| |

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

    View this newsletter in full

COVID-19: New 'game-changing' X-ray technology developed which can detect coronavirus in minutes

Experts in Scotland have developed groundbreaking Artificial Intelligence (AI) technology which is capable of accurately diagnosing COVID-19 in just a few minutes, much quicker than a PCR test. The research, by the University of the West of Scotland (UWS), uses X-ray technology, comparing scans to a database of around 3,000 images, belonging to patients with COVID- 19, healthy individuals and people with viral pneumonia. It then uses an AI process, an algorithm typically used to analyse visual imagery, to make a diagnosis.
20th Jan 2022 - Sky News

Swiss researchers launch trial for COVID "patch" vaccine

Swiss medical researchers said on Wednesday they have launched an early-stage study to test a next-generation COVID-19 vaccine candidate which would be administered via an arm patch, the latest to look at alternative methods of giving injections. Unlike conventional vaccines that stimulate antibody production, the new PepGNP-Covid19 vaccine candidate focuses on T-cells, which are responsible for cellular immunity, to eliminate cells infected by the virus and prevent it from replicating.
20th Jan 2022 - Reuters

Valneva says early studies show COVID-19 vaccine effective against Omicron

French biotech firm Valneva said that preliminary studies showed that three doses of its inactivated COVID-19 vaccine candidate neutralised the Omicron variant of the disease. All of the serum samples tested presented neutralizing antibodies against the ancestral virus and Delta variant, it said, while 87% of samples did so against the Omicron variant. "We are extremely pleased with these results," said Chief Medical Officer Juan Carlos Jaramillo in a statement, noting that these added to an earlier Phase III trial that showed improved immune response with two doses of the VLA2001 candidate.
20th Jan 2022 - Reuters

Analysis: How Omicron highlights fading hope of herd immunity from COVID

The Omicron variant, which is spreading far faster than previous versions of the coronavirus, is not likely to help countries achieve so-called herd immunity against COVID-19, in which enough people become immune to the virus that it can no longer spread, leading disease experts say. From the earliest days of the pandemic, public health officials have expressed hope that it was possible to achieve herd immunity against COVID-19, as long as a high enough percentage of the population was vaccinated or infected with the virus.
20th Jan 2022 - Reuters

Pfizer CEO awarded $1M Genesis Prize for developing COVID vaccine

Albert Bourla, chairman and CEO of Pfizer, has been awarded the 2022 Genesis Prize for his “leadership, determination and especially for his willingness to assume great risks” in developing a coronavirus vaccine in record time. The Genesis Foundation recognises individuals for their contribution to humanity and commitment to Jewish values.
20th Jan 2022 - Al Jazeera English

Novavax becomes Australia’s 5th approved COVID-19 vaccine

Novavax’s COVID-19 vaccine on Thursday became the fifth coronavirus vaccine approved for use in Australia. The country has ordered 51 million doses of the U.S.-manufactured vaccine, supplied under the brand Nuvaxovid, for its population of 26 million. Pfizer, AstraZeneca and Moderna vaccines are already in use in Australia. Johnson and Johnson’s Janssen vaccine is also approved but the government has not bought any. The Novavax vaccine will be available to unvaccinated Australians aged 18 years and older but will not be used as a booster for the 95% of the population aged 16 and older who have already received a vaccine. “There are some individuals, notwithstanding a massive take up of vaccination in this country, who have been waiting for Novavax, and it’s great that it’s finally been approved,” said chief regulator John Skerritt, head of the Therapeutic Goods Administration.
20th Jan 2022 - The Associated Press

Prior Covid-19 Infection Offered Better Protection Than Vaccination During Delta Wave

Surviving a previous infection provided better protection than vaccination against Covid-19 during the Delta wave, federal health authorities said, citing research showing that both the shots and recovery from the virus provided significant defense. The Centers for Disease Control and Prevention said Wednesday that data from 1.1 million Covid-19 cases in California and New York last year showed people who were unvaccinated and hadn’t previously contracted Covid-19 faced a far greater risk than both people who had gotten the shots and people who had been infected. The data on testing, cases and immunization was collected between May and November, as the Delta variant emerged and became dominant in the U.S., before the more-infectious Omicron variant began to spread widely. The hospitalization data came from more than 50,000 people in just California.
20th Jan 2022 - The Wall Street Journal

Drugmakers Sign Pacts to Widen Access to Merck's Covid Pill

More than two dozen generic-drug manufacturers have agreed to produce low-cost versions of Merck & Co.’s Covid-19 pill, a key step in bringing virus-fighting tools to lower-income countries that have struggled to get vaccines. Companies in Bangladesh, China, India, Kenya, South Africa, Vietnam and other countries signed pacts to supply more than 100 low- and middle-income nations, the United Nations-backed Medicines Patent Pool said Thursday.
20th Jan 2022 - Bloomberg

Cheap version of Merck COVID pill to be made for poorer nations

Nearly 30 generic drugmakers in Asia, Africa and the Middle East will make cheap versions of Merck & Co's COVID-19 pill, under a landmark U.N.-backed deal to give poorer nations wider access to a drug seen as a weapon in fighting the pandemic. Merck's early greenlight to production of its anti-viral pill molnupiravir by other companies during the pandemic is a rare example in the pharmaceutical sector, which usually protects its patented treatments for longer periods.
20th Jan 2022 - Reuters

Waiting for Novavax? The company hopes to vaccinate 1 million unjabbed Australians

Hundreds of thousands of vaccine-hesitant Australians can now choose another jab with Novavax chief commercial officer John Trizzino hoping the newly approved protein-based vaccine could persuade the 5 per cent of the nation yet to be vaccinated. Australia has one of the highest vaccination rates in the world but a persistent group has been “waiting for Novavax” rather than taking the Pfizer or Moderna mRNA vaccines, or the AstraZeneca doses.
20th Jan 2022 - Sydney Morning Herald

Game recognizes game—Lilly, Novartis execs commend Pfizer on Paxlovid, but where does that leave them in the COVID market?

It’s not often that high profile pharmaceutical executives publicly laud a direct competitor’s medicine, but that’s what’s happening these days for Pfizer’s COVID-19 antiviral Paxlovid. “The Pfizer compound was developed kind of from whole cloth during the course of the pandemic,” said Eli Lilly CEO David Ricks, during an interview for Fierce JPM Week. “Small molecule drug development is a tricky business, and it involves as much art as science sometimes, so hats off to them.” That sentiment was echoed by Jay Bradner, M.D., president of the Novartis Institutes for BioMedical Research, the Swiss pharma's R&D engine. “The Pfizer medicine is a remarkable contribution,” Bradner said. “I mean, to take an inhibitor designed for a completely different virus, and then boost what is a peptide-like inhibitor … with a second drug to prevent its disposal, I think it's a pretty heroic act of repurposing, and the activity of the molecule is quite breathtaking.”
20th Jan 2022 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Jan 2022

    View this newsletter in full

Merck-Ridgeback to supply courses of Covid-19 oral antiviral to UNICEF

Merck (MSD) and Ridgeback Biotherapeutics have entered a supply agreement with the United Nations Children’s Fund (UNICEF) to aid in wider worldwide access for investigational oral antiviral, molnupiravir, for Covid-19. According to the long-term deal, Merck will allocate up to three million courses of the oral antiviral to UNICEF for supply in over 100 low and middle-income nations during the first half of this year on obtaining regulatory authorisations.
19th Jan 2022 - Pharmaceutical Technology

WHO says no evidence healthy children, adolescents need COVID-19 boosters

There is no evidence at present that healthy children and adolescents need booster doses of COVID-19 vaccine, the World Health Organization's chief scientist Soumya Swaminathan said on Tuesday. Speaking at a news briefing, she said that while there seems to be some waning of vaccine immunity over time against the rapidly spreading Omicron variant of the coronavirus, more research needs to be done to ascertain who needs booster doses.
19th Jan 2022 - Reuters

Mild COVID cases still lead to attention and memory issues - study

People with mild COVID-19 who do not suffer any other traditional "long COVID" symptoms can still exhibit deteriorated attention and memory six to nine months after infection, a study by Britain's Oxford University has found. Cognitive issues impacting concentration levels, along with forgetfulness and fatigue, are features of long COVID - a condition that afflicts some after an initial bout of infection - but it has not been established how widespread issues with attention span might be following COVID-19 infection.
19th Jan 2022 - Reuters

Fuzzy Hamsters Are Hong Kong’s Newest Enemy in Its Covid-Zero Campaign

Authorities ordered some 2,000 hamsters in Hong Kong to be killed over concerns that the animals may have transmitted Covid-19 to humans, one of the city’s latest measures to try to stamp out a fresh outbreak. Under the latest order, authorities will cull the animals at almost three dozen pet shops across the city, including a store selling small animals linked to two recent Covid-19 infections in the city. One of the two infections was an employee at the pet store, while another was a recent visitor to the store, authorities said. Health chiefs said the order was being made out of prudence as there was no international evidence that pets can transmit the Covid-19 to humans.
19th Jan 2022 - The Wall Street Journal

To Help Battle Covid-19, a Hospital Borrows Tactics From Combat Veterans

At Rush University Medical Center, nurses still talk about their feelings of guilt from the early months of treating Covid-19 patients. How they hadn’t known how to best treat desperate patients. How worried they were about bringing Covid-19 home to their families. Except now they report having more mental and emotional tools at their disposal than they did at the beginning of the pandemic, thanks in large part to the work of Mark Schimmelpfennig, a hospital chaplain who is also an Army veteran. Mr. Schimmelpfennig months ago noticed that phrases nurses were using in conversation sounded like what he had heard from troops who had served in combat zones. The same techniques veterans use to wrestle with combat trauma also could be used by the healthcare profession, he said.
19th Jan 2022 - Wall Street Journal

Are hospital admissions still the best way to gauge the COVID crisis?

More people in hospital with COVID are there for other reasons. Italian regions want to overhaul way admissions counted. ICU occupancy may better reflect severity, scientist says. Omicron still putting hospitals under pressure, doctors warn
19th Jan 2022 - Reuters

Report outlines 8 steps for current, future pandemics

A new report from the Center for Strategic and International Studies (CSIS) comments on the "ineffectual and fragmented" US COVID-19 pandemic responses thus far and recommends eight steps to manage the ongoing crisis amid variant fatigue, inflation, and supply chain disruptions. CSIS, a bipartisan, nonprofit policy research organization based in Washington, DC, said it issued the recommendations to secure US global leadership in the next phase of the pandemic response. Among the steps recommended in the "2022 is the year of decision" report are to launch a US international pandemic readiness project and to appoint a presidential global health security envoy.
19th Jan 2022 - CIDRAP

Why big data didn’t deliver on its big promises to combat Covid-19

When the pandemic hit, technology companies pledged to do their part by cracking open their secretive datasets and letting public health researchers mine it for clues about how to bring Covid-19 under control. Two years in, it’s clear that big data isn’t the panacea they’d hoped for. In part, that’s because the pandemic has stretched far longer than most anticipated. But as Andrew Schroeder, a co-leader of the Covid-19 Mobility Data Network, lay out in an opinion published in PLOS Digital Health, it’s also because public health goals ran headlong into the business interests of the companies that provided their data for analysis, including Facebook and a cluster of ad-tech firms that tie clicks to location data.
18th Jan 2022 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Jan 2022

    View this newsletter in full

Pfizer’s New Covid-19 Pill Works Against Omicron in Lab

Pfizer Inc.’s new Covid-19 pill, Paxlovid, was effective against the Omicron variant in laboratory tests, an encouraging early sign the drug will be an important tool while the strain spreads. Pfizer said Tuesday the drug’s main component, nirmatrelvir, worked in three separate laboratory studies. Patients take two tablets of nirmatrelvir with one tablet of another antiviral called ritonavir twice a day for five days. The company issued the results by news release. The research hasn’t been published in a peer-reviewed medical journal.
19th Jan 2022 - The Wall Street Journal

Placebo effect accounts for more than two-thirds of COVID-19 vaccine adverse events, researchers find

The placebo effect is the well-known phenomenon of a person's physical or mental health improving after taking a treatment with no pharmacological therapeutic benefit—a sugar pill, or a syringe full of saline, for example. While the exact biological, psychological and genetic underpinnings of the placebo effect are not well understood, some theories point to expectations as the primary cause and others argue that non-conscious factors embedded in the patient-physician relationship automatically turn down the volume of symptoms
18th Jan 2022 - Medical Xpress

Merck signs supply deal with UNICEF for 3 mln courses of COVID-19 pill

Merck & Co Inc and partner Ridgeback Biotherapeutics said on Tuesday they had signed an agreement with the United Nations Children's Fund (UNICEF) to supply up to 3 million courses of their COVID-19 antiviral pill. Merck would supply the pill, molnupiravir, to UNICEF through the first half of 2022 for distribution in more than 100 low- and middle-income countries upon regulatory authorizations, the companies said. The pill received authorization from the U.S. Food and Drug Administration in December and has also been authorized in several other countries including India, Mexico and the UK. Many countries have signed supply deals with Merck for the drug.
18th Jan 2022 - Reuters

EU regulator finds mRNA COVID-19 shots safe during pregnancy

COVID-19 vaccines made using mRNA technology do not cause pregnancy complications for expectant mothers and their babies, the European Union's drug regulator said on Tuesday, following a detailed review of several studies. The review based on studies involving around 65,000 pregnancies at different stages did not find any sign of higher risk of complications, miscarriages, preterm births or severe side-effects on the unborn babies from mRNA shots, the European Medicines Agency said.
18th Jan 2022 - Reuters

Hong Kong to cull 2000 hamsters after COVID-19 outbreak

Hong Kong warned people not to kiss pets and ordered a mass cull of hamsters on Tuesday, to the outrage of animal-lovers, after 11 of the rodents tested positive for COVID-19. A recent coronavirus cluster in humans traced to a pet shop worker prompted checks on hundreds of animals in the Chinese-ruled territory, with 11 hamsters found infected, officials said. Echoing the mainland's zero-tolerance policy even as much of the world shifts to living with COVID, Hong Kong ordered 2,000 hamsters "humanely" put down, and imports and sales stopped.
18th Jan 2022 - Reuters

WHO urges manufacturers to provide COVID-19 vaccine data

A World Health Organization committee urged COVID-19 vaccine manufacturers on Tuesday to provide it with the data it requires in order to list their shots for emergency use, saying the delays were affecting equitable vaccine access. An emergency use listing with the U.N. agency means shots can be shipped to multiple developing nations that rely on WHO guidance for their regulatory decisions. It also allows them to be used by the COVAX vaccine-sharing programme that aims to ramp up vaccinations in poorer countries.
18th Jan 2022 - Reuters

Covid-19 Infected Lions Prompt Variant Warning in South Africa

Lions and pumas at a zoo in the South African capital of Pretoria got severe Covid-19 from asymptomatic zoo handlers, raising concerns that new variants could emerge from animal reservoirs of the disease,
18th Jan 2022 - Bloomberg

‘Deltacron’: Should we worry about new COVID-19 variants merging?

During the past week, my inbox has been flooded with messages telling me a new COVID-19 variant had been discovered in Cyprus. Dubbed “Deltacron”, it was said to be responsible for a series of hospitalisations in the country. I groaned at the thought of a new variant and one that was said to be a combination of the Delta and Omicron variants sounded ominous. So, I decided to do some digging.
18th Jan 2022 - Al Jazeera English

2,000 hamsters to be culled in Hong Kong over fears of animal-to-human Covid-19 link

Hong Kong authorities have asked pet shops and owners to hand over about 2,000 hamsters for a mass cull and temporarily suspended imports of small animals after finding evidence of the first possible animal-to-human transmission of Covid-19 in the city. Officials on Tuesday also ordered all 34 licensed pet stores that sell hamsters to suspend operations and about 150 customers who had visited the Little Boss shop in Causeway Bay since January 7 to enter quarantine. Pet owners whose hamsters test positive must also be isolated as well. While animal welfare groups expressed shock at the “drastic action”, authorities and health experts stressed the risks to public health made the cull necessary. Two people tied to the Little Boss shop have been confirmed as infected and another is listed as a suspected case, while 11 hamsters from the store were categorised as preliminary-positive.
18th Jan 2022 - South China Morning Post

'The next variant is just around the corner': Experts warn the world's at risk until all are vaccinated

New Covid-19 variants are likely to keep on emerging until the globe has been vaccinated against the virus, experts warn, saying that the sharing of vaccines is not just an altruistic act but a pragmatic one. “Until the whole world is vaccinated, not just rich Western countries, I think we are going to remain in danger of new variants coming along and some of those could be more virulent than omicron,” Dr. Andrew Freedman, an academic in infectious diseases at Cardiff University Medical School, told CNBC on Thursday. Viruses “tend to become milder” as they evolve, Freedman noted, but he cautioned that this “isn’t always the case.”
18th Jan 2022 - CNBC

Your Child's Fussy Eating May Stem From Covid-19

Covid infection could be turning more and more children into fussy eaters, experts have suggested. This may be because they are suffering from parosmia - a disorder where people experience strange and often unpleasant smell distortions. For example, chocolate may smell like petrol, or someone may smell rotting cabbage instead of lemon. Smell experts at the University of East Anglia and Fifth Sense, the charity for people affected by smell and taste disorders, say children in particular may be finding it hard to eat foods they once loved. Fifth Sense and Carl Philpott, from UEA's Norwich Medical School, are launching guidance to help parents and healthcare professionals better recognise the disorder.
18th Jan 2022 - Bloomberg

China cites coronavirus on packaging, despite doubts abroad

Chinese state media say parcels mailed from overseas may have spread the omicron variant of the coronavirus in Beijing and elsewhere, despite doubts among overseas health experts that the virus can be transmitted via packaging. The State Post Bureau said it has ordered stronger measures to ventilate and disinfect sites where items mailed from overseas are handled. Postal workers must wear protective equipment, receive booster shots and undergo regular testing, it said on its website. International packages must be isolated, cleaned and held for a waiting period to ensure they are free from the virus, it said. Global health experts say the virus mainly spreads through respiratory droplets when infected people breathe, speak, cough and sneeze.
18th Jan 2022 - The Associated Press

Uncorking today’s Covid-19 supply chain to meet the challenges of future pandemics

At what point do the benefits of local production of medical supplies outweigh the potentially higher cost? The sudden and near-overwhelming demand for Covid-19 testing during the Omicron phase of the pandemic means that the U.S. is now at a critical point where we need better — and quicker — access to testing supplies via a domestic supply chain. Over the last three decades, the world’s economy has become increasingly globalized, resulting in lower inflation-adjusted prices for goods and products and improved standards of living around the world. The Covid-19 pandemic has provided an opportunity to once again debate the United States’ reliance on inexpensive overseas manufacturing, and reconsider the value of high-quality domestic production.
18th Jan 2022 - STAT News

U.S. would seek global approach to updating Covid-19 vaccines, official says

If the Food and Drug Administration decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone. Instead, a senior FDA official told STAT, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines. The approach would ensure decisions are not left solely to individual vaccine manufacturers. “We can’t have our manufacturers going willy-nilly [saying], ‘Oh well, the EMA decided they wanted this composition, but FDA wanted that composition,’” the official said, referring to the European Medicines Agency. “So we are very much of the mind that we would like to be part of a more global process in helping to come to what vaccine composition there should be now.”
18th Jan 2022 - STAT News


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

    View this newsletter in full

India's Gennova developing Omicron-specific COVID-19 vaccine

India's Gennova Biopharmaceuticals is working on an Omicron-specific mRNA COVID-19 vaccine candidate, it told Reuters on Monday, after a person with direct knowledge of the matter said the product could be ready in a month or two. "The Omicron-specific variant of the vaccine is under development and will be ready for human clinical trials, subject to regulatory approvals," a company spokesperson said in a text message. "We will keep you posted."
17th Jan 2022 - Reuters

Study evaluates acute and long-term adverse events following immunization with COVID-19 Moderna vaccine

In a recent study posted to the medRxiv* pre-print server, a team of researchers conducted a case-control study at a mass vaccination center in Japan to evaluate acute and long-term adverse events following immunization (AEFI) with coronavirus disease 2019 (COVID-19) Moderna vaccine. There were 3,014 incidences of AEFI in 2,913 Moderna vaccine recipients, of which 101 recipients showed AEFI twice, first at the time of receiving the first dose and next on receiving the second vaccine dose. Except for anaphylaxis, the incidence rate of AEFI at the first dose was significantly higher than at the time of the second dose. Among the 1,201,688 vaccine recipients, the incidence rate of IHSR was 266, ISRR was 2129, anaphylaxis was two, and vasovagal syncope was 72. Among the 611,238 vaccine recipients without AEFI, 1,208 recipients were selected as matched controls 1 for Cases 1 and 9,940 recipients as control 2 for Cases 2.
17th Jan 2022 - News Medical

A Thai start-up is working on a Covid vaccine — using tobacco leaves

Thailand’s Baiya Phytopharm wants to develop the the country’s first plant-based Covid vaccine. The start-up completed phase one human trials of the shot in December. Baiya says it’s still too early to ascertain its efficacy, but the goal is to use available vaccines as a benchmark.
17th Jan 2022 - CNBC

Covid-19: Severe complications during pregnancy are more common in unvaccinated women, study finds

Unvaccinated women accounted for 77% of SARS-CoV-2 infections that have occurred during pregnancy in Scotland and 98% of infections that led to a critical care admission, a study has found. Researchers looked at 4950 confirmed infections in pregnant women from 1 December 2020—when routine SARS-CoV-2 testing of maternity admissions began—which were spread relatively evenly throughout pregnancy (1543 in the first trimester, 1850 in the second, and 1557 in the third). They found that “severe complications,” such as critical care admission, stillbirths, and early neonatal deaths, were more common in those who were unvaccinated compared with those who were vaccinated. Commenting on the study, Asma Khalil, professor of obstetrics and maternal fetal medicine at St George’s University of London, said, “The study shows that the overwhelming majority of pregnant women and babies becoming unwell or dying as a result of covid-19 were unvaccinated. The pandemic is far from over and with tens of thousands of covid-19 cases still being reported in the UK every day, it is paramount that pregnant women continue to take up the offer of a vaccine.”
17th Jan 2022 - The BMJ

Covid-19: Focus should be on new vaccines rather than boosters, says WHO

Giving repeated booster doses of existing covid-19 vaccines in developed countries is not a sustainable global strategy for tackling the pandemic, the World Health Organization has said. Instead, WHO argues that the focus should shift towards producing new vaccines that work better against transmission of emerging variants. In a statement1 published on 11 January, the WHO Technical Advisory Group on Covid-19 Vaccine Composition said, “A vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.” The expert group, which is assessing the performance of covid-19 vaccines, said that to deal with emerging variants such as omicron, new vaccines needed to be developed that not only protect people against serious illness but against infection. “Covid-19 vaccines that have high impact on prevention of infection and transmission, in addition to the prevention of severe disease and death, are needed and should be developed,” the group said.
17th Jan 2022 - The BMJ

Pfizer to boost COVID-19 pill production with French deal

Pfizer will add a production facility for its antiviral COVID-19 pill in France as part of a plan to invest 520 million euros ($594 million) in the country over the next five years, the U.S. drugmaker said on Monday. The decision is part of Pfizer's strategy to boost global production of the pill, paxlovid, which was found to be nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to clinical trial data. The investment will initially involve the production of active pharmaceutical ingredient (API) for paxlovid at a plant run by French pharmaceutical group Novasep, Pfizer said, noting that additional Novasep facilities will be added next year.
17th Jan 2022 - Reuters

Pakistan says trial of Chinese traditional medicine for COVID-19 successful

Pakistani health authorities on Monday announced the completion of a successful clinical trial of Chinese traditional herbal medicine for treating COVID-19, as the South Asian nation enters a fifth wave of the pandemic driven by the Omicron variant. The Chinese medicine, Jinhua Qinggan Granules (JHQG) manufactured by Juxiechang (Beijing) pharmaceutical Co Ltd, is already being used in treatment of COVID-19 patients in China. "Since it was tried on patients with different variants of COVID-19, we expect it to be effective on Omicron as on other variants," Professor Iqbal Chaudhry, director of the International Center for Chemical and Biological Science (ICCBS) where trials were conducted, told reporters.
17th Jan 2022 - Reuters

Which Mask Is Best for Covid N95, KN95 or Cloth? Understanding 2022 Guidance

Advice from U.S. authorities on the need for face masks has flipped back and forth since Covid-19 took hold in 2020. In May, the Centers for Disease Control and Prevention said immunized Americans could ditch their masks in most settings. It reversed course in July amid a rise in cases caused by the more transmissible delta variant. Now, with the quickly spreading omicron variant causing a surge in infections, the agency is urging wider use of medical-grade masks in the general public. It revised earlier guidelines that had discouraged the use of gold-standard N95 masks in order to reserve them for medical workers.
17th Jan 2022 - Bloomberg

What do we know about the 175,000 people who died of Covid in the UK?

Two startlingly different figures for what is ostensibly the same count have been released within days of each other: the government reported 150,000 Covid-19 deaths days before the UK’s lead statistical agency reported a death toll of more than 175,000. The difference between the two figures is stark but easily explained: the government’s figures count only those deaths that are known to have occurred within 28 days of a positive coronavirus test. The Office for National Statistics, on the other hand, counts all deaths where the virus was mentioned on the death certificate. But regardless of the counting method, the numbers represent individual human tragedies. So, what do we know about the 175,000 people whose deaths have been recorded to date?
17th Jan 2022 - The Guardian

Australia regulator flags 'significant concerns' of price hike in COVID-19 antigen tests

Australia's competition regulator on Monday said it had "significant concerns" about reports of price gouging of COVID-19 rapid antigen tests and sought information from suppliers, retailers and pharmacy chains about rising costs. Australia is facing a shortage of at-home rapid antigen test kits after authorities urged asymptomatic close contacts to bypass government-funded testing hubs, where high volumes delayed results, and take their own tests. "In the middle of a significant outbreak of COVID-19 in a pandemic, the excessive pricing of rapid antigen tests required to diagnose the illness and protect other members of the public, is of significant concern," the Australian Competition and Consumer Commission (ACCC) Chair Rod Sims said.
17th Jan 2022 - Reuters

At Davos, a ‘good news, bad news’ message emerges about Covid-19

As the coronavirus continues to wreak havoc, an expert panel at the World Economic Forum delivered a mix of good news and bad news on Monday: More variants will emerge, but vaccine production is accelerating and research is progressing toward a combined shot that may be able to attack these different variants. On one hand, the world needs to prepare for newer strains that could be more vexing, or the “worst case scenario,” said Annelies Wilder-Smith, a professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. “Omicron will not be the last variant. There’s a high probability we will have another variant coming up. The question is when and will it be less dangerous?”
17th Jan 2022 - STAT News

Covid-19: Pregnant women urged to get vaccine after new study

Pregnant women have been urged to get vaccinated after a new study found an increased risk of birth-related complications after getting Covid-19. Northern Ireland's chief medical officer said Covid in the later stages "can have serious consequences for both mother and baby". Sir Michael McBride said having Covid-19 during pregnancy "carries a far higher risk than having the vaccine". It comes as the Omicron variant continues to spread in communities. A University of Edinburgh study found that pre-term births, stillbirths and new-born deaths are more common among women who have Covid-19 28 days, or less, before their delivery date. The study's authors said that "addressing low vaccine uptake in pregnant women is imperative to protect the health of women and babies"
17th Jan 2022 - BBC News

WHO recommends two new drugs to treat COVID-19

WHO has recommended two new drugs for COVID-19, providing yet more options for treating the disease. The extent to which these medicines will save lives depends on how widely available and affordable they will be. The first drug, baricitinib, is strongly recommended for patients with severe or critical COVID-19. It is part of a class of drugs called Janus kinase (JAK) inhibitors that suppress the overstimulation of the immune system. WHO recommends that it is given with corticosteroids. Baricitinib is an oral drug, used in the treatment of rheumatoid arthritis. It provides an alternative to other arthritis drugs called Interleukin-6 receptor blockers, recommended by WHO in July 2021.
16th Jan 2022 - World Health Organization


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

    View this newsletter in full

Thailand and Indonesia unveil plans to develop molnupiravir COVID-19 pill

Thailand's health minister said on Friday the country planned to develop the anti-viral pill molnupiravir to combat COVID-19 infections amid rising infections driven by the Omicron variant. The molnupiravir COVID-19 treatment pill for adult patients at risk of developing severe illness was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics. The Southeast Asian nation intends to join other countries in the region also planning to make versions of the drug including Bangladesh and India.
15th Jan 2022 - Reuters

South African study suggests Omicron less severe even for unvaccinated

Unvaccinated people infected with the Omicron variant of coronavirus may be less prone to severe illness and requiring hospital care or dying than was the case with previous variants, a South African study showed on Friday. The study, by the National Institute of Communicable Diseases (NICD) in the Western Cape region, which has not yet been peer-reviewed, concluded.compared about 11,600 patients from the first three COVID-19 waves with about 5,100 from the Omicron-driven wave that began in November. Omicron globally has tended to cause less severe disease, and proportionally fewer hospital admissions and deaths, than previous variants.
15th Jan 2022 - Reuters

Italy's sewers will give early alert for future COVID spikes

Italy will use the nation's sewage to predict future coronavirus spreads and to alert authorities to rising cases and new variants before they appear in testing and hospitals, a senior official said, announcing a project to be launched in coming months. The new tool will be rolled out as governments look for new ways to track the virus to inform public health policy and to decide whether they have to take unpopular measures like restrictions that disrupt people's lives and economies. It could also be useful amid concerns about shortages of testing kits and labs being overwhelmed as the more infectious Omicron variant sweeps the world. Like many other countries, Italy is seeing surging cases.
15th Jan 2022 - Reuters

