd Jun 2022 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Jun 2022

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Are the Russian covid-vaccine results accurate?

Dr Sheldrick’s team published their analysis on June 20th in the American Journal of Therapeutics. It was motivated by concerns that other researchers had raised earlier about one particular pattern in the Sputnik V paper: the vaccine’s efficacy was almost identical in each of the five age groups shown. The Russian scientists’ answer was that these results reflected a true efficacy that did not differ by age. But clinical trials are usually affected by all sorts of random circumstances, known as “noise” in the jargon. The implication is that, in this particular trial, the various sources of noise cancelled one another out in a way that generated a pattern of equivalent efficacy in all age groups.
22nd Jun 2022 - The Economist

Covid-19: Risk of mutated variants among immunocompromised patients, new study shows

Immunocompromised patients tend to develop chronic coronavirus infections, leading to highly mutated variants that bear multiple antibody-resistant mutations, according to a new study carried out by a research team at Tel Aviv University, Israel. The study involved an examination of chronic COVID-19 patients at the Tel Aviv Sourasky Medical Center (“Ichilov Hospital”) and was published this week in Nature Medicine. The researchers found that a weakened antibody response, particular in the lower airways of these chronic patients, may prevent full recovery from the virus and drive the virus to mutate many times during a lengthy infection. They explained that the virus’ ability to survive and reproduce in the immunosuppressed patient’s body without restriction leads to the evolution of many variants.
22nd Jun 2022 - The Brussels Times

Biological E has place in India's COVID-19 vaccine market following Corbevax' approval

The Drugs Controller General of India (DCGI) recently approved Biological E’s Corbevax vaccine as the first heterogeneous COVID-19 booster vaccine in India for adults above 18 years who have received two shots of Covaxin or Covishield. Corbevax has the added advantage of scalability and thermostability, making it suitable for deployment in low-resource settings, says GlobalData.
22nd Jun 2022 - The Pharma Letter

Afrigen, Univercells partner to develop African-owned Covid-19 vaccine

Afrigen Biologics has signed an agreement with the Univercells Group to develop the first African-owned Covid-19 vaccine. The partnership will focus on developing a new messenger ribonucleic acid (mRNA) vaccine leveraging intellectual property (IP) from both parties, as well as a new IP and boosting access to the shot. mRNA specialist eTheRNA will extend support to Afrigen and Univercells in the partnership. The firms will jointly work to address two key challenges, the lack of domestic cost-efficient manufacturing and the requirement for cold- or super-cold chains.
22nd Jun 2022 - Pharmaceutical Technology

Moderna calls for approval of two-strain Covid vaccine booster

Although the vaccine did not elicit as many antibodies to the new subvariants as it did to the original Omicron, suggesting its efficacy may already be declining, Moderna still feels there would be more of a benefit than not
22nd Jun 2022 - Financial Times

COVID-19 vaccine from Moderna 'provides good clinical protection' against Omicron subvariants

Omicron subvariants BA.4 and BA.5 are becoming the dominant forms of COVID-19 in Australia and abroad. New data from Moderna shows an updated booster tailored to Omicron generates high levels of antibodies against BA.4 and BA.5. Moderna's chief medical officer says, pending approval, the new booster could be supplied to Australia in August
22nd Jun 2022 - ABC News

Scientists evaluate JNK inhibitors in treating moderate to severe COVID-19 patients

Janus kinase (JNK) inhibitors with antiviral and anti-inflammatory properties have shown promising outcomes in treating symptomatic coronavirus disease 2019 (COVID-19) patients. In a systematic review article published in the journal Cochrane Database of Systematic Reviews, scientists have described the clinical outcomes in hospitalized COVID-19 patients who have been treated with JNK inhibitors together with standard of care.
22nd Jun 2022 - News-Medical.Net

Covid-19: How has the pandemic differed across the four UK nations?

Although the overall course of the pandemic has been similar across the UK, there have been instances when the countries’ trajectory has diverged. In the first wave Northern Ireland had far fewer deaths and hospital admissions. Lockdown restrictions were similar across the UK at this time. One possible explanation for the divergence is that lockdown began at a slightly earlier stage in the pandemic in Northern Ireland, reducing the size of the peak there. In the second wave Scotland had relatively fewer cases, hospital admissions, and deaths than England and Wales. Scotland also had the most consistent set of restrictions in place between September and December 2020, which may have helped to delay the spread of the alpha variant (which was dominant in England by the beginning of December but not in Scotland until January 2021).34 Northern Ireland had a slightly later peak in cases in this wave, which may have contributed to lower mortality, as a result of the vaccination programme reducing severe disease. Northern Ireland’s younger population may also have been a factor in its lower cumulative mortality. From the middle of 2021 to February 2022 Northern Ireland had consistently higher rates of hospital admission for covid-19 than elsewhere in the UK, although case rates and mortality have been broadly similar. This suggests that hospital care for patients with covid-19 may have been organised differently in Northern Ireland, resulting in a higher admission rate. Another possibility is that hospital acquired covid-19, which has been a significant concern,5 may be a particular problem in hospitals in Northern Ireland. In February and March 2022 Scotland had the highest case rates and a rapid increase in hospital admissions, despite retaining restrictions longest in response to omicron.
22nd Jun 2022 - The BMJ

Moderna booster candidate shows strong response against Omicron subvariants

Moderna Inc said on Wednesday that an updated version of its COVID-19 vaccine designed to target the Omicron variant also generated a strong immune response against the fast-spreading Omicron subvariants BA.4 and BA.5, which have gained a foothold in the U.S. in recent weeks. The updated vaccine, which Moderna is hoping will be approved for use as a booster shot for the fall, is a bivalent vaccine, meaning it contains vaccine designed to target two different coronavirus variants - the original variant from 2020 and the Omicron variant that was circulating widely last winter.
22nd Jun 2022 - Reuters

Pfizer sued for patent infringement over COVID-19 drug Paxlovid

Pfizer Inc's blockbuster COVID-19 treatment Paxlovid violates an Enanta Pharmaceuticals Inc patent for its COVID drug still in development, according to a lawsuit filed Tuesday in Boston federal court. Watertown, Massachusetts-based Enanta told the court it received the patent for its antiviral medication last week based on applications dating from July 2020. The company said it began human testing for its once-daily, oral COVID treatment in February, and that the Food and Drug Administration fast-tracked its review in March. Enanta requested an unspecified amount of money damages from Pfizer, including royalties. It also said in a statement that it was not asking the court to block Pfizer from selling Paxlovid. Paxlovid is an oral antiviral pill for high-risk patients that is intended to stave off serious complications from COVID-19. Pfizer said last month it expects to make $22 billion from Paxlovid sales this year. The company did not immediately respond to a request for comment on the lawsuit.
22nd Jun 2022 - Reuters

Moderna CEO: COVID variant vaccine to be ready for shipping in August

Moderna's COVID-19 variant vaccine will be ready to ship in August as the company has been making shots ahead of approval, Chief Executive Stephane Bancel told Reuters on Wednesday, adding that the only bottleneck to supply was a regulatory one. "Our goal is as early as August given we're going to file all the data in June, by the end of June... hopefully in the August timeframe, the vaccine is authorised," Bancel said in an interview.
22nd Jun 2022 - Reuters

Moderna’s New Covid-19 Shot Shows Promise Against Omicron Subvariants

The shot targeting both Omicron and the original virus strain produced a strong immune response against subvariants BA.4 and BA.5, the company said
22nd Jun 2022 - The Wall Street Journal

Women more likely to have long COVID, different symptom profile

Women are significantly more likely than men to experience long COVID, with symptoms that follow a distinct clinical pattern, researchers reported today. They said more efforts are needed to explore sex differences in outcomes, including greater risks of exposure for some jobs. The researchers from the Johnson & Johnson Office of the Chief Medical Officer reported their findings yesterday in Current Medical Research and Opinion, a peer-reviewed journal.
22nd Jun 2022 - CIDRAP

Nearly 1 in 5 adults who had COVID have lingering symptoms - U.S. study

Nearly 1 in 5 American adults who reported having COVID-19 in the past are still having symptoms of long COVID, according to survey data collected in the first two weeks of June, U.S. health officials said on Wednesday. Overall, 1 in 13 adults in the United States have long COVID symptoms lasting for three months or more after first contracting the disease, and which they did not have before the infection, the data showed.
22nd Jun 2022 - Reuters

UK Polio Spread Detected With Vaccine-Derived Virus Found in London Sewage

Britain’s polio-free status could be at risk for the first time in almost two decades after several samples of vaccine-derived poliovirus were found during routine London sewage testing. Several closely related viruses were found in samples taken in north and east London between February and May. The findings suggest some spread between closely linked individuals and the virus has continued to evolve and is now classified as a vaccine-derived poliovirus type 2, the UK Health Security Agency said Wednesday. Polio can on rare occasions cause serious illness, such as paralysis, in people are not fully vaccinated. No cases of polio or associated paralysis have been reported, according to the agency.
22nd Jun 2022 - Bloomberg

More vulnerable people receiving fewer COVID pills - U.S. study

People in socially and economically disadvantaged regions are about half as likely to receive an oral antiviral COVID-19 pill than residents of wealthier zip codes, according to a U.S. government study published on Tuesday. The findings by the U.S. Centers for Disease Control and Prevention (CDC) revealed this disparity even as there were more dispensing sites located in high-vulnerability U.S. zip codes than in the more advantaged areas.
21st Jun 2022 - Reuters


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COVID and Kidney Pain: How COVID-19 Can Affect Kidneys

COVID-19 can cause a variety of different symptoms. However, when you think of COVID-19 symptoms, kidney pain probably isn’t one of them. While it’s possible for COVID-19 to cause kidney damage, this condition isn’t typically associated with kidney pain. Keep reading to discover more about what we know so far about COVID-19 and the kidneys.
22nd Jun 2022 - Healthline

U.S. COVID vaccines start to roll out for young children

The United States has begun distributing COVID vaccines for children as young as six months around the country, and availability of the shots will improve in the coming days, according to White House COVID-19 response coordinator Dr. Ashish Jha. U.S. regulators authorized Moderna Inc's two-dose vaccine for children aged six months to five years and the Pfizer-BioNTech three-shot regimen for children aged six months to four years late last week.
22nd Jun 2022 - Reuters

After maternal COVID vaccination, infants have persistent anti-SARS-CoV-2 antibodies at 3 months

A recent article published in the journal Clinical Infectious Diseases assessed the kinetics of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies derived from mothers among infants in association with the timing of prenatal SARS-CoV-2 vaccination.
21st Jun 2022 - News-Medical.Net

Afrigen, Univercells Team Up to Develop African Covid Vaccine

South African biotech company Afrigen Biologics will work with a Belgian partner to develop the first African-owned Covid-19 shot as part of a broader effort to reduce the continent’s reliance on other regions for vaccines. Afrigen and the Univercells Group aim to build on expertise developed through the World Health Organization’s messenger RNA vaccine hub, the companies said in a statement Tuesday. Afrigen, based in Cape Town, said it’s working to facilitate the production of mRNA vaccines at more than 15 manufacturing sites in low- and middle-income nations across the world. Africa, which imports about 99% of all the shots it needs, was left far behind wealthier nations in securing shots during the pandemic with manufacturing concentrated in just a handful of countries. The partners said they’ll seek to develop vaccines that are cheaper to produce and easier to store and distribute in rural and remote locations where few people have been vaccinated.
21st Jun 2022 - Bloomberg

Ainos COVID-19 Antigen Self-Test Receives Approval for Sale in Taiwan

Ainos, Inc. a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that the Company has begun marketing the Ainos SARS-CoV-2 Antigen Rapid Self-Test (“COVID-19 Antigen Self-Test Kit” or “the Test”) under an Emergency Use Authorization (“EUA”) issued by the Taiwan Food and Drug Administration (“TFDA”) on June 13, 2022 to Taiwan Carbon Nano Technology Corporation (“TCNT”), the manufacturer and product co-developer of the Test in conjunction with Ainos. Ainos is the exclusive master sales and marketing agent for the COVID-19 Antigen Self-Test Kit.
21st Jun 2022 - The Associated Press

RMI's COVID-19 vaccine partnership with Acacium proves a success

The joint aim of the companies was to provide vaccines to vulnerable communities Remote Medical International (RMI) – which specialises in protecting the health of workers in diverse areas across the world – partnered with healthcare solutions company Acacium Group to provide vaccinations in areas of notable need during 2021-22. Their joint aim was to deliver mobile vaccination and COVID-19 test processing units throughout the Midlands and South East of the UK during the pandemic. The companies delivered mobile-testing with a results turnaround time of less than three hours and, throughout the course of their deployment, processed in the excess of 200,000 tests
21st Jun 2022 - PharmaTimes