EMA lists rare spinal condition as side effect of AstraZeneca's COVID-19 shot

A safety panel of the European drug regulator on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca's COVID-19 vaccine. The European Medicines Agency's (EMA) safety committee also recommended a similar warning be included for Johnson & Johnson's (JNJ.N) one-shot vaccine in October, and reiterated the decision on Friday. Transverse myelitis is an inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, sensory symptoms or problems with bladder or bowel function.
15th Jan 2022 - Reuters

UK study finds more Omicron hospitalisations in youngest children, but cases mild

Young children and babies are proportionally more likely to be hospitalised with Omicron compared to older children than with previous variants but the cases are still mild, British researchers said, adding the overall picture was reassuring. Omicron has spread rapidly in Britain and fuelled a spike in cases to record highs, though the variant is less severe than previous ones, and high vaccination levels among adults have also helped to limit the rise in hospitalisations. Children are less vulnerable than older adults to COVID-19.
15th Jan 2022 - Reuters

Study finds COVID-19 may increase risk of diabetes in kids: What parents should know

Kids who have recovered from COVID-19 may have an increased risk of developing diabetes, according to a new study from the Centers for Disease Control and Prevention. The study, which looked at databases with information for over 2.5 million patients under 18, found that children diagnosed with COVID-19 were about 2.5 times more likely to receive a new diabetes diagnosis a month or more after infection.
14th Jan 2022 - ABC News

New study says air knocks down COVID-19 infection rate by 90 percent

New research found that after COVID-19 becomes airborne, the virus loses infectivity by 50 to 60 percent within seconds. By the first two minutes, the infectivity rate of COVID-19 dropped further by 90 percent. The new research was published out of the U.K. and has yet to be peer-reviewed.
14th Jan 2022 - The Hill


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

    View this newsletter in full

Covid in Pregnancy Linked to Stillbirths and Newborn Deaths, Study Suggests

Women who have Covid-19 towards the end of their pregnancy are more vulnerable to stillbirths, newborn deaths and birth related complications, a new study suggests. The research also found that most complications occurred in women who were not vaccinated, with the majority (98%) of pregnant women with Covid-19 who were admitted to critical care being unvaccinated. The study, which included more than 87,000 women in Scotland, found that preterm births, stillbirths and newborn deaths were more common among women who had the virus 28 days or less before their delivery date, compared to background rates. All the women whose babies died had not been vaccinated against Covid-19 at the time of infection, though experts stressed that it is not possible to say if Covid-19 contributed directly to the deaths or preterm births as they did not have access to detailed clinical records for individual women.
13th Jan 2022 - Bloomberg

How Does Covid Spread? Virus' Infection Capacity Weakens After 20 Minutes in Air

Coronavirus loses most of its ability to infect shortly after being exhaled and is less likely to be contagious at longer distances, a study from the University of Bristol’s Aerosol Research Centre showed. Researchers found that the virus loses 90% of its contagion capacity 20 minutes after becoming airborne and that most of that loss happens in the first five minutes of it reaching the air, according to the study, that simulates how the virus behaves after exhaling. With some countries opening the debate in Europe about an endemic phase to the virus, insights into the way the virus travels across the air will help guide containment measures.
13th Jan 2022 - Bloomberg

New data finds AstraZeneca booster generates higher antibodies against Omicron

AstraZeneca said on Thursday preliminary data from a trial it conducted on its COVID-19 shot, Vaxzevria, showed it generated a higher antibody response against the Omicron variant and others, including Beta, Delta, Alpha and Gamma, when given as a third booster dose. The increased response was seen in people who were previously vaccinated with either Vaxzevria or an mRNA vaccine, the drugmaker said, adding that it would submit this data to regulators worldwide given the urgent need for boosters. AstraZeneca has developed the vaccine with researchers from the University of Oxford, and lab studies last month found a three-dose course of Vaxzevria was effective against the rapidly spreading new variant.
13th Jan 2022 - Yahoo Finance

AstraZeneca says early trial data indicates third dose helps against Omicron

AstraZeneca said that preliminary data from a trial showed that its COVID-19 shot, Vaxzevria, generated an increase in antibodies against the Omicron and other variants when given as a third booster dose. The increased response, also against the Delta variant, was seen in a blood analysis of people who were previously vaccinated with either Vaxzevria or an mRNA vaccine, the drugmaker said, adding that it would submit this data to regulators worldwide given the urgent need for boosters. read more
13th Jan 2022 - Reuters

Swissmedic temporarily approves Regkirona COVID-19 treatment

Swiss drugs regulator Swissmedic said on Thursday it had granted temporary approval to Regkirona, antibody medicine that can be used for the treatment of COVID-19 in adults. Swissmedic said the applicant did not submit any information on its efficacy against the highly contagious Omicron variant of the coronavirus. Regkirona, which contains the active substance regdanvimab, can be used to treat adult COVID patients if oxygen therapy or hospitalisation is not required, and there is a high risk of developing a severe form of COVID-19.
13th Jan 2022 - Reuters

Moderna expects COVID-19 vaccine trial data for children aged 2-5 in March

Moderna Inc said on Wednesday it expects to report data from its COVID-19 vaccine trial in children aged between 2 to 5 years in March. "If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2-5 years of age thereafter," the company said. Moderna's vaccine, based on the messenger RNA platform, already has authorizations in Europe, UK, Australia, and Canada for adolescents aged 12-17 years, and has submitted applications for children in 6 to 11 years.
13th Jan 2022 - Reuters

Long COVID brain fog found similar to 'chemo brain'; clip-on device shows promise in virus detection

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. Long COVID "brain fog" shares features with "chemo brain" The "brain fog" reported by some people after COVID-19 shows striking similarities to the condition known as "chemo brain" - the mental cloudiness some people experience during and after cancer treatment, according to new research.
13th Jan 2022 - Reuters

COVID-19 pill rollout stymied by shortages as omicron rages

Two brand-new COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. are in short supply and have played little role in the fight against the omicron wave of infections. The problem, in part, is that production is still being ramped up and the medicines can take anywhere from five to eight months to manufacture. While the supply is expected to improve dramatically in the coming months, doctors are clamoring for the pills now, not just because omicron is causing an explosion of cases but because two antibody drugs that were once the go-to treatments don’t work as well against the variant.
13th Jan 2022 - Scientific Viewpoint

UK virus hunting labs seek to bolster global variant network

The air conditioners hum constantly in the lab at the Wellcome Sanger Institute, countering the heat thrown off by rows of high-tech sequencing machines that work seven days a week analyzing the genetic material of COVID-19 cases from throughout the U.K. The laboratory is one example of how British scientists have industrialized the process of genomic sequencing during the pandemic, cutting the time and cost needed to generate a unique genetic fingerprint for each coronavirus case analyzed. That made the U.K. a world leader in COVID-19 sequencing, helping public health authorities track the spread of new variants, develop vaccines and decide when to impose lockdowns. But now researchers at the Sanger Institute in Cambridge and labs around the U.K. have a new mission: sharing what they’ve learned with other scientists because COVID-19 has no regard for national borders.
13th Jan 2022 - The Associated Press

Unvaccinated pregnant people are at higher risk for Covid complications and newborn deaths

Unvaccinated pregnant people who get Covid-19 are at much higher risk for complications from the disease and death of their babies than their vaccinated counterparts, according to a new study from Scotland. Authors of the population-level study, published Thursday in Nature Medicine, examined data from all pregnant people across Scotland between December 2020 and October 2021 that included information on Covid-19 vaccination status and infection. Almost all of the pregnant people who needed critical care for Covid-19 — 102 out of 104 overall — were unvaccinated. There were over 450 total fetal and newborn deaths that coincided with Covid-19 — all among unvaccinated mothers. “Vaccination in pregnancy is the safest and most effective way for pregnant women to protect themselves and their babies,” said Sarah Stock, an author of the study who is an obstetrician and maternal and fetal medicine specialist at the University of Edinburgh. “This advice needs to go out to partners and parents and grandparents and friends.”
13th Jan 2022 - STAT News

Polish scientists find gene that doubles risk of serious COVID

Polish scientists have found a gene that they say more than doubles the risk of becoming severely ill with COVID-19, a discovery they hope could help doctors identify people who are most at risk from the disease. With vaccine hesitancy a major factor behind high coronavirus death rates in central and eastern Europe, researchers hope that identifying those at greatest risk will encourage them to get a shot and give them access to more intensive treatment options in case of an infection. "After more than a year and a half of work it was possible to identify a gene responsible for a predisposition to becoming seriously ill (with coronavirus)," said Health Minister Adam Niedzielski.
13th Jan 2022 - Reuters

Pfizer's Covid-19 antiviral pill was hailed as a game-changer, but supplies are scarce

The Omicron variant of the coronavirus is causing Covid-19 cases to spike, with an average of more than 747,000 new cases a day, according to the latest numbers from Johns Hopkins University. That's almost three times the average daily cases from a year ago, when the country was going through its previous peak, and it's putting an incredible strain on hospitals and emergency rooms. The good news since the last peak is that the US Food and Drug Administration authorized new antiviral pills. Both Paxlovid and molnupiravir were given emergency use authorization in late December to treat mild to moderate Covid-19. They interfere (through different pathways) with the virus' ability to replicate -- and they can be taken at home, before someone becomes seriously ill.
13th Jan 2022 - CNN

Global study notes risk factors for uncommon severe COVID-19 in kids

A 10-country study of more than 3,000 children who tested positive for COVID-19 in emergency departments (EDs) finds that 3% went on to develop severe disease within 2 weeks, with risk factors being older age, having chronic conditions, and experiencing symptoms longer. The study was published yesterday in JAMA Network Open. An international group of scientists report that, among 3,221 children 17 years and younger studied in Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States, 107 (3.3%) experienced severe outcomes within 2 weeks, and 4 (0.12%) died. Among children discharged home from the ED, the risk was much lower.
12th Jan 2022 - CIDAP

AstraZeneca sells another half-million doses of its COVID-19 antibody combo to the US

Order up. Shortly after topping off supplies of COVID-19 drugs from Pfizer and GlaxoSmithKline, the U.S. has asked for a second helping of AstraZeneca’s antibody combo. The government has purchased an additional 500,000 doses of AZ’s long-acting antibody cocktail Evusheld, or tixagevimab plus cilgavimab. That comes on top of 700,000 doses the U.S. already ordered, for a total supply of 1.2 million, the British drugmaker said Wednesday. AstraZeneca plans to complete the entire delivery within the first quarter of 2022. Unlike the COVID-19 antibody drugs from Eli Lilly, Regeneron and GlaxoSmithKline-Vir Biotechnology, AstraZeneca’s therapeutic is authorized for prevention before exposure to the virus. Specifically, the FDA in December authorized Evusheld in people with moderately to severely compromised immune systems, either from a medical condition or the use of immunosuppressive medications. People with a history of severe reactions to COVID-19 vaccines are also eligible to receive the therapeutic.
12th Jan 2022 - FiercePharma


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

    View this newsletter in full

Cannabis Compounds Prevented Covid Infection in Laboratory Study

Cannabis compounds prevented the virus that causes Covid-19 from penetrating healthy human cells, according to a laboratory study published in the Journal of Nature Products. The two compounds commonly found in hemp -- called cannabigerolic acid, or CBGA, and cannabidiolic acid, or CBDA -- were identified during a chemical screening effort as having potential to combat coronavirus, researchers from Oregon State University said. In the study, they bound to spike proteins found on the virus and blocked a step the pathogen uses to infect people. The researchers tested the compounds’ effect against alpha and beta variants of the virus in a laboratory. The study didn’t involve giving the supplements to people or comparing infection rates in those who use the compounds to those who don’t.
12th Jan 2022 - Bloomberg

Third dose of mRNA COVID vaccine induces strong immunity in older adults

The study results showed that two doses of an mRNA vaccine in older adults produced significantly lower levels of humoral response in terms of both binding and neutralizing antibodies as compared to younger people throughout the period of assessment. After a two-dose mRNA vaccine regimen, the predictors of weak binding antibody response included having more concomitant illnesses. Conversely, having a longer gap between the first and second doses was linked to a superior binding antibody response, confirming earlier reports. However, binding antibody levels fell faster in older adults, which is likely due to the more significant number of health conditions in this group.
12th Jan 2022 - News-Medical.Net

Fauci warns of ‘urgent need’ for super vaccine as other variants emerge

Dr Anthony Fauci warned at a Senate committee hearing that the US faced an “urgent need” for a so-called super vaccine that would be more effective at preventing new variants of Covid-19 and other coronaviruses. “Looking ahead in the context of the inevitable continual emergence of new variants, the importance of developing a pan-coronavirus vaccine, namely one that would be effective against all SARS-COVID-2 variants, and ultimately against all coronaviruses, becomes even more apparent,” he told the senators on Tuesday. He added that there was an “urgent need for such an effort”, and added that NIAID was making significant progress on the issue.
12th Jan 2022 - The Independent

Novavax coronavirus vaccine authorized in South Korea

South Korea’s drug regulator on Wednesday granted final authorization to Novavax’s coronavirus vaccine for use in adults, health officials said in a news release, making it the fifth coronavirus vaccine available in the country. Although the authorization is conditioned on the Maryland-based company’s submission of the final results of clinical studies regarding its vaccine, the Ministry of Food and Drug Safety said Novavax’s coronavirus vaccine has received “final” approval in South Korea. The vaccine, which will be produced locally, is effective and safe, the regulator said.
12th Jan 2022 - The Washington Post

Pfizer study shows COVID-19 booster can be given along with pneumonia shot

Pfizer Inc said on Wednesday booster doses of its COVID-19 vaccine can be administered along with its pneumonia vaccine and produced strong safety and immune responses in people aged 65 and above in a late-stage study. The study, initiated in May, tested the company's next-generation pneumococcal conjugate vaccine, PREVNAR 20, with a third dose of the Pfizer-BioNTech COVID-19 shot in 570 participants. The aim of the study was to test the safety of the combination and the immune response after adding the pneumonia vaccine to the existing COVID-19 vaccine.
12th Jan 2022 - Reuters

S.Korea authorises Novavax COVID-19 vaccine, imports Pfizer pills

South Korea is turning to additional pharmaceutical tools as it looks to pre-empt a surge of COVID-19 omicron infections, authorising the use of Novavax Inc's vaccine on Wednesdayand preparing to distribute the first of Pfizer's antiviral pills. At least 21,000 of Pfizer's antiviral pills, called Paxlovid, will arrive in South Korea on Thursday, with another 10,000 more expected to arrive by the end of the month, the health ministry said. The pills, which were authorised for emergency use in December, will begin being used in treatments for more than 1,000 people per day starting on Friday, the ministry added
12th Jan 2022 - Reuters

A Deceptive Covid Study, Unmasked

An honest summary of the study might have said: “There is a low transmission rate of the virus among students, even when unmasked at lunch or during sports.” But a summary like that wouldn’t have reinforced the politically acceptable message of public-health authorities today, and so unfounded points had to be fashioned to fit the narrative. This isn’t a first for the ABC collaborative and the Duke press office. In July they made a series of bold claims about the efficacy of masking children in schools based on a study that didn’t include an unmasked control group. Scientific communication should limit itself to the communication of science, rather than to the manipulation of human behavior.
12th Jan 2022 - The Wall Street Journal

Omicron Causes Fewer and Shorter Hospitalizations, Study Shows

A new study of nearly 70,000 Covid patients in California demonstrates that Omicron causes less severe disease than other coronavirus variants, results that align with similar findings from South Africa, Britain and Denmark, as well as a host of experiments on animals. Compared with Delta, Omicron infections were half as likely to send people to the hospital. Out of more than 52,000 Omicron patients identified from electronic medical records of Kaiser Permanente of Southern California, a large health system, the researchers found that not a single patient went on a ventilator during that time.
12th Jan 2022 - The New York Times

Repeat Booster Shots Spur European Warning on Immune-System Risks

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune response and may not be feasible. Repeat booster doses every four months could eventually weaken the immune response and tire out people, according to the European Medicines Agency. Instead, countries should leave more time between booster programs and tie them to the onset of the cold season in each hemisphere, following the blueprint set out by influenza vaccination strategies, the agency said. The advice comes as some countries consider the possibility of offering people second booster shots in a bid to provide further protection against surging omicron infections. Earlier this month Israel became the first nation to start administering a second booster, or fourth shot, to those over 60.
12th Jan 2022 - Bloomberg

Covid Study to Assess Pfizer, J&J Suitability for HIV Infected

A South African Covid-19 vaccine trial will assess the safety and impact of varying doses of Johnson & Johnson and Pfizer Inc. shots as boosters for those infected with HIV as well as the wider population. The study being carried out by the Johannesburg-based Wits Reproductive Health and HIV Institute will recruit about 300 health workers, of which about a third will be HIV positive, said Lee Fairlie, head of child and maternal health at the institute. With about 8.2 million people in South Africa, or 13% of the population, infected with HIV, the effectiveness, or immunogenicity, of Covid-19 vaccines in generating an immune system response in immuno-compromised individuals has been a key concern. HIV causes AIDS, which weakens the immune system.
12th Jan 2022 - Bloomberg


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

    View this newsletter in full

5 reasons you should not deliberately catch Omicron to 'get it over with'

The idea of intentionally trying to catch Omicron is "all the rage," said Dr. Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, with an exasperated sigh. "It's caught on like wildfire," agreed Dr. Robert Murphy, executive director of the Havey Institute for Global Health at Northwestern University Feinberg School of Medicine. "And it's widespread, coming from all types of people, the vaccinated and boosted and the anti-vaxxers," he added, with a warning. "You'd be crazy to try to get infected with this. It's like playing with dynamite." In case the thought had crossed your mind, here are five reasons why you should not purposely try to catch Omicron.
11th Jan 2022 - CNN

WHO says more research needed on vaccine efficacy against Omicron

A World Health Organization technical body said on Tuesday that current COVID-19 vaccines may need to be reworked to ensure they are effective against Omicron and future variants of the coronavirus. The technical group, made up of independent experts, said it would consider a change in vaccination composition and stressed that shots needed to be more effective in protecting against infection. "The composition of current COVID-19 vaccines may need to be updated to ensure that COVID-19 vaccines continue to provide WHO-recommended levels of protection against infection and disease by VOCs (variants of concern), including Omicron and future variants," the technical body, tasked with making recommendations to the WHO, said in a statement.
11th Jan 2022 - Reuters

Novavax CEO says its Covid vaccine could be cleared in multiple countries over next 90 days

The Novavax Covid-19 vaccine could be cleared by 10 regulators for use in multiple countries, including the U.S., in the coming months, the vaccine maker’s CEO said Monday. The company expects feedback from American regulators in February, Stanley Erck told CNBC’s “Squawk on the Street.” The vaccine is currently available for use in 170 countries.
11th Jan 2022 - CNBC

Moderna vaccines the best — and Sinovac least effective — at stopping covid deaths, Singapore data suggests

In a real-world indicator of how coronavirus vaccines are performing, Singapore has released new figures suggesting shots produced by Moderna and Pfizer-BioNTech are much more effective at preventing deaths than the Chinese-developed Sinopharm and Sinovac doses. Eight hundred and two people died of covid-19 in the city state in 2021, of which 555 were not fully vaccinated, while 247 received one of several locally available vaccines, Health Minister Ong Ye Kung told lawmakers on Monday. In terms of deaths per 100,000 people, there were 11 for those immunized with Sinovac and 7.8 for the Sinopharm vaccine, the state-affiliated Straits Times newspaper reported. The rate dropped for people who received messenger RNA — or mRNA — vaccines, with 6.2 deaths for Pfizer-BioNTech and one fatality for Moderna.
11th Jan 2022 - The Washington Post

Are Throat Swabs Better at Detecting Omicron in Covid-19 Rapid Tests?

A growing debate surrounds whether people testing for Omicron should swab their throats. Most people in the U.S. have been doing Covid-19 rapid tests with nasal swabs. That is what the Food and Drug Administration endorses and what rapid tests sold in the U.S. instruct. But some scientists say a throat swab may be more effective at detecting Omicron. Some are calling on the FDA and test manufacturers to better study throat swabs, saying that the reliance on nasal swabs may be one reason why rapid tests seem to be less sensitive in detecting Omicron than previous variants.
11th Jan 2022 - The Wall Street Journal

Wellcome Trust to spend £16bn on research with focus on Covid vaccines

The Wellcome Trust, Britain’s biggest charity, is ramping up spending on science research to £16bn over the next 10 years, with a focus on funding next-generation Covid vaccines, after it reaped the highest investment returns in a quarter of a century. Wellcome said it was making its biggest funding commitment to science and health in its 85-year history. It was created by the will of the pharmaceuticals entrepreneur Sir Henry Wellcome in 1936. The £16bn promise comes after it spent more than £9bn on research grants and other charitable activities over the past decade, including £1.2bn last year alone. The trust made a 34.5% return in the year to 30 September on its investment portfolio, which is now worth £38.2bn, about £10bn more than a year ago. This is its best performance since it was created in its present form as an independent charitable foundation in 1995, when Wellcome plc was sold off to the drugmaker Glaxo, which later became GlaxoSmithKline.
11th Jan 2022 - The Guardian

COVID-19 vaccine and periods: Study finds small, temporary change

Some may be hesitant to get vaccinated due to claims of a possible link between COVID-19 vaccines and abnormal menstrual cycles. So far, clinical trials of COVID-19 vaccines have not collected menstrual cycle data post-vaccine. By May 2021, however, a small number of people had reported menstrual-cycle-related issues. The authors of a new study write that “[t]he International Federation of Gynecology and Obstetrics classifies a variation in cycle length as normal if less than 8 days.” Also, stress can cause cycle lengths to varyTrusted Source or lead to a person skipping a cycle.
11th Jan 2022 - Medical News Today

Covid-19: We have good treatments for omicron, but questions remain, say doctors

Although the impact of omicron has largely been mitigated by vaccination, prior SARS-CoV-2 infection, and better treatments, general medical wards still face high numbers of patients, with many parts of the UK still bracing themselves for the peak, say clinicians. The most recent report from the Intensive Care National Audit and Research Centre (ICNARC),1 with data up to 7 January, showed that 629 had been patients admitted to critical care with covid-19 in the previous fortnight. As a proportion of overall hospital admissions, the figures for covid related critical care are at the lowest they have been since reporting began in April 2020. On 10 January 18 655 patients were in hospital with covid-19, with daily admissions reaching 2332.2 Simon Ashworth, a consultant in intensive care medicine at Imperial College Healthcare NHS Trust, told The BMJ, “Hospitals are very full, emergency departments are really busy, there are lots of admissions, difficulties in getting people into care homes, and we need to isolate covid patients from others.”
11th Jan 2022 - The BMJ

WHO warns against treating Covid-19 like flu

The World Health Organization (WHO) on Tuesday warned against treating COVID-19 as an endemic illness like flu, rather than as a pandemic, saying the spread of the Omicron variant has not yet stabilized. Spain's Prime Minister Pedro Sanchez said on Monday it may be time to change how it tracks COVID-19's evolution to instead use a method similar to how it follows the flu, because its lethality has fallen. That would imply treating the virus as an "endemic illness", rather than a pandemic.
11th Jan 2022 - Reuters

South African studies suggest Omicron has higher 'asymptomatic carriage'

Preliminary findings from two South African clinical trials suggest the Omicron coronavirus variant has a much higher rate of "asymptomatic carriage" than earlier variants, which could explain why it has spread so rapidly across the globe. The studies - one of which was carried out when Omicron infections were surging in South Africa last month and another which resampled participants around the same time - found a far greater number of people tested positive for the coronavirus but were not showing symptoms compared to previous trials. In the Ubuntu study evaluating the efficacy of Moderna's COVID-19 vaccine in people living with HIV, 31% of 230 participants undergoing screening tested positive, with all 56 samples available for sequencing analysis verified to be Omicron.
11th Jan 2022 - Reuters

Pfizer CEO says Omicron-targeted vaccine is most likely outcome

Pfizer Inc Chief Executive Albert Bourla on Monday said a redesigned COVID-19 vaccine that specifically targets the Omicron coronavirus variant is likely needed and his company could have one ready to launch by March. Bourla said Pfizer and partner BioNTech SE are working on both an Omicron-targeted vaccine version as well as a shot that would include both the previous vaccine as well as one targeted at the fast-spreading variant. "I think it is the most likely scenario," Bourla said, speaking at J.P. Morgan's annual healthcare conference, which is being held virtually this year. "We're working on higher doses. We're working different schedules. We're doing a lot of things right now, as we speak."
11th Jan 2022 - Reuters

PharmaMar shares soar after drug study suggests efficacy against Omicron

Shares in PharmaMar jumped almost 20% on Tuesday after the Spanish drugmaker said lab trials suggested its Plitidepsin drug was effective against the main COVID-19 variants, including the highly contagious Omicron. Results from in-vitro tests published in the Life Science Alliance journal showed that Plitidepsin, also known as Aplidin, had a potent antiviral effect in all variants and decreased the viral load detected in animal lung tissue by 99%, the company said. The same paper also included previously published positive effects in Phase I and II clinical trials carried out on patients who were hospitalised with COVID-19.
11th Jan 2022 - Reuters

Too soon to treat COVID-19 like flu as Omicron spreads - WHO

That would imply treating the virus as an endemic illness, rather than a pandemic, without recording every case and without testing all people presenting symptoms. But that is "a way off", WHO's senior emergency officer for Europe, Catherine Smallwood, said at the briefing, adding that endemicity requires a stable and predictable transmission. "We still have a huge amount of uncertainty and a virus that is evolving quite quickly, imposing new challenges. We are certainly not at the point where we are able to call it endemic," Smallwood said. "It may become endemic in due course, but pinning that down to 2022 is a little bit difficult at this stage."
11th Jan 2022 - Reuters

Repeat Covid Booster Shots Risk Overloading Immune System, EU Regulators Warn

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune system and may not be feasible. Repeat booster doses every four months could eventually weaken the immune system and tire out people, according to the European Medicines Agency. Instead, countries should leave more time between booster programs and tie them to the onset of the cold season in each hemisphere, following the blueprint set out by influenza vaccination strategies, the agency said.
11th Jan 2022 - Bloomberg

Pfizer COVID vaccine 91% effective against inflammatory syndrome

Among 12- to 18-year-old hospitalized COVID-19 patients, two doses of the Pfizer/BioNTech vaccine was 91% effective in preventing the rare but serious coronavirus-related multisystem inflammatory syndrome in children (MIS-C), according to a US study published late last week in Morbidity and Mortality Weekly Report. In the first real-world evaluation of the Pfizer vaccine's effectiveness against MIS-C, a team led by Centers for Disease Control and Prevention (CDC) researchers compared the odds of COVID-19 vaccination in 102 adolescent MIS-C patients and 181 controls at 24 sites. Controls included 90 COVID-19–negative patients and 91 MIS-C–negative patients from Jul 1 to Dec 9, 2021, after the emergence of the more virulent Delta (B1617.2) variant but before the even more highly transmissible Omicron (B.1.1.529) strain. Median participant age was 14.5 years, and 58% had one or more underlying medical conditions. About 36% of controls and 5% of COVID-19 patients were fully vaccinated at least 28 days before hospitalization.
11th Jan 2022 - CIDRAP


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

    View this newsletter in full

T Cells Triggered by Common Cold Fend Off Covid in Study

High levels of protective immune cells that fight some common colds also made people less likely to contract Covid-19 in a study. Researchers found higher levels of T cells against certain colds in people who didn’t develop Covid while living with someone who had the disease, according to a study released Monday by the U.K.’s Imperial College London. The prior illnesses were caused by other coronaviruses related to SARS-CoV-2. The findings, published in the journal Nature Communications, provide further evidence of the protective effects of T cells, an arm of the immune system that’s gaining attention as the pandemic stretches into its third year and new variants like omicron erode vaccine protection.
10th Jan 2022 - Bloomberg

T-cells from common colds can provide protection against COVID-19 - study

High levels of T-cells from common cold coronaviruses can provide protection against COVID-19, an Imperial College London study published on Monday has found, which could inform approaches for second-generation vaccines.
10th Jan 2022 - Reuters on MSN.com

Rapid testing for Omicron: is a nose swab enough?