Paxlovid of no benefit to low risk patients with COVID-19

Paxlovid is of no benefit to patients at a low risk of either being hospitalised or death after infection with COVID-19. According to the results of a press release from the manufacturer, Pfizer, paxlovid does not benefit patients who are either unvaccinated or vaccinated and who are deemed not at a high risk of severe complications such as hospitalisation or death if infected with COVID-19. Paxlovid is a protease inhibitor antiviral therapy against COVID-19 and was developed to be taken orally, at the first sign of infection or at first awareness of an exposure. The early use of the drug could therefore help patients avoid severe illness and which might lead to hospitalisation or death, or avoid disease development following contact with an infected individual.
21st Jun 2022 - Hospital Healthcare Europe

Some Omicron sub-variants escaping antibodies from Sinopharm shot, Chinese study says

A small Chinese study detailed in The Lancet Infectious Diseases journal showed neutralising antibodies against some Omicron sub-variants were largely undetectable after two doses of a Sinopharm COVID-19 vaccine, with a booster shot only partly restoring them. The study comes as China, which has approved only locally developed COVID shots including the Sinopharm vaccine, strives to improve vaccination rates, maintaining a "dynamic zero COVID" policy aimed at eradicate all outbreaks while many countries have adopted an approach of learning to live with the virus
21st Jun 2022 - Reuters


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Covid-19: Long covid risk is lower with omicron than delta, researchers find

The risk of developing long covid is lower among people with the omicron variant of SARS-CoV-2 than with delta, shows an analysis of self reported data to the UK ZOE covid app.Researchers from King’s College London looked at data logged by 56 003 adults who tested positive between 20 December 2021 and 9 March 2022, when the omicron variant was dominant. They compared these with 41 361 who tested positive between 1 June 2021 and 27 November 2021, when the delta variant was most common. Among the cases in the omicron period, 2501 people (4.5%) reported they had experienced long covid, defined as having new or ongoing symptoms four weeks or more after they had tested positive. This compared with 4469 (10.8%) of people in the delta period, according to the analysis, published as a letter in the Lancet.
18th Jun 2022 - The BMJ

Can We Develop a Covid-19 Vaccine That Lasts?

Though most vaccines take years to develop, the Covid shots now in use were created in record time—in a matter of months. For health authorities and a public desperate for tools to deal with the pandemic, their speedy arrival provided a huge lift, preventing hospitalizations and deaths while helping people to escape lockdowns and return to work, school and many other aspects of pre-Covid life. But the Covid vaccines don’t last nearly as long as shots given for other viral illnesses such as polio, mumps and hepatitis, which remain effective for years or decades. Even more worrisome to some scientists and public health officials, the current vaccines don’t fully protect against infections, which hurts their overall effectiveness and gives the virus an opportunity to mutate into more contagious and lethal strains.
18th Jun 2022 - The Wall Street Journal

Monkeypox Cases Could Spread Unseen in US If 'Testing Bottlenecks' Don't Improve

US testing for monkeypox is insufficient to determine how widespread the virus is and where new cases are cropping up, according to infectious disease experts and advocates concerned about a sluggish response to the outbreak that’s already hit 32 countries. While government labs have the capacity to test as many as 8,000 samples a week, they’re only using 2% of that capability, suggesting that about 23 monkeypox tests are being performed a day, said James Krellenstein, the cofounder of PrEP4All, an HIV advocacy group that widened its focus during the pandemic. Much more testing is needed to find out where the pathogen is and how fast it’s moving, he said.
18th Jun 2022 - Bloomberg

Omicron less likely to cause long COVID, UK study says

The Omicron variant of coronavirus is less likely to cause long COVID than previous variants, according to the first peer-reviewed study of its kind from the United Kingdom. Researchers at King's College London, using data from the ZOE COVID Symptom study app, found the odds of developing long COVID after infection were 20% to 50% lower during the Omicron wave in the UK compared to Delta. The figure varied depending on the patient's age and the timing of their last vaccination.
18th Jun 2022 - Reuters

WHO panel backs use of Omicron-adapted vaccine as booster dose

A modified coronavirus vaccine that targets the Omicron variant can be administered as a booster dose to broaden immunity, a technical advisory group set up the World Health Organization said on Friday. Such a variant-adapted vaccine may benefit those who have already received the primary series of shots, the agency's panel on COVID-19 Vaccine Composition said, citing available data. The vaccines could be considered for use globally by the agency once they get emergency use authorization or an approval by a stringent national regulatory authority.
18th Jun 2022 - Reuters

Early Omicron infection unlikely to protect against current variants

People infected with the earliest version of the Omicron variant of the coronavirus, first identified in South Africa in November, may be vulnerable to reinfection with later versions of Omicron even if they have been vaccinated and boosted, new findings suggest. Vaccinated patients with Omicron BA.1 breakthrough infections developed antibodies that could neutralize that virus plus the original SARS-CoV-2 virus, but the Omicron sublineages circulating now have mutations that allow them to evade those antibodies, researchers from China reported on Friday in Nature.
18th Jun 2022 - Reuters

COVID vaccine rollout for U.S. children close after CDC panel vote

The U.S. Centers for Disease Control and Prevention on Saturday recommended COVID-19 vaccines for children as young as six months, allowing a nationwide rollout to start next week. The CDC's move came after a panel of advisers to the institution voted earlier on Saturday to recommend COVID-19 vaccines for those children. "We know millions of parents and caregivers are eager to get their young children vaccinated, and with today's decision, they can," said Rochelle Walensky, the CDC director, in a statement.
18th Jun 2022 - Reuters

EU drugs watchdog begins review of Moderna's variant COVID vaccine

The European Medicines Agency (EMA) started a rolling review on Friday of a variant-adapted COVID-19 vaccine from Moderna (MRNA.O), as coronavirus cases linked to Omicron sub-variants see an uptick in the region. U.S.-based Moderna's so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID, the original strain first identified in China, and the Omicron variant. Last week, Moderna said its bivalent vaccine produced a better immune response against Omicron than the original shot.
17th Jun 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Jun 2022

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More South Australians now able to test for different viruses at COVID drive-through sites

More vulnerable South Australians will now be able to test for 12 different viruses, such as influenza, alongside their COVID-19 tests. The test can detect a dozen viruses including COVID, influenza and respiratory syncytial virus. Flu cases are skyrocketing in SA. The multi-virus tests take about 24 hours to process SA Pathology has doubled its multi-virus testing from 500 to 1,000 a day to support doctors to give early diagnosis and treatment to at-risk patients. Tests are available at drive-through testing clinics and at private pathologies with a GP referral, which can also be obtained via telehealth. Health Minister Chris Picton said multi-virus testing has been available since the start of the pandemic, but spiking flu cases have prompted health authorities to provide more testing.
17th Jun 2022 - ABC News

WHO getting monkeypox tests for Africa, urges vaccine readiness

The World Health Organization (WHO) is in the process of procuring thousands of monkeypox tests for Africa but is not recommending mass vaccination at this stage, WHO Africa Director Matshidiso Moeti said on Thursday. She added that the continent should be prepared for vaccination should the need arise.
16th Jun 2022 - Reuters

EMA begins rolling review of Pfizer-BioNTech’s Covid-19 vaccine

The European Medicines Agency (EMA) has commenced a rolling review of Pfizer and BioNTech’s variant-adapted version of their Covid-19 vaccine, Comirnaty. This review is preliminarily based on chemistry, manufacturing, and controls (CMC) data submitted to the EMA recently. As the development of the adapted vaccine advances and clinical data become available, including findings on immunogenicity against Omicron and its subvariants, it will be included in the rolling submission. By initiating a rolling review, the regulatory agency will be able to analyse these findings when they become available. The rolling review will progress until sufficient data for a formal application is obtained.
16th Jun 2022 - Pharmaceutical Technology

Fauci: NIH is researching a pan-coronavirus vaccine to combat COVID-19 twists, new threats

Dr. Anthony Fauci, speaking by video-link because he contracted COVID-19, told Congress on Thursday his agency is studying vaccines that better target the omicron variant and it will be “paramount” to develop a new generation of shots that can tackle a range of coronaviruses. Dr. Fauci said existing vaccines can stave off severe disease from spinoffs of the virus first detected in China, especially if someone is boosted. But the National Institutes of Health is trying to increase the breadth of the vaccines’ immune response and improve children’s uptake. “Looking ahead to the anticipated emergence of new variants, the importance of developing the next generation of coronavirus vaccines is paramount,” said Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases. “This virus is changing, and we need to keep up with it.”
16th Jun 2022 - Washington Times

Researchers evaluate artemisinin for COVID-19 management

A study observed that artesunate-mefloquine displayed high anti-SARS-CoV-2 activity with approximately 72.1 ± 18.3% inhibition. Additionally, other ACTs such as artesunate-amodiaquine, artesunate-pyronaridine, artemether-lumefantrine, and dihydroartemisinin-piperaquine also inhibited SARS-CoV-2 by 27.1 to 34.1%. This indicated that ACT drugs could be effectively used for COVID-19 treatment. Artesunate was also found to inhibit the production of interleukin-1B (IL-1B), IL-6, and IL-8. Since high IL-6 levels in COVID-19 patients have been attributed to the cytokine release syndrome, controlling the levels of IL-6 could potentially reduce the severity of COVID-19. Overall, the study revealed that A. annua, and artemisinin and its derivatives such as artemether and artesunate could potentially inhibit SARS-CoV-2. The researchers believe that Artemisia-based treatment options could be used to boost immunity and improve tolerance against viral infections such as COVID-19.
16th Jun 2022 - News-Medical.Net

Valneva reaches COVID-19 vaccine settlement with UK government, while EU deal remains uncertain

Valneva has reached a settlement with the UK government over an abandoned COVID-19 vaccine contract. Meanwhile, the future of its COVID-19 vaccine in the EU could become clearer next week after an EMA committee vote.
16th Jun 2022 - BioPharma-Reporter.com

Valneva reaches settlement with Britain on COVID-19 vaccine deal termination

French drugmaker Valneva said on Wednesday it reached a settlement agreement with the British government linked to the termination of the supply agreement for its COVID-19 vaccine candidate VLA2001. Valneva said in September that it had received a termination notice from the British government of its COVID-19 vaccine supply deal, sending its shares plunging 35% that day. The settlement agreement resolves certain matters relating to the obligations of the company and the British government following the termination of the supply agreement, Valneva said.
16th Jun 2022 - Reuters

Despite efficacy doubts, FDA advisors endorse Pfizer, Moderna COVID shots for preschoolers

An FDA advisory committee of independent specialists has recommended by a unanimous vote that the Pfizer and Moderna COVID-19 vaccines be sanctioned for preschoolers. While the blessing sets up the vaccines for long-awaited FDA authorizations, questions remain about how effective the shots will be given the rapidly evolving virus. The panel based its recommendation on clinical data gathered early this year when the omicron variant was predominant. Months later, the BA.4 and BA.5 subvariants of omicron are quickly changing the COVID landscape. CDC data show that the new strains account for 21% of new infections. Just five weeks ago, BA.4 and BA.5 accounted for just 1% of cases.
16th Jun 2022 - Fiercepharma

FDA advisers endorse 1st COVID-19 shots for kids under 5

The first COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday. The Food and Drug Administration’s vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids. The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5 — that’s roughly 18 million youngsters. They are the last age group in the U.S. without access to COVID-19 vaccines and many parents have been anxious to protect their little children. If all the regulatory steps are cleared, shots should be available next week.
15th Jun 2022 - Reuters

People who caught Covid in first wave get ‘no immune boost’ from Omicron

People who caught Covid during the first wave of the pandemic get no boost to their immune response if they subsequently catch Omicron, a study of triple vaccinated people reports. Experts say that while three doses of a Covid jab help to protect individuals against severe outcomes should they catch Omicron, previous infections can affect their immune response. “If you were infected during the first wave, then you can’t boost your immune response if you have an Omicron infection,” said Prof Rosemary Boyton, of Imperial College London, a co-author of the study. The team also found an Omicron infection offered little extra protection against catching the variant again. “When Omicron started flying around the country, people kept saying that’s OK, that will improve people’s immunity,” said Boyton. “What we’re saying is it’s not a good booster of immunity.”
15th Jun 2022 - The Guardian


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Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months

Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date. The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September. BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months. Moderna’s vaccine is authorized for use in adults 18 and older. The company has requested expanding the vaccine’s use to children ages 6 months through 17 years, and a decision by the Food and Drug Administration on that request could come within days.
15th Jun 2022 - The Wall Street Journal

WHO to Convene Emergency Meeting on Monkeypox Amid Spread

The World Health Organization will hold an emergency meeting to assess whether the current spread of monkeypox constitutes a public health emergency of international concern, or PHEIC. A special committee will meet next week to advise on the spread in non-endemic countries, Hans Kluge, regional director of the WHO for Europe, said at a media briefing Wednesday. A PHEIC is the WHO’s highest alert level, and such a declaration can be used to encourage nations to cooperate on countermeasures, while letting the agency recommend steps such as travel advisories.
15th Jun 2022 - Bloomberg

NTAGI to review Covaxin, Corbevax vaccine data for 6-12 years on Thursday

Government advisory panel NTAGI will meet on Thursday to review data on Covaxin and Corbevax vaccines for the 6-12 age group and also deliberate on reducing the gap between the second and precaution doses from the current nine to six months. The National Technical Advisory Group on Immunisation (NTAGI) will hold its meeting amid a fresh spike in COVID-19 cases in the country. Currently, those aged 12 years and above are vaccinated against COVID-19.
15th Jun 2022 - Business Standard

Vaccine makers claims efficacy against Omicron variant of Covid-19

With Omicron and its sub-variants spreading rapidly across the globe, vaccine makers have started claiming efficacy of their Covid-19 vaccines against this Sars-CoV-2 variant.
15th Jun 2022 - Business Standard

Covid-19: Omicron infection is poor booster to immunity, study finds

People infected with the omicron variant show poor immunity boosting against future covid-19 infection, researchers have found. This may explain why breakthrough and repeat infections have been a common feature of the omicron wave of the pandemic, even among people who have been triple vaccinated, said the research team. Omicron is “an especially stealthy immune evader” said Danny Altmann, study coauthor from Imperial College London. “Not only can it break through vaccine defences, it looks to leave very few of the hallmarks we’d expect on the immune system,” he said. “It’s more stealthy than previous variants and flies under the radar, so the immune system is unable to remember it.”
15th Jun 2022 - The BMJ

Pfizer halts Paxlovid trial in less vulnerable COVID patients after failing to find evidence of benefit

Pfizer’s Paxlovid has proven useful in COVID-19 patients at high risk of severe disease. But the antiviral drug may not help less vulnerable patients. Pfizer has stopped enrollment into the EPIC-SR trial that’s been evaluating Paxlovid in standard-risk patients, the company said Tuesday. These include unvaccinated adults without additional risk and vaccinated people who have at least one risk factor for progressing to severe disease. The clinical trial previously flopped on its primary goal, showing the Pfizer antiviral was no better than placebo at sustaining symptom relief for four consecutive days.
15th Jun 2022 - FiercePharma

FDA panel unanimously backs Moderna’s Covid vaccine for children ages 6 to 17

A panel of experts convened by the Food and Drug Administration voted unanimously Tuesday to recommend the agency authorize the Moderna Covid vaccine for children ages 6 to 17. The authorization would mirror the current emergency use authorization of the Covid vaccine developed by Pfizer and BioNTech, which is authorized for individuals 6 years and older. “I believe this vote, and I am happy to say it was unanimous, is standing up for vulnerable populations that merit protection against this virus,” said Ofer Levy, a member of the FDA’s expert panel and director of the precision vaccines program at Boston Children’s Hospital. “I believe this will provide families with an important option.”
15th Jun 2022 - STAT News

Pfizer’s Paxlovid study fails to answer key questions over benefit for broader populations

Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations. Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid. The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid.
15th Jun 2022 - STAT News

Severe covid-19 symptoms linked to more than 1300 genetic variants

More than 1000 genes may contribute to a person’s risk of developing severe covid-19, on top of life circumstances such as their age, ethnicity and any health conditions. Most of the genes, discovered in a study of more than 1 million people, affect the functioning of two kinds of immune cell. If the results are confirmed, they could inform a test that assesses a person’s risk of getting badly ill with covid-19, says Johnathan Cooper-Knock at the University of Sheffield, UK. “We know there are young people who are otherwise fit that get severe covid,” he says. “We are trying to get at the genetic determinants that put people at risk irrespective of the more obvious things.” Cooper-Knock’s team used artificial intelligence to analyse results from a global data set called the COVID-19 Host Genetics Initiative, a genetics project run by a group of researchers and companies.
14th Jun 2022 - New Scientist

People who caught Covid in first wave get ‘no immune boost’ from Omicron

People who caught Covid during the first wave of the pandemic get no boost to their immune response if they subsequently catch Omicron, a study of triple vaccinated people reports. Experts say that while three doses of a Covid jab help to protect individuals against severe outcomes should they catch Omicron, previous infections can affect their immune response. “If you were infected during the first wave, then you can’t boost your immune response if you have an Omicron infection,” said Prof Rosemary Boyton, of Imperial College London, a co-author of the study. The team also found an Omicron infection offered little extra protection against catching the variant again. “When Omicron started flying around the country, people kept saying that’s OK, that will improve people’s immunity,” said Boyton. “What we’re saying is it’s not a good booster of immunity.”
14th Jun 2022 - The Guardian

How long is your COVID vaccine good for? You can soon find out, thanks to a new test that informs patients of their immunity’s ‘magnitude and duration’

Until recently, it’s been nearly impossible to say. Immunity, whether from vaccine or prior infection, is thought to wane after three or four months, but it varies by person. That knowledge is based on what’s known about typical antibody response—but antibodies are only half of the picture. The other half: T-cell response, which hasn’t been examined in patients nearly as often owing to technical challenges. Now that response can be tested affordably and en masse, researchers at Mount Sinai Health System in New York say. Along with researchers at Duke-NUS Medical School in Singapore, they developed a rapid blood test called the dqTACT assay that measures the activation of such cells in response to COVID. The test will allow for mass monitoring of the population’s immunity and effectiveness of vaccines new and old, they said in a study published Tuesday in Nature Biotechnology.
14th Jun 2022 - Fortune


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Jun 2022

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The next virus pandemic threat (and what the experts are doing about it)

Two years ago the first human trials of the University of Oxford’s game-changing Covid-19 vaccine were just under way, only five months after the pandemic virus was identified. Bill Gates has hailed this super-rapid progress as “miraculous”. The scientists responsible prefer to put it down to preparation. Back then no one was even sure that a vaccine against Covid-19 could work. Now, having succeeded in creating several of them, the knowledge accrued when developing such drugs is being put to good use on new projects. In America, for instance, scientists in collaboration with BioNTech, the German firm behind the Pfizer coronavirus jab, are trialling a vaccine to treat pancreatic cancer, the deadliest common cancer, using the same mRNA technology as was used in Covid jabs.
14th Jun 2022 - The Times

Covid vaccine protection wanes more quickly for cancer patients, finds study

The level of protection offered by Covid vaccination is lower for cancer patients than those in the general population, according to the UK Coronavirus Cancer Evaluation Project. The study, co-led by the Universities of Oxford, Birmingham and Southampton and the UK Health Security Agency (UKHSA), published in The Lancet Oncology, represents the first time that Covid vaccine effectiveness had been examined in people with cancer on this scale. It found that Covid vaccination was effective in most cancer patients, but the level of protection against Covid infection, hospitalisation and death was reduced over time. Three to six months after a second vaccination, protection was found to be reduced by nearly a third in cancer patients compared to people with no active or recent cancer.
14th Jun 2022 - Pulse Today

U.S. FDA advisers weigh Moderna COVID vaccine heart risk for young men

Moderna's COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer/BioNTech shot, according to data presented on Tuesday to U.S. Food and Drug Administration advisers weighing its use for those aged 6 to 17. An FDA official told the expert panel that while the data showed a higher risk for the Moderna shot, the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.
14th Jun 2022 - Reuters

Moderna COVID-19 vaccine's safety slightly bests Pfizer's

An observational study today in JAMA Internal Medicine reports a slightly better safety profile for the Moderna mRNA COVID-19 vaccine than for the Pfizer/BioNTech version in US veterans, but both vaccines had very good safety profiles. A team led by Harvard University researchers reviewed the electronic health records of 433,672 US Department of Veterans Affairs patients across the country who received their first dose of the Pfizer or Moderna COVID-19 vaccine from Jan 4 to Sep 20, 2021, with a second dose scheduled for 21 to 28 days later, depending on the vaccine. Median patient age was 69 years, 93% were men, 20% were Black, and 8% were Hispanic. Median follow-up was 223 days.
14th Jun 2022 - CIDRAP

Study finds vitamin D status and COVID-19 diagnosis shows inconsistent associations

A large study revealed no consistent associations between vitamin D status and COVID-19 outcomes such as infection, hospitalisation and death. There are inconsistent associations between vitamin D status and the diagnosis of COVID-19, hospitalisations and mortality according to the findings of a large cohort study by researchers from Faculty of Epidemiology & Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
14th Jun 2022 - Hospital Healthcare Europe

The severity of COVID-19 compared to seasonal influenza

In a recent study under review at the Archives of Virology journal and currently posted to the Research Square* preprint server, investigators in Israel assessed the disparities and similarities between seasonal influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections.
14th Jun 2022 - News-Medical.Net

Moderna COVID vaccine may pose higher heart inflammation risk - U.S. CDC

Moderna's COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer/BioNTech shot, according to data presented on Tuesday to U.S. Food and Drug Administration advisers weighing its use for those aged 6 to 17. An FDA official told the expert panel that while the data showed a higher risk for the Moderna shot, the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.
14th Jun 2022 - Reuters

FDA advisers consider Moderna’s COVID shots for older kids

A government advisory panel met Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens. The Food and Drug Administration’s outside experts will vote on whether Moderna’s vaccine is safe and effective enough to give kids ages 6 to 17. If the panel endorses the shot and the FDA agrees, it would become the second option for those children, joining Pfizer’s vaccine. The same expert panel will meet Wednesday to consider tot-sized shots from Moderna and Pfizer for the littlest kids, those under 5. Moderna’s COVID-19 vaccine has long been available for adults in the U.S. and elsewhere and dozens of countries offer it to children, too. In the U.S., children ages 12 to 17 would get two full-strength doses; ages 6 to 11 would get half-sized doses. The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose..
14th Jun 2022 - The Associated Press

U.S. FDA advisers overwhelmingly back Moderna COVID vaccine for ages 6-17

Advisers to the U.S. Food and Drug Administration on Tuesday unanimously recommended that the agency authorize Moderna Inc's COVID-19 vaccine for children and teens aged 6 to 17 years of age. Around 77 million people in the United States have received at least a two-dose course of Moderna's vaccine, which has long been available for people aged 18 and older. The committee of outside experts is scheduled on Wednesday to consider the Moderna shot for children under 6, and Pfizer and BioNTech's COVID vaccine for children under 5 - and in both cases as young as 6 months.
14th Jun 2022 - Reuters

FDA Should Authorize Moderna’s Vaccine for Ages 6 to 17, Advisers Say

A panel of advisers to the Food and Drug Administration recommended the agency expand use of Moderna Inc.’s Covid-19 vaccine to children ages 6 through 17. The advisory committee voted 22-0 on Tuesday that the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older. “This vote is standing up for vulnerable populations that merit consideration in terms of protection against this virus,” said FDA committee member Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital. “I believe this will provide families an important option.”
14th Jun 2022 - The Wall Street Journal

To save global health, we need vaccine patent waivers now

Global health is on its deathbed. For almost two years, a handful of rich countries have resisted a life-saving proposal tabled by India and South Africa that could speed up global COVID-19 vaccination, but the new vaccine patent waiver proposal pushed by the European Union and the head of the World Trade Organization is worse than no deal at all, says Hugo López-Gatell.
14th Jun 2022 - Al Jazeera English

Covid-19 Variant Shot From Sanofi, GSK Shows Strong Response to Omicron in Studies

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found. The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots. In the studies, the Beta-targeted vaccine induced a stronger antibody response to certain Omicron variants than first-generation vaccines, according to Sanofi. One study compared the Beta-targeted vaccine to the original vaccine produced by Pfizer Inc. and BioNTech SE. Neither study has yet been peer-reviewed.
13th Jun 2022 - The Wall Street Journal


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Jun 2022

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EMA’s PRAC finds no link between mRNA Covid-19 vaccines and menstruation