The fast-spreading Omicron variant has made us more reliant on rapid at-home antigen tests to tell us if we have COVID-19. But should we be swabbing our throats as well as our noses? For now, the guidance depends on where you live. Some scientists have said people can transmit Omicron when it has infected their throat and saliva but before the virus has reached their noses, so swabbing the nostrils early in the infection will not pick it up.
10th Jan 2022 - Reuters

Will we ever reach herd immunity to Covid?

n May 2020, we and other scientists predicted that many regions of the world might never reach the herd immunity threshold for Covid-19 – the point at which enough people are immune to infection that transmission begins to slow down. This remains true today, even as vaccines have become accessible in wealthy nations and many people have built up immunity through vaccinations, boosters and previous infections. The herd immunity threshold was commonly misunderstood as a universal target to hit early in the pandemic. But the threshold has always been changeable: it depends on how transmissible the pathogen is, and the behavioural and immunological characteristics of the population in which it is spreading – how much they mix and how easily they are infected.
10th Jan 2022 - The Guardian

Swab throat too when using rapid COVID test, Israel's Health Ministry says

Israel's Health Ministry on Monday instructed people self-testing for COVID-19 to swab their throat as well as their nose when using rapid antigen kits to increase the chances of detecting the Omicron variant. The recommendation goes against the advice of the U.S. Food and Drug Administration, which has said manufacturers' instructions should still be followed and that incorrect use of throat swabs could pose a safety risk. On Israeli Army Radio, Sharon Alroy-Preis, Israel's public health chief, said antigen tests, used widely in the country, are less sensitive than PCR tests in detecting illness.
10th Jan 2022 - Reuters

EU regulator could issue decision on Pfizer COVID-19 pill 'within weeks'

The European Union's drug regulator said on Monday it could issue "within weeks" a decision on whether to approve the use of Pfizer's COVID-19 pill, Paxlovid, after the U.S. drugmaker submitted an application seeking authorisation. The approval sought is for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older, weighing at least 40 kilograms and are at high risk of their illness worsening, the European Medicines Agency
10th Jan 2022 - Reuters

Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine

Pfizer Inc Chief Executive Albert Bourla on Monday said a redesigned COVID-19 vaccine that specifically targets the Omicron coronavirus variant is likely needed and his company could have one ready to launch by March. Bourla said Pfizer and partner BioNTech SE are working on both an Omicron-targeted vaccine version as well as a shot that would include both the previous vaccine as well as one targeted at the fast-spreading variant. "I think it is the most likely scenario," Bourla said, speaking at J.P. Morgan's annual healthcare conference, which is being held virtually this year. "We're working on higher doses. We're working different schedules. We're doing a lot of things right now, as we speak."
10th Jan 2022 - Reuters

Avacta pauses sales of COVID-19 antigen test to improve Omicron sensitivity

Britain's Avacta Group is halting sales of its COVID-19 rapid antigen lateral flow test to replace antibodies in the device and boost its ability to detect the Omicron variant, the biotech firm said on Monday, sending its shares plunging nearly 27%. The London-listed company's test, AffiDX, can detect the Omicron variant when the virus is present in high numbers in samples, but tests carried out by Avacta found AffiDX is less sensitive to Omicron at lower viral loads versus other variants.
10th Jan 2022 - Reuters

Novartis in-licenses COVID-19 treatment ensovibep from Molecular Partners

Novartis said it will license in a new drug it has been developing with Molecular Partners to treat COVID-19, the Swiss company said on Monday, after getting positive trial data. Novartis will pay 150 million Swiss francs ($162.92 million) to in-license ensovibep from Molecular Partners to speed up its manufacturing ramp up and get approvals for the drug more quickly. The decision comes after the two companies said they had received positive topline data from a phase 2 study for ensovibep (mp0420), an antiviral therapeutic for COVID-19 that will from now on be developed and manufactured by Novartis.
10th Jan 2022 - Reuters

T-cells from common colds can provide protection against COVID-19 - study

High levels of T-cells from common cold coronaviruses can provide protection against COVID-19, an Imperial College London study published on Monday has found, which could inform approaches for second-generation vaccines. Immunity against COVID-19 is a complex picture, and while there is evidence of waning antibody levels six months after vaccination, T-cells are also believed to play a vital role in providing protection. The study, which began in September 2020, looked at levels of cross-reactive T-cells generated by previous common colds in 52 household contacts of positive COVID-19 cases shortly after exposure, to see if they went on to develop infection.
10th Jan 2022 - Reuters

Qatar Approves Pfizer Boosters for Children Aged 12 to 15 Years

Qatar approved the Pfizer-BioNTech booster coronavirus vaccine for children aged 12 to 15 years as nations fight the spread of the omicron variant. Children who received their second dose more than six months ago are eligible for the booster shots, according to a statement. Recently, the Ministry of Public Health had approved booster doses to those aged 16 and 17 years. Qatar reported 3,056 new confirmed cases among the community and 633 among travelers on Sunday. That is one of the highest daily numbers in the recent past.
10th Jan 2022 - Bloomberg

Cyprus Finds Covid-19 Infections That Combine Delta and Omicron

A strain of Covid-19 that combines delta and omicron was found in Cyprus, according to Leondios Kostrikis, professor of biological sciences at the University of Cyprus and head of the Laboratory of Biotechnology and Molecular Virology. “There are currently omicron and delta co-infections and we found this strain that is a combination of these two,” Kostrikis said in an interview with Sigma TV Friday. The discovery was named “deltacron” due to the identification of omicron-like genetic signatures within the delta genomes, he said. Kostrikis and his team have identified 25 such cases and the statistical analysis shows that the relative frequency of the combined infection is higher among patients hospitalized due to Covid-19 as compared to non-hospitalized patients. The sequences of the 25 deltacron cases were sent to GISAID, the international database that tracks changes in the virus, on Jan. 7.
10th Jan 2022 - Bloomberg

Covid-19 Variant Deltacron Is Real, Scientist Says

A Cypriot scientist defended his assertion that a new strain of Covid-19 exists that combines characteristics of the delta and omicron variants. Other scientists have speculated that Leonidos Kostrikis’s findings are a result of laboratory contamination. But he told Bloomberg in an emailed statement Sunday that the cases he has identified “indicate an evolutionary pressure to an ancestral strain to acquire these mutations and not a result of a single recombination event.”
10th Jan 2022 - Bloomberg

Germany assessing reliability of antibody tests for Omicron - minister

Germany will study how reliable rapid antigen tests are in detecting the fast-spreading Omicron variant of COVID-19, Health Minister Karl Lauterbach said on Sunday. "We do not know exactly how well these tests work for Omicron," Lauterbach said on public broadcasting channel ARD, adding the results of the assessment would become available within the next few weeks. It was clear, however, that "the alternative not to test at all ... would be far too dangerous," said Lauterbach, a scientist and physician.
10th Jan 2022 - Reuters

Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine

Pfizer Inc Chief Executive Officer Albert Bourla said on Monday he was unsure about the need for a fourth dose of COVID-19 vaccine and that a shot targeting the highly contagious Omicron variant would be ready in March. The comments contrasted with those made by Moderna Inc CEO Stephen Bancel, who said last week people could need another shot in the fall of 2022 as the efficacy of boosters was likely to decline over the next few months.
10th Jan 2022 - Reuters


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

    View this newsletter in full

COVID-19 infections in children may increase their risk of diabetes: CDC

Children who have had COVID-19 seem to be at increased risk of developing Type 1 or Type 2 diabetes, according to a study by the Centers for Disease Control and Prevention released Friday. Past studies show increased risk in developing diabetes as an adult after recovering from COVID-19. Research in Europe also found a higher rate of diabetes diagnoses among children since the beginning of the pandemic. The study examined two large insurance claim databases across the United States to document the number of diabetes diagnoses among children under 18 who had previously been diagnosed with COVID-19. These children were compared with those who had never been diagnosed with COVID-19.
10th Jan 2022 - The Hill

Pfizer/BioNTech vaccine protects children against rare COVID-19 complication - CDC

Two doses of the Pfizer Inc and BioNTech COVID-19 vaccine are highly protective against a rare but often serious condition in children that causes organ inflammation weeks after COVID-19 infections, a U.S. Centers for Disease Control and Prevention report said on Friday. The vaccine was estimated to be 91% effective in preventing Multisystem Inflammatory Syndrome in Children (MIS-C) in 12- to 18-year-olds, the study said. MIS-C causes inflammation in children in organs including the heart, lungs, kidneys and brain two to six weeks after a mild or asymptomatic infection. The estimate is based on the assessment of 283 hospitalized patients aged 12–18 years at 24 children's hospitals in 20 states between July and early December, when the prevalence of the Delta coronavirus variant was high.
8th Jan 2022 - Reuters on MSN.com

CDC reports record number of child COVID-19 hospitalizations

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky reported Friday that there have been a record number of pediatric hospitalizations due to COVID-19 and announced new isolation guidelines for students, staff and teachers to preserve in-person learning in schools. During a media briefing, Walensky cautioned that pediatric hospitalizations are at the highest point they have ever been during the pandemic, even though they are much lower when compared to adults. She said it’s still not clear if the increase is due to a greater burden of disease in children's communities or their lower rates of vaccination. The increase was seen most in children younger than 4, who are ineligible for vaccination, and the data include those admitted to hospitals for reasons other than COVID-19 who then tested positive.
8th Jan 2022 - The Hill

Study: COVID-19 vaccination may cause temporary, slight change to menstrual cycle

COVID-19 vaccination may cause a temporary change to a person's menstrual cycle, but it appears to be a “small change,” according to a study published on Thursday. The study, published in the Obstetrics and Gynecology journal, examined close to 4,000 people — vaccinated and unvaccinated — and examined menstruation data that individuals entered through an app called Natural Cycles. Researchers then examined the difference between menstruation data before and after individuals received their vaccine doses. For individuals who did not receive the vaccine, researchers looked at six consecutive menstruation cycles. The researchers found that in vaccinated individuals, bleeding was prolonged by a time that amounted to less than one day. However, they concluded that this slight change, while statistically significant, was not clinically significant.
8th Jan 2022 - The Hill

Omicron Study in South Africa Points to End of Acute Pandemic Phase

A South African study from the epicenter of the world’s omicron surge offers a tantalizing hint that the acute phase of the Covid-19 pandemic may be ending. The infection wave moved with “unprecedented speed” and caused much milder illness than earlier strains, a study of patients infected with Covid-19 at a large hospital in the South African city where the first outbreak of the omicron variant was recorded showed. “If this pattern continues and is repeated globally, we are likely to see a complete decoupling of case and death rates,” the researchers said. That suggests “omicron may be a harbinger of the end of the epidemic phase of the Covid pandemic, ushering in its endemic phase.”
7th Jan 2022 - Bloomberg

Moderna CEO expects a second COVID booster will be needed later this year

Moderna Inc.’s CEO expects fully vaccinated people to need an additional COVID-19 booster shot later this year, as the efficacy of the first booster wanes over time. Speaking Thursday at a virtual conference of health-care CEOs held by Goldman Sachs Group Inc., Moderna MRNA, Chief Executive Stephane Bancel said the current booster should be enough to protect people through the winter omicron surge. However, “I will be surprised when we get that data in the coming weeks that it’s holding nicely over time — I would expect that it’s not gonna hold great,” Bancel said in reference to the booster’s strength. “I still believe we’re going to need boosters in the fall of ’22 and forward.” “We have been saying that we believe first this virus is not going away,” Bancel said. “We’re going to have to live with it.” Bancel said the United Kingdom and South Korea have already submitted orders for a second round of boosters.
7th Jan 2022 - MarketWatch

Moderna CEO warns Americans they may need ANOTHER COVID booster in the fall because the shot's effectiveness won't 'hold great' after a few months

Stephane Bancel, the CEO of Moderna, spoke on Thursday at a Goldman Sachs conference of healthcare professionals. Bancel said he expects a second booster shot will be necessary in the fall, as the data from the first boosters is not expected to be strong. Only around a third of Americans have had their booster shot and convincing a COVID-weary population to get a fourth jab is likely to be a struggle Britain and South Korea have already placed orders for a fourth jab, Bancel said His comments echo those of Pfizer's CEO, who said he too expects a fourth jab to be necessary
7th Jan 2022 - Daily Mail

Rapid nose swab tests for COVID may not detect Omicron quickly enough -expert says

Swabbing the nose with a rapid antigen test will not reliably detect the Omicron variant in the first few days of an infection, so manufacturers should seek U.S. approval to allow users to safely collect samples from the throat as well, according to an infectious diseases expert. The U.S. Food and Drug Administration has expressed concerns over the safety of self throat swabbing. People can already transmit Omicron to others when it has infected their throat and saliva but before the virus reaches their nose, so swabbing the nostrils too early in the course of infection will not pick it up, Dr. Michael Mina, formerly of the Harvard T.H. Chan School of Public Health and now chief science officer at eMed, said during a news conference on Thursday.
7th Jan 2022 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Jan 2022

    View this newsletter in full

Gavi and India's Bharat discuss possible COVAX use of Covaxin

The Gavi vaccine alliance is in talks with India's Bharat Biotech over potential procurement of the company's Covaxin COVID-19 shot for the COVAX global vaccine distribution programme, a Gavi spokesperson told Reuters on Thursday. "We are in discussion with (Bharat Biotech) as we consider the overall needs of the COVAX portfolio in 2022. However, we have no agreement for supply of Covaxin to COVAX at this time," the spokesperson said in an email.
6th Jan 2022 - Reuters

Indonesia survey finds 85% of population have COVID-19 antibodies

More than 85% of Indonesia's population has antibodies against COVID-19, a government-commissioned survey showed, but epidemiologists warned it was not clear whether this immunity could help contain a fresh wave of coronavirus infections. The survey, conducted between October and December by researchers at the University of Indonesia, found Indonesians had developed antibodies from a combination of COVID-19 infections and vaccinations.
6th Jan 2022 - Reuters

Pandemic may affect infants' brain development; coronavirus can trigger kidney scarring

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. Pandemic may be affecting infants' brains Coronavirus infection during pregnancy does not appear to affect infants' brain function, but the pandemic itself may be having an impact, a study published on Tuesday in JAMA Pediatrics suggests.
6th Jan 2022 - Reuters

Vaccines company Valneva sticks to goal of COVID vaccine approvals in Q1

Speciality vaccines company Valneva (VLS.PA) said it was keeping its previous timetable on clinical trials and regulatory submissions for its VLA2001 COVID-19 vaccine candidate, with regulatory approvals targeted in the first quarter of this year. "We continue to believe that our inactivated vaccine candidate could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can," said Valneva chief executive Thomas Lingelbach.
6th Jan 2022 - Reuters

CDC recommends Pfizer's COVID-19 booster for ages 12 to 15

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it expanded the eligibility of Pfizer Inc and BioNTech SE's booster doses to those 12 to 15 years old. The move came after a panel of outside experts advising the CDC voted earlier to recommend booster shots of the COVID-19 vaccine be made available for ages 12 to 15.
6th Jan 2022 - Reuters

Pfizer Covid Booster Gets CDC Panel’s Backing for Use in Teens

U.S. public health advisers said vaccinated teens should get a Covid-19 booster shot from Pfizer Inc. and BioNTech SE, an important step in efforts to expand immunizations and keep schools open. The panel of outside experts convened by the Centers for Disease Control and Prevention voted to 13 to 1 to recommend the booster shot for people ages 12 to 17 who received their second dose at least five months earlier. CDC Director Rochelle Walensky endorsed the recommendation, making it official.
6th Jan 2022 - Bloomberg on MSN.com

Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different?

With rapid testing becoming a key tool in the fight against Covid-19, in a mid-October call with the White House I offered to sell my Covid testing company — recently valued at $99.8 million — to the government for just $1. As an alternative, I also offered to sell the government our test at cost. My company, Global Diagnostic Systems, had just completed clinical trials showing our rapid Covid-19 home test had 100% sensitivity (meaning no false negatives) and 95% specificity (meaning just 5% false positives). On hearing about this performance, a senior White House official told me, “Apply to the FDA ASAP.”
6th Jan 2022 - STAT News

Study raises doubts about rapid Covid tests’ reliability in early days after infection

A new study raises significant doubts about whether at-home rapid antigen tests can detect the Omicron variant before infected people can transmit the virus to others. The study looks at 30 people from settings including Broadway theaters and offices in New York and San Francisco where some workers were not only being tested daily but were, because of rules at their workplaces, receiving both the antigen tests and a daily test that used the polymerase chain reaction, or PCR, which is believed to be more reliable. On days 0 and 1 following a positive PCR test, all of the antigen tests used produced false-negative results, even though in 28 of the 30 cases, levels of virus detected by the PCR test were high enough to infect other people. In four cases, researchers were able to confirm that infected people transmitted the virus to others during the period before they had a positive result on the rapid antigen test.
6th Jan 2022 - STAT News


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

    View this newsletter in full

Cuba’s vaccine success story sails past mark set by rich world’s Covid efforts

The island nation struggles to keep the lights on but has inoculated 90% of population with home-developed vaccines General Máximo Gómez, a key figure in Cuba’s 19th-century wars of independence against Spain once said: “Cubans either don’t meet the mark – or go way past it.” A century and a half later, the aphorism rings true. This downtrodden island struggles to keep the lights on, but has now vaccinated more of its citizens against Covid-19 than any of the world’s major nations. More than 90% of the population has been vaccinated with at least one dose of Cuba’s homegrown vaccines, while 83% have been fully inoculated. Of countries with populations of over a million, only the United Arab Emirates has a stronger vaccination record.
5th Jan 2022 - The Guardian

Omicron estimated to be 95.4% of coronavirus variants in U.S. - CDC

The Omicron variant was estimated to be 95.4% of the coronavirus strains circulating in the United States as of Jan. 1, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday. The variant has swiftly spread across the country since its detection on Dec. 1, replacing Delta as the dominant strain and sparking a new wave of infections that pushed daily cases near the 1 million mark on Monday. The CDC said the variant accounted for an estimated 77% of cases in the week ended Dec. 25, up from the 58.6% projection it had disclosed last week.
5th Jan 2022 - Reuters

COVID case counts may be losing importance amid omicron

The explosive increase in U.S. coronavirus case counts is raising alarm, but some experts believe the focus should instead be on COVID-19 hospital admissions. And those aren’t climbing as fast. Dr. Anthony Fauci, for one, said Sunday on ABC that with many infections causing few or no symptoms, “it is much more relevant to focus on the hospitalizations as opposed to the total number of cases.” Other experts argue that case counts still have value. As the super-contagious omicron variant rages across the U.S., new COVID-19 cases per day have more than tripled over the past two weeks, reaching a record-shattering average of 480,000. Schools, hospitals and airlines are struggling as infected workers go into isolation.
5th Jan 2022 - The Associated Press

Fourth COVID-19 vaccine dose boosts antibodies five-fold in Israeli study, PM says

A fourth dose of COVID-19 vaccine boosts antibodies five-fold a week after the shot is administered, Israeli Prime Minister Naftali Bennett said on Tuesday, citing preliminary findings of an Israeli study. "A week into the fourth dose, we know to a higher degree of certainty that the fourth dose is safe," Bennett said at Sheba Medical Center, which is giving second booster shots in a trial among its staff amid a nationwide surge in Omicron variant infections.
4th Jan 2022 - Reuters

Novavax gathers its COVID-19 vaccine data for long-delayed FDA filing

Novavax spent much of 2021 working to file its COVID-19 vaccine with U.S. regulators but falling short of its own deadlines. As the year came to a close, the company celebrated the fact that it was nearly there. Friday, Novavax said it "completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request." This step is not an official emergency use application. Novavax plans to complete that process by the end of this month, the company said. The news comes after a 2021 filled with missed deadlines for the Gaithersburg, Maryland-based biotech. The company originally hoped to file for an EUA by 2021's second quarter, but later pushed that deadline to the third quarter thanks to a manufacturing issue. By October, Novavax said it was eyeing an end-of-year deadline to submit its "complete regulatory package" to the FDA
4th Jan 2022 - FiercePharma

Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US

With two COVID-fighting antiviral pills now on tap, the U.S. government is calling for a second helping of Pfizer’s treatment. The U.S. has doubled its order for Pfizer’s COVID-19 antiviral Paxlovid from 10 million courses to 20 million, the company said Tuesday. At the same time, the government aims to speed up the delivery of those treatments, a senior Biden administration official told Fox News. Roughly 10 million treatment courses of the antiviral, also known as nirmatrelvir tablets and ritonavir tablets, are set for delivery by the end of June, Pfizer said in a release. The remaining 10 million courses are pegged for delivery by the end of September, Pfizer said.
4th Jan 2022 - FiercePharma


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

    View this newsletter in full

Why are so many vaccinated people getting COVID-19 lately?

Why are so many vaccinated people getting COVID-19 lately? A couple of factors are at play, starting with the emergence of the highly contagious omicron variant. Omicron is more likely to infect people, even if it doesn’t make them very sick, and its surge coincided with the holiday travel season in many places. People might mistakenly think the COVID-19 vaccines will completely block infection, but the shots are mainly designed to prevent severe illness, says Louis Mansky, a virus researcher at the University of Minnesota. And the vaccines are still doing their job on that front, particularly for people who’ve gotten boosters.
4th Jan 2022 - The Associated Press

JCVI to consider expanding Covid vaccine rollout to all primary-age school children

Experts on the Joint Committee on Vaccination and Immunisation (JCVI) will be considering whether to expand the Covid jabs programme to all primary-age school children as part of their work, the Prime Minister’s official spokesman said. The Pfizer/BioNTech coronavirus vaccine was approved for use in vulnerable primary school children in December. The JCVI updated its advice after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the jab for five to 11-year-olds following a robust review of safety data. The Prime Minister’s spokesman said: “Obviously this is something the JCVI would keep under constant review. “They only relatively recently made that decision to move to vulnerable children.
4th Jan 2022 - Wales Online

Multivariant Covid-19 vaccine booster shows promise, early trial data suggests

A Covid vaccine booster aimed at tackling multiple variants shows promise in inducing a comprehensive immune response, early data suggests. The first results of a phase one trial, launched in Manchester in September 2021, reveal the jab has strong levels of neutralising antibodies. They are similar to approved mRNA vaccines (like Pfizer BioNTech and Moderna), but at up to a 10-fold lower dose in the first 10 individuals, the research indicates.
4th Jan 2022 - The Independent

50-second Covid test designed for use in schools and airports submitted to UK regulator for approval

A 50-second Covid-19 test that has been designed for use in schools, airports and at entertainment events has been submitted to the UK’s medicines regulator for approval, i has learned. The testing device, which is portable and around the size of a desktop-computer, is able to detect Covid infected particles in saliva samples in under a minute, according to creator Kidod Science and Technology. The firm claims it can provide results comparable to a PCR test and that it could be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) within weeks.
4th Jan 2022 - iNews

COVID-19: Worst of the pandemic is 'absolutely behind us', says scientist behind Oxford/AstraZeneca vaccine

Speaking a year on from the first time the AstraZeneca vaccine was administered to a member of the public, Professor Sir Andrew Pollard says: "The worst is absolutely behind us. We just need to get through the winter."
4th Jan 2022 - Sky News

FDA clears Pfizer, BioNTech COVID booster for younger teens

The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech’s Comirnaty shot as it tries to keep the Omicron variant under control. The US regulator has also reduced the time between completion of the first two doses of Comirnaty and a third dose to five months from six as a wave of new COVID-19 cases caused by Omicron has started washing over the country. That’s still longer than some other countries, including the UK which has pared down the time between the second and third doses to three months. The number of new COVID-19 cases in the US has doubled in the last few days to an average of around 418,000 a day, according to Reuters, while figures suggest there were more than a million new cases in the country yesterday, the highest number recorded since the start of the pandemic.
4th Jan 2022 - Pharmaphorum

WHO sees more evidence that Omicron causes milder symptoms

More evidence is emerging that the Omicron coronavirus variant is affecting the upper respiratory tract, causing milder symptoms than previous variants and resulting in a "decoupling" in some places between soaring case numbers and low death rates, a World Health Organization official said on Tuesday. "We are seeing more and more studies pointing out that Omicron is infecting the upper part of the body. Unlike other ones, the lungs who would be causing severe pneumonia," WHO Incident Manager Abdi Mahamud told Geneva-based journalists.
4th Jan 2022 - Reuters

Israeli study finds fourth COVID-19 vaccine dose boosts antibodies five-fold, PM says

A fourth dose of COVID-19 vaccine boosts antibodies five-fold a week after the shot is administered, Israeli Prime Minister Naftali Bennett said on Tuesday, citing preliminary findings of an Israeli study. "A week into the fourth dose, we know to a higher degree of certainty that the fourth dose is safe," Bennett said at Sheba Medical Center, which is giving second booster shots in a trial among its staff amid a nationwide surge in Omicron variant infections. "The second piece of news: We know that a week after administration of a fourth dose, we see a five-fold increase in the number of antibodies in the vaccinated person," he told reporters.
4th Jan 2022 - Reuters

Australia regulator to review price hike in COVID-19 antigen tests

Australia's antitrust regulator said on Tuesday it has contacted suppliers of COVID-19 rapid antigen test kits to examine pricing pressures in the market, as calls grow louder for the government to make the tests free amid a severe shortage of the kits. The Australian Competition and Consumer Commission (ACCC) said it will review information received from suppliers, retailers and the public to determine any potential misconduct. Australia approved more than a dozen rapid antigen test kits and a majority of them are from China.
4th Jan 2022 - Reuters

Covid Science: Virus leaves antibodies that may attack healthy tissues

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. Coronavirus leaves survivors with self-attacking antibodies Months after recovering from SARS-CoV-2 infection, survivors have elevated levels of antibodies that can mistakenly attack their own organs and tissues, even if they had not been severely ill, according to new findings.
4th Jan 2022 - Reuters

Dr Reddy's to launch generic COVID-19 Merck drug at about 50 cents a pill

Indian drugmaker Dr Reddy's Laboratories Ltd will launch its generic version of Merck's antiviral COVID-19 pill, molnupiravir, and price it at 35 rupees per capsule, a company spokesperson said on Tuesday. The overall cost for a patient treated with a 5-day course of 40 capsules of the generic drug, to be sold under brand name 'Molflu', will come up to 1,400 rupees ($18.77). In comparison, the treatment with Merck's pill in the United States costs $700. "Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of COVID-19," the company spokesperson said.
4th Jan 2022 - Reuters

COVID-19 vaccination during pregnancy not linked to complications at birth -U.S. study

COVID-19 vaccination during pregnancy was not associated with preterm delivery or underweight newborns, in a study published by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday. Rates of preterm birth were 4.9% among more than 10,000 women who received at least one dose of a COVID-19 vaccine, compared to 7.0% for roughly 36,000 unvaccinated women, researchers said on Tuesday in The CDC's Morbidity and Mortality Weekly Report. The difference was not deemed to be statistically significant.
4th Jan 2022 - Reuters


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

    View this newsletter in full

Omicron Surge Stymies Public-Transit Systems

Public-transit services in New York and other cities are being interrupted, as the Omicron variant of Covid-19 continues to drive staffing shortages. Service on several New York City subway and bus lines was partially suspended Monday. An MTA spokesman said hundreds of employees have been out sick in recent days. He declined to give an exact number or say how many workers have tested positive for Covid-19, adding that the agency doesn’t track specific illnesses. MTA ridership is down about 50% compared with pre-pandemic levels, New York City Transit Interim President Craig Cipriano said. The MTA is currently running over 90% of the buses and trains it typically operates, he said. Mr. Cipriano said that the MTA has contingency plans that outline service tweaks in case of staff shortages on any given day.
3rd Jan 2022 - The Wall Street Journal

Omicron evades immunity better than Delta, Danish study finds

The Omicron coronavirus variant is better at circumventing vaccinated peoples' immunity than the Delta variant, according to a Danish study published last week, helping explain why Omicron is spreading more rapidly. Since the discovery of the heavily mutated Omicron variant in November, scientists have been racing to find out whether it causes less serious disease and why it appears more contagious than the previously dominating Delta variant.
3rd Jan 2022 - Reuters

U.S. Covid-Test Positives Suggest Case Numbers Are Undercounted

The U.S. is reporting record Covid-19 infections, but the true tally may be significantly higher. Average daily cases reached about 405,000 in the past week, about 60% higher than the previous U.S. peak in January 2021, according to Johns Hopkins University data. But the numbers of tests reported by states are still running below their 2021 highs. Meanwhile, the rate of positives among the polymerase chain reaction (PCR) tests is at 17%, the highest since April 2020. In New York City, one in three tests are coming back positive, according to data as of Dec. 31.
3rd Jan 2022 - Bloomberg

Omicron Cases Are Hitting Highs, But New Data Puts End in Sight

A string of new studies has confirmed the silver lining of the omicron variant: Even as case numbers soar to records, the numbers of severe cases and hospitalizations have not. The data, some scientists say, signal a new, less worrying chapter of the pandemic. “We’re now in a totally different phase,” said Monica Gandhi, an immunologist at the University of California, San Francisco. “The virus is always going to be with us, but my hope is this variant causes so much immunity that it will quell the pandemic.”
3rd Jan 2022 - Bloomberg on MSN.com

U.S. FDA authorizes Pfizer's COVID-19 booster for 12- to 15-year-olds

The U.S. Food and Drug Administration on Monday authorized the use of a third dose of the Pfizer (PFE.N) and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the interval for booster shot eligibility to five months from six. The agency also authorized a third shot for children aged 5 through 11 years who are immunocompromised. The regulatory decisions come with COVID-19 cases surging due to the Omicron variant of the virus and just as many workers and school children return from holiday vacations, raising the prospect of overwhelming health systems. Some businesses and schools closed Monday as staff called in sick.
3rd Jan 2022 - Reuters

Virus leaves antibodies that may attack healthy tissues; B cell antibodies weakened, not defeated by Omicron

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. Coronavirus leaves survivors with self-attacking antibodies. Months after recovering from SARS-CoV-2 infection, survivors have elevated levels of antibodies that can mistakenly attack their own organs and tissues, even if they had not been severely ill, according to new findings.
3rd Jan 2022 - Reuters

Israel Gives Fourth 4th Shot of Covid Vaccine

Israel will start offering a fourth dose of the coronavirus vaccine to people aged 60 and over, becoming the first country in the world to widely disseminate the extra jab to fight off the omicron strain. The fourth dose will also be made available to medical staff who had their last jab at least four months ago, Prime Minister Naftali Bennett said in a press conference on Sunday. Last week, Israel approved the extra shot for people who are immunocompromised, as well as residents of nursing homes and patients in geriatric wards. New daily cases, which topped 5,000 last week in the country of 9.5 million, are expected to quadruple by the end of the week, Bennett said. The caseload could reach as many as 50,000 cases a day, he said, or nearly five times the previous peak. Critical cases remain well below previous records but have started to creep up over the past week.
2nd Jan 2022 - Bloomberg