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has found no link between messenger ribonucleic acid (mRNA) Covid-19 vaccines and the absence of menstruation (amenorrhea). The development comes after the committee analysed all the available findings, including cases reported during clinical trials, those reported spontaneously in Eudravigilance and data from the literature. Data also comprise the literature and cases of amenorrhea reported to EudraVigilance following dosing with the Covid-19 vaccines of Pfizer-BioNTech and Moderna, Comirnaty and Spikevax, respectively.
13th Jun 2022 - Pharmaceutical Technology

Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Australian Therapeutic Goods Administration has granted provisional registration of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over. "Today's provisional registration for Nuvaxovid as a booster in Australia is an important step in ensuring broad global access to diversified vaccine options," said Stanley C. Erck, President and Chief Executive Officer, Novavax
13th Jun 2022 - Asia One

Ivermectin Has Little Effect on Recovery Time From Covid, Study Finds

The antiparasite drug ivermectin does not meaningfully reduce the time needed to recover from Covid, according to a large study posted online Sunday. It is the largest of several clinical trials to show that the drug, popular since the early pandemic as an alternative treatment, is not effective against the virus. The new trial, conducted by researchers at Duke University and Vanderbilt University, tested more than 1,500 people with Covid, about half getting the drug and the others a placebo. The study has not yet been published in a scientific journal. “Given these results, there does not appear to be a role for ivermectin outside of a clinical trial setting, especially considering other available options with proven reduction in hospitalizations and death,” Dr. Adrian Hernandez, the executive director of the Duke Clinical Research Institute who led the trial, said in a statement on Sunday night.
13th Jun 2022 - The New York Times

Vaccinated people who recovered from Omicron found to be best protected against BA.5

People vaccinated against COVID-19 and who recovered from an Omicron infection are best protected against the BA.5 subvariant that has been spreading, according to new findings by an Israeli hospital. Initial results of research by Sheba Medical Center showed those who were vaccinated and had been sick with Omicron developed the most antibodies against BA.5, the Kan public broadcaster reported Sunday. The report added that those who were either vaccinated and did not contract Omicron or vice versa had significantly fewer antibodies than people who were both inoculated and previously infected with the coronavirus variant.
13th Jun 2022 - The Times of Israel

Covid is making flu and other common viruses act in unfamiliar ways

At one point last month, children were admitted to Yale New Haven Children’s Hospital with a startling range of seven respiratory viruses. They had adenovirus and rhinovirus, respiratory syncytial virus and human metapneumovirus, influenza and parainfluenza, as well as the coronavirus — which many specialists say is to blame for the unusual surges. “That’s not typical for any time of year and certainly not typical in May and June,” said Thomas Murray, an infection-control expert and associate professor of pediatrics at Yale. Some children admitted to the hospital were co-infected with two viruses and a few with three, he said. More than two years into the coronavirus pandemic, familiar viruses are acting in unfamiliar ways. Respiratory syncytial virus, known as RSV, typically limits its suffocating assaults to the winter months.
13th Jun 2022 - The Washington Post

COVID Death Rates Explained, Dismal Booster Stats, and New Vaccines

On this episode of the COVID, Quickly podcast, we clear up some data misconceptions, get to the bottom of the booster uptake issue and talk Novavax.
13th Jun 2022 - Scientific American

Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says

The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid illness in children under 5, judging by the level of virus-blocking antibodies the shots induced. The agency’s evaluation was posted online ahead of Wednesday’s meeting of outside vaccine experts, summoned to recommend how the F.D.A. should rule on applications from both Pfizer and Moderna on vaccinating the nation’s youngest children. Some public health experts are expecting the F.D.A. to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the F.D.A. acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots.
13th Jun 2022 - The New York Times

Japan Has Fewest Covid-19 Deaths Per Capita in OECD, New Data Show

Japan has the lowest number of Covid-19 deaths per capita among wealthy nations, according to new data, with health experts citing the country’s mask habit and low obesity rate as possible reasons. As of Sunday, Japan’s cumulative Covid-19 deaths per million population stood at 245, according to Our World in Data, a website that tallies Covid-19 statistics. That is the lowest figure among the 38 member states in the Organization for Economic Cooperation and Development, a club of wealthy nations that includes the U.S. and most of Europe. The Japanese rate compares with 2,469 Covid-19 deaths per million people in Europe and 3,038 per million in the U.S., which has the highest rate in the OECD. While the reasons for the U.S. rate aren’t well-understood, widespread obesity, less mask-wearing, disparities in access to healthcare and a lower vaccination rate than some other OECD countries likely played a role, public-health specialists have said.
13th Jun 2022 - The Wall Street Journal

Sanofi and GSK share positive data for two COVID-19 booster vaccine trials

In the phase 3 VAT02 cohort 2 trial, the Sanofi/GSK vaccine candidate caused – at day 15 post-immunisation – a significant boost in antibody titres above baseline against multiple variants of concern in adults who previously received mRNA COVID-19 vaccinations. Specifically against Omicron, the preliminary data demonstrated 40 times as much of an increase against the BA.1 variant. In addition to this, the Sanofi/GSK booster produced twice the number of neutralising antibodies against Omicron BA.1 and BA.2 when compared to the original parent virus booster. Thomas Triomphe, executive vice president, Sanofi Vaccines, said: “COVID-19 keeps evolving and the combination of emergence of variants and waning immunity is likely to lead to the need for additional booster shots, at least in some populations. The Beta variant expresses similar mutations across multiple variants of concern, including Omicron, making it a strong vaccine candidate to confer broad protection against multiple strains of COVID-19.
13th Jun 2022 - PMLiVE

Risk of severe COVID-19 in adults with immune-mediated inflammatory diseases and those on immune-modifying therapies

A total of 17,672,065 subjects, of which 1,163,438 subjects (55% females and 45% males, and 71% Whites) had inflammatory disorders, and 16,508,627 subjects (49.8% females and 50.2% males, and 64% of Whites) were included from the general public. Out of 1,163,438 subjects with immunological inflammatory disorders, 1.6% (n=19,119) were administered immunomodulatory therapeutic agents, whereas 15.6% (n=181,694) were administered standard systemic therapies. Compared to the general public, individuals with inflammatory disorders showed a higher risk of SARS-CoV-2 infection-associated mortality after data adjustments for confounding variables (HR 1.2) and mediators (HR = 1.2). In addition, individuals with inflammatory disorders showed a higher risk of SARS-CoV-2 infection-associated admissions in critical care settings or mortality (confounder-adjusted HR and mediator-adjusted HRs were 1.2 and 1.2, respectively) and hospitalization (confounder-adjusted HR 1.3, and mediator-adjusted HR 1.2).
13th Jun 2022 - News-Medical.Net

Pfizer COVID vaccines safe and effective for small children, FDA staff say

U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech's, COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years. The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children. The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from the external advisers will determine the FDA's decision on the vaccines.
13th Jun 2022 - Reuters

Sanofi says next-gen COVID booster shot has potential against main variants

French drugmaker Sanofi said on Monday an upgraded version of the COVID-19 vaccine candidate it is developing with GSK showed potential in two trials to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot. While the two companies' first experimental COVID shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is molded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations.
13th Jun 2022 - Reuters

Valneva shares plunge as European COVID vaccine deal flounders

Valneva shed around a quarter of its market value on Monday after the French drugmaker warned that the future of its COVID-19 vaccine was in jeopardy. Valneva has been trying to salvage a deal with the European Commission (EC) which has indicated it would terminate an advance purchase agreement for up to 60 million doses. "We do understand that the European Commission is faced with this challenge of having too many vaccine doses on stock," Valneva CEO Thomas Lingelbach told Reuters.
13th Jun 2022 - Reuters

Understanding long Covid will take the lived experiences of long haulers

I went from training for the Big Sur 21-miler to barely being able to climb a flight of stairs in just six months. The cause? Covid-19 or, more specifically, long Covid. As a researcher, I want to know how this happened and, more importantly, how to fix it. I’m not alone. The “fix it” question is on the minds of as many as 23 million Americans and 100 million people worldwide who have experienced long Covid, which has emerged as a new chronic illness. In August 2021, two members of my household tested positive for Covid. Being fully vaccinated, I didn’t test myself but, between the exposure and developing a number of Covid symptoms, saw the writing on the wall.
13th Jun 2022 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Jun 2022

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Why your returning sense of smell after COVID may feel strange

The loss or change in one’s sense of smell and taste has proven to be a more accurate indicator of a COVID-19 infection than even a fever and cough. The exact percentage of people who experience a loss or change in their sense of smell after contracting COVID-19 is difficult to estimate as it relies on affected people self-reporting, but one analysis suggests it could be just more than 50 percent.
12th Jun 2022 - Al Jazeera English

Valneva working on remediation plan for COVID-19 vaccine candidate

French drugmaker Valneva said on Friday it had proposed a remediation plan after receiving the European Commission's notice of intent to terminate the advance purchase agreement for its inactivated COVID-19 vaccine candidate. "Some member states have confirmed their interest in having an inactivated, adjuvanted whole-virus vaccine solution in their portfolio," the company said in a statement.
12th Jun 2022 - Reuters

U.S. FDA staff says Moderna COVID vaccine effective and safe for children

U.S. Food and Drug Administration staff reviewers on Friday said Moderna Inc's COVID-19 vaccine appears safe and effective for use in children aged 6 months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children. The FDA's reviewers said in briefing documents published on Friday evening that the vaccine had generated a similar immune response in the children than that observed in adults in previous trials.
12th Jun 2022 - Reuters

EU drug regulator: mRNA COVID vaccines do not cause absence of menstruation

Available data suggest that mRNA COVID-19 vaccines do not cause an absence of menstruation, the European Union's health regulator concluded on Friday. The assessment was prompted by reports of menstrual disorders after receiving one or two shots of either the Moderna (MRNA.O) or the Pfizer-BioNTech (PFE.N)(22UAy.DE) vaccines. Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.
12th Jun 2022 - Reuters

South Africa's Death Claims Triple Last Year Due to Covid-19

The value of death claims almost tripled and suicides rose 18% last year as South Africa was battered by coronavirus infections, Discovery Life Ltd. said, citing data from its clients. In early 2021, South Africa grappled with the later stages of a beta variant-driven wave of Covid-19 infections. It was hit by the delta variant in mid-year and omicron toward the end of the year. “It was completely unprecedented,” Discovery Life’s Deputy Chief Executive Officer Gareth Friedlander said in an interview on Thursday. “Add all causes of death together -- that’s your cancers, motor-vehicle accidents, heart attacks, strokes -- add them all together and it’s still 50% less than the Covid-death claims.”
10th Jun 2022 - Bloomberg

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases

An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18–25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit–risk profile, continue to support vaccination using either of the two mRNA vaccines.
10th Jun 2022 - The Lancet

'More work' to be done': Key takeaways from the WHO report on origins of the Covid-19 pandemic

Current data suggests a zoonotic origin of SARS-CoV-2 -- which means the virus originated in animals and jumped to humans. The most closely genetically related viruses were found to be beta coronaviruses identified in bats in China and Laos, according to SAGO. "However, so far neither the virus progenitors nor the natural/intermediate hosts or spill-over event to humans have been identified," the report said. The group pointed to published surveys of animals sold at the Huanan Seafood Market in Wuhan, where the virus was first identified. Between 2017 and 2019, the survey showed that several species known to be susceptible to SARS-CoV-2, such as racoon dogs and red foxes, were present in the market. But those animals were not sampled in the studies presented to the team by invited Chinese scientists. SAGO said further information about studies into the testing of these animals, as well as tracing back to source farms and serologic investigations into people who farmed and sold or traded the animals have been requested.
10th Jun 2022 - CNN

COVID-19: How long-term smell loss can impact daily life

Recent studies show that 12-18 months after getting COVID-19, up to 46% of people are still experiencing a clinical reduction in their sense of smell. But what are the impacts of long-term smell loss on everyday life? Issues can include challenges with food safety, weight, relationships and mental health, according to a neuroscientist. Smell training can improve olfactory functions over time.
10th Jun 2022 - World Economic Forum

Preventing another Covid-19: Ugandan lab leads hunt for zoonotic diseases

On the shores of Lake Edward, near Uganda’s border with the Democratic Republic of Congo (DRC), a renovated building houses a research laboratory capable of handling serious diseases such as anthrax. This building is the newest front in the hunt for zoonotic diseases and is at the forefront of a growing research movement that focuses on east Africa and other infection hotspots. The recent emergence of Covid-19 and monkeypox, both of which jumped from animals to humans, have been a reminder of the power that such diseases have to reshape our world, and the importance of early identification and genomic sequencing to help stop their spread.
10th Jun 2022 - Financial Times


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Jun 2022

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Covid During Pregnancy Doubled Babies' Risk of Delays in Study

Babies whose mothers caught Covid-19 during pregnancy faced nearly double the risk of being diagnosed with delayed speech or motor skills by their first birthday, according to a study of medical records. While the risk of developmental delays was low overall, it rose to about 6% among babies who were exposed to Covid in the womb, while unexposed infants’ risk was about 3%, according to findings released Thursday in the journal JAMA Network Open. The lags were seen in behaviors such as rolling over, reaching for objects or babbling -- basic milestones of infancy.
10th Jun 2022 - Bloomberg

UK Monkeypox Cases Told to Avoid Contact With Household Members

UK residents diagnosed with monkeypox are being told to self-isolate from other people in their household, as the nation ramps up efforts to slow the spread of the disease. The UK Health Security Agency on Thursday advised infected Britons to sleep and eat in different rooms from other household members and to use a separate bathroom if possible. People diagnosed with the disease have also been told to keep their laundry apart and to avoid close contacts with pets.
10th Jun 2022 - Bloomberg

HIV may predispose to post-vaccination COVID, requiring extra doses

The risk of COVID-19 infection after primary vaccination was 28% higher in adults diagnosed as having HIV, suggesting they may benefit from two additional doses, according to a US study published yesterday in JAMA Network Open. Johns Hopkins University researchers led a team assessing the risk of COVID-19 infection among 113,994 vaccinated patients—33,029 of whom had HIV and 80,965 who didn't—through Dec 31, 2021. Participants were part of the Corona-Infectious-Virus Epidemiology Team (CIVET)-II cohort and were seen at Kaiser Permanente Mid-Atlantic States, Kaiser Permanente Northern California, the University of North Carolina Chapel Hill HIV Clinic, and the Veterans Aging Cohort Study (VACS) sites.
9th Jun 2022 - CIDRAP

Nine Omicron symptoms affecting the fully vaccinated - and signs you may have it

Researchers in Norway conducted a study interviewing 111 out of 117 guests to a party on 26 November 2021 where there was an Omicron outbreak. Of the group interviewed, 66 had definitive cases of Covid-19 and 15 had possible cases of the virus. Of the 111 participants, 89 per cent had received two doses of an mRNA vaccine and none had received a booster shot. According to the findings published in the infectious disease and epidemiology journal Eurosurveillance, there were eight key symptoms experienced by the group of fully vaccinated partygoers. These were: a persistent cough, runny nose, fatigue, sore throat, headache, muscle pain, fever and sneezing.
9th Jun 2022 - The Independent

Trials of new Covid vaccine raise hopes of once-a-year booster

The vaccine is the first “bivalent” formulation to combine protection against Omicron and the original strain of coronavirus, and is the company’s leading candidate for upcoming autumn booster programmes. Dr Paul Burton, Moderna’s chief medical officer, said the new vaccine raised antibody levels to such a degree that one booster a year could be enough, unless a substantially different variant calls for the vaccine to be redesigned again. “The data we show today are really important because we get a really strong antibody response against Omicron,” he said. “For the first time, we could really be looking at the potential for just once-yearly boosting, because we can get people to such a high level that they will take longer to decay.” The new vaccine, called mRNA1273.214, combines 25 micrograms of the original Moderna Covid vaccine with 25 micrograms of vaccine specifically targeted at the Omicron variant. In the phase 2/3 trial, the 50mcg shots were given to 437 people who had already received two primary jabs and a booster of the original Moderna vaccine earlier in the pandemic.
9th Jun 2022 - The Guardian

Covid-19 news: Moderna's omicron booster has promising immune response

Moderna’s omicron-tailored booster candidate produces eight times as many virus-neutralising antibodies against the variant as its original booster vaccine An updated version of Moderna’s covid-19 vaccine that targets the BA.1 sublineage of omicron leads to an eight-fold increase in antibody levels against the variant of concern, according to a small, preliminary study. Moderna’s new booster is the first covid-19 vaccine to combine the jab that targeted the original strain of the coronavirus – which emerged in Wuhan, China, at the end of 2019 – with a vaccine that specifically targets the omicron variant. In the clinical trial, the updated vaccine was given to 437 people who had already received two full-dose Moderna vaccines and its booster.
9th Jun 2022 - New Scientist

Japan's Shionogi says continuing Vietnam COVID projects after partner scandals

Japan's Shionogi & Co Ltd said its COVID-19 projects in Vietnam are still progressing, after fraud scandals enveloped its partner there and the health ministry. Shionogi is carrying out trials of its experimental COVID vaccine and oral treatment in Vietnam, following a memorandum of understanding with the government and Advanced International Joint Stock Co in November. Vietnam's health minister Nguyen Thanh Long was arrested on Tuesday, following dismissal from his post on charges of falsely inflated prices for COVID tests.
9th Jun 2022 - Reuters

Moderna says Omicron-targeted COVID shot shows better response

Moderna Inc said on Wednesday a new version of its coronavirus vaccine produced a better immune response against Omicron than the original shot, as the drugmaker pursues a booster against a surge in infections in the fall season. The vaccine, which was given as a fourth dose in a trial that enrolled more than 800 people, raised virus-neutralizing antibodies by eight-fold against Omicron. The company said it plans to submit data on the vaccine, which targets Omicron as well as the original coronavirus strain, to regulators in the coming weeks and the doses could be available to consumers in late summer, sending its shares up 3%.
9th Jun 2022 - Reuters

AstraZeneca trots out Evusheld data to expand the COVID preventive drug into the treatment arena

AstraZeneca is back in the COVID-19 game with new data for its antibody cocktail, Evusheld. While it's existing authorizations cover the prophylactic setting, the latest results from the Big Pharma puts the drug in contention as a treatment for patients with mild-to-moderate disease. The company posted data from a phase 3 trial in the Lancet Respiratory Medicine, showing that the medicine reduced the risk of progression to severe COVID or death from any cause by 50% compared to placebo at day 28, which was the trial's primary endpoint. The drug was tested in non-hospitalized adults with mild-to-moderate COVID-19, and 90% of the patients were at risk of progressing to severe COVID. While the study, dubbed Tackle, included patients who had symptoms for seven days or less, it was designed with a pre-specified analyses to assess patients who received the intramuscular injection within three days of symptom onset. In this group, Evusheld reduced the risk of severe COVID or death from any cause by 88% compared to placebo, and the risk reduction was 67% when participants received Evusheld within five days of symptom onset.
9th Jun 2022 - FiercePharma

WHO: COVID origins unclear but lab leak theory needs study

More than two years after coronavirus emerged in China and after at least 6.3 million deaths have been counted worldwide from the pandemic, the World Health Organization is recommending in its strongest terms yet that a deeper probe is required into whether a lab accident may be to blame. That stance marks a sharp reversal of the U.N. health agency’s initial assessment of the pandemic’s origins, and comes after many critics accused WHO of being too quick to dismiss or underplay a lab-leak theory that put Chinese officials on the defensive. WHO concluded last year that it was “extremely unlikely” COVID-19 might have spilled into humans in the city of Wuhan from a lab. Many scientists suspect the coronavirus jumped into people from bats, possibly via another animal.
9th Jun 2022 - FiercePharma

Pandemic's origins obscured by lack of Chinese data - WHO panel

The World Health Organization said on Thursday its latest investigation into the origins of COVID-19 was inconclusive, largely because data from China is missing, another blow to its years-long effort to determine how the pandemic began.
9th Jun 2022 - Reuters

Diabetes may increase long COVID risk; COVID while pregnant linked to baby brain development issues

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Diabetes may increase long COVID risk. Diabetes may increase the risk of long COVID, new analyses of seven previous studies suggest. Researchers reviewed studies that tracked people for at least four weeks after COVID-19 recovery to see which individuals developed persistent symptoms associated with long COVID such as brain fog, skin conditions, depression, and shortness of breath. In three of the studies, people with diabetes were up to four times more likely to develop long COVID compared to people without diabetes, according to a presentation on Sunday at the annual Scientific Sessions of the American Diabetes Association. The researchers said diabetes appears to be "a potent risk factor" for long COVID but their findings are preliminary because the studies used different methods, definitions of long COVID, and follow-up times, and some looked at hospitalized patients while others focused on people with milder cases of COVID-19.
9th Jun 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Jun 2022

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A new coronavirus found in Swedish bank voles

The current study discusses the discovery of a novel beta-CoV in Swedish bank voles and presents its full sequence for the first time. The failure to detect this virus using a published pan-CoV PCR test is traceable to the highly divergent RNA sequence of the Grimso virus. The use of specific spike gene primers in the customized PCR used in the present study yielded several samples over the three-year study period. The two complete sequences obtained in this study showed almost 3.5% non-identity, which amounted to about 1,340 differences at the nucleotide level. This exceeds the expected rate of nucleotide substitution over three years. Either several strains of the Grimso virus are co-circulating in this rodent species, or the true reservoir of this virus includes other species that regularly transmit it to bank voles. The prevalence of the Grimso virus in this rodent species was about 3.4%, thus suggesting that this animal is a suitable host for the virus. As a result, the Grimso virus presents a potential zoonotic host for spillover events between bank voles and human beings.
9th Jun 2022 - News-Medical.Net

Revised Moderna Vaccine Works Better Against Omicron, Trial Suggests

Moderna released preliminary results on Wednesday on an updated coronavirus vaccine that targets the Omicron variant, calling it “our lead candidate” to serve as a U.S. booster shot in the fall. The firm’s researchers tested a booster dose combining the original vaccine with one that specifically targeted Omicron, the variant that became dominant last winter. They found that among those with no evidence of prior coronavirus infection, the combination produced 1.75 times the level of neutralizing antibodies against Omicron as the existing Moderna vaccine did alone. While those results may seem encouraging on their face, many experts worry that the virus is evolving so quickly that it is outpacing the ability to modify vaccines, at least as long as the United States relies on human clinical trials for results.
9th Jun 2022 - The New York Times

FDA AdCom strongly backs EUA of Novavax COVID-19 Vaccine

The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over. The vaccine was developed by US biotech firm Novavax (Nasdaq: NVAX), whose shares leapt 22% to $58.05 in after-hours trading on Tuesday.
8th Jun 2022 - The Pharma Letter

Researchers plan to commence a clinical trial on new COVID-19 inactivated vaccine

A medical research team from the University of Hong Kong (HKU) will start a large-scale clinical trial on a new COVID-19 inactivated vaccine (Omicron variant) developed by China National Biotec Group (Sinopharm). Led by Professor Ivan Hung, Chief of Division of Infectious Diseases and Clinical Professor of Department of Medicine, LKS Faculty of Medicine, The University of Hong Kong (HKUMed) and with the coordination and technical support by HKU Clinical Trials Centre (HKU-CTC), the study aims to evaluate the investigational vaccine's safety and immune response as a booster for adults and will last for around a year. 1,800 adult volunteers who have already received two or three doses of inactivated or mRNA COVID-19 vaccines will be recruited to take part in the study.
8th Jun 2022 - News-Medical.Net

Pfizer Covid Vaccine Protects Against Omicron Sublineages BA.4 and BA.5: Study

Pfizer Inc. and BioNTech’s Covid-19 vaccine appears to largely prevent severe disease from the coronavirus omicron variants sublineages BA.4 and BA.5, a study by South Africa’s biggest health insurer shows. The two-shot Pfizer course offers 87% protection against being hospitalized with the strains that are driving the country’s fifth wave of infections, Discovery Health Ltd., basing its study on the the more than 1 million clients it has in Gauteng province. That level of protection was based on infection in patients one to two months after receiving their second dose. The study showed that protection waned to 84% three to four months after the second dose and 63% at five to six months post inoculation, Ryan Noach, the company’s chief executive officer, said in a LinkedIn post dated June 6.
8th Jun 2022 - Bloomberg

FDA advisers support Novavax's Covid-19 vaccine for authorization

Vaccine advisers to the US Food and Drug Administration decided Tuesday that authorizing Novavax's Covid-19 vaccine -- which uses different technology from the three vaccines currently in use in the US -- for emergency use in adults would be beneficial. Most of the FDA's Vaccines and Related Biological Products Advisory Committee voted "yes" in response to a question of whether the benefits of Novavax's vaccine, given as a two-dose primary series, outweigh its risks in people 18 and older, based on available evidence. Twenty-one members voted yes, one abstained, and none voted no. If the full FDA gives the vaccine the green light, it will become the fourth Covid-19 vaccine authorized in the United States. Novavax's vaccine is made using small laboratory-built pieces of the coronavirus to stimulate immunity. This protein-based approach is a more traditional one for vaccine development than the mRNA vaccines from Pfizer/BioNTech and Moderna.
8th Jun 2022 - CNN

Moderna Says Bivalent COVID-19 Booster Shows Superior Antibody Response Against Omicron

Biotechnology company Moderna Inc. said Wednesday that its omicron-containing bivalent booster candidate mRNA-1273.214, which contained mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern, demonstrated superior antibody response against omicron. According to the company, mRNA-1273.214 met all primary endpoints in the phase 2/3 trial including neutralizing antibody response against Omicron when compared to a 50 micrograms booster dose of mRNA-1273 in baseline seronegative participants. The study results showed mRNA-1273.214 exhibited an eight-fold boost in neutralizing geometric mean titers against omicron among baseline seronegative participant
8th Jun 2022 - Business Insider

Hospital studying long-term effects of COVID-19 in kids

Adriana Vaughan tested positive for COVID-19 in October 2021. Eight months later, the 12-year-old has a string of new medical issues: fatigue, headaches, stomach problems and more. Vaughan can't even walk for six minutes without losing her breath. She says swimming, which she did before getting COVID, is also hard. "I do really love the water and swimming. I tried to do it a few days ago, it was really a lot for me," Vaughan told CBS News.
8th Jun 2022 - CBS News

Can I Trust My Rapid Covid-19 Test if It Says I’m Negative?