New Zealand to Reduce Booster Interval to 4 Months from Jan. 5

New Zealand will reduce the interval between the second Covid-19 vaccine dose and a booster shot to four months from six as part of its response to the omicron variant. People aged 18 or older who have had second shots of the vaccine at least four months ago will be eligible for a booster from Jan. 5, the Ministry of Health said in a statement. The shorter interval means that more than 82% of vaccinated people in the country will be eligible for a booster by the end of February, Dr. Ashley Bloomfield, director general of health, said in the statement. Over 70% of people who were eligible for a booster in 2021 have already had the shot, according to the statement.
1st Jan 2022 - Bloomberg

Omicron hospitalisation risk around one third of Delta, UK analysis shows

The risk of hospitalisation with the Omicron variant of coronavirus is about one-third that of the Delta variant, according to British analysis of more than a million cases of both types in recent weeks. Britain is experiencing a surge in COVID-19 cases driven by the highly-transmissible Omicron variant, with record daily infections of 189,846 reported on Friday. While hospital admissions have started to rise, the government has said it believes the new variant is milder than the Delta variant.
1st Jan 2022 - Reuters

J&J booster slashes Omicron hospitalisations -S.African study

A booster dose of Johnson & Johnson Inc's (JNJ.N) single-dose COVID-19 vaccine was 84% effective at preventing hospitalisation in South African healthcare workers who became infected as the Omicron variant spread, researchers said on Thursday. The real-world study, which has not been peer-reviewed, was based on a second dose of the J&J vaccine administered to 69,092 workers between Nov. 15 and Dec. 20.
31st Dec 2021 - Reuters

Turkey rolls out its own COVID-19 vaccine as infections surge

Turkey began administering its domestically developed COVID-19 vaccine, Turkovac, at hospitals across the country on Thursday, amid a rapid surge in infections due to the Omicron variant. Turkey has already administered more than 130 million doses of vaccines using shots developed by China's Sinovac and by Pfizer/BioNTech. It also began administering booster shots. Turkovac received emergency use authorisation from Turkish authorities last week, after its launch was beset by delays for months.
31st Dec 2021 - Reuters

Pfizer's COVID-19 shot causes mostly mild side effects in young kids - U.S. CDC

Pfizer Inc and BioNTech SE's COVID-19 vaccine caused mostly mild side effects in children aged 5 to 11 years, according to data published by the U.S. Centers for Disease Control and Prevention on Thursday. The data showed that after the second dose of the vaccine some children reported injection-site pain and other systemic reactions such as fatigue and headache. The CDC said it also received reports of 11 cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who had received the vaccine. Of them, seven had recovered, and four were recovering at the time of the report.
31st Dec 2021 - Reuters

Scientists to test high dexamethasone doses in severely ill COVID-19 patients

British scientists will be studying whether higher doses of a cheap and widely used steroid called dexamethasone could work better for patients with severe COVID-19 compared to the standard low doses, they said on Thursday. Last year, the same scientists conducting the large trial, dubbed RECOVERY, showed that dexamethasone was able to save the lives of COVID-19 patients in what was called a "major breakthrough" in the coronavirus pandemic.
31st Dec 2021 - Reuters

Sinovac COVID-19 shot with Pfizer booster less effective against Omicron - study

Sinovac's two-dose COVID-19 vaccine followed by a booster Pfizer-BioNTech shot showed a lower immune response against the Omicron variant compared with other strains, according to a study by researchers. The study, which has not been peer-reviewed yet, was conducted by researchers from Yale University, the Dominican Republic's Ministry of Health and other institutions.
31st Dec 2021 - Reuters

Britain approves Pfizer's antiviral COVID-19 pill

Britain has approved Pfizer's Paxlovid COVID-19 pill for adults who have mild to moderate infection and are at high risk of their illness worsening, its second easily administered antiviral against the coronavirus. Britain is scrambling to build its defences amid a record surge in COVID-19 cases in the winter season as the Omicron variant of the virus spreads quickly.
31st Dec 2021 - Reuters UK

Novavax Files Final Data on Covid Vaccine to U.S. Regulators

Novavax Inc. submitted the final data package for its Covid-19 vaccine candidate to U.S. regulators, bringing it one step closer to clearance. The submission to the Food and Drug Administration included details on chemistry, manufacturing and controls for the shot known as NVX-CoV2373, Novavax said in a statement. The company expects to file a request for emergency use authorization in one month, in line with the FDA’s guidance around such filings. If authorized, the shot would become the fourth Covid vaccine cleared in the U.S. and the first of its kind. European regulators and the World Health Organization cleared the product this month after months of delays. Novavax has grappled with manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic.
31st Dec 2021 - Bloomberg


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

    View this newsletter in full

Who Invented Covid-19 Vaccines? Drugmakers Battle Over Patents

A high-stakes legal battle is taking shape over lucrative patent rights for Covid-19 vaccines, with drug companies pitted against each other and government and academic scientists over who invented what. The U.S. government and Moderna Inc., MRNA whose collaboration led to one of the most widely used shots, have fought over who discovered a key component and owns its rights. Meantime, Pfizer Inc. PFE and BioNTech SE, makers of another leading vaccine, are in a patent battle with a smaller company, and some analysts think they could end up facing off against Moderna. At the heart of the disputes: Who can claim to have invented important elements of the Covid-19 vaccines? Hundreds of millions of dollars are at stake. If anyone succeeds in establishing a role in the discovery of the vaccines, Pfizer and Moderna would have to share with others a bigger cut of the tens of billions of dollars in vaccine sales being generated. “It’s scientific credit and money. That’s what people want,” said Jacob Sherkow, a professor who specializes in biotechnology intellectual property at the University of Illinois College of Law. “This is a major biotech invention, for which tens of billions of dollars are riding on the line.”
29th Dec 2021 - The Wall Street Journal

Postal Covid vaccine patch could provide alternative to jabs by delivering protection ‘like a plaster’

Scientists developing a Covid-19 vaccine skin patch say the invention could revolutionise the coronavirus immunisation process by delivering it to people through the post and allowing them to “vaccinate” themselves by simply sticking it on their skin. Experts at Lancaster University have developed a new Covid-19 vaccine which has shown highly promising results in animal trials and they are already working on a nasal spray method of delivery. However, researchers have revealed they are now developing a patch version of the same vaccine which will have exciting implications if it proves successful in trials and is approved.
29th Dec 2021 - iNews

Israeli hospital launches first test of second COVID-19 booster

An Israeli hospital administered fourth COVID-19 vaccine doses to a test group of health workers on Monday, in what it called the first major study into whether a second round of boosters will help contend with the fast-spreading Omicron variant. Results of the trial, likely to be closely watched internationally, will be submitted to Israel's Health Ministry in about two weeks, said a spokesperson for Sheba Medical Centre near Tel Aviv. Israel was the fastest country to roll out initial vaccinations a year ago, and became one of the first to launch a booster programme after observing that immunity waned over time
29th Dec 2021 - Reuters

Israel's Oramed gets Vietnam pre-order for 10 mln COVID-19 vaccine doses

Israel's Oramed Pharmaceuticals said on Wednesday its Oravax Medical unit signed a deal with Vietnam's Tan Thanh Holdings for the pre-order of 10 million doses of its oral COVID-19 vaccine that is in clinical trials. The agreement gives Tan Thanh, a drug distributor, the right to sell Oravax’s oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN), which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam, Oramed said.
29th Dec 2021 - Reuters

Omicron May Cut Delta Infections, South African Study Shows

Infection with the omicron coronavirus variant can also strengthen immunity against the earlier delta strain, reducing the risk of severe disease, according to a paper released by South African scientists. While omicron has been shown to be highly transmissible and can evade some antibodies, after two weeks of getting symptoms immunity to subsequent infections from the strain rose 14-fold, according to the authors led by Alex Sigal and Khadija Khan of the Durban, South Africa-based Africa Health Research Institute. A smaller improvement was found against delta, they said. “If we are lucky, omicron is less pathogenic, and this immunity will help push delta out,” said Sigal, who has previously found a two-dose course of Pfizer Inc. and BioNTech SE’s Covid-19 shot as well as a previous infection may give stronger protection against omicron.
29th Dec 2021 - Bloomberg

Covid With Omicron Isn't 'Same Disease,' Oxford Scientist Says

The omicron variant that’s taking the world by storm is not “the same disease we were seeing a year ago,” a University of Oxford immunologist said, reinforcing reports about the strain’s milder nature. The strain first discovered at the end of November appears to be less severe and even patients who do end up in the hospital spend less time there, John Bell, regius professor of medicine at Oxford, said on BBC Radio 4’s Today program. “The horrific scenes that we saw a year ago -- intensive care units being full, lots of people dying prematurely -- that is now history in my view, and I think we should be reassured that that’s likely to continue,” Bell said.
29th Dec 2021 - Bloomberg


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

    View this newsletter in full

Australia records first Omicron death, authorities stick to reopening plan

Australia reported its first confirmed death from the new Omicron variant of COVID-19 on Monday amid its biggest daily surge in infections, but the authorities refrained from imposing new restrictions saying hospitalisation rates remained low. The death, a man in his 80s with underlying health conditions, marked a grim milestone for the country which has had to reverse some parts of a staged reopening after nearly two years of stop-start lockdowns, due to the fresh outbreak. Omicron, which health experts say appears more contagious but less virulent than previous strains, began to spread in the country just as it lifted restrictions on most domestic borders and allowed Australians to return from overseas without quarantine, driving case numbers to the highest of the pandemic.
27th Dec 2021 - Reuters

Unvaccinated 60 times more likely to end up in ICU with Covid, new research says

Unjabbed people who catch Covid are up to 60 times more likely to end up in an intensive care ward than those who have been vaccinated, figures reveal. The startling data also shows the difference between the jabbed and unjabbed needing intensive care is starkest among older people – who are more likely to suffer more seriously from Covid. Figures from the Intensive Care National Audit and Research Centre (ICNARC), which covers hospital units in England, Wales and Northern Ireland, show that between May and November the rate of admission for double-jabbed Covid sufferers in their 60s was just 0.6 cases per 100,000 people per week. But among unjabbed people of the same age the rate was 37.3 per 100,000 per week – equating to a relative risk about 60 times higher
27th Dec 2021 - The Mirror

Latin America Is Now a World Leader in Vaccinations

Latin America, once a hot spot of Covid-19 deaths, now leads the U.S. and much of the world in vaccinations, as supply concerns have eased and health policy makers rush to shield their countries from new variants roiling other regions. Applying a mix of Chinese, European and American vaccines, about 62% of South America’s population has received two shots or the single dose by Johnson & Johnson. That is more than the 60% of Europeans inoculated with two doses, the 56% of people in North America and the 54% in Asia, according to Our World in Data, a pandemic research project at the University of Oxford. Only Australia has fully vaccinated a bigger percentage of its people.
26th Dec 2021 - The Wall Street Journal

India to Vaccinate Teens, Offer Boosters, Modi Says

India will begin vaccinating teenagers from the ages of 15 to 18 from Jan. 3 and also administer booster vaccine doses for health-care workers a week later, as omicron-fueled Covid-19 cases spike, Prime Minister Narendra Modi said. Citizens who are older than 60 years and suffer from co-morbidities can also get booster shots of Covid vaccines in January, Modi said in a televised national address. “India needs to be vigilant about the spread of the coronavirus,” Modi said, adding that people should not pay attention to rumors nor panic about rising infection numbers. India has so far reported 415 cases of omicron infections from across 17 states, according to the latest data from the federal Health Ministry Saturday. The South Asian nation’s confirmed Covid cases so far total nearly 34.8 million.
26th Dec 2021 - Bloomberg

Vallance hits back at Tory accusations of Omicron fear-mongering

The UK government’s chief scientific adviser has hit back at accusations from Conservative MPs that epidemiological modellers had “spread gloom” about the Omicron variant. Sir Patrick Vallance said it was not the responsibility of the Scientific Advisory Group for Emergencies (Sage) “to take a particular policy stance or to either spread gloom or give Panglossian optimism”. He used an article in the Times to respond to criticism that was widely circulated among Tory MPs and ministers that suggested Sage’s Omicron modelling had been an exercise in fear-mongering. The Spectator’s editor, Fraser Nelson, had a Twitter exchange with the Sage member Graham Medley over the weekend, suggesting ministers asked Sage to model worst-case scenarios. The exchange was reportedly widely shared in the WhatsApp groups of Tory MPs.
24th Dec 2021 - The Guardian

S.Africa Omicron data should not be extrapolated to all countries- Africa CDC

Data from South Africa which suggests the Omicron coronavirus variant is 70% to 80% less severe than Delta should not be extrapolated to all countries, the head of the Africa Centres for Disease Control (CDC) said on Thursday. A South African study published on Wednesday found that people diagnosed with Omicron in the country in October and November were 80% less likely to be admitted to hospital than those diagnosed with another variant in the same period.
24th Dec 2021 - Reuters

CDC cuts quarantine time for healthcare workers amid Omicron surge

Healthcare workers in the United States who test positive for COVID-19 but are asymptomatic can return to work after seven days in isolation, provided they test negative, the Centers for Disease Control and Prevention said on Thursday. The new guidance cuts the quarantine time from a previously recommended 10 days, which the CDC said was in preparation for an anticipated increase in Omicron cases. Omicron now accounts for 73% of coronavirus infections in the United States, the CDC said on Monday. The CDC said the quarantine time can be cut further if there are staffing shortages due to COVID-19, adding that healthcare workers who have been fully vaccinated, including a booster, do not need to quarantine at home following high-risk exposures.
24th Dec 2021 - Reuters

China's Sinovac COVID-19 booster weaker against Omicron- Hong Kong study

Three doses of Sinovac's CoronaVac COVID-19 vaccine do not produce adequate levels of antibodies to fight the Omicron variant of the coronavirus, researchers from Hong Kong said in a statement. Their analysis revealed Pfizer-BioNTech vaccine was more effective, as a third dose of the shot administered after two doses of the same or China's Sinovac vaccine provided "protective levels" of antibody against Omicron. Pfizer and its German partner BioNTech have said their three-shot course was able to neutralise the new Omicron variant in a laboratory test.
23rd Dec 2021 - Reuters

Omicron Study in U.K. Bolsters Evidence of Lower Hospital Risks

Omicron appears to be less severe but more contagious than any other Covid-19 strain to date, a U.K. government study concluded, bolstering research that has shown a lower risk of hospitalization from the fast-spreading variant. People infected with omicron are 50% to 70% less likely than those with delta to be admitted to hospitals, the U.K. Health Security Agency said Thursday. Omicron patients are also 31% to 45% less likely to arrive at emergency departments than those with delta. The agency’s data came with an important caveat: While a booster shot improves protection against omicron, its effectiveness starts to wane more rapidly than with delta and is 15% to 25% lower starting 10 weeks after the third dose. The agency also cautioned that the new variant is so infectious that it could still produce significant numbers of severe cases.
23rd Dec 2021 - Bloomberg

U.S. pauses allocation of Regeneron, Lilly COVID-19 antibodies

The U.S. government has paused the distribution of COVID-19 antibody treatments from Regeneron Pharmaceuticals and Eli Lilly, saying the therapies were unlikely to be effective against the Omicron coronavirus variant. The variant has become the dominant strain in the United States with lightning speed, resurrecting restrictions and stretching the country's testing infrastructure. The halt on the allocation of the therapies will continue until new data emerges on their efficacy, the U.S. Food and Drug Administration and the office of Assistant Secretary for Preparedness and Response said in a joint statement on Thursday
23rd Dec 2021 - Reuters

Australia Brings Forward Booster Shots Amid Omicron Outbreaks

Australia has brought forward implementing third-dose booster shots for Covid-19 as the nation battles outbreaks of the omicron variant. From Jan. 4, Australians will be be able to get their booster shot four months after receiving their second dose, narrowing the current five-months wait time, Health Minister Greg Hunt said in Canberra. From Jan. 31, the gap will be cut again to three months. “These dates have been set out of an abundance of caution to give Australians early continued protection,” Hunt said. About 91% of Australians aged 16 and over have had two jabs, he said.
23rd Dec 2021 - Bloomberg

New U.K. Study Reinforces Conclusion That Omicron Causes Less Severe Disease

People infected with the Omicron variant of coronavirus are between 50% to 70% less likely to be admitted to the hospital than those who caught earlier strains, according to a new U.K. study that adds to a growing body of evidence of Omicron’s reduced severity in populations with high levels of immunity. The analysis from England, published Thursday by the U.K.’s Health Security Agency, follows studies in Scotland and South Africa that also pointed to a substantially lower risk of hospitalization with Omicron than with more established variants, including Delta. Scientists are still unsure how these encouraging findings around hospitalizations will stack up against Omicron’s much increased transmissibility, and ability to partially evade the protection of vaccines. The risk, they say, is the variant could still cause a big wave of hospital admissions simply by infecting many more people.
23rd Dec 2021 - The Wall Street Journal

FDA Authorizes Merck’s Covid-19 Pill for At-Home Treatment

U.S. regulators cleared use of a Covid-19 pill from Merck and partner Ridgeback Biotherapeutics LP, the latest easy-to-use therapy that infected people can take to keep out of the hospital. The authorization by the U.S. Food and Drug Administration permits doctors to prescribe the drug, called molnupiravir, to adults at high risk of severe disease shortly after they develop mild to moderate symptoms. The FDA recommended using the Merck drug only if other authorized drugs aren’t available and medically appropriate. Health experts have raised safety concerns about the Merck drug, which also was less effective in testing than an antiviral from Pfizer Inc. On Wednesday, the FDA cleared the Pfizer pill, Paxlovid, also for people to take at home to try to stay out of the hospital. The authorization by the U.S. Food and Drug Administration permits doctors to prescribe the drug, called molnupiravir, to adults at high risk of severe disease shortly after they develop mild to moderate symptoms. The FDA recommended using the Merck drug only if other authorized drugs aren’t available and medically appropriate. Health experts have raised safety concerns about the Merck drug, which also was less effective in testing than an antiviral from Pfizer Inc. On Wednesday, the FDA cleared the Pfizer pill, Paxlovid, also for people to take at home to try to stay out of the hospital.
23rd Dec 2021 - The Wall Street Journal

COVID: Study suggests AstraZeneca booster works against Omicron

AstraZeneca has said that a third dose of its COVID-19 vaccine “significantly” lifted antibody levels against the Omicron coronavirus variant, citing data from a new laboratory study. Findings from the study, yet to be published in a peer-reviewed medical journal, match those from rivals Pfizer-BioNTech and Moderna, which have also found a third dose of their shots works against Omicron.
23rd Dec 2021 - Al Jazeera English

South African health regulator approves J&J COVID-19 boosters

South Africa's health regulator on Thursday approved the use of Johnson & Johnson vaccine for a second dose or booster, paving the way for the shot widely used in South Africa to shore up protection against the Omicron variant. The country already announced in December that it was preparing to offer people booster doses of both the Pfizer and J&J shots, but it did not specify when J&J boosters would be available. The South African Health Products Authority (SAPHRA) said in a statement on Thursday that it had approved J&J shots for use as a second dose or booster at least two months after the completion of the person's primary vaccination, with either J&J's single-shot course or another approved mRNA COVID-19 vaccine.
23rd Dec 2021 - Reuters


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

    View this newsletter in full

Army to announce it has developed a single vaccine that protects from ALL variants of COVID and SARS

Walter Reed Army Institute of Research is set to announce the development of a vaccine that is effective against all COVID and SARS variants. Army researchers at Walter Reed have been working on a vaccine for two years. The Spike Ferritin Nanoparticle COVID-19 vaccine (SpFN) has so far been proven to protect against all existing and potential variants of the viruses. The Omicron COVID variant has been quickly spreading across the world and now accounts for 73 per cent of all new diagnoses in the US. Some states including New York and neighboring New Jersey say the super-infectious variant is behind 90 per cent of positive cases there
23rd Dec 2021 - Daily Mail

Omicron COVID symptoms milder than Delta in UK, early data suggests

Britons who fall ill with the Omicron variant of the coronavirus are less likely to become severely sick than those who contract Delta, U.K. government scientists are set to say in early real-world data on the severity of the disease. But while Omicron cases in the U.K. seem milder overall, the U.K. Health Security Agency (UKHSA) has found it is not necessarily mild enough to avoid large numbers of hospitalizations, according to the data, which is due to be published before Christmas and was previewed by POLITICO's London Playbook. The UKHSA found evidence that for those who do become severely ill with Omicron, there is still a high chance of hospitalization and death. The scientists also confirmed that the transmissibility of Omicron is very high, meaning that even though it is milder, infections could rocket to the point large numbers could still end up in hospital. The UKHSA is also expected to conclude that while two doses of a COVID vaccine are not enough to offer strong protection against Omicron, a booster dose does significantly reduce the chance of both symptomatic infection and hospitalization, London Playbook reported. A UKHSA spokesperson said they would not comment on unpublished data.
22nd Dec 2021 - POLITICO

Pfizer to provide 2.5 mln additional doses of its COVID-19 pill to UK

Pfizer Inc said on Wednesday it will provide an additional 2.5 million doses of its COVID-19 pill Paxlovid to the United Kingdom. A total of 2.75 million doses of the pill are expected to be delivered to the UK through 2022, the drugmaker said.
22nd Dec 2021 - Reuters

France cancels order for Merck's COVID-19 antiviral drug

France has cancelled its order for Merck & Co's COVID-19 antiviral drug following disappointing trial data and hopes instead to receive Pfizer's competing drug before the end of January, the health minister said on Wednesday. France is the first country to publicly say it has cancelled an order for the Merck treatment after the company released data in late November suggesting its drug was markedly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by about 30%. "The latest studies weren't good," Olivier Veran told BFM TV. A spokesperson for Merck said the country's planned purchase did not take place after the French health authority refused to authorise the pill earlier this month.
22nd Dec 2021 - Reuters

Turkey's domestic COVID-19 vaccine receives emergency use authorisation -minister

Turkey's domestically developed COVID-19 vaccine, Turkovac, has received emergency use authorisation by Turkish authorities and will be open to use from next weekend, Health Minister Fahrettin Koca said on Wednesday. Turkey began developing Turkovac this year, but the launch date for the vaccine has been beset by delays. President Tayyip Erdogan has said Turkey would make the shot available globally.
22nd Dec 2021 - Reuters

JCVI recommends Covid jabs for vulnerable children aged 5-11

Hundreds of thousands of clinically vulnerable five- to 11-year-olds are to be offered Covid vaccines for the first time, with some scientists calling for the programme to be extended to the whole age group before the new UK school term. The Joint Committee on Vaccination and Immunisation (JCVI) has recommended vaccinations for about 330,000 younger children at clinical risk, and also those living with someone who is immunosuppressed. They will be offered two doses of the Pfizer vaccine – in 10-microgram amounts, a third of the quantity used for adults – with a gap of eight weeks. A parallel announcement will expand the booster programme to more teenagers, including 16 and 17-year-olds.
22nd Dec 2021 - The Guardian

U.K. Allows Pfizer Covid Shot for At-Risk Children Aged 5 to 11

The U.K. vaccines panel cleared the Pfizer Inc. Covid-19 shot for use in vulnerable young children in a bid to widen vaccination coverage against the omicron variant. The Joint Committee on Vaccination and Immunisation changed its advice to allow at-risk children aged 5 to 11 years old to become eligible for two doses of the Pfizer-BioNTech vaccine. Each inoculation will be one-third of the dose used for those aged 12 and above. Only children in a clinical risk group or who are a household contact of an immunosuppressed person are eligible for vaccination at this stage. The JCVI said it would issue advice on shots for less vulnerable children “in due course.”
22nd Dec 2021 - Bloomberg

France Scraps Order for Merck Antiviral Pill, Looks to Pfizer

France canceled an order for Merck & Co.’s antiviral pill on disappointing test results and is now counting on a treatment from Pfizer Inc., according to the country’s health minister. “We had to cancel because the last studies weren’t good,” Olivier Veran said Wednesday in an interview on BFM TV. “It cost us nothing.” Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. Veran had initially expressed optimism about the Merck drug. The treatments, in which patients take pills at home over several days, could ease the burden on stretched hospitals as infections are soaring in the U.S. and Europe.
22nd Dec 2021 - Bloomberg

Is It Safe to Fly Right Now? Omicron May Double Infection Risk on Planes: IATA

Aircraft passengers are twice or even three times more likely to catch Covid-19 during a flight since the emergence of the omicron variant, according to the top medical adviser to the world’s airlines. The new strain is highly transmissible and has become dominant in a matter of weeks, accounting for more than 70% of all new cases in the U.S. alone. While hospital-grade air filters on modern passenger jets make the risk of infection much lower on planes than in crowded places on the ground such as shopping malls, omicron is rapidly spreading just as more travelers take to the skies for year-end holidays and family reunions.
22nd Dec 2021 - Bloomberg

S.African study offers Omicron hope as nations reimpose curbs

South African data offered a glimmer of hope on Wednesday about the severity of the Omicron coronavirus variant, but World Health Organization officials cautioned that it was too soon to draw firm conclusions as the strain spread across the globe. With the second Christmas of the pandemic days away, countries imposed new restrictions on their citizens while worrying about the damage the variant might inflict on their economies. Plans for Christmas parties and celebrations were wiped out from London to New Delhi amid the uncertainty.
22nd Dec 2021 - Reuters

Pharma 2022 forecast: With omicron extending the pandemic, how will biopharma respond to COVID?

Well, thanks to omicron, here we are again, asking many of the same questions and with renewed anxiety about the future. At least now we know the drill. “I see COVID continuing to have new variants and coming back each season,” Cantor Fitzgerald’s Grace Chen told Fierce Pharma. We also know what questions to ask. Is omicron more contagious? Will vaccines and treatments be effective? Are we destined for a return of restrictions and lockdowns? And, after omicron, what’s next? Are we simply on a coronavirus hamster wheel, with many more variants yet to contend with? As the pharmaceutical industry approaches 2022, there is some comfort knowing that a blueprint is in place to respond to the pandemic—and one that will allow business to continue. But what about those best-laid plans based on the belief that the pandemic would transition into an endemic in 2022?
22nd Dec 2021 - FiercePharma

A computational biologist weighs in on Omicron, the future of vaccines, and the CDC’s variant forecast

What do the data so far tell us about Omicron and whether it causes milder disease than previous Covid-19 variants? What can we expect to see as Omicron infections crash up against the country’s health care system? Why do Omicron waves seem to decline so quickly after scaling such heights? We don’t know. So we asked Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Research Center in Seattle, for his thoughts. Bedford believes that while there may be something intrinsically different about the way Omicron viruses attack human bodies, much of what is being reported in terms of mildness of cases can be explained by the fact that many people being infected have some immunity to the SARS-CoV-2 virus, either because they were previously infected or they’ve been vaccinated.
22nd Dec 2021 - STAT News


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

    View this newsletter in full

Covid US: Fauci says Omicron spreads at 'unprecedented' speed and cases will DOUBLE every two days

Dr Anthony Fauci, the nation's top infectious disease expert, said Tuesday that the Omicron COVID-19 variant is spreading at an 'unprecedented' speed. The CDC revealed on Monday night that the new variant accounts for 73% of new cases in the U.S., and is now the nation's dominant strain. It only accounted for 12% of cases last week. Fauci says that while cases of the variant are usually more mild, the speed of which it spreads could still cause massive issues for the U.S. healthcare system. The first U.S. based Omicron COVID-19 death was recorded on Monday in an unvaccinated Texas man between ages 50 and 60. More than 250,000 COVID-19 cases were recorded on Monday, the first time since early September the mark was reached. In New York and New Jersey, the Midwest, the Southeast, the Gulf Coast, and the Northwest, the Omicron variant now account for more than 90 percent of new cases
21st Dec 2021 - Daily Mail

EU drug regulator: COVID-19 boosters help restore some protection against Omicron

The European Union's drug regulator said early data shows a booster dose of a COVID-19 vaccine helps restore some protection against the new Omicron variant, although there is no evidence yet that tweaks to existing shots will be necessary. "Data is showing that indeed there is a drop in the ability of the (COVID-19) vaccine to exert good neutralisation for Omicron," said Marco Cavaleri, head of biological health threats and vaccines strategy at the European Medicines Agency (EMA). "A booster dose is indeed able to restore quite (a) high level of protection from symptomatic disease," he said later in the same briefing.
21st Dec 2021 - Reuters

Belgian researchers warn against holiday reliance on COVID antigen tests

Belgian researchers on Tuesday issued a pre-holiday warning against over-reliance on COVID-19 rapid antigen tests, saying they believed the breath of people infected with the disease had high levels of virus in the first two days after an infection -- a period when many antigen tests were negative. The organizations involved said they were communicating their findings in advance of a peer-reviewed publication in the interests of public health, as many families may be planning to use antigen tests as a way of screening for illness before family gatherings. "A negative rapid antigen test just before a meeting offers no guarantee to protect others, in particular when the person tested has recently been exposed to the virus," said Emmanuel Andre, a microbiologist at KU Leuven, which conducted the research together with UZ Leuven, a university hospital, and IMEC, a microelectronics think-tank.
21st Dec 2021 - Reuters

Long Covid Patients Report Vibrations, Tremors: ‘My Body Is Moving Inside, It’s Jolting’

Ms. Morrison, a 50-year-old transplant coordinator at a New Orleans hospital, says the sensations are among the symptoms she has experienced since testing positive for Covid-19 in March 2020. Long Covid patients—estimated to be 10% to 30% of people who have had Covid-19—experience a range of symptoms including fatigue, cognitive problems, shortness of breath and sensory issues, such as numbness and tingling. Internal vibrations and external tremors are less common and have received less attention. Yet a study this summer from the Patient-Led Research Collaborative, a group of long Covid patients that conduct research, found that roughly 40% of patients reported experiencing tremors and 30% vibrating sensations.
21st Dec 2021 - The Wall Street Journal

Omicron is more transmissible, but is it really milder?