When my 14-year-old son had a sore throat and congestion recently, I whipped out a Covid-19 rapid antigen test. Negative. The next day I tested him again. Negative. Days later when his friend tested positive for Covid-19 and my son still had cold symptoms, we tested again. Negative again. Could I safely assume he was Covid-19 free? It’s a question many people are asking now as Omicron subvariants circulate alongside colds, allergies and other viruses. With Americans largely returning to prepandemic habits, and precautions such as mask mandates dropped, many people have come to rely on rapid testing to avoid spreading the virus. But with so many people having symptoms and still testing negative, it’s hard to know whether to trust the results. A positive test has ramifications well beyond validating symptoms, potentially keeping you out of work or your children out of school.
8th Jun 2022 - The Wall Street Journal

Study: Many children who contracted COVID-19 did not develop antibodies to ward off Omicron

A new study from researchers at Harvard Medical School, Boston Children’s Hospital, and the U.S. Food and Drug Administration shows that fewer than 10 percent of kids who contracted COVID-19 in 2020 or early 2021 developed antibodies capable of warding off the Omicron variant of the virus, according to a statement posted to the medical school’s website. The statement said the study findings, published May 27 in the journal Nature Communications, track with prior studies of adults that showed getting COVID-19 once sadly doesn’t guarantee antibody protection against repeat infection at a later date. “I hear parents say, ‘oh, my kid had COVID last year,’” said Dr. Adrienne G. Randolph, a co-senior investigator on the HMS/Children’s study and HMS professor of anesthesia and of pediatrics at Boston Children’s, in the statement. “But we found that antibodies children produced during prior infections don’t neutralize Omicron.
8th Jun 2022 - Boston.com

Moderna says updated Covid-19 vaccine booster shows stronger antibody response against Omicron

Moderna said on Wednesday its bivalent Covid-19 vaccine booster that contained a vaccine targeting the Omicron variant showed a stronger immune response against the variant.
8th Jun 2022 - CNN on MSN.com

Catalent, MigVax enter deal to develop tablet vaccine for Covid-19

Catalent and Israeli biopharmaceutical firm MigVax have entered a development agreement to use the former’s Zydis Bio orally disintegrating tablet (ODT) technology for delivering the Covid-19 vaccine, MigVax-101. A lead oral vaccine programme of MigVax, MigVax-101 is an orally disintegrating freeze-dried tablet vaccine against Covid-19. It demonstrated positive data in preclinical tests. The oral formulation of the vaccine could provide substantial potential benefits in low-and middle-income nations over the existing first-generation injected vaccines. These benefits include ease of dosing, storage and transportation, the potential to address variants in the future and applicability to a wider population.
8th Jun 2022 - Pharmaceutical Technology

Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel

Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's (NVAX.O) COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The panel of outside vaccine experts voted 21-0 with one abstention in favor of the vaccine for those 18 and older after discussing whether the shot's benefits outweigh risks, including rare occurrences of heart inflammation that may be associated with the vaccine.
8th Jun 2022 - Reuters

Moderna says Omicron-targeted COVID shot shows better response

Moderna Inc said on Wednesday a new version of its coronavirus vaccine produced a better immune response against Omicron than the original shot, as the drugmaker pursues a booster against a surge in infections in the fall season. The vaccine, which was given as a fourth dose in a trial that enrolled more than 800 people, raised virus-neutralizing antibodies by eight-fold against Omicron. The company said it plans to submit data on the vaccine, which targets Omicron as well as the original coronavirus strain, to regulators in the coming weeks and the doses could be available to consumers in late summer, sending its shares up 3%.
8th Jun 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Jun 2022

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How to Compare COVID Deaths for Vaccinated and Unvaccinated People

Looking at COVID data in recent months, it may appear that a significant proportion of the people who have died of COVID were vaccinated against the disease. But it is important to put those numbers in context. The U.S. Centers for Disease Control and Prevention has compiled data from 28 geographically representative state and local health departments that keep track of COVID death rates among people age 12 and older in relation to their vaccination status, including whether or not they got a booster dose, and age group. Each week in March, on average, a reported 644 people in this data set died of COVID. Of them, 261 were vaccinated with either just a primary round of shots—two doses of an mRNA vaccine or a single dose of Johnson & Johnson’s vaccine—or with that primary series and at least one shot of a booster.
7th Jun 2022 - Scientific American

FDA advisers meeting on Novavax, a latecomer in COVID-19 vaccine race

A federal advisory committee Tuesday will vote on whether regulators should authorize a COVID-19 vaccine made by Novavax, an early beneficiary of the government’s Operation Warp Speed program. The experts to the Food and Drug Administration will base their recommendation on the company’s clinical trial data, which is strong. But before the agency could authorize the shots, the FDA would also need to sign off on Novavax’s manufacturing process, which has stumbled repeatedly over the course of two years. If the FDA authorizes the Novavax two-dose vaccine, it would become the fourth shot to win clearance for adults in the United States. But even if the company does get the green light, it is unclear when or how widely the vaccine might be available. Shots from Pfizer, Moderna and Johnson & Johnson have been authorized for well over a year, and the country is not short of doses. And in a number of countries where Novavax has already earned authorization, uptake has been low.
7th Jun 2022 - Chicago Tribune

Study: Ineffective blood oxygen readers have endangered Black and Latino Covid-19 patients

Black and Latino patients experienced significant delays in obtaining life-saving Covid-19 treatments due to a popular medical device that inaccurately reads darker skin tones, according to a study released last week in JAMA Internal Medicine. The report shows that pulse oximeters, a device that clips onto a person’s fingertips and reads oxygen levels, is more likely to produce inaccurate results in Black, Latino and Asian Americans than in white patients. The device can make patients of color appear healthier than they actually are, researchers said. “Not only less accurate, but in particular, more optimistic,” Tianshi David Wu, a co-lead author of the study and assistant professor of pulmonary medicine at Baylor College of Medicine in Texas, told NBC News. “In this study we found that minority patients appeared healthier than they really were based on this bias in pulse oximetry.”
7th Jun 2022 - NBC News

Influenza vaccination rates of health and aged care facility staff during the COVID-19 pandemic

In a recent study published in the Medical Journal of Australia, researchers assessed the impact of coronavirus disease 2019 (COVID-19) on influenza vaccination. The target rate for the influenza vaccine uptake to be received by healthcare workers was 75% in 2014, which increased to 92% in 2021. Moreover, staff of the residential aged care services (RACS) were compulsorily required to be vaccinated against influenza from May 2020 throughout Australi
7th Jun 2022 - News-Medical.Net

Imatinib yields sustained clinical benefit in patients with hypoxemic COVID-19

Treatment with imatinib resulted in a sustained clinical benefit after 90 days in hospitalized patients with hypoxemic COVID-19, according to results of the CounterCOVID study. At the American Thoracic Society International Conference, Job R. Schippers, MD-PhD candidate for pulmonary medicine at Amsterdam University Medical Center, presented long-term clinical outcomes at 90 days after treatment with imatinib.
7th Jun 2022 - Healio

U.S. FDA expert panel weighs Novavax COVID vaccine

Advisers to the U.S. Food and Drug Administration on Tuesday will vote on whether to recommend authorizing Novavax Inc's COVID-19 vaccine, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The shot being considered by the FDA panel of outside experts is a more traditional type of vaccine employing technology that has been used for decades to combat diseases including Hepatitis B and influenza.
7th Jun 2022 - Reuters

J&J gives notice to terminate Emergent manufacturing deal for COVID vaccine

Johnson & Johnson said on Monday it had formally informed Emergent BioSolutions Inc of its decision to terminate agreement with the contract manufacturer to make COVID-19 vaccine for the drugmaker. The termination notice comes about a week after J&J had initially informed Emergent of its intent to end the pact based on the contract manufacturer's breaches, including failure to supply COVID-19 vaccine drug substance, J&J said.
7th Jun 2022 - Reuters

Experts predict increase in Covid hospital admissions and another wave

A new Covid wave could be looming in England, experts say, as Covid hospital admissions stop falling. Admissions of people to hospital with Covid in England have stopped declining, according to an analysis of new NHS figures by John Roberts a leading actuary from the Covid actuaries group. When asked if the UK was heading into another wave Mr Roberts, told The Independent said “yes we could be but...how big that wave and how serious it will be in terms of admissions and deaths is very, very difficult to judge at this stage.” His comments come after experts in Europe warned there will be a new wave driven by growth of the BA.5 and BA. Covid variants.
7th Jun 2022 - The Independent

Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel

Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The panel of outside vaccine experts voted 21-0 with one abstention in favor of the vaccine for those 18 and older after discussing whether the shot's benefits outweigh risks, including rare occurrences of heart inflammation that may be associated with the vaccine.
7th Jun 2022 - Reuters

U.S. CDC removes mask recommendation from monkeypox travel notice to avoid confusion

The U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday it had removed a mask recommendation from its monkeypox travel notice to avoid "confusion" over the disease, which primarily spreads through direct contact. "Late yesterday, CDC removed the mask recommendation from the monkeypox Travel Health Notice because it caused confusion," a CDC spokesperson said on Tuesday. The agency had earlier suggested that travellers wear masks as it can help protect against "many diseases, including monkeypox"
7th Jun 2022 - Reuters

FDA advisers back Novavax COVID shots as 4th US option

American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot. Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus shot for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option. N ovavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial vaccinations or as mix-and-match boosters. But U.S. clearance is a key hurdle for the Maryland-based company. FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves.
7th Jun 2022 - The Associated Press

Novavax coronavirus vaccine would be fourth authorized in United States

More than a year after people began rolling up their sleeves for cutting-edge coronavirus shots, a new vaccine, this one based on a classic decades-old technology, is expected to begin rolling out in the United States this summer. Advisers to the Food and Drug Administration are scheduled to debate Tuesday whether a shot developed by the Maryland biotechnology company Novavax, an underdog in the vaccine race, is safe and effective. If the shot gets the green light, it will become the fourth coronavirus vaccine in the nation. For most people, some already on their third or fourth messenger RNA coronavirus shot from Moderna or Pfizer-BioNTech, it looks like a puzzle: A new vaccine? Why bother? But for a small contingent of holdouts who have closely tracked the progress of the Novavax vaccine, this is a moment of truth.
5th Jun 2022 - The Washington Post


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Jun 2022

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N.S. researchers receive nearly $1.5M to study impacts of COVID-19

Three teams of researchers from Nova Scotia have received almost $500,00 each from the Canadian Institutes of Health Research to examine how the pandemic is affecting the lives of children with complex needs, woman who face violence and equity-deserving groups. The studies are among 965 research projects related to the COVID-19 pandemic funded by the national funding organization to date. They are designed to offer recommendations on how to better serve those specific groups when public health safeguards are imposed.
6th Jun 2022 - CBC.ca on MSN.com

I am an epidemiologist with COVID-19 and I want to be counted

I am an epidemiologist who is home sick with COVID-19. Upon a positive self-test, I contacted my primary care physician to ask about treatment and report my case. As my symptoms worsened and more of my family members tested positive on a self-test, I turned to the Centers for Disease Control and Prevention (CDC) to find out how to report our cases. CDC guidance suggests that I tell my health care provider that I have tested positive, but the health care system has no means of reporting self-tests for COVID-19 surveillance. I cannot report the cases of COVID-19 in my family and we, like so many Americans suffering during this current wave, will go uncounted.
6th Jun 2022 - The Hill on MSN.com