The emergence of the Omicron variant has changed the course of the pandemic once again. Just as many countries were beginning to enjoy easing of restrictions and many families were planning for Christmas, the new variant arrived, forcing governments to scramble over measures to help curb its spread. Although it is widely accepted the Omicron variant did not originate in South Africa, because it had the technology and sense of responsibility to report the new variant, it has unfairly had the most severe travel restrictions imposed upon it by other countries. South African doctors and politicians have been critical of the global response, feeling it too harsh and disproportionate to the threat posed by the Omicron variant.
21st Dec 2021 - Al Jazeera English

Covid-19 Pills Expected to Win FDA Authorization This Week

The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter -- a milestone in the fight against the pandemic that will soon expand therapies for the ill. An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change. Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S.
21st Dec 2021 - Bloomberg

Pardes to go public, says COVID-19 antiviral pill does not need booster

Pardes Biosciences on Tuesday said early human testing of its experimental COVID-19 antiviral pill supports its potential as a standalone treatment and announced plans to go public by merging with a special purpose acquisition company. If the drug, PBI-0451, proves effective in later-stage testing, it could have an advantage over similar medicines that need to be taken with a second, booster medication, such as Pfizer Inc's (PFE.N) two-drug antiviral regimen, Paxlovid, now under review by the U.S. Food and Drug Administration. Pardes said it expects to complete its current Phase I study in healthy volunteers early next year. It aims to begin by mid-year a larger trial that could be used to seek regulatory approval for the COVID-19 antiviral pill.
21st Dec 2021 - Reuters

German COVID experts push for immediate contact limits

Germany will introduce new measures to curb the spread of COVID-19 before New Year's Eve, including limiting private gatherings for vaccinated people to a maximum of 10 people, Chancellor Olaf Scholz said on Tuesday. Stopping well short of a nationwide lockdown, Scholz also agreed with the premiers of Germany's 16 states to close clubs and discos and to only allow big events, including soccer matches, without spectators.
21st Dec 2021 - Reuters

Moderna could be ready to develop Omicron booster in weeks - CEO

COVID-19 vaccine maker Moderna (MRNA.O) does not expect any problems in developing a booster shot to protect against the Omicron variant of the coronavirus and could begin work in a few weeks, Chief Executive Stephane Bancel said in an interview. Moderna hopes to start clinical trials early next year on a vaccine to protect against the fast-spreading Omicron variant but for now is focussing on a booster dose of its current mRNA-1273 vaccine. "It only needs minor adjustments for Omicron. I don't expect any problems," Bancel said in an interview with the Swiss newspaper TagesAnzeiger published on Tuesday.
21st Dec 2021 - Reuters

Omicron cases could hit 200,000 a day next year without tougher restrictions, Doherty modelling warns

Surging Omicron infections will overwhelm the health system unless some restrictions return, according to modelling prepared for national cabinet that also recommends bringing coronavirus vaccine boosters forward. The Doherty Institute modelling predicts that without low-to-medium restrictions such as density and visitor limits, waning vaccine protection against the Omicron variant puts Australia on track to hit about 200,000 cases a day by late January or early February.
21st Dec 2021 - Sydney Morning Herald


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

    View this newsletter in full

EU Commission authorises Novavax COVID-19 vaccine

The European Commission authorised on Monday the use of the Novavax COVID-19 vaccine in the European Union. "With five approved vaccines, the EU has a varied portfolio, based both on novel technologies, such as mRNA, and classic ones, like Novavax, which is protein-based," the head of the bloc's executive Commission, Ursula von der Leyen, said on Twitter.
20th Dec 2021 - Reuters

Covid-19 news: Moderna booster stimulates antibodies against omicron

Moderna booster jab leads to 37-fold increase in levels of antibodies against the omicron variant. A booster dose of Moderna’s coronavirus vaccine appears to increase neutralising antibodies against the coronavirus, the company announced on Monday. A 50mg dose of the booster – the dose authorised for use in the UK and US – was found to stimulate a 37-fold increase in antibodies against omicron. A 100mg dose of the booster saw an 83-fold increase in antibodies. The 37-fold increase “should provide some good level of protection as we go into the holiday season”, Paul Burton, Moderna’s chief medical officer, told the Washington Post. The findings are based on antibody levels measured in the blood of 20 people 29 days after receiving a third dose of the vaccine. Moderna announced the results in a press release – the study has not yet been published or peer reviewed.
20th Dec 2021 - New Scientist

Kremlin convinced WHO will approve Sputnik V vaccine within months -Ifax

The Kremlin is convinced that the World Health Organization (WHO) will recognise Russia's flagship Sputnik V COVID-19 vaccine within a few months, the Interfax news agency cited Kremlin spokesperson Dmitry Peskov as saying on Sunday. The Kremlin on Tuesday said Russia had still not handed over all the information needed for the vaccine to be approved by the WHO because of differences in regulatory standards. "I am deeply convinced that literally within a few months... the WHO will approve Sputnik and it will also then be possible to move forward on this path with the Europeans," Interfax quoted Peskov as saying.
20th Dec 2021 - Reuters

French health regulator approves Pfizer vaccine for 5-11 year olds

France's Haute Autorite de Sante (HAS) health regulator approved the Pfizer-BioNTech COVID-19 vaccine for all children aged 5-11 on Monday. The vaccine, which will be administered in a paediatric formulation when it becomes widely available, showed high efficacy among children, said Lise Alter, one of the doctors charged with the risk evaluation of new drugs. "The HAS suggests that all parents who want it can have their children aged 5 to 11 years vaccinated," she added. Last week France started vaccinating 5-11 year olds with medical conditions that require special protection and ramped up logistics to roll out vaccination of all children in the age group once the HAS approves the move.
20th Dec 2021 - Reuters

New Zealand links 26-year-old man's death to Pfizer COVID-19 vaccine

New Zealand authorities on Monday said they had linked a 26-year-old man's death to Pfizer Inc's COVID-19 vaccine after the person suffered myocarditis, a rare inflammation of the heart muscle, after taking his first dose. The death is New Zealand's second linked to a known but rare side effect from the vaccine after health authorities in August reported a woman had died after taking her doses. "With the current available information, the board has considered that the myocarditis was probably due to vaccination in this individual," a COVID-19 Vaccine Independent Safety Monitoring Board said in a statement.
20th Dec 2021 - Reuters

Bharat Biotech seeks trial for intranasal COVID-19 vaccine booster

Indian vaccine maker Bharat Biotech said on Monday it has submitted an application to the country's drug regulator to conduct a late-stage trial for a booster dose of its intranasal COVID-19 vaccine. Indian COVID-19 vaccine makers are lobbying the government to authorise boosters as supplies have far outstripped demand, but the health ministry said there is no immediate plan to approve boosters and the priority remains complete vaccination of eligible adults. read more "We have submitted phase 3 clinical trial application to DCGI (Drugs Controller General of India)," a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
20th Dec 2021 - Reuters

Sinopharm COVID-19 booster weaker against Omicron - study

A COVID-19 booster shot produced by China's Sinopharm had "significantly lower" neutralising activity against the Omicron variant, Chinese researchers said in a paper, although they added the vaccine's efficacy against Omicron remained unclear. The study - conducted by researchers from Shanghai Jiao Tong University and a Shanghai-based lab specializing in respiratory infectious diseases - compared the activity of Sinopharm's booster vaccine against an older coronavirus strainfrom Wuhan. The neutralising antibody activity of a Sinopharm BBIBP-CorV booster against Omicron showed a 20.1-fold reduction, compared with its activity against a Wuhan strain, according to the paper published on Saturday.
20th Dec 2021 - Reuters

Moderna says booster dose of its COVID-19 vaccine appears protective vs. Omicron

Moderna Inc said that a booster dose of its COVID-19 vaccine appeared to be protective against the fast-spreading Omicron variant of the coronavirus in laboratory testing and that the current version of the shot would continue to be its "first line of defense against Omicron." The company said its decision to focus on the current vaccine, mRNA-1273, was driven in part by how quickly the recently-discovered variant is spreading. Moderna said it still plans to develop a vaccine to protect against Omicron specifically and hopes to start clinical trials early next year.
20th Dec 2021 - Reuters

Novavax expected to start delivering COVID-19 shots to EU in first quarter 2022 -EU source

Novavax is expected to start delivering its COVID-19 vaccines to the European Union in the first quarter of 2022, an EU source said, as experts for the region's drug regulator met on Monday to decide whether to approve the shot. The EU Commission had no immediate comment and the U.S. biotech company was not immediately available for comment. The EU source declined to be identified because they were not authorised to speak to the media.
20th Dec 2021 - Reuters

Pharma After EMA recommendation, Novavax's COVID-19 vaccine nears rollout in Europe

In less than a week, Novavax has clinched a second major win in its bid to expand the reach of its COVID-19 vaccine. The European Medicines Agency (EMA) on Monday blessed Novavax’s shot, Nuvaxovid, with a recommendation for conditional marketing authorization in the European Union. The news comes just a few days after the vaccine, also known as NVX-CoV2373, won emergency use listing from The World Health Organization (WHO), teeing up shipments to the agency’s equitable vaccine access scheme COVAX. The shot will carry the Nuvaxovid name if it’s authorized in Europe. Elsewhere, the vaccine has been authorized under the Covovax moniker.
20th Dec 2021 - FiercePharma

For an antiviral researcher, Covid brings a flood of attention — and opportunity

At the heart of the effort to develop these therapies are scientists like Glenn. For them, Covid is a chance to prove that they can make a difference by developing new treatments not just for the current pandemic but also future threats. “We’ve always believed that what we work on is meaningful and can be very impactful, but now the world gets it,” Glenn said. There remain questions about how long the boom times will last. Antiviral researchers have seen interest in their work flare — with the 2003 SARS outbreak, for instance, or the anthrax attacks after Sept. 11, 2001 — only to quickly dissipate. The same could happen with Covid, though many experts are hoping this time is different. “I seriously hope there is a realization that this needs to be a sustained effort,” said Kara Carter, entrepreneur-in-residence at the biotechnology company Evotec and president of the International Society for Antiviral Research. “We’ve already had multiple viral epidemics and pandemics in our lifetimes, and this is not going to stop.”
20th Dec 2021 - STAT News

Facing intense criticism, Moderna pauses bitter dispute with the NIH over Covid-19 vaccine patents

Moderna has halted a rancorous patent dispute with the U.S. government over assigning credit for its Covid-19 vaccine, saying the ongoing quarrel “could interfere with further discussions aimed at an amicable resolution” with the National Institutes of Health. The move comes amid intensifying complaints that many vaccine makers are failing to make their intellectual property available so that still other companies can produce vaccines needed for a global eradication campaign. Moderna, which recently projected $18 billion in vaccine sales this year, has been a particular focus of criticism because U.S. taxpayers provided $2.5 billion to help develop the shot.
19th Dec 2021 - STAT News


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

    View this newsletter in full

Pfizer says pandemic could extend through 2023, studies three-dose vaccine course for children

The U.S. pharmaceutical company made its comments as European countries geared up for further travel and social restrictions and a study warned that the rapidly spreading Omicron coronavirus variant was five times more likely to reinfect people than its predecessor, Delta. Pfizer executives said the company believed that by 2024, the disease should be endemic around the globe, meaning it would no longer be a pandemic. The company projected that "COVID will transition to an endemic state potentially by 2024."
19th Dec 2021 - Reuters

CDC recommends Moderna, Pfizer COVID-19 vaccines over J&J's

The U.S. Centers for Disease Control and Prevention on Thursday recommended Americans choose to receive one of two other authorised COVID-19 vaccines over Johnson & Johnson's shot, due to rare but sometimes fatal cases of blood-clotting. The CDC's move came after its Advisory Committee on Immunization voted unanimously to make the recommendation in favour of the vaccines made by Moderna Inc and Pfizer)/BioNTech over the J&J shot.
19th Dec 2021 - Reuters

S.Africa says vaccines, prior infection help mildness of COVID cases

South Africa's health minister said on Friday that the government believed that vaccines and high levels of prior COVID-19 infection were helping to keep disease milder in a wave driven by the Omicron variant. There have been early anecdotal accounts suggesting that Omicron is causing less severe illness than previous variants in South Africa but scientists say it is too early to draw firm conclusions. The country reported a record number of daily infections earlier this week.
19th Dec 2021 - Reuters

The Science Behind Omicron’s Rapid Spread

As Omicron has rapidly taken over as the dominant variant of the coronavirus in South Africa and the U.K., scientists are beginning to piece together what gives it its evolutionary advantage. Researchers are still refining and augmenting their findings, but Omicron’s heightened transmissibility appears to be a combination of several properties: It seems able to more easily bind to and break into human respiratory cells; it appears to replicate faster once within our bodies; and it can substantially evade the immunity gained from past infection or vaccination. These advantages mean Omicron is spreading across the world at a breakneck pace. Since scientists in South Africa first flagged its presence last month, it has been detected in 77 countries and is probably present in most others, according to the World Health Organization.
19th Dec 2021 - The Wall Street Journal

Fauci says omicron variant is `just raging around the world’

The COVID-19 omicron variant is “just raging around the world,” the White House’s top medical adviser said Sunday as President Joe Biden prepares to issue “a stark warning of what the winter will look like” for unvaccinated Americans. Dr. Anthony Fauci, the country’s leading infectious disease expert, told NBC’s “Meet the Press” that “the real problem” for the U.S. hospital system is that “we have so many people in this country who are eligible to be vaccinated who have not yet been vaccinated.” The prospect of a winter chilled by a wave of coronavirus infections is a severe reversal from the optimism projected by Biden some 10 months ago, when he suggested at a CNN town hall that the country would essentially be back to normal by this Christmas. Biden has been careful not to overpromise, yet confidence in the country has been battered by an unrelenting wave of COVID-19 mutations and variations that have left many Americans emotionally exhausted, dispirited and worried about infections.
19th Dec 2021 - The Associated Press

Is UK heading for New Year lockdown? Professor Neil Ferguson: 7,000 Omicron deaths a DAY

Professor Ferguson - the UK Government adviser whose modelling has spooked No10 into lockdowns before -  said tighter curbs were needed before New Year to stop a massive hospital surge.
17th Dec 2021 - Daily Mail

Moderna COVID-19 shot likelier to cause heart inflammation than Pfizer's: study

Moderna's COVID-19 vaccine is up to four times more likely to cause inflammation of the heart muscle, a very rare side effect, than its rival vaccine from Pfizer-BioNTech, according to a Danish study published in the British Medical Journal late on Thursday. The study, in which almost 85% of Danes, or 4.9 million individuals, aged 12 and older participated, investigated the link between mRNA-based COVID-19 vaccines and heart inflammation, also known as myocarditis or myopericarditis. Earlier studies from Israel and the United States have indicated an increased risk of heart inflammation after inoculation with the mRNA-vaccines developed by Pfizer-BioNTech and Moderna.
17th Dec 2021 - Reuters

'Tidal wave': Omicron could put U.S. COVID-19 surge into overdrive

Two years into the coronavirus pandemic, the United States is confronting another dark winter, with the red-hot Omicron variant threatening to worsen an already dangerous surge of cases. Hospitalizations for COVID-19 have jumped 45% over the last month, and confirmed cases have increased 40% to a weeklong average of 123,000 new U.S. infections a day, according to a Reuters tally. Pfizer Inc, one of the chief vaccine makers, on Friday predicted the pandemic would last until 2024 and said a lower-dose version of its vaccine for children ages 2 to 4 generated a weaker-than-expected immune response, which could delay authorization
17th Dec 2021 - Reuters

EU to place order with Pfizer for COVID shots adapted to Omicron

European Union governments have agreed to exercise an option to buy more than 180 million doses of a version of the COVID-19 vaccine adapted for the Omicron variant developed by BioNTech and Pfizer, the head of the European Commission said. Pfizer and BioNTech began development of a prototype Omicron-specific vaccine on November 25, and said they could have it ready in March. "The Member States have agreed to trigger a first tranche of over 180 million extra doses of adapted vaccines, in our third contract with BioNTech-Pfizer," Ursula von der Leyen told a news conference on Thursday night at the end of a regular summit with EU leaders.
17th Dec 2021 - Reuters

Moderna Drops Pursuit of U.S. Patent for Key Component of Covid-19 Vaccine

Moderna Inc. has abandoned its application for a U.S. patent covering its Covid-19 vaccine that has been the subject of a heated dispute with the National Institutes of Health over the invention of a key component of the shot. The Cambridge, Mass., company said Friday it dropped the patent application “to allow more time for discussions with the NIH” aimed at an amicable resolution. At issue was credit for a key component of Moderna’s Covid-19 vaccine, among the most widely used in the world. Patent holders could seek a cut of the shot’s billions of dollars in sales, though NIH hasn’t said whether it is interested in royalties.
17th Dec 2021 - The Wall Street Journal


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

    View this newsletter in full

EU Strikes Deal With Moderna to Speed German Vaccine Supply

The European Union brokered a deal to expedite deliveries of the Moderna Covid-19 vaccine to countries like Germany that are experiencing temporary shortages as they try to accelerate inoculation and ward off the omicron variant. Moderna Inc. agreed to bring forward delivery of 10 million doses to Germany in December, enough for 20 million boosters, the European Commission said Thursday. The company will also provide 25 million extra shots to Germany in the first quarter of 2022. Germany has started rationing Covid vaccines through the rest of the year as it seeks to maintain momentum in its ramped-up booster campaign going despite an unexpected shortage of BioNTech SE vaccines.
16th Dec 2021 - Bloomberg

Denmark approves treatment with Merck's COVID-19 tablet molnupiravir

Danish health authorities on Thursday approved treatment with Merck & Co Inc’s molnupiravir tablet for COVID-19 patients at risk of serious illness, including the elderly. The medication has yet to be approved by the European Medical Agency, which in late November started reviewing U.S. drugmaker Merck’s experimental COVID-19 antiviral pill for adults and said it could issue an opinion within weeks.
16th Dec 2021 - KFGO News

Pfizer says its COVID pill will protect against severe disease, even from Omicron

Scientists are working to learn more about a new COVID-19 variant, Omicron, that was first detected in South Africa, setting out to discover how transmissible it is, whether the vaccines that are currently available are effective against it, and other answers as much is still unknown about the strain. In order to shore up protection against the virus amid data that show immunity wanes from the vaccines over time, US health officials have expanded their recommendations for who should get COVID-19 booster shots to include people 16 and older. The expansion comes as COVID-19 cases and hospitalizations rise in Massachusetts, in what experts fear is the start of a winter surge.
16th Dec 2021 - MSN

GSK/Sanofi Covid booster delayed by lack of uninfected people to test it on

Efforts by the British and French drugmakers GSK and Sanofi Pasteur to produce a Covid-19 vaccine have suffered a further setback, with final clinical data on the jab and a potential launch delayed until next year as they struggle to find enough uninfected people to test it on. The two vaccine specialists announced positive preliminary results from a trial that showed the vaccine raised antibody levels against Covid by nine to 43 times when given as a single booster shot in people who had already received doses of AstraZeneca, Johnson & Johnson, Moderna or Pfizer/BioNTech vaccines, for all age groups. There were no safety concerns, according to an independent review body. It is the most comprehensive booster trial to date, said GSK and Sanofi.
16th Dec 2021 - The Guardian

Covid 19: US cases rise amid omicron fears but booster shots offer protection, experts say

Some 800 000 Americans have died from covid-19, the highest number of any country in the world, and cases, deaths, hospital admissions, and local transmission are increasing as the threat of omicron is growing, Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), has said. However, two doses of an mRNA vaccine and a booster provide good protection and there is no need for a booster specific for the variant, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and President Joe Biden’s medical advisor. Both spoke at a White House press briefing yesterday on 15 December.1 Jeffrey Zients, the White House coronavirus response coordinator, said, “The US vaccination programme has already prevented 10.3 million hospital admissions. And it has saved 1.1 million American lives.”
16th Dec 2021 - The BMJ

Covid-19 antiviral drug thapsigargin excites researchers in early tests with ‘one of a kind’ results

A researcher at a British university believes he may have found a unique new antiviral drug that can stop the cause of Covid-19, could be made into a pill, tackles respiratory syncytial virus (RSV) and influenza, and crucially would not encourage drug resistance. Prof Kin-Chow Chang of Nottingham University told i that early lab results for the antiviral, thapsigargin, have been so promising in the way it arms the body against the Sars-CoV-2 coronavirus that they almost appear “too good to be true” – showing it is “one of a kind”. Prof Chang emphasises that his team’s research, using cells and mice, is still at a preliminary stage. But further trials on animals are expected next year and his confidence is growing.
16th Dec 2021 - iNews

Takeda submits approval request for Novavax's COVID-19 vaccine in Japan

Takeda Pharmaceutical Co Ltd has submitted an approval request for Novavax's COVID-19 vaccine to Japan's health ministry, the U.S. drugmaker said late on Wednesday.
16th Dec 2021 - Reuters

Japan approves Moderna COVID vaccine as booster, Novavax files for 1st approval

Japan on Thursday officially approved Moderna Inc's COVID-19 vaccine for its booster programme, while Novavax Inc filed for first approval of its shot in the country. Moderna's mRNA-type vaccine, used mostly in Japan to date at workplace inoculation sites, was approved for used as a third booster shot for those aged 18 or older, following a recommendation from health ministry experts on Wednesday.
16th Dec 2021 - Reuters

Omicron thrives in airways, not lungs; new data on asymptomatic cases

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. Omicron multiplies faster in airways, slower in lungs Major differences in how efficiently Omicron and other variants of the coronavirus multiply may help predict Omicron's effects, researchers said on Wednesday. Compared to the earlier Delta variant, Omicron multiplies itself 70 times more quickly in tissues that line airway passages, which may facilitate person-to-person spread, they said. But in lung tissues, Omicron replicates 10 times more slowly than the original version of the coronavirus, which might contribute to less-severe illness.
16th Dec 2021 - Reuters

EU regulator okays COVID-19 treatments from GSK-Vir and Sobi

The European Union's drug regulator on Thursday approved a COVID-19 treatment from British-U.S. duo GSK and Vir Biotechnology and another from Swedish drugmaker Sobi, as the bloc builds its defences against Omicron. The approval by the European Medicines Agency (EMA) of GSK-Vir's antibody drug Xevudy and Sobi's arthritis drug Kineret come as governments struggle with soaring infections and worry about the swiftly-spreading Omicron variant of the coronavirus. EMA's human medicines committee recommended using Kineret to treat COVID-19 in adults with pneumonia requiring oxygen support and those at risk of developing severe respiratory failure.
16th Dec 2021 - Reuters

Valneva says its booster works as a follow up to its own COVID-19 shot

French biotech firm Valneva said on Thursday its COVID-19 vaccine candidate was efficient as a booster for people who had received the same shot as an initial vaccination. "Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination," it said in a statement. The news comes almost two weeks after a British study showed VLA2001 was the only shot out of seven that offered no immunity boost when given to people previously immunised with Pfizer's COVID-19 vaccine
16th Dec 2021 - Reuters

Regeneron says its COVID-19 therapy has lower potency against Omicron

AstraZeneca and Regeneron on Thursday reported contrasting data on the effectiveness of their COVID-19 antibody therapies against the Omicron variant of the coronavirus, underscoring the major challenges ahead for drugmakers. U.S.-based Regeneron said its REGEN-COV therapy, also called Ronapreve, is less effective against Omicron, though it is still active against the Delta variant, confirming indications from lab tests and computer modelling late last month
16th Dec 2021 - Reuters

As COVID cases rise, Spain approves booster shots for over 40s

Spain will administer a third dose of coronavirus vaccine to people aged 40 and over, the Health Ministry said on Thursday, expanding the booster programme a day after its child vaccination campaign kicked off amid a sharp rise in cases. The ministry, which had already rolled out booster shots for the over 60s, health workers and clinically vulnerable, said the most elderly remained the priority, as well as those yet to receive any shot. "Progressively, the booster dose may be administered to persons aged 49 to 40 years, starting with the oldest age cohorts," the ministry said in a statement.
16th Dec 2021 - Reuters

Denmark approves Merck's COVID-19 pill for at-risk patients

Denmark on Thursday approved Merck & Co Inc's molnupiravir antiviral pill for COVID-19 patients at risk of serious illness, including the elderly. The treatment is still under review by the European Medicines Agency (EMA). Faced with rising coronavirus cases, the EU drug regulator issued advice in November on using it for adults ahead of providing any wider recommendation. Announcing its approval for restricted use in Denmark, Health Authority chief medical officer Kirstine Moll Harboe said: "We believe that the benefits of being treated (with it) outweigh the disadvantages for those patients who are most at risk of becoming seriously ill with COVID-19."
16th Dec 2021 - Reuters


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

    View this newsletter in full

Sanofi, GSK say COVID-19 vaccine booster candidate give good immune response

Sanofi and GlaxoSmithKline said on Wednesday a single booster dose of their COVID-19 vaccine candidate provided strong immune responses, preliminary data from clinical trials show, a boost for the drugmakers after lagging the vaccine race.
15th Dec 2021 - Reuters

The Hunt for a One-Shot Coronavirus Vaccine

Wang’s lab is one of several racing to develop such a shot. Others include researchers at Duke University, the California Institute of Technology and Walter Reed Army Institute of Research. The research is still in its early days, and scientists have yet to figure out which parts of the virus to target, what technology works best and how broad-acting the shot could be. But in the long term, the biggest question may be not the science but who is going to fund large trials and manufacturing scale-up if the pan-coronavirus results continue to remain promising. Many existing Covid-19 vaccine companies haven’t invested heavily in the pan-coronavirus work, as they wait for the research to mature. Until they decide to invest more significantly, large dollops of government and nonprofit funding will be required to move it forward, and it isn’t yet clear where all the money would come from.
15th Dec 2021 - Bloomberg

Vaccines still provide ‘significant protection’ against severe COVID-19

Omicron has been the latest variant to test the effectiveness of COVID-19 vaccines. COVID-19 vaccines appear to have become less effective in preventing severe COVID-19 disease and death, but they still provide ‘significant protection’, says the World Health Organisation (WHO), according to Reuters. The Omicron variant, first detected in South Africa and Hong Kong last month, has now been reported by 77 countries. WHO director general Tedros Adhanom Ghebreyesus emphasised that it should not be dismissed as “mild”.
15th Dec 2021 - PharmaTimes

U.S. study suggests vaccines may be ineffective against Omicron without booster

All three U.S.-authorized COVID-19 vaccines appear to be significantly less protective against the newly-detected Omicron variant of the coronavirus in laboratory testing, but a booster dose likely restores most of the protection, according to a study released on Tuesday. The study from researchers at Massachusetts General Hospital, Harvard and MIT that has not yet been peer reviewed tested blood from people who received the Moderna, Johnson & Johnson and Pfizer/BioNTech vaccines against a pseudovirus engineered to resemble the Omicron variant.
15th Dec 2021 - Reuters

Hong Kong researchers urge third COVID-19 shot after new Omicron study

Researchers in Hong Kong have urged people to get a third dose of COVID-19 vaccine as soon as possible, after a study showed insufficient antibodies were generated by the Sinovac and BioNTech products to fend off Omicron. Tuesday's release of the results of a study by scientists in the microbiology department of the University of Hong Kong was the first published preliminary data on the impact of Sinovac's vaccine against the Omicron variant of coronavirus. None of the serum of the 25 Coronavac vaccine recipients contained sufficient antibodies to neutralise the new variant, according to the study, accepted for publication in the journal Clinical Infectious Diseases, the researchers said.
15th Dec 2021 - Reuters

EU regulator backs J&J COVID-19 booster dose for adults

The European Union's drug regulator on Wednesday recommended that a booster dose of Johnson & Johnson's COVID-19 shot may be given at least two months after a first dose in people aged 18 years and older, as the bloc battles surging infections. The Omicron coronavirus variant is swiftly spreading across the globe, with many new cases linked to the mutant and the World Health Organization warning that Omicron poses a "very high" risk but data on its severity is limited. The European Medicines Agency (EMA) said its recommendation to allow J&J booster doses follows data which showed the additional shot led to a rise in antibodies against the COVID-causing SARS-CoV-2 coronavirus.
15th Dec 2021 - Reuters

Pfizer set to oust AstraZeneca as top supplier of COVID-19 shots to poor nations

Pfizer and BioNtech are set to displace AstraZeneca as the main suppliers of COVID-19 vaccines to the global COVAX programme at the start of 2022, a shift that shows the increasing importance of their shot for poorer states. The expected change comes with headaches for receiving countries that lack sufficient cold storage capacity to handle the Pfizer vaccine, and amid risks of a shortage of syringes needed to administer that shot. AstraZeneca is currently the most distributed vaccine by COVAX, according to data from Gavi, the vaccine alliance that co-manages the programme with the World Health Organization (WHO).
15th Dec 2021 - Reuters

Sanofi, GSK delay data on COVID-19 vaccine booster candidate until 2022

Sanofi and GlaxoSmithKline said on Wednesday they expect data from late-stage clinical trials of its booster dose of their COVID-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as the French and British partners said preliminary data from trials showed the single-dose booster provided strong immune responses. The companies said they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted COVID-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022."
15th Dec 2021 - Reuters

COVID-19 vaccines may be less effective against Omicron - WHO

Preliminary evidence indicates that COVID-19 vaccines may be less effective against infection and transmission linked to the Omicron coronavirus variant, which also carries a higher risk of reinfection, the World Health Organization said on Wednesday. The WHO, in its weekly epidemiological update, said that more data was needed to better understand the extent to which Omicron may evade immunity derived from either vaccines or previous infection.
15th Dec 2021 - Reuters

Will we always need Covid-19 boosters? Experts have theories

With the world facing the latest in a seemingly endless stream of coronavirus variants — and with bullish talk from manufacturers about a need for even more vaccine shots — you wouldn’t be alone if you were wondering: Are Covid boosters always going to be a fixture in our future? The simple truth is that, at this point, there’s no definitive answer to that question. But virologists, immunologists, and vaccinologists have opinions that are anchored in an understanding of how the immune system works and in emerging data on how Covid vaccines engage with this complicated enterprise that has evolved to help humans fend off disease threats.
15th Dec 2021 - Stat News


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

    View this newsletter in full

Needle-free Covid-19 vaccine being trialled in the UK

A trial is being launched of a new needle-free Covid-19 vaccine that could give ‘wide-ranging protection’ against variants and future coronaviruses. The University of Southampton has developed the new vaccine which uses a jet of air to push it through the skin rather than a needle. Saul Faust, clinical chief investigator and director of the NIHR Southampton Clinical Research Facility, said: ‘This isn’t simply ‘yet another’ coronavirus vaccine as it has both Covid-19 variants and future coronaviruses in its sights. ‘This technology could give wide-ranging protection to huge numbers of people worldwide.’
14th Dec 2021 - Metro.co.uk

Covid-19 milestones: 800,000 deaths, 50 million infections, 1 year of vaccines

Tuesday marks precisely one year since the first coronavirus vaccine shots were going into arms in the US. Over the course of that year, an incredible 202 million people and counting -- more than 60% of the entire US population -- have been fully vaccinated; about 484 million vaccine doses have been delivered; and now the government is encouraging everyone 16 and older to get a booster shot. The number of people fully vaccinated is both incredible and not nearly enough. Fights over how to get the rest of the country to utilize the shots waiting for them have turned into a massive political and legal standoff over requirements.
14th Dec 2021 - CNN

Malaysia gives conditional approval for use of Ronapreve COVID-19 treatment

Malaysia's health ministry said on Tuesday it has given conditional approval for the use of the single-dose antibody cocktail Ronapreve, developed by Regeneron (REGN.O) and Roche (ROG.S), to treat COVID-19. It has also approved a request from Merck & Co (MRK.N) for a clinical trial import license for its COVID-19 pill Molnupiravir, to be used as part of studies being conducted in Malaysia, the ministry said in a statement.
14th Dec 2021 - Reuters

Russia yet to hand over all data for COVID vaccine's WHO approval - Kremlin

Russia has still not handed over all the information needed for its flagship Sputnik V COVID-19 vaccine to be approved by the World Health Organisation because of differences in regulatory standards, the Kremlin said on Tuesday. Moscow rushed to approve the Sputnik V shot for domestic use last year, but it has still not been certified by either the WHO or the European Medicines Agency, the EU's drug regulator. Asked what was causing the delay, Kremlin spokesman Dmitry Peskov told reporters the certification process was under way.
14th Dec 2021 - Reuters

India stuck with COVID-19 vaccines it can't export

India is struggling to export its surplus of COVID-19 vaccines as logistical hurdles delay their use in many countries despite low levels of inoculation, vaccine producer the Serum Institute of India (SII) and a government official said on Tuesday. The SII, the world's biggest vaccine maker that produces the AstraZeneca, Novavax and Sputnik COVID-19 shots, has already announced plans to temporarily halve output of the AstraZeneca drug until more orders came, including possibly through boosters. read more
14th Dec 2021 - Reuters

Higher risk of heart complications from COVID-19 than vaccines -study

COVID-19 infections are more likely to trigger rare cardiovascular complications such as heart inflammation and irregular heartbeat than vaccines, a British study showed on Tuesday, after scientists parsed data of about 38 million vaccinated people. The study, published in the Nature Medicine journal, compared the risks of myocarditis, pericarditis and cardiac arrhythmia following a first and second dose of COVID-19 vaccines – from AstraZeneca-Oxford, Pfizer-BioNTech, and Moderna - with coronavirus infections.
14th Dec 2021 - Reuters

Pfizer says COVID-19 pill near 90% effective in final analysis

Pfizer Inc on Tuesday said its antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus. The U.S. drugmaker last month said the oral medicine was around 89% effective in preventing hospitalizations or deaths when compared to placebo, based on interim results in around 1,200 people. Data from its final analysis of the trial disclosed on Tuesday includes an additional 1,000 people. Nobody in the trial who received the Pfizer treatment died, compared with 12 deaths among placebo recipients.
14th Dec 2021 - Reuters

Moderna to produce millions of mRNA vaccines in Australia

U.S. drugmaker Moderna Inc will produce millions of mRNA vaccines a year in Australia after agreeing to set up one of its largest manufacturing facilities outside the United States and Europe. The deal, a second such commitment in Asia Pacific by a western mRNA vaccine developer, underscores efforts by governments around the world to build up local production and prepare for future pandemic threats after limited early access to shots led to slow COVID-19 vaccine rollouts.
14th Dec 2021 - Reuters

Pfizer Covid Pill Effective to Stop Hospitalization, New Study Shows

New study data showed Pfizer Inc.’s experimental Covid-19 pill was highly effective at keeping patients out of the hospital, but less adept at erasing milder symptoms often associated with breakthrough infections. Pfizer disclosed findings from two studies in a statement Tuesday. In one, its treatment, Paxlovid, failed to meet the primary goal of reducing self-reported symptoms in 673 adults at standard risk of developing Covid-19 complications. The drug showed a trend toward reducing hospitalizations in the group by 70%, however. In the other study, the treatment remained 89% effective in preventing hospitalizations in high-risk unvaccinated people when used within 3 days of the appearance of symptoms. That confirmed Pfizer’s earlier analysis of results from a smaller number of patients.
14th Dec 2021 - Bloomberg

Data indicate omicron is milder, better at evading vaccines

The omicron variant is offering more hints about what it may have in store as it spreads around the globe: A highly transmissible virus that may cause less severe disease, and one that can be slowed — but not stopped — by today’s vaccines. An analysis Tuesday of data from South Africa, where the new variant is driving a surge in infections, suggests the Pfizer vaccine offers less defense against infection from omicron and reduced, but still good, protection from hospitalization. The findings are preliminary and have not been peer-reviewed — the gold standard in scientific research — but they line up with other early data about omicron’s behavior, including that it seems to be more easily spread from person to person.
14th Dec 2021 - The Associated Press

New Australian plant could make 100 million vaccines a year

Australia’s government said Tuesday it plans to start making mRNA vaccines at home with a new plant that could produce up to 100 million doses each year. The announcement came as coronavirus cases in Sydney and surrounding areas jumped, driven in part by the omicron variant. The new factory would be built in Victoria state in a partnership between vaccine manufacturer Moderna and the federal and state governments. It is expected to open by 2024. Australian Prime Minister Scott Morrison said it was in the country’s national interest to produce vaccines locally.
14th Dec 2021 - The Associated Press

Pfizer jab protects against hospitalisation with Omicron: Study

Two doses of Pfizer-BioNTech’s COVID-19 vaccine appear to provide 70 percent protection against hospitalisation from the Omicron coronavirus variant, according to an extensive real-world study in South Africa. The analysis released on Tuesday by South Africa’s largest private health insurance administrator, Discovery Health, was based on more than 211,000 positive COVID-19 test results of adults from November 15 to December 7, about 78,000 of which were attributed to Omicron.
14th Dec 2021 - AlJazeera

Leading Covid-19 experts on the questions they want answered about Omicron

For some Covid experts, what’s most unsettling about the Omicron variant is all the uncertainty surrounding it. That’s what keeps John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, up at night. “I’ve lost more sleep worrying about answering questions about Omicron than over Omicron itself,” he said during a panel at STAT’s “A Look Ahead at Biotech 2022”event last week. Moore, like many other experts, is waiting for more data before judging how the new variant is going to pan out. More time will tell us whether Omicron will fizzle out and be forgettable like Beta, or if it will be much more consequential and replace Delta, in much the same way Delta replaced Alpha.
14th Dec 2021 - STAT News

Pfizer shot less effective in South Africa after Omicron emerges, study shows

Pfizer-BioNTech's COVID-19 vaccine has been less effective in South Africa at keeping people infected with the virus out of hospital since the Omicron variant emerged last month, a real-world study published on Tuesday showed. Between Nov. 15 and Dec. 7, people who had received two doses of the shot had a 70% chance of avoiding hospitalisation, down from 93% during the previous wave of Delta infections, the study showed.
14th Dec 2021 - Reuters

One year of vaccines: Many lives saved, many needlessly lost

One year ago, the biggest vaccination drive in American history began with a flush of excitement in an otherwise gloomy December. Trucks loaded with freezer-packed vials of a COVID-19 vaccine that had proved wildly successful in clinical trials fanned out across the land, bringing shots that many hoped would spell the end of the crisis. That hasn’t happened. A year later, too many Americans remain unvaccinated and too many are dying. The nation’s COVID-19 death toll stands at around 800,000 as the anniversary of the U.S. vaccine rollout arrives. A year ago it stood at 300,000.
13th Dec 2021 - The Associated Press


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

    View this newsletter in full

Two-Dose Covid Vaccine Less Effective Against Omicron Than Delta, Study Shows

The omicron variant dented the protection afforded by two doses of Pfizer Inc.’s and AstraZeneca Plc’s Covid vaccines as feared, researchers found, increasing the risk of infection. Blood samples collected from people vaccinated with the two different shots and tested against the new strain showed a substantial drop in neutralizing antibodies, a proxy for protection, particularly compared with the delta variant, researchers from the University of Oxford said Monday in a paper.
14th Dec 2021 - Bloomberg

Moderna amends Covid-19 vaccine supply deal with Gavi

Moderna has amended an existing contract with Gavi, the Vaccine Alliance, to expedite the supply of 20 million doses of its Covid-19 vaccine to COVAX by the end of this year. Under the deal, the company agreed to deliver a total of 54 million vaccine doses to COVAX this year. The supply of the vaccine doses to COVAX Advance Market Commitment (AMC) nations has already been initiated. They were initially agreed to be delivered in the first quarter of next year as part of the company’s prior agreement with Gavi.
13th Dec 2021 - Pharmaceutical Technology

Vaccine committee rules against fourth COVID shot

Individuals double vaccinated against COVID-19 within the last six months can't receive a booster and still need to wait to get their third jab, the Pandemic Response Team and the Advisory Committee on Vaccines said late Sunday night. The committee met for several hours to discuss the issue, as 67 cases of Omicron were discovered in Israel and dozens more are under investigation.
13th Dec 2021 - The Jerusalem Post

China's Brii says its COVID-19 antibody cocktail retains activity against Omicron

China's Brii Biosciences said on Sunday lab studies showed that its COVID-19 antibody cocktail retained activity against the Omicron variant, although one of the antibodies showed a substantial drop in activity when tested alone. Test details for the dual-antibody treatment, which last week became the first approved COVID-19 antibody cocktail in China, would not be available until publication in a scientific journal, but results from three independent labs showed similar pattern, Brii chief executive Hong Zhi said on Monday
13th Dec 2021 - Reuters

Israeli study finds Pfizer COVID-19 booster protects against Omicron

Israeli researchers said on Saturday they found that a three-shot course of the Pfizer/BioNTech, COVID-19 vaccine provided significant protection against the new Omicron variant. The findings were similar to those presented by BioNTech and Pfizer earlier in the week, which were an early signal that booster shots could be key to protect against infection from the newly identified variant. The study, carried out by Sheba Medical Center and the Health Ministry's Central Virology Laboratory, compared the blood of 20 people who had received two vaccine doses 5-6 months earlier to the same number of individuals who had received a booster a month before.
13th Dec 2021 - Reuters

Omicron poses 'very high' risk but data on severity limited

The Omicron coronavirus variant, reported in more than 60 countries, poses a "very high" global risk, with some evidence that it evades vaccine protection but clinical data on its severity is limited, the World Health Organization says. Considerable uncertainties surround Omicron, first detected last month in southern Africa and Hong Kong, whose mutations may lead to higher transmissibility and more cases of COVID-19 disease, the WHO said in a technical brief issued on Sunday. "The overall risk related to the new variant of concern Omicron remains very high for a number of reasons," it said, reiterating its first assessment of Nov. 29.
13th Dec 2021 - Reuters

Antibody response from China Zhifei's COVID shot weaker against Omicron

China's Anhui Zhifei Longcom Biopharmaceutical said on Monday a small laboratory test showed its COVID-19 vaccine could trigger antibodies against the Omicron variant though the response was weaker than against an older variant of the virus. The unit of Chongqing Zhifei Biological Products is the first Chinese vaccine developer to announce early data on how its COVID-19 vaccine work against Omicron, which has triggered global alarm about another surge in infections.
13th Dec 2021 - Reuters

Omicron spreads faster and weakens jabs: WHO

The omicron coronavirus variant is more transmissible than the delta strain and reduces vaccine efficacy but causes less severe symptoms according to early data, the World Health Organization said Sunday. The delta variant, first identified in India earlier this year, is responsible for most of the world’s coronavirus infections. But South Africa’s discovery of omicron — which has a large number of mutations — last month prompted countries around the world to impose travel bans on southern African countries and reintroduce domestic restrictions to slow its spread.
13th Dec 2021 - Arab News


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

    View this newsletter in full

How Sequencing Covid-19’s Viral Genome Helps Hunt for Variants

To keep up with changes to the virus that causes Covid-19, scientists are using a technology called genomic sequencing. The process starts with a Covid-19 test. Some samples that test positive for the coronavirus in a laboratory are pulled aside and sent off for sequencing, a review of the virus’s genetic material that can take as little as a day or more than a week. The SARS-CoV-2 genome has about 30,000 individual building blocks to decode, compared with about three billion in the human genome. Sometimes researchers have equipment to sequence the samples on hand or nearby. But often samples must be shipped elsewhere, which can take days. “Just the sheer logistics of shipping these samples from where they’re tested to where they’re going to be sequenced, that can be huge,” said Pavitra Roychoudhury, an acting instructor in the laboratory medicine and pathology department at the University of Washington.
12th Dec 2021 - The Wall Street Journal

Taiwan confirms first cases of Omicron variant

Taiwan confirmed on Saturday its first cases of the Omicron variant of coronavirus, found in three people who had arrived from abroad. The island's Central Epidemic Command Centre said the infections were found in travellers arriving from Britain, the southern African nation of Eswatini and the United States. Like all entrants, they were tested on arrival and already subject to two weeks of quarantine.
11th Dec 2021 - Reuters

COVID-19: Two jabs offer little protection against Omicron - but booster makes vaccine at least 70% effective

Two doses of the AstraZeneca and Pfizer/BioNtech vaccines offer little protection against the Omicron variant of COVID, but a booster raises their effectiveness to between 70 and 75 percent. The UK Health Security Agency also said the country will have more than one million Omicron infections by the end of this month if current trends continue unchanged. Analysis of 581 people with confirmed Omicron showed the AstraZeneca and Pfizer/BioNtech jabs provided "much lower levels of protection against symptomatic infection compared to the protection that they provide against Delta", it said in a statement. But it added: "The preliminary data showed effectiveness against the new variant appears to increase considerably in the early period after a booster dose, providing around 70-75% protection against symptomatic infection.
11th Dec 2021 - Sky News

South Africa says no signal of increased Omicron severity yet

South African scientists see no sign that the Omicron coronavirus variant is causing more severe illness, they said on Friday, as officials announced plans to roll out vaccine boosters with daily infections approaching an all-time high. South Africa alerted the world to Omicron late last month, prompting alarm that the highly mutated variant could trigger a new surge in global infections. Hospital data show that COVID-19 admissions are now rising sharply in more than half of the country's nine provinces, but deaths are not rising as dramatically and indicators such as the median length of hospital stay are reassuring.
11th Dec 2021 - Reuters

Japan researchers use ostrich cells to make glowing COVID-19 detection masks

Japanese researchers have developed masks that use ostrich antibodies to detect COVID-19 by glowing under ultraviolet light. The discovery by Yasuhiro Tsukamoto and his team at Kyoto Prefectural University in western Japan could provide for low-cost testing of the virus at home, they said in a press release. The scientists started by creating a mask filter coated with ostrich antibodies targeting the novel coronavirus, based on previous research showing the birds have strong resistance to disease.
11th Dec 2021 - Reuters

South African doctors see signs omicron is milder than delta

As the omicron variant sweeps through South Africa, Dr. Unben Pillay is seeing dozens of sick patients a day. Yet he hasn’t had to send anyone to the hospital. That’s one of the reasons why he, along with other doctors and medical experts, suspect that the omicron version really is causing milder COVID-19 than delta, even if it seems to be spreading faster. “They are able to manage the disease at home,” Pillay said of his patients. “Most have recovered within the 10 to 14-day isolation period.” said Pillay. And that includes older patients and those with health problems that can make them more vulnerable to becoming severely ill from a coronavirus infection, he said.
11th Dec 2021 - The Associated Press

Omicron Now Dominant Variant in Cape Town, Wastewater Shows

Omicron is now the dominant coronavirus variant in Cape Town, the South African Medical Research Council said, citing wastewater analyses. The variant was found in 11 of 12 wastewater samples collected in Cape Town on Nov. 30, the council said in a statement on Friday. The delta variant was only dominant at one wastewater plant in the city, it said. People infected with Covid-19 shed viral particles in their feces. While the particles are not infectious, they provide an indication of the prevalence of the disease and can be used to determine which variant is dominant
10th Dec 2021 - Bloomberg

Omicron Will Be Dominant Strain Within Days, Say U.K. Officials

Covid vaccine boosters improve protection to as much as 75% against a rapidly spreading omicron variant that’s much more likely to bypass two doses than earlier strains, preliminary U.K. data show. The basic course of shots from AstraZeneca Plc and the Pfizer Inc.-BioNTech SE partnership provided much lower defenses against symptomatic infection with omicron, compared with the delta strain, the initial study showed. A booster lifted protection to 70% to 75% in the early days after the shot. “These early estimates should be treated with caution, but they indicate that a few months after the second jab, there is a greater risk of catching the omicron variant,” Mary Ramsay, head of immunization at the U.K. Health Security Agency, said in a statement.
10th Dec 2021 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Dec 2021

    View this newsletter in full

FDA expands Pfizer COVID booster, opens extra dose to age 16

The U.S. is expanding COVID-19 boosters, ruling that 16- and 17-year-olds can get a third dose of Pfizer’s vaccine. The U.S. and many other nations already were urging adults to get booster shots to pump up immunity that can wane months after vaccination, calls that intensified with the discovery of the worrisome new omicron variant. On Thursday, the Food and Drug Administration gave emergency authorization for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech -- if it’s been six months since their last shot.
9th Dec 2021 - Associated Press on MSN.com

Could a One-Shot Coronavirus Vaccine Protect You From All Variants?

As Covid-19 began spreading in early 2020, one of Linfa Wang’s first ideas was to test the blood of people who’d survived a previous coronavirus outbreak. The virologist, who works out of Duke-NUS Medical School, a collaboration between Duke and the National University of Singapore, has been studying bat-borne viruses for decades. He’d helped show that SARS-CoV-1, which killed almost 800 people in 2003, likely jumped to humans from horseshoe bats. Wang’s new theory was that people who’d recovered from the original SARS might harbor antibodies that could help fight the new one, SARS-CoV-2.
9th Dec 2021 - Bloomberg

COVID-19: Omicron variant may be 'milder' but its infection rate could be 'devastating', expert warns

The new Omicron variant of coronavirus appears to be causing "milder" cold-like symptoms, but its reported rapid infection rate "even in the vaccinated" could still have "devastating" consequences, a top scientist has warned. Early data has suggested the new variant could result in less severe disease than previous waves. However, Tim Spector, lead scientist on the Zoe COVID Study, warned against complacency, saying, "this is not a reason to be relaxed about Omicron".
9th Dec 2021 - Sky News

Doctors weigh COVID-19 impact on children as vaccine drives ramp up

One month after her son Eran had recovered from a mild case of COVID-19, Sara Bittan rushed the three-year-old to the emergency room. He had high fever, a rash, his eyes and lower body were swollen and red, his stomach was hurting and he was crying in pain. Eventually diagnosed with the rare multisystem inflammatory syndrome in children (MIS-C), also known as pediatric inflammatory multisystem syndrome, or PIMS, Eran was hospitalized in October for a week and has fully recovered, Bittan said.
9th Dec 2021 - Reuters

Britain starts recruiting for real-world COVID antiviral trial

British researchers on Wednesday started recruitment for a clinical trial to test antiviral COVID-19 treatments for use in people early on in the disease who are at higher risks of complications, starting with Merck's molnupiravir. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November. Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the antiviral pill for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.
9th Dec 2021 - Reuters

U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail

The U.S. Food and Drug Administration on Wednesday authorized the use of AstraZeneca's antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines. The antibody cocktail, Evusheld, is only authorized for adults and adolescents who are not currently infected with the novel coronavirus and have not recently been exposed to an infected individual, the regulator said. The authorization for the therapy, made up of two monoclonal antibodies tixagevimab and cilgavimab, marks a significant step for AstraZeneca, whose widely used COVID-19 vaccine is yet to be approved by U.S. authorities.
9th Dec 2021 - Reuters

China approves Brii Biosciences antibody COVID treatment

China's medical products regulator said on Wednesday it had approved the use of Brii Biosciences' neutralising antibody cocktail for COVID-19, the first treatment of its type against the virus given the go-ahead in the country. The combination of BRII-196/BRII-198 showed a 80% reduction of hospitalisation and deaths in non-hospitalised COVID-19 patients at high risk of developing severe disease, based on final results from a Phase III clinical trial, Brii said in a statement on Thursday.
9th Dec 2021 - Reuters

Vaccine makers racing to update COVID shots, just in case

Vaccine makers are racing to update their COVID-19 shots against the newest coronavirus threat even before it’s clear a change is needed, just in case. Experts doubt today’s shots will become useless but say it’s critical to see how fast companies could produce a reformulated dose and prove it works -- because whatever happens with omicron, this newest mutant won’t be the last. Omicron “is pulling the fire alarm. Whether it turns out to be a false alarm, it would be really good to know if we can actually do this -- get a new vaccine rolled out and be ready,” said immunologist E. John Wherry of the University of Pennsylvania.
9th Dec 2021 - The Associated Press

The AP Interview: CDC chief says omicron mostly mild so far

More than 40 people in the U.S. have been found to be infected with the omicron variant so far, and more than three-quarters of them had been vaccinated, the chief of the CDC said Wednesday. But she said nearly all of them were only mildly ill. In an interview with The Associated Press, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said the data is very limited and the agency is working on a more detailed analysis of what the new mutant form of the coronavirus might hold for the U.S. “What we generally know is the more mutations a variant has, the higher level you need your immunity to be. ... We want to make sure we bolster everybody’s immunity. And that’s really what motivated the decision to expand our guidance,” Walensky said, referencing the recent approval of boosters for all adults.
9th Dec 2021 - The Associated Press

FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds

The Food and Drug Administration on Thursday expanded the emergency use authorization for Pfizer and BioNTech’s Covid-19 booster shot to cover 16- and 17-year-olds, making it the only booster shot currently available in the United States for teenagers in this age group. Within hours, Rochelle Walensky, director of the Centers for Disease Control and Prevention, signed off on the expanded authorization, clearing the way for 16- and 17-year olds to book booster shot appointments. “Today, CDC is strengthening its booster recommendations and encouraging everyone 16 and older to receive a booster shot,” Walensky said in a statement. “We know that Covid-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”
9th Dec 2021 - STAT News


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

    View this newsletter in full

Pfizer, BioNTech vaccine neutralises Omicron with three shots

Neutralising antibodies seen one month after third dose. Pfizer CEO says seeking booster shot is the best option. Vaccine may still protect against severe disease Any vaccine relaunch could be achieved in March 2022.
8th Dec 2021 - Reuters

Moderna COVID-19 vaccine approved for booster shots in Australia

The Moderna COVID-19 vaccine has been approved for use in booster shots for adults in Australia. Australia's medicines authority, the Therapeutic Goods Administration (TGA), has given the green light to the shot being used as a booster for people aged 18 and over. Until now, only the Pfizer COVID-19 vaccine has been available for booster shots in Australia. As is advised with the Pfizer booster shot, the Moderna booster shot should be given six months after the second dose of any COVID-19 vaccine. The TGA has also said immunocompromised people aged 12 and over can have a third shot as soon as 28 days after their second vaccine. The TGA said its decision to allow the Moderna vaccine to be used for booster shots was guided by expert advice from the independent Advisory Committee on Vaccines.
8th Dec 2021 - 9News

China approves Brii Biosciences' COVID-19 treatment

China's medical products regulator said on Wednesday it had approved the use of Brii Biosciences' neutralising antibody cocktail for COVID-19, the first treatment of its type against the virus given the go-ahead in the country. The combination of BRII-196/BRII-198 showed a 78% reduction of hospitalization and death in non-hospitalized COVID-19 patients at high risk of developing severe disease in a Phase III clinical trial, Brii said in October. The medicine from a Brii subsidiary was approved to treat mild COVID-19 and the disease of "normal type" with high risk of progressing to hospitalization or death in adults and minors aged 12-17, the National Medical Products Administration said.
8th Dec 2021 - Reuters

EU expects Europe plants to produce 3.6 billion COVID shots in 2022

Vaccine plants in the European Union are expected to produce 3.6 billion COVID-19 shots next year, out of a global output of more than 20 billion, two senior EU officials said on Wednesday. EU countries are administering boosters after having completed the primary vaccination of nearly 70% of the EU population, whereas in Africa only 7% have been immunised against the coronavirus, EU data show.
8th Dec 2021 - Reuters

'I'm so happy': first person to get fully-tested COVID-19 shot says one year on

The first person in the world to be given a fully-tested COVID-19 vaccine, 91-year-old Briton Margaret Keenan, urged people on Wednesday to get vaccinated, one year on from her shot. Keenan described receiving the Pfizer-BioNTech COVID-19 vaccine on Dec. 8 2020 as the "best thing that has ever happened". "It was wonderful. I cannot believe it now, what happened at the time... I'm so happy I got the jab," Keenan, known to friends as Maggie, said in a broadcast clip to mark the anniversary.
8th Dec 2021 - Reuters

Pfizer says COVID booster offers protection against omicron

Pfizer said Wednesday that a booster of its COVID-19 vaccine may offer important protection against the new omicron variant even though the initial two doses appear significantly less effective. Pfizer and its partner BioNTech said that while two doses may not be strong enough to prevent infection, lab tests showed a booster increased by 25-fold people’s levels of antibodies capable of fighting off omicron. For people who haven’t yet had a booster, the companies said two doses still should prevent severe disease or death. Health authorities in the U.S. and other countries have urged eligible people to get a third dose even before these results.
8th Dec 2021 - The Associated Press

Pfizer, BioNTech say omicron partially evades its COVID vaccine but booster can restore protection

The COVID-19 vaccine produced by Pfizer and BioNTech, Comirnaty, provides less protection against the omicron variant than it did against wild-type COVID and other variants, the companies said on Wednesday. They also reported that a third (booster) shot is needed to gain protection against omicron comparable to that provided by the two-dose series against wild-type COVID-19 and other variants. The announcement from the companies came hours after the release of a study by scientists in South Africa that showed the omicron variant could largely evade the antibodies generated by the Pfizer-BioNTech vaccine. The lab study also indicated that booster shots would help restore some level of protection and that the original two-dose series was still likely to prevent a severe form of the disease.
8th Dec 2021 - FiercePharma

Pfizer, ex-employee reach a deal in COVID-19 vaccine trade secrets case

A now-former Pfizer employee is playing nice after the drugmaker sued her in November alleging the 15-year veteran uploaded more than 12,000 sensitive files—including documents on the company's wildly successful COVID-19 vaccine—to personal devices and a Google Drive account. The defendant, Chun Xiao Li, agreed to let Pfizer's lawyers search her personal emails, Google drive accounts and all other personal computing devices or accounts that could contain confidential information or trade secrets by Dec. 6, court documents filed Monday show. Pfizer aims to complete its search by Dec. 29, at which point it will return Li's devices and accounts. By that same day, Li must send Pfizer a sworn declaration that she's cooperated with the investigation to the best of her ability and that she no longer possesses any proprietary information or trade secrets.
8th Dec 2021 - FiercePharma

Pfizer’s vaccine chief on Omicron, mix-and-match boosters, and being prepared for the unknown

Pfizer and partner BioNTech announced Wednesday that new data show that antibodies generated by their Covid vaccine appear less effective against the Omicron variant than other variants, but that a third booster dose likely provides sufficient antibody protection. Those data are very preliminary. But STAT took the opportunity to catch up with Pfizer’s head of vaccine research, Kathrin Jansen, who has been one of the main architects of the development program that has helped make the Pfizer-BioNTech vaccine the most widely used of the Covid shots. Jansen emphasized that Pfizer is developing an Omicron-specific vaccine, but that she does not know exactly what strategy the world should or will take over the coming months. Instead, she is focused on being prepared for anything.
8th Dec 2021 - STAT News

Pfizer-BioNTech Covid-19 shot loses power against Omicron variant, but booster restores protection

People who have received two doses of the Pfizer-BioNTech Covid-19 vaccine are likely susceptible to infection from the Omicron variant of the coronavirus, but a third shot restores antibody activity against the virus, the companies said Wednesday. Their findings are based on lab experiments using the blood of people who have received the vaccine. In a press release, the companies reported a 25-fold reduction on average in the levels of neutralizing antibody activity against the Omicron variant in people who had received two doses of their Covid-19 vaccine. But they also found that blood, or sera, from people who had received boosters “neutralized the Omicron variant to levels that are comparable to those observed” for the original form of the coronavirus that the vaccine was based on, with neutralizing antibody levels increased 25-fold by a third shot.
8th Dec 2021 - STAT News


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

    View this newsletter in full

Study suggests Pfizer COVID-19 vaccine only partially protects against Omicron

The Omicron variant of the coronavirus can partially evade the protection from Pfizer Inc (PFE.N) and partner BioNTech's COVID-19 vaccine, the research head of a laboratory at Africa Health Research Institute in South Africa said on Tuesday. Alex Sigal, a professor at the Africa Health Research Institute, said on Twitter there was "a very large drop" in neutralization of the Omicron variant relative to an earlier strain of COVID. The lab tested blood from 12 people who had been vaccinated with the Pfizer/BioNTech vaccine, according to a manuscript posted on the website for his lab. The preliminary data in the manuscript has not yet been peer reviewed.
7th Dec 2021 - Reuters

Scientists find ‘stealth’ version of Omicron that may be harder to track

Scientists say they have identified a “stealth” version of Omicron which cannot be distinguished from other variants using the PCR tests that public health officials deploy to gain a quick picture of its spread around the world. It came as the number of cases of the original Omicron variant detected in the UK rose by 101 to 437 in a single day and Scotland announced a return to working from home. The stealth variant has many mutations in common with standard Omicron, but it lacks a particular genetic change that allows lab-based PCR tests to be used as a rough and ready means of flagging up probable cases. The variant is still detected as coronavirus by all the usual tests, and can be identified as the Omicron variant through genomic testing, but likely cases are not flagged up by routine PCR tests that give quicker results.
7th Dec 2021 - The Guardian

Impact of obesity and metabolic disorders on severity of COVID-19 and vaccine-breakthrough infections

Obesity and impaired metabolic health are important risk factors for severe COVID-19. Novel data indicate that these risk factors might also promote vaccine-breakthrough SARS-CoV-2 infections in fully vaccinated people. In a Nature Reviews Endocrinology “Year in Review” article DZD-Researcher Norbert Stefan summarizes the most important and up-to-date findings about the relationships of obesity, diabetes and cardiovascular diseases with the severity of COVID-19 and SARS-CoV-2 vaccine-breakthrough infections.
7th Dec 2021 - EurekAlert!