Strong T-cell response for blood cancer patients after vaccine; COVID breakthrough often serious for cancer patients

The following is a summary of some recent studies on COVID-19 and cancer presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Blood cancer patients show strong T-cell response to COVID vaccines. Patients with blood cancers have a significantly weaker antibody response to COVID-19 vaccines than patients with solid tumors, but they may still be well protected against severe illness from the virus, new data suggests.
6th Jun 2022 - Reuters

Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the US

Pfizer Inc.announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which will create more than 250 additional high-skilled jobs at Pfizer’s Kalamazoo site. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S., increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. and around the world.
6th Jun 2022 - Pfizer

FDA to rule on long-awaited 'protein based' COVID-19 vaccine this week

The FDA's lead vaccine advisory panel, VRBPAC, will meet this week to discuss approval for the Novavax COVID-19 vaccine. Novavax's shot has been heralded by some experts for its effectiveness and because it is a protein-based shot similar to the standard flu shot. The jab was expected to become available last year, but supply issues faced by Novavax delayed its application. The review comes as an NBC report finds that more than 10% of the nation's purchased vaccines since they first became available in late 2020 have been discarded
6th Jun 2022 - Daily Mail

Ofatumumab for Multiple Sclerosis Does Not Increase COVID-19 Severity

No increased risk for breakthrough COVID-19 infection, severe COVID-19, or fatal outcomes among patients receiving ofatumumab for relapsing multiple sclerosis (MS) was found in an updated analysis presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) held from June 1-4, in National Harbor, Maryland. SARS-CoV-2 is associated with a severe respiratory infection which can be fatal. Since the beginning of the pandemic, there has been concern and uncertainty about specific risks for patients receiving disease-modifying therapy (DMT).
6th Jun 2022 - Neurology Advisor

Safety and efficacy of SCB-2019 COVID vaccine candidate as a ChAdOx1-S booster

The standard formulation containing 30 μg SCB-2019 with the toll-like receptor 9 (TLR-9) agonist CpG-1018 and alum showed the best booster response. This formulation demonstrated acceptable reactogenicity, comparable to that observed in the SPECTRA study. Moreover, it was safe and highly efficacious as a heterologous booster following primary vaccination.
6th Jun 2022 - News-Medical.Net

Why Variants Keep Covid-19 Cases Simmering in the U.S.

In recent weeks, a new version of the Covid-19 virus—named BA.2.12.1—became the dominant variety in the U.S., according to the Centers for Disease Control and Prevention. The variant’s rapid spread, coupled with growing case counts, raised concern among health officials, who last month strengthened their recommendations for Covid-19 boosters.
6th Jun 2022 - The Wall Street Journal

Long-term exposure to air pollution associated with greater risk of severe COVID-19

Long-term exposure to air pollution is linked to a greater risk of severe COVID-19, new research being presented at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care (ESAIC) in Milan, Italy (4-6 June), finds. The German study found that people living in counties with higher levels of the pollutant nitrogen dioxide (NO2) were more likely to need ICU care and mechanical ventilation if they had COVID-19. Long-term exposure to NO2, a gas released into the atmosphere when fossil fuels are burned, can have harmful effects on the lungs. This includes damage to the endothelial cells, which play a key role in oxygen transfer – the transfer of oxygen from inhaled air to the blood.
6th Jun 2022 - News-Medical.Net

Contract manufacturer Emergent says J&J breached vaccine contract

Contract manufacturer Emergent BioSolutions Inc said on Monday U.S. drugmaker Johnson & Johnson had breached an agreement by failing to buy the minimum quantity of COVID-19 vaccines made by the company. Emergent said J&J had failed to provide required forecasts for the amount of vaccines it needed and had wound down the agreement instead of fulfilling minimum requirements. If the agreement is terminated, Emergent said J&J would owe it roughly $125 million to $420 million.
6th Jun 2022 - Reuters

U.S. FDA flags risk of heart inflammation after Novavax COVID vaccine

The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease. In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot. "These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.
6th Jun 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Jun 2022

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India approves Biological E. COVID shot as a booster

India has approved Hyderabad-based drugmaker Biological E's COVID-19 vaccine as the first mix-and-match booster dose in the country, the company said on Saturday. The Drugs Controller General of India (DCGI) gave the nod for the Corbevax vaccine to be administerd as a booster shot to people age 18 years and over who have already received two doses of either AstraZeneca Plc's Covishield or Bharat Biotech's Covaxin.
5th Jun 2022 - Reuters

Even a Diehard Covid Test Advocate Says China Is Going Too Far

Michael Mina has long pushed for widespread testing as a way to stop Covid-19 outbreaks in their tracks. But what China is doing, he says, is going too far. Wedded to a pandemic strategy that still seeks to eliminate every coronavirus case, the world’s most populous country is rolling out a vast network of testing booths in urban areas so that millions of people are within a 15-minute walk of getting swabbed at all times. Cities like Beijing, Shanghai, Shenzhen and Hangzhou are requiring tests as often as every 48 hours to access public transit, entertainment venues -- and even workplaces.
4th Jun 2022 - Bloomberg

Novavax hopes its COVID shot wins over FDA, vaccine holdouts

Americans may soon get a new COVID-19 vaccine option -- shots made with a more tried-and-true technology than today’s versions. The big question: Why should they care? After long delays, the Food and Drug Administration is expected to decide within weeks whether to authorize Novavax's vaccine. It’s late in the pandemic for a new choice, with about three-quarters of U.S. adults already vaccinated. But the company is hoping to find a niche among some of the unvaccinated millions who might agree to a more traditional kind of shot -- a protein vaccine — and also to become a top choice for boosters, regardless of which type people got first. Only about half of vaccinated adults have gotten a booster.
3rd Jun 2022 - Yahoo News UK

Developing world should reap benefits of new monkeypox research, experts urge

As cases of monkeypox in wealthier Western nations spark a flurry of scientific research to combat the outbreak, scientists are urging the world to make sure lower-income nations benefit from the fruits of that labor as well. More than 550 confirmed cases of monkeypox have been reported by at least 30 countries outside of Africa, where the virus is typically found, according to the World Health Organization (WHO).
3rd Jun 2022 - Reuters

Vaccination during pregnancy cuts infant infections; vaccines only modestly reduce long COVID risk

Article reports that the following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Vaccines in pregnancy reduce infants' COVID-19 risk COVID-19 vaccination during pregnancy appears to lower newborns' risk of coronavirus infection, according to a study conducted in Norway.
3rd Jun 2022 - Reuters

U.S. FDA flags risk of heart inflammation after Novavax COVID vaccine

The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's (NVAX.O)COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease. In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation calledmyocarditis detected within 20 days of taking the protein-based shot. "These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.
3rd Jun 2022 - Reuters

Novavax Plunges on 'Harsh' FDA Review Ahead of Tuesday Panel

Novavax Inc. slumped 20% on Friday after US regulators raised concerns over the biotech’s much-anticipated Covid-19 vaccine. Briefing documents released by the Food and Drug Administration ahead of a meeting with experts on Tuesday noted some heart risks with the shot, though the agency was positive on its effectiveness against the omicron variant and more severe disease.
3rd Jun 2022 - Bloomberg

Japan study shows women more likely to get skin rash from Moderna shot

A study in Japan found that women were significantly more likely than men to develop rash-like side effects after a first dose of Moderna Inc's COVID-19 vaccine. The study of 5,893 participants between May and November last year showed that 22.4% of women developed delayed skin reactions after the first shot, compared to 5.1% of men. The symptoms were mild and not considered a contraindication of the mRNA-based vaccine, according to the June 1 report in JAMA Dermatology.
2nd Jun 2022 - Reuters

Health agency confirms community spread of monkeypox in England

Monkeypox appears to be spreading from person to person in England, the UK Health Security Agency (UKHSA) said on Wednesday. The usually mild viral disease, which is endemic in west and central Africa, is understood to spread through close contact. Until early May, cases rarely cropped up outside Africa and were typically linked to travel to there. "The current outbreak is the first time that the virus has been passed from person to person in England where travel links to an endemic country have not been identified," the agency said.
2nd Jun 2022 - Reuters

Moderna delays COVID vaccine deliveries to EU by several months

Moderna Inc said on Thursday it has agreed to push back some COVID-19 vaccine deliveries to the European Union by several months to later in 2022 or early next year. Shares of Moderna fell nearly 2% before the bell over the delay, even though the company stuck to its vaccine sales forecast of $21 billion for 2022. Delivery of the doses were originally planned in the second quarter, the European Commission said in a statement.
2nd Jun 2022 - Reuters

Pfizer's Paxlovid reduces COVID risk in seniors regardless of vaccine status -study

Pfizer Inc's antiviral treatment Paxlovid reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, according to a new study in Israel conducted during the rise of the Omicron variant of the coronavirus. The treatment, however, was not found to prevent severe illness among younger adults, according to research from Clalit Health Services, Israel's largest healthcare provider.
2nd Jun 2022 - Reuters

COVID-19: Two million people in UK estimated to be suffering from long COVID, Office for National Statistics says

A record two million people in the UK are estimated to be suffering from long COVID, the Office for National Statistics has said. Of the two million, 1.4 million said they first had coronavirus, or suspected they had the illness, at least 12 weeks previously, while 826,000 first had it at least a year earlier. Another 376,000 said they first had COVID-19 at least two years previously. The condition is estimated to be adversely affecting the day-to-day activities of 1.4 million people - around seven in 10 of those who reported having it.
1st Jun 2022 - Sky News

Pfizer Submits Covid Shot for Kids Under 5 for FDA Authorization

Pfizer Inc. asked U.S. regulators to clear its Covid-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest. The drugmaker and BioNTech SE finalized their rolling application to the Food and Drug Administration for emergency-use authorization of their vaccine in kids ages 6 months through 4 years old, the companies said in a statement on Wednesday. The vaccine partners began the submission process in February. Pfizer and BioNTech announced in late May that a three-shot regimen was highly effective and prompted a strong immune response in children under age 5, based on early results from a highly anticipated trial that is likely to pave the way for infants and toddlers to get immunized.
1st Jun 2022 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Jun 2022

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Evidence on COVID-19 vaccine effectiveness and duration of protection against Omicron

In the present study, researchers reported results from an interim analysis of a living systematic review (LSR) summarizing evidence on VE and duration of protection against SARS-CoV-2 Omicron. For the LSR, the researchers included studies investigating VE against SARS-CoV-2 infection among people aged 12 years or older for European Medicine Agency (EMA) approved vaccines. For the current analysis, only the studies which investigated the mentioned outcomes due to SARS-CoV-2 Omicron or during the Omicron period were considered. The coronavirus disease 2019 (COVID-19) literature database created by the Robert Koch Institute (RKI) library was searched for studies published from October 23, 2021, to January 14, 2022, regardless of publication status or language.
31st May 2022 - News-Medical.Net

Philippine FDA grants approval for Spikevax Covid-19 vaccine for children

The Philippine FDA has granted approval for Moderna’s Covid-19 vaccine, Spikevax, for use in children who are aged six to 11 years.
31st May 2022 - Pharmaceutical Technology

Study shows low social cohesion is a factor in reducing vaccine responses

Loneliness and social stresses can have a negative impact on the antibody response to Covid-19 vaccines, new research has revealed. University of Limerick researchers have found that lower neighbourhood cohesion is associated with antibody response to Covid-19 vaccines. In a study published in the journal Brain, Behaviour and Immunity, the research team demonstrated that lower social cohesion also made people feel lonelier, and this was an additional factor in reducing Covid-19 vaccine responses. The report stated that social cohesion is the degree of social connectedness and solidarity among different community groups within a society, including levels of trust and connectedness between individuals and across community groups.
31st May 2022 - Belfast Telegraph

International study reveals factors contributing to COVID-19 vaccine hesitancy among healthcare providers

A new 23-country study by a multidisciplinary team of researchers in the journal Vaccine, published by Elsevier, sheds light on the factors that contribute to COVID-19 vaccine hesitancy among healthcare providers. To assess the associations between self-reported vaccine hesitancy and a number of sociodemographic and COVID-19 vaccine perception factors, CUNY Graduate School of Public Health and Health Policy (CUNY SPH) Senior Scholar Jeffrey Lazarus, PhD, Dean Ayman El-Mohandes, MBBCh, MD, MPH, FAAP, and colleagues from the School of Health Administration at Dalhousie University, Halifax, Canada and the Barcelona Institute for Global Health, Barcelona, Spain, developed a cross-sectional survey relating to perceptions of risk, efficacy, safety and trust, and current COVID-19 vaccine uptake.
31st May 2022 - EurekAlert!