Cuba's COVID vaccines: the limited data available suggests they're highly effective

Cuba has been quietly working on its own vaccines, immunising its population and selling doses abroad. Cuba’s vaccine efforts have maintained a relatively low profile in the west to date. Politics may well be a reason. The US embargo against Cuba that began in the cold war is still in effect, and tensions between the countries remain high. But for those familiar with Cuba, its COVID vaccine development should come as no surprise – the country has a long history of manufacturing its own vaccines and medicines. Nor should it be surprising that two of its COVID vaccines – Abdala and Soberana 02 – appear to have performed very well in trials. Here’s how they work...
7th Dec 2021 - The Conversation Africa

Medicago and GSK announce CoVLP, a plant-based coronavirus vaccine

Pharmaceutical companies Medicago and GlaxoSmithKline announced on Tuesday “positive efficacy and safety results” from a global trial using what they say is the world’s first plant-based coronavirus vaccine.
7th Dec 2021 - The Washington Post

The explosion of Covid PTSD cases is a mental health crisis in the making

When the Covid-19 pandemic began, people working in the trauma field knew the psychological toll would be colossal. In the spring of 2020, I began interviewing professionals about the mental health fallout of the pandemic, specifically its impact on frontline medical staff. During the first wave, two in every five intensive care staff in England reported symptoms of post-traumatic stress disorder. That work continued for almost a year, during which time a second wave hit and the initial traumas were exacerbated. But it wasn’t only frontline workers who were experiencing trauma symptoms: Covid has posed perhaps the biggest threat to mental health in England since the second world war. Now, at the tail end of 2021, the pandemic is still not over. The NHS forecasts that nationally, there will be 230,000 new cases of PTSD as a result of Covid-19.
7th Dec 2021 - The Guardian

Growing use of home Covid-19 tests leaves health agencies in the dark about unreported cases

When fans of the band Phish started falling ill with Covid-19 all over the country after a Halloween concert weekend in Las Vegas, public health officials were largely in the dark about what appears to have been a superspreader event. In a Facebook post from mid-November with hundreds of responses, concertgoers compared symptoms and positive test results, many of those from tests taken at home. But those data weren’t added to state public health tallies of Covid’s spread. It’s a story that’s becoming commonplace in the era of rapid home Covid testing: People who test positive are almost never counted by public health agencies charged with bringing the pandemic to heel. While home tests have distinct advantages — they’re convenient and quickly inform people of their infection status so they can take steps to avoid spread the virus — most who test positive don’t come to the attention of health officials unless they are sick enough to see a doctor.
7th Dec 2021 - STAT News

Canadian drugmaker says its COVID-19 vaccine is effective

A Canadian drugmaker said its plant-based COVID-19 vaccine showed strong protection against the virus and will soon seek authorization at home and elsewhere. Medicago announced Tuesday that its two-dose vaccine was 71% effective at preventing COVID-19 infection in a large, late-stage study that included several variants including the delta variant. The company’s results did not include the emerging omicron variant, which wasn’t circulating during the study period. The Quebec City company said it will seek Canadian approval “imminently” and has also begun the process to file with regulators in the U.S., U.K. and other countries. The company said it's also preparing to send its data to the World Health Organization.
7th Dec 2021 - The Independent

COVID-19: Early indications Omicron is more transmissible than Delta variant, Boris Johnson says

The early indications are that the Omicron variant of coronavirus is more transmissible than Delta, the prime minister has said. Boris Johnson made the comment as he updated his team of ministers on the latest COVID-19 situation at a cabinet meeting on Tuesday morning. Downing Street said it is still unclear how severe the disease caused by Omicron is and what impact the vaccines have on the variant.
7th Dec 2021 - Sky News

COVID-19: Previous infection and vaccination combine for best protection against variants

People who have overcome a coronavirus infection and also received a vaccine have higher-quality antibodies against variants, researchers have found. The new study comes amid concerns that new variants of the SARS-CoV-2 virus, such as Omicron, can still infect people who have received two vaccine doses. According to researchers at the American Society for Microbiology, the study could help identify the optimal mix of antibodies to "help guide future preventive efforts".
7th Dec 2021 - Sky News

UK study shows mixing Pfizer and AstraZeneca COVID-19 vaccines with Moderna elicits better immune response

Results show support in favour of heterologous dosing which may help to advance vaccination programmes in poorer countries. A British study mixing COVID-19 vaccines has found that people had a better immune response when they received their first dose of AstraZeneca or Pfizer-BioNTech shots, followed by Moderna nine weeks later, according to Reuters. These results support mix-and-match dosing, otherwise known as heterologous dosing. This is expected to boost vaccine drives in poor and middle income countries, which may need to combine different brands between first and second shots if supplies are running low. Matthew Snape, the Oxford professor behind the study dubbed Com-COV2, said: “We found a really good immune response across the board…, in fact, higher than the threshold set by Oxford-AstraZeneca vaccine two doses
7th Dec 2021 - PharmaTimes

Merck ties up with Thermo Fisher to make its COVID-19 pill in Canada

Drugmaker Merck & Co on Monday announced a deal with Thermo Fisher Scientific to manufacture its experimental COVID-19 pill at the medical device maker's site in Whitby, Ontario. The site will manufacture the pill, molnupiravir, for distribution in Canada and the United Kingdom as well as markets in the European Union, Asia Pacific and Latin America. The Ontario site is one of three manufacturing sites in the world for the pill, which is being developed with Ridgeback Biotherapeutics.
7th Dec 2021 - Reuters

EU regulator backs Roche's arthritis drug for treating severe COVID-19

The European Union's drug regulator on Monday recommended extending the use of Roche's RoActemra arthritis drug for adult COVID-19 patients on systemic treatment with steroids and those who need oxygen support or mechanical ventilation. The European Medicines Agency (EMA) said its human medicines committee evaluated data from a main study involving over 4,000 hospitalised adults, and concluded that the medicine's benefits outweigh the risks for these patients. The EMA's endorsement comes after Europe crossed at least 75 million coronavirus cases as the world braces for the new Omicron variant. Formal approval is up to the European Commission, which typically follows EMA recommendations.
7th Dec 2021 - Reuters

New data shows GSK-Vir drug works against all Omicron mutations

British drugmaker GSK said on Tuesday its antibody-based COVID-19 therapy with U.S. partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement.
7th Dec 2021 - Reuters

Novavax COVID-19 vaccine could be approved very soon, says EMA chief

The head of the European Medicines Agency (EMA) on Tuesday said that it could soon approve the COVID-19 vaccine developed by U.S. biotech company Novavax (NVAX.O). "The vaccine from Novavax could be authorised in the very near future," Emma Cooke told EU health ministers during a public session of a meeting in Brussels.
7th Dec 2021 - Reuters

EU agencies endorse mix-and-match of COVID-19 vaccines

EU health agencieshave recommended that COVID-19 vaccines be mixed and matched for both initial courses and booster doses as the region battles rising cases ahead of Christmas. Evidence suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the coronavirus causing COVID-19, the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) said in a joint statementon Tuesday.
7th Dec 2021 - Reuters

Omicron v. delta: Battle of coronavirus mutants is critical

As the omicron coronavirus variant spreads in southern Africa and pops up in countries all around the world, scientists are anxiously watching a battle play out that could determine the future of the pandemic. Can the latest competitor to the world-dominating delta overthrow it? Some scientists, poring over data from South Africa and the United Kingdom, suggest omicron could emerge the victor. “It’s still early days, but increasingly, data is starting to trickle in, suggesting that omicron is likely to outcompete delta in many, if not all, places,” said Dr. Jacob Lemieux, who monitors variants for a research collaboration led by Harvard Medical School.
7th Dec 2021 - The Associate Press

New data shows GSK-Vir drug works against all Omicron mutations

British drugmaker GSK (GSK.L) said on Tuesday its antibody-based COVID-19 therapy with U.S. partner Vir Biotechnology (VIR.O) is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies. The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement.
7th Dec 2021 - Reuters


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

    View this newsletter in full

Canada enters deals to procure Merck and Pfizer’s Covid-19 antiviral pills

The Government of Canada has entered agreements with Merck and Pfizer to procure courses of their Covid-19 oral antiviral pills. According to the agreement with Merck (MSD), Canada will obtain 500,000 courses of the company’s oral antiviral, molnupiravir, on obtaining authorisation from Health Canada. The government also holds options to procure up to 500,000 additional courses of the pill. In June, Merck entered a deal valued at about $1.2bn with the US Government to supply molnupiravir.
6th Dec 2021 - Pharmaceutical Technology

Argentina approves Sputnik Light Covid-19 shot as standalone and booster

The Ministry of Health of Argentina has granted approval for Russia’s single-dose Sputnik Light vaccine as a standalone and a booster vaccine for Covid-19. This vaccine is based on human adenovirus serotype 26, which is also used in Russia’s Sputnik V vaccine as the first component, the Russian Direct Investment Fund (RDIF) said. According to data from 28,000 participants in Moscow, Russia, Sputnik Light given as standalone demonstrated an efficacy of 70% against Covid-19 infection from the Delta variant during the initial three months following inoculation. The shot was found to have an effectiveness of 75% in people aged below 60 years.
6th Dec 2021 - Pharmaceutical Technology

Runny-nosed hippos test positive for Covid-19 in Belgium

Two hippos at a zoo in Antwerp, Belgium, have tested positive for Covid-19, in what is believed to be the first such infection reported in the species. The hippos, named Imani and Hermien, have shown no symptoms "other than runny noses," according to a news release from the zoo. How the animals were exposed to the virus is unknown -- their caretakers have not shown any Covid-19 symptoms and all tested negative for the virus, the release said.
6th Dec 2021 - CNN

COVID-19 vaccines: Antibody levels might help speed up approval

Health authorities only approve the use of COVID-19 vaccines that have gone through rigorous clinical trials. Scientists assess whether a vaccine is effective by checking whether participants in a trial develop the infection after having the vaccine. In the present study, researchers find that a person’s antibody response could serve a correlate of effectiveness, instead of whether people develop the infection. Using this proposed measure could speed up the regulatory approval of future vaccines.
6th Dec 2021 - Medical News Today

South Africa's Biovac to start making Pfizer-BioNTech COVID-19 vaccine in early 2022 - exec

South Africa's Biovac Institute will start making Pfizer-BioNTech's, COVID-19 vaccine early next year after receiving the drug substance from Europe, a Pfizer executive said on Monday. Biovac's "fill and finish" deal with Pfizer, announced in July, will make it one of the few companies processing COVID-19 shots in Africa, where many countries have struggled to access sufficient doses during the pandemic. "We expect that the Cape Town facility will be incorporated into our supply chain by the end of this year," Patrick van der Loo, Pfizer regional president for Africa and the Middle East, told a conference in Kigali on vaccine manufacturing in Africa.
6th Dec 2021 - Reuters

Novartis working on pan-coronavirus oral treatment, CEO says

Novartis hopes to still play a role in the development of COVID-19 treatments with research ongoing for a pill that could work broadly against coronaviruses, not just the one that causes COVID-19, chief executive Vas Narasimhan told Reuters. In an interview following his recent presentation at Total Health last week, the head of the Swiss drugmaker pointed to Novartis' manufacturing support to COVID-19 vaccine and drug makers when asked if it had been on the sidelines during the pandemic. "Now I would have loved for some of our own clinical trials to have worked out, but they didn't. I mean, that's part of the deal," Narasimhan said.
6th Dec 2021 - Reuters

Next pandemic could be more lethal than COVID, vaccine creator says

Future pandemics could be even more lethal than COVID-19 so the lessons learned from the outbreak must not be squandered and the world should ensure it is prepared for the next viral onslaught, one of the creators of the Oxford-AstraZeneca vaccine said. The novel coronavirus has killed 5.26 million people across the world, according to Johns Hopkins University, wiped out trillions of dollars in economic output and turned life upside down for billions of people. "The truth is, the next one could be worse. It could be more contagious, or more lethal, or both," Sarah Gilbert said in the Richard Dimbleby Lecture, the BBC reported. "This will not be the last time a virus threatens our lives and our livelihoods."
6th Dec 2021 - Reuters

Gilead recalls 2 lots of COVID-19 drug Veklury after finding glass particulates in vials

Gilead Sciences' surprise blockbuster Veklury has braved its share of efficacy critiques. Now, the drug has run up against a manufacturing glitch. Gilead is recalling two lots of the COVID-19 antiviral Veklury, also known as remdesivir, after a customer complaint flagged the presence of glass particulates. Gilead confirmed the complaint through its own investigation, the company said Friday. Veklury was among the vanguard of COVID-19 treatments last year. It remains the first and only coronavirus med to snag a full FDA approval. Despite questions about its efficacy, the antiviral has enjoyed a resurgence in the second half of 2021 thanks to the spread of virus variants and elevated hospitalization rates.
6th Dec 2021 - FiercePharma

AstraZeneca weighs spinning out COVID-19 products into separate company

AstraZeneca recently bundled its COVID-19 vaccine and antibody treatment into a separate division. But there’s a chance that the new unit might not stay with it for long. The British drugmaker is considering the potential listing of the newly created vaccines and immune therapies division into a separate entity as part of a review of the best path forward, Bloomberg reported, citing people with knowledge of the discussions. In a statement shared with Fierce Pharma, AstraZeneca said it has “no plans” to list the division. Separating the business would be an answer to earlier concerns that tapping into COVID-19 might have been a distraction for the company. But senior executives are evaluating various possibilities with advisers and could eventually decide against a spinoff, the people said, according to the news service.
6th Dec 2021 - FiercePharma

Mixing Pfizer, AstraZ COVID-19 shots with Moderna gives better immune response -UK study

A major British study into mixing COVID-19 vaccines has found that people had a better immune response when they received a first dose of AstraZeneca or Pfizer-BioNTech shots followed by Moderna nine weeks later, according to the results on Monday. "We found a really good immune response across the board..., in fact, higher than the threshold set by Oxford-AstraZeneca vaccine two doses," Matthew Snape, the Oxford professor behind the trial dubbed Com-COV2, told Reuters. The findings supporting flexible dosing will offer some hope to poor and middle income countries which may need to combine different brands between first and second shots if supplies run low or become unstable.
6th Dec 2021 - Reuters

Omicron may raise re-infection risk; booster protection documented

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. Re-infection risk may be higher with Omicron variant Survivors of previous infection with the virus that causes COVID-19, known as SARS-CoV-2, may be at higher risk for re-infection with the Omicron variant than with earlier versions of the virus, according to preliminary findings.
6th Dec 2021 - Reuters

Early data from South Africa hints Omicron variant may cause less severe Covid, but more research is needed

As the world waits for studies that give a clear picture of the Omicron variant, early clinical data emerging from South Africa hint at a virus that may cause less severe cases of Covid-19. The South African Medical Research Council posted a report Saturday of the early experiences at several hospitals in Gauteng Province, where Omicron was first spotted in the country. Strikingly, most hospitalized patients who tested positive for Covid did not need supplemental oxygen. Few developed Covid pneumonia, few required high-level care, and fewer still were admitted to intensive care.
4th Dec 2021 - STAT News


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

    View this newsletter in full

Covid Therapy News and Research: Brii Says 80% Cut of Hospitalization

Brii Biosciences Ltd. said additional results of a late-stage study of a Covid-19 therapy confirmed a significantly reduced risk of death and hospitalization. The topline data readout from the National Institutes of Health-sponsored trial showed combined hospitalization and death risk cut by 80% for “non-hospitalized Covid-19 patients at high risk of clinical progression,” the Chinese company said in a Hong Kong stock exchange filing Sunday. That’s was in line with a 78% reduction disclosed in August, based on an interim analysis. In-vitro testing data suggest the therapy is able to treat those with Covid-19 variants including delta, Brii said, while efforts are ongoing to determine effects against the emerging omicron variant.
5th Dec 2021 - Bloomberg

Lilly’s Covid-19 Antibody Treatment Authorized for Use in Children

Eli Lilly & Co.’s monoclonal antibody drug has been cleared for emergency use in children under the age of 12, the Food and Drug Administration said on Friday. The authorization is the first for an antibody drug to treat young children, including newborns, who have tested positive for Covid-19 or been exposed to the virus and who are at high risk of developing severe cases including hospitalization or death. “Now all patients at high risk of severe Covid-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. Children under one year of age who are exposed to the virus that causes Covid-19 may be at particularly high risk of severe disease, said Dr. Cavazzoni. She emphasized, however, that antibody drug treatment isn’t a substitute for vaccination, which is authorized for children five years of age and up.
5th Dec 2021 - The Wall Street Journal

Omicron Mutations Signal Vaccine Evasion, But Similar Symptoms

As fears of another global surge of Covid-19 cases send jitters through global markets, spur a new round of travel bans and cause Americans to rethink their holiday plans, scientists studying the omicron variant are getting the first hints of what’s in store for the months to come. The new variant’s mutations suggest that it is likely to evade the protections of vaccines to at least some extent, but that it is unlikely to cause more severe illness than previous versions of the coronavirus. These early hypotheses appear in line with real-world observations from places like South Africa, where infections have included the vaccinated and previously ill but appear so far largely mild.
5th Dec 2021 - Bloomberg

Omicron variant may have picked up a piece of common-cold virus

The Omicron variant of the virus that causes COVID-19 likely acquired at least one of its mutations by picking up a snippet of genetic material from another virus - possibly one that causes the common cold - present in the same infected cells, according to researchers. This genetic sequence does not appear in any earlier versions of the coronavirus, called SARS-CoV-2, but is ubiquitous in many other viruses including those that cause the common cold, and also in the human genome, researchers said.
4th Dec 2021 - Reuters

Omicron Cases at Norway Christmas Party Provide Clues on New Variant’s Spread

An Omicron outbreak at a Norwegian Christmas party is providing an early, if still anecdotal, data point on the ease through which the new variant spreads between vaccinated people, and how mild its symptoms at times can be. Before Scatec AS A, a Norway-based renewable-energy company, hosted the annual holiday party, it took all the major safety precautions, said Stian Tvede Karlsen, a company spokesman. Only vaccinated employees were invited. All had to take a rapid test the day before. The party, at Louise, an upscale Oslo restaurant serving seafood and Scandinavian fare, included about 120 people, several of whom had just returned from South Africa, where the company has a solar-panel project. More than half of those present have since tested positive for Covid-19, with at least 13 confirmed to have the new variant in what appears to be the world’s biggest Omicron outbreak outside southern Africa—and a glimpse into how it fares in a highly-vaccinated population.
4th Dec 2021 - The Wall Street Journal

Most Covid Vaccines Will Work as Boosters, Study Suggests

People looking for a booster shot of a Covid-19 vaccine probably don’t need to fret about what brand it is: Many combinations of shots are likely to provide strong protection, according to a large new study. In a comparison of seven different vaccine brands, British researchers found that most of them prompted a strong immune response, with the mRNA shots from Moderna and Pfizer-BioNTech eliciting the largest responses. The study was published on Thursday in The Lancet. These are welcome data for policymakers,” said Merryn Voysey, a statistician at the University of Oxford who was not involved in the study. “The most significant take-home message here is that there are a large number of excellent boosting options for third doses.”
3rd Dec 2021 - The New York Times

Key Omicron Findings May Be Known in Days, WHO Scientist Says

Urgent studies to understand how effective Covid vaccines are against omicron have begun in a global collaboration that may yield answers in a few days, a World Health Health Organization scientist said. Some 450 researchers around the world have begun work to isolate the highly mutated variant from patient specimens, grow it in the lab, verify its genomic sequence, and establish methods to test it in blood-plasma samples, said Ana-Maria Henao-Restrepo, who co-leads the WHO’s research and development blueprint for vaccines and innovations during outbreaks and pandemics.
3rd Dec 2021 - Bloomberg

How Scientists Race Against Omicron and Future Variants

What happens when two nasty Covid-19 variants get together and share their most effective mutations? Omicron and delta have brought us closer to the answer, says Peter White, a virologist at the University of New South Wales who warns of the inevitability of a new Covid-19 "super strain." He joined Stephanie Topp, a global public health expert at James Cook University in Townsville, Australia, and Bloomberg Opinion columnist David Fickling for a Twitter Spaces discussion on the implications of the newest coronavirus variant shaking up the world. Leading the conversation, which has been lightly edited for length and clarity, is Bloomberg Opinion columnist Anjani Trivedi.
3rd Dec 2021 - Bloomberg

WHO's top scientist says Omicron could displace Delta

The World Health Organization's chief scientist told the Reuters Next conference on Friday the Omicron variant could become dominant because it is highly transmissible, but that a different vaccine may not be needed. Soumya Swaminathan also said it was too early to say whether Omicron is milder than other variants of the coronavirus that causes COVID-19 and cast doubt over its origin, saying it was far from certain it emerged in southern Africa. "It is possible that it could become (the) dominant variant," Swaminathan said, adding that it was however impossible to predict. The Delta variant now accounts for 99% of infections globally, she said.
3rd Dec 2021 - Reuters

BioNTech CEO says vaccine upgrade on the cards, ready to move quickly

BioNTech should be able to adapt its coronavirus vaccine relatively quickly in response to the Omicron variant, and the next few weeks will show how urgently an upgrade is needed, its CEO Ugur Sahin told the Reuters Next conference on Friday. Sahin said people should continue to seek the established shot, developed with Pfizer as it very likely continues to protect against severe disease. "I believe in principle at a certain timepoint we will need a new vaccine against this new variant. The question is how urgent it needs to be available," Sahin said.
3rd Dec 2021 - Reuters

Slovakia's COVID-19 case record inflated by system glitch

Slovakia reported 15,278 new COVID-19 cases on Friday, the highest number in a single day since the pandemic broke out, but the Health Ministry said a technical issue inflated the number. "The reason for today's high number of positive test results is additional data, which did not pass from laboratories to the information system on Nov. 30," the ministry said. The ministry did not specify the actual number of cases detected on Thursday. The country of 5.5 million has 3,404 people hospitalised with the illness, including 630 in intensive care.
3rd Dec 2021 - Reuters

Valneva says no conclusions to be drawn on its COVID shot from UK booster study

French biotech firm Valneva said on Friday no conclusions should be drawn on the effectiveness of its COVID-19 vaccine by a British study, which found it was the only shot out of seven that offered no immunity boost when given to people previously immunized with Pfizer's vaccine. Shares in Valneva fell by up to 24% on Friday following the publication of results of Britain's COV-Boost study, which looked at the effectiveness of alternative vaccines as boosters for people who previously received Pfizer or AstraZeneca shots.
3rd Dec 2021 - Reuters

WHO chief scientist urges people not to panic over Omicron

The International Monetary Fund is likely to lower its global economic growth estimates due to the new Omicron variant of the coronavirus, the global lender's chief said at the Reuters Next conference on Friday in another sign of the turmoil unleashed by the ever-changing pandemic. Omicron has spread rapidly to at least 40 countries since it was first reported in South Africa last week, officials say, and many governments have tightened travel rules to try to keep it out
3rd Dec 2021 - Reuters

Omicron likely less severe due to vaccine, prior infection: India

India’s health ministry says the severity of COVID-19 disease from the Omicron variant in the country could be low due to vaccination and widespread exposure to the Delta variant that infected nearly 70 percent of the population by July. “Given the fast pace of vaccination in India and high exposure to Delta variant as evidenced by high seropositivity, the severity of the disease is anticipated to be low,” it said in a statement on Friday.
3rd Dec 2021 - Aljazeera.com

Germany: 1 in 100 infected with virus, health minister says

Germany's health minister said Friday that more than 1% of the population is currently infected with the coronavirus, and he called on citizens to get vaccinated if they haven't done so yet. The country confirmed 74,352 new daily COVID-19 cases and 390 additional deaths, figures published by the federal disease control agency showed . According to the Robert Koch Institute's calculations, some 925,800 people in Germany are considered actively infected with the virus.
3rd Dec 2021 - The Associated Press on MSN.com

‘The fire that’s here’: US is still battling delta variant

While all eyes are on the new and little-understood omicron variant that is popping up around the country, the delta form of the coronavirus isn’t finished wreaking havoc in the U.S., swamping hospitals with record numbers of patients in the Midwest and New England. “Omicron is a spark that’s on the horizon. Delta variant is the fire that’s here today,” said Dr. Nirav Shah, director of the state Center for Disease Control and Prevention in Maine, where an unprecedented 334 people were in the hospital with COVID-19 as of midweek. The U.S. recorded its first confirmed omicron infection on Wednesday, in a Californian who had been to South Africa, where the variant was first identified a week ago. Several more cases were reported Thursday — five in the New York City area and one each in Minnesota, Hawaii and Colorado — under circumstances suggesting the variant has begun spreading within the U.S.
3rd Dec 2021 - The Associated Press

WHO says measures used against delta should work for omicron

Measures used to counter the delta variant should remain the foundation for fighting the coronavirus pandemic, even in the face of the new omicron version of the virus, World Health Organization officials said Friday, while acknowledging that the travel restrictions imposed by some countries may buy time. While about three dozen countries worldwide have reported omicron infections, including India on Thursday, the numbers so far are small outside of South Africa, which is facing a rapid rise in COVID-19 cases and where the new variant may be becoming dominant. Still, much remains unclear about omicron, including whether it is more contagious, as some health authorities suspect, whether it makes people more seriously ill, or whether it can evade vaccine protection.
3rd Dec 2021 - The Associated Press

BioNTech CEO says likelihood of annual COVID-19 vaccines increasing

The likelihood that people will need to have an annual COVID-19 vaccine, similar to the influenza shot, is increasing, German company BioNTech, chief executive and co-founder Ugur Sahin told the Reuters Next conference on Friday.
3rd Dec 2021 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Dec 2021

    View this newsletter in full

Italy approves Pfizer and BioNTech’s Covid-19 vaccine for children

The Italian Medicines Agency (AIFA) has approved the use of the Pfizer and BioNTech Covid-19 vaccine, Comirnaty, for children aged five to 11 years. The Covid-19 vaccine is approved to be administered in two doses at a gap of three weeks. The dosage for this age group is indicated to be a third of the authorised 30µg dose given to adults and adolescents. AIFA’s Technical Scientific Commission (CTS) noted that the vaccine showed a high efficacy level with no warning signals highlighted in terms of safety, according to the data submitted by the companies. The CTS stated that “although SARS-CoV-2 infection is certainly more benign in children, in some cases it can be associated with serious consequences, such as the risk of developing multisystem inflammatory syndrome (MIS-c), which may also require hospitalisation in intensive care.”
2nd Dec 2021 - Pharmaceutical Technology

New Covid-19 drug Sotrovimab that could be effective against the Omicron variant approved by regulators

The Medicines and Healthcare products Regulatory Agency has authorised the drug for use in people with mild to moderate Covid-19 symptoms but who are at a higher risk of developing severe disease. Work will now be done to see if the drug will be effective against the new Omicron strain,
2nd Dec 2021 - iNews