GSK offers £2.6bn for US vaccine maker after failing to bring Covid jab to market

GSK has offered to pay up to $3.3bn (£2.6bn) for a US vaccine maker, after the pandemic pushed the importance of biotechnology to the top of the healthcare agenda. The British pharmaceutical giant is set to pay $2.1bn (£1.6bn) upfront, and up to $1.2bn (£951m) more if the biopharmaceutical firm Affinivax meets specified development milestones, GSK said in a statement this morning. Affinivax, based in Boston, focuses on vaccines which target pneumococcal disease, which includes pneumonia, meningitis, bloodstream infections and milder diseases such as sinusitis.
31st May 2022 - City A.M.

Leicester study finds promising link between treatment of 'long Covid' and vaccinations

Symptoms of 'long Covid' can decrease after being vaccinated, a Leicester study has found. The research conducted by the University of Leicester was published in the British Medical Journal. It found that a first dose of the Covid-19 vaccination was associated with a reduction in the likelihood of continuing symptoms of the virus by 12.8 per cent. A second dose showed a further reduction of 8.8 per cent, according to the study. Between February 3 and September 5, 2021, a team of academics and government statisticians assessed the results of the Office for National Statistics’ COVID-19 Infection Survey to examine the health outcomes of 28,356 people who had received a vaccine after contracting the coronavirus. More than 23 per cent of the participants went on to experience symptoms of long Covid 12 weeks after they were infected with the virus.
31st May 2022 - Leicestershire Live

Japan Panel OKs J&J Coronavirus Vaccine

A panel of Japan's health ministry Monday endorsed a ministry plan to give pharmaceutical approval to U.S. drugmaker Johnson & Johnson's COVID-19 vaccine. The ministry is expected to grant the approval soon to what will be the fifth COVID-19 vaccine that can be used in the country. The ministry does not plan to make inoculations of the vaccine free of charge at public expense because it has already secured necessary amounts of vaccines. Japan has not signed to buy the J&J vaccine. The J&J product is a viral vector vaccine like the one made by British drugmaker AstraZeneca PLC. It can be administered only to people aged 18 or above. Only a single shot is necessary for the J&J vaccine unlike the previously approved vaccines, all of which require two shots at an interval of at least three to four weeks.
31st May 2022 - Nippon.com

Study struggles to explain why Quebec has high COVID-19 death toll but low excess death

Researchers are having a hard time explaining why Quebec had the country's highest official COVID-19 death toll despite a relatively low number of excess deaths between March 2020 and October 2021. A new study released Monday by the Canadian Medical Association Journal tried to answer that question but came up short. "I would say at this point it's something we need to understand,'' Kimberlyn McGrail, professor at University of British Columbia's school of population and public health, said in an interview. The study, titled Excess mortality, COVID-19 and health-care systems in Canada, says Quebec had 4,033 excess deaths between March 2020 and October 2021, but reported 11,470 COVID-19 fatalities — almost three times more.
31st May 2022 - CBC.ca

How nasal COVID-19 vaccines can help prepare for infection where it starts

Imagine inhaling just a few drops of liquid or mist to get protected from COVID-19. That is the idea behind nasal COVID-19 vaccines, and they have been getting a lot of attention recently as a spray or liquid. These nasal vaccines would be based on the same technology as normal vaccines given by injection. But as Mayuresh Abhyankar, a University of Virginia researcher who studies infectious diseases and works on nasal vaccines, explains, vaccinating someone right where the coronavirus is likely to start its attack comes with many immunological benefits.
31st May 2022 - PBS NewsHour

Long term implications of covid-19 in pregnancy

Complications in pregnancy, including maternal and perinatal deaths, increased with each wave of the covid-19 pandemic. By contrast, serious illness fell in other high risk groups because of vaccines and approved treatments. More than a year after the UK’s Joint Committee on Vaccination and Immunisation (JVCI) opened up covid-19 vaccination to pregnant women, 40% of women giving birth have still not received a first dose.2 This is despite a positive benefit-risk profile, endorsement in guidelines, and public health campaigns. Worryingly, 69.5% of black women giving birth have not received any covid-19 vaccine. Meanwhile the JCVI has chosen not to include pregnant women in its interim autumn booster plans. Strategies for treating covid-19 in pregnancy and potential long term complications are also underused.1 A large portion of the diffidence for both vaccination and treatment in pregnancy stems from the continued exclusion of pregnant women from much of the pre-approval drug development process. This results in delayed or even absent data on benefit-risk profiles and a dangerous spiral of indecision
31st May 2022 - The BMJ

Swissmedic weighing new COVID booster recommendation for children

Swiss drugs regulator Swissmedic said on Tuesday it is reviewing an application from pharmaceutical company Pfizer for a new dosage recommendation for a COVID-19 booster shot for children. The regulator said it was looking at the data submitted and assessing the benefits and risks of recommending a booster shot administered at least six months after basic immunisation for children between ages 5 and 11.
31st May 2022 - Reuters

Covid Booster Shots Are Key to Stopping Severe Infection: Study

A third dose of messenger RNA Covid-19 vaccine provides a key boost to immunity against the coronavirus, regardless of the original type of immunization, researchers said. An mRNA booster following an initial course of two shots of the same type is the most effective way to prevent non-severe Covid infections, according to an analysis of studies published Wednesday in the BMJ medical journal. Adding a third mRNA shot to other primary vaccination regimens raises protection to almost the same level, the authors from the Chinese University of Hong Kong said.
31st May 2022 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st May 2022

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Nasal COVID-19 vaccines help the body prepare for infection right where it starts—in your nose and throat

Imagine inhaling just a few drops of liquid or mist to get protected from COVID-19. That is the idea behind nasal COVID-19 vaccines, and they have been getting a lot of attention recently as a spray or liquid. These nasal vaccines would be based on the same technology as normal vaccines given by injection. But as Mayuresh Abhyankar, a University of Virginia researcher who studies infectious diseases and works on nasal vaccines, explains, vaccinating someone right where the coronavirus is likely to start its attack comes with many immunological benefits.
30th May 2022 - Medical Xpress

Online education and the mental health of faculty during the COVID-19 pandemic in Japan | Scientific Reports

While the negative impact of the pandemic on students’ mental health has been studied around the world, very little is known about the mental health of faculty and staff. This research aims to examine mental health among Japanese faculty members who taught online courses during the COVID-19 pandemic. We recruited 537 university faculty members and assessed their mental health using the World Health Organization-Five Well-Being Index (WHO-5), both retrospectively (during the academic year before the onset of the pandemic) and during the pandemic.
30th May 2022 - Nature.com

CT chest scans reveal fewer cases of pneumonia in breakthrough COVID-19 infections

CT chest scans in patients with breakthrough COVID-19 infections show lower levels of pneumonia compared to scans of unvaccinated patients. A significantly higher proportion of CT chest scans in fully vaccinated patients who experience a breakthrough infection showed no signs of pneumonia during their stay in hospital, according to a study by Korean researchers. COVID-19 vaccination across the globe has led to a protection against both symptomatic and asymptomatic COVID-19 as well as severe disease, hospitalisation and death. Although a CT chest scan has been described as an indispensable diagnostic tool in COVID-19, no studies have reported on using this imaging modality to examine the features associated with breakthrough infections that are generally less severe.
30th May 2022 - Hospital Healthcare Europe

Fourth COVID-19 vaccination effectiveness drops after 10 weeksHospital Healthcare Europe

A fourth COVID-19 vaccination’s effectiveness against infection drops after only 10 weeks but remains high against severe disease. A fourth COVID-19 vaccination dose offers greater protection against infection than three doses but this effectiveness quickly wanes within 10 weeks but is maintained against more severe disease. This was the key finding of a retrospective analysis by Israeli researchers. The use of a third COVID-19 vaccination is more effective at protecting individuals against severe COVID-19-related outcomes in comparison to only two doses. Nevertheless, it is also becoming clear that in the presence of COVID-19 variants such as Omicron, the relative protection against infection even from three doses wanes over time. For instance, in one study, the effectiveness of a third COVID-19 vaccine, waned from 53.4% a month after vaccination to 16.5% three months later.
30th May 2022 - Hospital Healthcare Europe

Increase in depression and anxiety rates in the U.K. identified during COVID-19 lockdowns

Though many studies have been conducted over the last two years, both during and after coronavirus disease 2019 (COVID-19) restrictions were implemented, the long-term effects of these events remain unclear. A new study published on the preprint server medRxiv* discusses changes in the prevalence of depressive and anxiety symptoms over the course of the COVID-19 pandemic and their association with individual and environmental factors.
30th May 2022 - News-Medical.Net

Launch of Scenario Hub projecting future COVID-19 health impact

A new online modelling hub launched today, the European COVID-19 Scenario Hub, will present modelling projections on how the COVID-19 pandemic may evolve in terms of cases, hospitalisations and deaths. It will serve as a resource for Member States in their pandemic planning and inform decisions aimed at minimising the expected burden caused by COVID-19 under different scenarios. The hub is developed and run by the European Centre for Disease Prevention and Control (ECDC) in co-operation with the Centre for Mathematical Modelling of Infectious Diseases (CMMID) at the London School of Hygiene & Tropical Medicine (LSHTM). “The Scenario Hub will help inform public health preparedness and anticipatory action as Europe transitions into new phases of the pandemic” said Andrea Ammon, ECDC Director. “It will also play a key role in supporting ECDC's risk analysis, assessment of public health advice and strategic planning.
30th May 2022 - ECDC.Europa.eu

Medical research stalled as NHS focuses on small number of trials, experts say

Government efforts to focus NHS resources on a smaller number of well-designed clinical trials could inadvertently be contributing to a backlog of stalled medical research, and result in some important trials being scrapped, researchers say. Their warning comes as a report outlines the scale of “research waste” that has occurred during the pandemic, with rampant duplication of scientific efforts and weakly designed clinical trials exposing millions of patients to unproven treatments, with little scientific benefit.
30th May 2022 - The Guardian


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th May 2022

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Covid-19 and mRNA technology are helping Africa fix its vaccine problems

After the disastrous effect of vaccine nationalism on access in Africa, boosting local production is key to preventing a repeat in future pandemics. WHO’s new mRNA vaccine hub is at the forefront, report Emma Bryce and Sandy Ong In June 2021, the World Health Organization selected South African biotech company Afrigen to be part of the “hub” where mRNA technology—which underpins the most effective covid-19 vaccines—would be developed and shared with other lower and middle income countries.1 More than 15 manufacturers (“spokes”) have been named so far, almost half located in Africa.2 For the world’s second largest continent, by size and population, this initiative has come not a moment too soon. Africa uses one quarter of global vaccines but produces just 1%3—a shortage that left it wrong footed as covid-19 swept the globe and rich nations hoarded vaccine supplies.
28th May 2022 - The BMJ

U.S. doctors reconsider Pfizer's Paxlovid for lower-risk COVID patients

Use of Pfizer Inc's COVID-19 antiviral Paxlovid spiked this week, but some doctors are reconsidering the pills for lower-risk patients after a U.S. public health agency warned that symptoms can recur after people complete a course of the drug, and that they should then isolate a second time. More quarantine time "is not a crowd-pleaser," Dr. Sandra Kemmerly, an infectious disease specialist at Ochsner Health in New Orleans, told Reuters. "For those people who really aren't at risk ... I would recommend that they not take it."
28th May 2022 - Reuters

Previous COVID-19 or MIS-C does not protect kids from omicron, study finds

Research drawing on the national Overcoming COVID-19 study, led by Boston Children's Hospital, and the hospital's own Taking On COVID-19 Together Group provides evidence that children who previously had COVID-19 (or the inflammatory condition MIS-C) are not protected against the newer omicron variant. The researchers obtained blood samples from 62 children and adolescents hospitalized with severe COVID-19, 65 children and adolescents hospitalized with MIS-C, and 50 outpatients who had recovered from mild COVID-19. All the samples were taken during 2020 and early 2021, before the emergence of the omicron variant. The researchers obtained blood samples from 62 children and adolescents hospitalized with severe COVID-19, 65 children and adolescents hospitalized with MIS-C, and 50 outpatients who had recovered from mild COVID-19. All the samples were taken during 2020 and early 2021, before the emergence of the omicron variant.
28th May 2022 - Medical Xpress

Exploring antigenic traits of SARS-CoV-2 Omicron BA.5 and BA.4 subvariants