COVID-19: 'Trigger' behind extremely rare AstraZeneca vaccine blood clots may have been discovered

Scientists led by a team from Arizona State University and Cardiff University worked with AstraZeneca to investigate the causes of thrombosis with vaccine-induced immune thrombocytopenia (VITT). TTS, which involves the formation of blood clots, is a life-threatening condition seen in a very small number of people after receiving the Oxford-AstraZeneca or Johnson & Johnson vaccines. The scientists say they now believe they have identified how a protein in the blood is attracted to a key component of the vaccine.
2nd Dec 2021 - Sky News

Covid-19 variants may not evolve to be less dangerous, says Neil Ferguson

People should not assume that Covid will evolve to become a milder disease, a senior scientist has warned, adding that the threat posed by the Omicron coronavirus variant will not be clear until the end of December. Prof Neil Ferguson, head of the disease outbreak analysis and modelling group at Imperial College London, told MPs on Wednesday that while evolution would drive Covid to spread more easily the virus might not become less dangerous. “Most of the transmission has already happened by the time people get hospitalised,” Ferguson told the Commons science and technology committee. “The virus cares about replicating very fast within the respiratory tract and getting out into the environment. If that happens to kill somebody 10 days later the virus really doesn’t care.”
2nd Dec 2021 - The Guardian

Pfizer begins application for Canada's approval of COVID-19 pill

Pfizer Inc said it had started the real-time submission of its application seeking Health Canada's approval of its oral COVID-19 antiviral drug candidate. The pill, PF-07321332, is designed to block a key enzyme needed for the coronavirus to multiply. The move comes after the Canadian government announced that it was in advanced talks with Pfizer and Merck & Co Inc regarding a purchase agreement for their COVID-19 antiviral drugs, as the country attempts to control the spread of the Omicron coronavirus variant.
2nd Dec 2021 - Reuters

Cuba to upgrade homegrown COVID-19 vaccine to confront Omicron

Cuban health authorities said that researchers in the communist-run country are upgrading its homegrown COVID vaccines to ensure protection against the new Omicron variant. The Caribbean island nation, whose economy hinges on tourism, sharply eased entry requirements in mid-November following a successful inoculation drive with domestically developed vaccines. Both infections and deaths from COVID-19 have dropped off to 2% or less of their peaks, according to a Reuters tally.
2nd Dec 2021 - Reuters

S.African data suggests Omicron gets around some, not all immunity

The Omicron variant appears able to get around some immunity but vaccines should still offer protection against severe disease, according to the latest data from South Africa where it is fast overtaking Delta to become the dominant variant.
2nd Dec 2021 - Reuters

EU regulator begins real-time review of Valneva's COVID-19 shot

The European Union's drug regulator said on Thursday it had started a rolling review of the inactivated-virus COVID-19 vaccine from French biotech firm Valneva, weeks after the EU signed a deal with the company for supplies of the shot. The decision to start the real-time review was based on preliminary studies that suggest the vaccine, VLA2001, triggers an antibody response against the coronavirus, the European Medicines Agency (EMA) said.
2nd Dec 2021 - Reuters

China accelerating research into COVID-19 shots targeting Omicron -state media

China is accelerating research and development of COVID-19 vaccines targeting the Omicron variant, a health official said on Thursday, amid concerns among global scientists that it may spread more quickly than other strains. Mainland China has not detected any Omicron case yet. "We are rapidly pushing forward the research and development of Omicron-specific vaccines based on different technologies," Zheng Zhongwei, who heads a group tasked with COVID-19 vaccine development in China, told state broadcaster CCTV.
2nd Dec 2021 - Reuters

Britain approves GSK-Vir antibody-based COVID-19 treatment

Britain's drug regulator on Thursday approved GSK and Vir Biotechnology's antibody based COVID-19 treatment, Xevudy, for people with mild-to-moderate COVID-19 who are at high risk of developing severe disease. The approval comes as GSK separately announced the treatment has shown to work against the Omicron variant.
2nd Dec 2021 - Reuters

Severe COVID tied to high risk of death, mostly by other causes, within year

Survivors of severe COVID-19—especially those younger than 65 years—may be at more than twice the risk of dying within the next year than those who had mild or moderate illness or were never infected, finds a study today in Frontiers in Medicine. Another finding of the analysis of electronic health records of 13,638 patients who tested positive or negative for COVID-19 is that only 20% of those who had severe COVID-19 (requiring hospitalization) and died did so because of complications of their infection, such as abnormal blood clotting, respiratory failure, or cardiovascular problems. Rather, 80% were due to different reasons typically considered unrelated to COVID-19. "Since these deaths were not for a direct COVID-19 cause of death among these patients who have recovered from the initial episode of COVID-19, this data suggests that the biological insult from COVID-19 and physiological stress from COVID-19 is significant," wrote the University of Florida at Gainesville researchers.
2nd Dec 2021 - CIDRAP

Aspen Pharmacare, pursuing J&J vaccine license, aims to shore up local capacity and quash shot inequality in Africa

History is repeating for Aspen Pharmacare. Nearly 20 years ago, as Africa grappled with an HIV epidemic, Aspen pioneered the first generic antiretroviral on the continent. Now, it has a chance to do something similar with Johnson & Johnson's COVID-19 vaccine. This time, however, the South African drugmaker's contribution could be even more of a "game changer," thanks to the scope of the pandemic and the disproportionate toll it's taken on Africa, an Aspen executive told Fierce Pharma. Aspen earlier this week signed a nonbinding term sheet with two J&J subsidiaries in a bid to license and sell the company's single-dose COVID-19 vaccine in Africa. The potentially "monumental" agreement is big for two reasons, Stavros Nicolaou, Ph.D., group senior executive of strategic trade at Aspen Pharma Group, said in an interview.
2nd Dec 2021 - FiercePharma

Another fight for Covid long-haulers: having their pain acknowledged

After his second hospitalization for acute Covid-19, Tony Marks expected to get better. Then pain invaded the 54-year-old software executive’s arms and legs. At first, he felt like he was covered by deep bruises, although nothing was visible on his skin. These days, he told me, he feels like he’s being beaten repeatedly with a baseball bat. Pain is increasingly being recognized as a key feature of what is commonly called long Covid, in which symptoms persist after the acute phase of the viral infection ends. In a recent study from Italy, for example, one-third of Covid long-haulers had symptoms of fibromyalgia or widespread muscle or bone pain. Other research links Covid-19 to neuropathic pain — often described as burning, stabbing, or feeling like electrical shocks — that results from damage to the nervous system. Pain, which also includes headache, ranks among the top symptoms of long Covid in large longitudinal studies.
2nd Dec 2021 - STAT News

Some experts suggest Omicron variant may have evolved in an animal host

When Covid-19 variants arise, the accepted wisdom is that the constellation of mutations they contain developed in an immunocompromised person who contracted the virus and couldn’t shake the infection. But some scientists have an alternative theory for where the latest variant of concern, Omicron, may have acquired the unusual mutations that stud its spike protein. They speculate the virus could have evolved in another animal species. The theory goes that some type of animal, potentially rodents, was infected with the SARS-CoV-2 virus sometime in mid-2020. In this new species, the virus evolved, accumulating roughly 50 mutations on the spike protein before spilling back over into people.
2nd Dec 2021 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Dec 2021

    View this newsletter in full

COVID-19: Most Omicron cases are 'mild' and there's no evidence to suggest vaccines may be less effective against the variant, says WHO official

Early indications suggest most Omicron coronavirus cases are "mild", an official at the World Health Organisation (WHO) has said. Speaking on behalf of the organisation, the official said there is no evidence to suggest the efficacy of vaccines has been reduced by the new strain - but did say some mutations of the virus indicate an increased risk of quicker transmission. They said more than 40 different mutations have been identified with the Omicron variant. The WHO official, quoted by Reuters, added there is still a lot unknown about the new strain.
1st Dec 2021 - Sky News

COVID-19: NERVTAG scientists 'can't rule out' Omicron causing biggest wave of infections yet that may overwhelm NHS

The Omicron variant could trigger a surge in COVID infections bigger than previous waves in the UK with a risk it may overwhelm the NHS, a key group of scientists have warned. Experts on the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), which advises the government, held an extraordinary meeting last week to consider the new COVID variant, known scientifically as B.1.1.529, following its detection in South Africa. According to a note of their meeting, which was observed by both a key Department of Health official and England's deputy chief medical officer Jonathan Van-Tam, the group concluded the introduction of Omicron to the UK "might have very serious consequences".
1st Dec 2021 - Sky News

Severe Covid infection doubles chances of dying in following year, study finds

Patients who survive severe Covid are more than twice as likely to die over the following year than those who remain uninfected or experience milder virus symptoms, a study says. The research, published in Frontiers in Medicine, suggests that serious coronavirus infections may significantly damage long-term health, showing the importance of vaccination. The increased risk of dying was greater for patients under 65, and only 20% of the severe Covid-19 patients who died did so because of typical Covid complications, such as respiratory failure.
1st Dec 2021 - The Guardian

Philippines says COVID variants highlight need for local vaccine development

New coronavirus variants highlight the need for countries to do their own research and development on COVID-19 vaccines, said a senior Philippines trade official, adding that people will only be safe once the whole world is vaccinated. The Philippines is looking to work with its trading partners on this as vaccine demand is unlikely to wane anytime soon, said Allan Gepty, assistant secretary at the Department of Trade and Industry in an interview at the Reuters Next conference. The new COVID-19 variants highlight that "we have to continue doing our respective research and development in this area because there is a truism that …no one is safe unless everyone is safe," said Gepty.
1st Dec 2021 - Reuters

BioNTech CEO says vaccine likely to protect against severe COVID from Omicron

BioNTech and Pfizer's COVID-19 vaccine will likely offer strong protection against any severe disease from the new Omicron virus variant, BioNTech's Chief Executive told Reuters, as the firm weighs the need to upgrade its commonly used shot. Lab tests are underway over the next two weeks to analyse the blood of people who had two or three doses of BioNTech's Comirnaty vaccine to see if antibodies found in that blood inactivate Omicron, shedding light on whether new vaccines are needed.
1st Dec 2021 - Reuters

Regeneron's COVID-19 antibody drug may be less effective against Omicron

Regeneron Pharmaceuticals Inc's COVID-19 antibody drug could be less effective against Omicron, it said on Tuesday, adding to fears about the efficacy of existing treatments after Moderna's top boss raised similar concerns about the company's vaccine. Global markets tumbled after comments from Moderna's chief executive officer rekindled worries that the variant may weigh on a nascent global economic recovery.
1st Dec 2021 - Reuters

U.S. FDA panel narrowly backs Merck's at-home COVID-19 pill

A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's (MRK.N) antiviral pill to treat COVID-19. If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency. Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
1st Dec 2021 - Reuters

WHO members agree to start drafting global pandemic convention

Member states of the World Health Organization (WHO) have agreed to start drafting a global agreement to prevent and tackle the next global pandemic. Countries adopted a resolution on Wednesday at a special meeting in Geneva, launching the process that it is hoped should result in a new agreement on pandemics.
1st Dec 2021 - AlJazeera

Weak immune systems tied to more COVID-19 breakthrough infections

While COVID-19 breakthrough infections—cases after vaccination—are rare, fully vaccinated people with compromised immune systems have them three times more often than those with strong immune systems and have more severe illnesses, according to a real-world US study involving nearly 1.3 million people. In the retrospective study, published today in the Journal of Medical Economics, a team led by researchers from Pfizer analyzed the health records of 1,277,747 people aged 16 or older who had received two doses of the Pfizer/BioNTech COVID-19 vaccine from Dec 10, 2020, to Jul 8, 2021. The latter part of the study period included the emergence of the Delta (B1617.2) variant in the United States.
1st Dec 2021 - CIDRAP

Merck's COVID-19 antiviral narrowly clears FDA panel—but committee echos support for revoking nod in favor of superior option

Merck and Ridgeback’s recent report that its antiviral molnupiravir wasn’t nearly as effective as previously indicated put a damper on enthusiasm that a game-changing oral treatment for COVID-19 was near. It also drew questions at the FDA on whether to approve the pill on an emergency use basis at all. On Tuesday, an FDA advisory committee voted by the narrow margin of 13-10 to endorse the use of molnupiravir. The recommendation comes despite a host of concerns, including over the efficacy and safety of the antiviral medicine. “In my many years of chairing this committee, this is the first meeting that has gone over (its time limit), which I think speaks to the complexity of the issues,” said Lindsey Baden, M.D., of the Brigham and Women’s Hospital of Boston.
1st Dec 2021 - FiercePharma

A reason for optimism on Omicron: Our immune systems are not blank slates

The emergence of a new Covid-19 variant with a startlingly large constellation of mutations has countries around the world sounding alarms. While the concerns are understandable, experts in immunology say people need to remember a critical fact: Two years and 8 billion vaccine doses into the pandemic, many immune systems are no longer blank slates when it comes to SARS-CoV-2. The new SARS-2 variant, known as Omicron, may more easily sidestep some of the immunity of some vaccinated and previously infected people. But there’s good reason to think people who already have some immune protections may avoid the worst of what Covid infections can do to immunologically naïve people.
1st Dec 2021 - STAT News

Pfizer research head envisions a sprint to develop Omicron vaccine, if it’s needed

A top Pfizer executive says the company is hopeful that booster shots will provide sufficient protection against the Omicron variant — but has already envisioned a timeline for the development of a new vaccine if that’s not the case. Mikael Dolsten, Pfizer’s chief scientific officer, likened the company’s researchers to firefighters: They don’t know how serious the blaze will be, but need to prepare for the worst. And in this case, the worst would mean the need to develop new vaccines. “We do take the new variant of concern, Omicron, with seriousness,” Dolsten told STAT. “It can indeed be a potential new threatening wave … although we don’t know that yet. But we always start with being prepared for the worst.”
1st Dec 2021 - STAT News


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

    View this newsletter in full

Testing, vaccines, sequencing: experts call for multi-pronged approach to Omicron

As new cases of the Omicron coronavirus variant are uncovered across the globe and threaten to spread in America, US officials are reacting by urging vaccinations and boosters instead of imposing restrictions which have increasingly provoked political fights. But the US should quickly invest in other tools as well, experts said, including testing, genomic sequencing and surveillance, better communication, and a strong focus on global vaccine equity to prevent the emergence of new variants. All of that would prepare America better to deal with a variant that many experts suspect is probably already inside the country, even if undetected so far.
30th Nov 2021 - The Guardian

UAE approves Sputnik Light as universal booster shot against COVID-19 - RDIF

The United Arab Emirates has approved Russia's Sputnik Light vaccine as a universal booster shot against COVID-19, Russian sovereign wealth fund RDIF said on Tuesday. The Russian Direct Investment Fund, which markets the vaccine abroad, said Sputnik Light can be administered six months after the second dose of any other vaccine used in the United Arab Emirates.
30th Nov 2021 - Reuters

Becton confident its COVID-19 tests will detect Omicron variant

Becton Dickinson and Co (BDX.N) said on Tuesday it was confident that its COVID-19 tests would be able to detect the new coronavirus variant Omicron. The company sells a variety of tests for COVID-19, including antigen and PCR tests. In October, it started shipping at-home rapid COVID-19 tests in the United States that can confirm results using an entirely automated smartphone app. Becton also said it had conducted analyses of the variant using all available genome sequences from the Global Initiative on Sharing All Influenza Data (GISAID) — the largest database of novel coronavirus genome sequences in the world.
30th Nov 2021 - Reuters

Regeneron says its COVID-19 antibody drug could be less effective against Omicron

Regeneron Pharmaceuticals Inc's COVID-19 antibody drug could be less effective against Omicron, it said on Tuesday, adding to fears about the efficacy of existing treatments after Moderna's top boss raised similar concerns about the company's vaccine. Global markets tumbled after comments from Moderna's chief executive officer rekindled worries that the variant may weigh on a nascent global economic recovery.
30th Nov 2021 - Reuters

It is high time we start preparing for future pandemics

Five million lives worldwide have already been lost to COVID-19, and the World Health Organization Access to COVID-19 Tools Accelerator (WHO/ACT-A) grimly predict five million more lives will be lost to the disease in months to come. Alarmingly also, COVID-19 cases will swell from the 260 million confirmed so far to 460 million by the end of 2022. The damage from COVID-19 has been so catastrophic that, when the World Health Assembly (WHA) meets in a special session, starting November 29, its task is nothing less than preventing such a tragedy from re-occurring. The damage from COVID-19 has been so ruinous that we now need an internationally binding agreement to prevent future outbreaks from ever becoming pandemics again.
30th Nov 2021 - Aljazeera.com

Pfizer now expects to produce 80 mln courses of COVID-19 pill, CEO tells CNBC

Pfizer Inc now expects to manufacture 80 million treatment courses of its experimental COVID-19 antiviral drug, up from a previous forecast of 50 million, Chief Executive Officer Albert Bourla said in a CNBC interview on Monday. Earlier this month, Pfizer said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022. "We can right now commit to 80 million doses ... thanks to our manufacturing machine," Bourla told CNBC.
30th Nov 2021 - Reuters

EU could approve shot against new Covid variant in 3-4 months

The EU drug regulator said on Tuesday it could approve vaccines adapted to target the Omicron variant of the coronavirus within three to four months if needed, but that existing shots would continue to provide protection. Speaking to the European Parliament, European Medicines Agency (EMA) executive director Emer Cooke said it was not known if drugmakers would need to tweak their vaccines to protect against Omicron, but the EMA was preparing for that possibility.
30th Nov 2021 - Reuters

U.S. FDA panel to weigh Merck's COVID-19 antiviral drug

A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's antiviral pill to treat COVID-19. If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency. Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
30th Nov 2021 - Reuters

COVID-19 vaccine makers start work on Omicron-tailored shots

BioNTech, Moderna and Johnson & Johnson are working on vaccines that specifically target Omicron in case their existing shots are not effective against the new coronavirus variant, the companies said on Monday. The variant's emergence has triggered a strong global response as countries worried that it could spread fast even in vaccinated populations impose travel curbs and other restrictions. BioNTech SE said it had started work on a vaccine tailored to Omicron, along with partner Pfizer
30th Nov 2021 - Reuters

COVID-19 reinfection less likely to be severe; cardiac stress test useful for unexplained lingering breathlessness

Reinfections with the virus that causes COVID-19 are rarely severe, new findings suggest. Researchers in Qatar compared 1,304 individuals with a second SARS-CoV-2 infection with 6,520 people infected with the virus for the first time. The odds of developing severe disease were 88% lower for people with second infections, the researchers reported online on Wednesday in The New England Journal of Medicine.
30th Nov 2021 - Reuters

Celltrion signs COVID-19 antibody therapy supply deals with Europe

South Korean biotech company Celltrion's distribution arm has signed supply deals for its monoclonal antibody to treat COVID-19 with nine European countries, Celltrion Healthcare said on Tuesday. The European Commission earlier this month approved the company's antibody therapy Regkirona, granting marketing authorisation for adults with COVID-19 who are at increased risk of progressing to a severe condition. The first batch of 50,000 doses will be shipped to Europe this year and the company is in talks with 47 other nations including in Asia, Central and South America and the Middle East, Celltrion said in a statement.
30th Nov 2021 - Reuters

WHO warns that new virus variant poses 'very high' risk

The World Health Organization warned Monday that the global risk from the omicron variant is “very high” based on the early evidence, saying the mutated coronavirus could lead to surges with “severe consequences.” The assessment from the U.N. health agency, contained in a technical paper issued to member states, amounted to WHO’s strongest, most explicit warning yet about the new version that was first identified days ago by researchers in South Africa. It came as a widening circle of countries around the world reported cases of the variant and moved to slam their doors in an act-now-ask-questions-later approach while scientists race to figure out just how dangerous the mutant version might be. Japan announced it is barring entry to all foreign visitors, joining Israel in doing so. Morocco banned all incoming flights. Other countries, including the U.S. and members of the European Union, have moved to prohibit travelers arriving from southern Africa.
30th Nov 2021 - The Associated Press

US tracking of virus variants has improved after slow start

After a slow start, the United States has improved its surveillance system for tracking new coronavirus variants such as omicron, boosting its capacity by tens of thousands of samples per week since early this year. Viruses mutate constantly. To find and track new versions of the coronavirus, scientists analyze the genetic makeup of a portion of samples that test positive. They’re looking at the chemical letters of the virus’s genetic code to find new worrisome mutants, such as omicron, and to follow the spread of known variants, such as delta. It’s a global effort, but until recently the U.S. was contributing very little. With uncoordinated and scattershot testing, the U.S. was sequencing fewer than 1% of positive specimens earlier this year. Now, it is running those tests on 5% to 10% of samples. That’s more in line with what other nations have sequenced and shared with global disease trackers over the course of the pandemic.
30th Nov 2021 - The Associated Press

Final US hurdle for Merck’s COVID-19 pill: FDA panel review

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. “I see this as an incredibly difficult decision with many more questions than answers,” said panel chair Dr. Lindsey Baden of Harvard Medical School, who voted in favor of the drug. He said FDA would have to carefully tailor the drug’s use for patients who stand to benefit most.
30th Nov 2021 - The Associated Press


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

    View this newsletter in full

India's Bharat Biotech resumes exports of COVID-19 vaccine

Indian vaccine maker Bharat Biotech said on Monday it has resumed export of its COVID-19 shot, Covaxin, and has executed long-pending orders in November. The company also said exports to additional countries will commence from December, according to a statement it shared on Twitter. It was not immediately clear whether or not these exports were made under the global vaccine-sharing facility COVAX.
29th Nov 2021 - Reuters

Could the Omicron variant have been avoided? It could set back vaccine successes around the world

I am an epidemiologist working in global health, and have worked in the field of vaccines for nearly 15 years. While the scientific successes of Sars-CoV-2 vaccine development have been surreal, the inequity of the pandemic and access to vaccines has left me despondent. As Australia reaches almost 90% coverage for two doses of Covid-19 vaccination, it’s a success story worth celebrating. Covid-19 vaccination has already proved to be highly effective at dampening wide-scale community transmission in settings such as New South Wales, where a rapid rollout with high levels of first-dose coverage along with other public health measures helped with the bending of the curve. But the vast majority of low- and middle-income countries have only vaccinated a small proportion of their population. An analysis suggests that while 66% of people in high-income countries are fully vaccinated, only 2.5% of the population in low-income countries are fully protected.
29th Nov 2021 - The Guardian

COVID-19: How the spread of Omicron went from patient zero to all around the globe

The speed with which new variants of the COVID-19 virus spread around the world can leave governments scrambling to catch up. What is sometimes more remarkable is the speed with which those new variants are detected. It has taken barely two weeks from the initial testing of 'patient zero', before potentially the entire globe is readying itself to examine COVID test samples to see if they contain the Omicron variant. Patient zero, called n=1 or the index case by the scientific community, arrived at Hong Kong International Airport on 11 November, having flown in from South Africa via Doha in Qatar, on flight QR818.
29th Nov 2021 - Sky News

The new Omicron variant is a reminder that 'the virus is still in control' regardless of Covid-19 fatigue, medical professor says

The new Omicron variant might prompt a return to stricter Covid-19 measures if not enough people get vaccinated or boosted, health experts say. Omicron -- or the B.1.1.529 strain of novel coronavirus -- has already spurred international travel bans. The World Health Organization officially called it a "variant of concern" on Friday. The variant has not yet been detected in the US, the Centers for Disease Control and Prevention said in a Saturday update. "But it's fairly likely we'll see cases," said Dr. Francis Collins, director of the National Institutes of Health.
29th Nov 2021 - CNN

South Africa's Aspen in advanced talks over COVID-19 vaccine deal

Aspen Pharmacare is in advanced discussions over a potential licensing agreement to package the COVID-19 vaccine in South Africa, it said on Monday. The South African company did not mention the name of the company with which it was in talks, but in early September it said it was in talks with U.S. pharma giant Johnson & Johnson over a vaccine packaging licence. Aspen currently packages J&J's COVID-19 vaccine at its South African plant under contract, which means it does not have any pricing or distribution power over the product. The company currently produces 300 million COVID-19 vaccine doses annually under its J&J contract, which are then supplied across Africa. It plans to ramp up capacity to 1.3 billion doses by February 2024, Chief Executive Stephen Saad told Reuters in October
29th Nov 2021 - Reuters

BioNTech starts work on Omicron-specific vaccine

BioNTech SE said on Monday it had started work on a vaccine tailored to Omicron, the worrying new coronavirus variant detected in South Africa, though it was not yet clear if it would have to rework its established COVID-19 shot. The development of an adapted vaccine is part of the company's standard procedure for new variants, BioNTech, which makes vaccines together with Pfizer, said in a statement. "The first steps of developing a potential new vaccine overlap with the research necessary in order to evaluate whether a new shot will be needed," it added.
29th Nov 2021 - Reuters

Omicron poses very high global risk, world must prepare -WHO

The heavily mutated Omicron coronavirus variant is likely to spread internationally and poses a very high risk of infection surges that could have "severe consequences" in some places, the World Health Organization (WHO) said on Monday. No Omicron-linked deaths had yet been reported, though further research was needed to assess its potential to resist vaccines and immunity induced by previous infections, it added. Anticipating increased case numbers as the variant, first reported last week, spreads, the U.N. agency urged its 194 member states to accelerate vaccination of high-priority groups.
29th Nov 2021 - Reuters

Thermo Fisher says its COVID-19 tests accurately detects Omicron variant

Thermo Fisher Scientific Inc said on Monday its COVID-19 diagnostic tests can accurately detect the new coronavirus variant Omicron that has prompted several countries to shut their borders. The World Health Organisation (WHO) last week classified the Omicron variant as a SARS-CoV-2 "variant of concern," saying it may spread more quickly than other forms. Thermo Fisher's TaqPath COVID-19 assays can report accurate results even in the case where one of the gene targets is impacted by a mutation, the company said in a statement.
29th Nov 2021 - Reuters

Omicron brings COVID-19 vaccine inequity ‘home to roost’

The emergence of the new omicron variant and the world’s desperate and likely futile attempts to keep it at bay are reminders of what scientists have warned for months: The coronavirus will thrive as long as vast parts of the world lack vaccines. The hoarding of limited COVID-19 shots by rich countries — creating virtual vaccine deserts in many poorer ones — doesn’t just mean risk for the parts of the world seeing shortages; it threatens the entire globe. That’s because the more the disease spreads among unvaccinated populations, the more possibilities it has to mutate and potentially become more dangerous, prolonging the pandemic for everyone.
29th Nov 2021 - The Associated Press

Moderna says Omicron vaccine could be ready by early 2022

Moderna Inc. is having its best two-day rally in a year after the company said a new vaccine to fight the omicron strain of the coronavirus could be ready by early 2022 if required. The stock soared as much as 14% to the highest level in two months, after jumping 21% during Friday’s global risk-asset selloff, to reclaim its place as top performer on the S&P 500 year-to-date. The company mobilized hundreds of workers on Thanksgiving Day last Thursday in order to start work on omicron, Chief Medical Officer Paul Burton said over the weekend.
29th Nov 2021 - AlJazeera

Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback

The efficacy data for Pfizer’s oral COVID-19 drug now look so appealing that the Big Pharma company is boosting manufacturing capacity even before an expected emergency use authorization from the FDA. Pfizer now expects to make 80 million courses of COVID drug Paxlovid by the end of 2022, Pfizer CEO Albert Bourla told CNBC during a Monday interview. The company previously said it plans to have capacity to make 50 million courses.
29th Nov 2021 - FiercePharma

Pfizer, Moderna, J&J and AstraZeneca assess omicron's effect on their COVID-19 vaccines

With the new omicron strain fueling fear around the globe that the coronavirus is regaining momentum, makers of the world’s most successful vaccines are investigating whether they need to tweak their shots. Over the last few days, Moderna, Pfizer-BioNTech, Johnson & Johnson and AstraZeneca revealed plans to address the threat posed by omicron, which emerged in South Africa and recently was detected in Australia, Israel, Hong Kong and parts of Europe. On Friday, the World Health Organization classified omicron as a “variant of concern.” Each of the companies said it's testing an omicron-specific vaccine. Moderna said it could have a tweaked version of its shot ready early next year if necessary. In the case of the delta and beta variants, Moderna needed “60-90 days” to advance new candidates to clinical testing, it said in a release.
29th Nov 2021 - FiercePharma

With winter looming, cancer patients and doctors seek more Covid protection

Michele Nadeem-Baker is steeling herself for another winter. Diagnosed with chronic lymphocytic leukemia in 2012, she lives with an impaired immune system that even a third dose of Moderna’s Covid-19 vaccine may not be able to rouse. Living in Boston in November now that the weather has turned cold means an end to backyard dinners and a return to a world narrowed by fear of infection. “I am not alone in that feeling,” said Nadeem-Baker, a patient advocate who also spoke to STAT in June. “Everyone is dreading yet another winter in lockdown. Just because there are these third vaccinations, it doesn’t mean everyone is protected. There is still a part of the population that is not.”
29th Nov 2021 - STAT News

Scientists rapidly identified the Omicron variant. But firm answers about its impact could take weeks

The emergence of the Omicron variant of the coronavirus, with a suite of mutations that suggests it might be extra transmissible and be able to evade at least some immune protection, has the world eager for answers about what it means for the Covid-19 pandemic. But so much remains unknown largely because the variant appears to have been detected and publicized so quickly. With other variants, a matter of months passed between the time they were first documented until they were designated “variants of concern” — in some cases giving scientists more opportunity to understand them before they attracted widespread attention. With Omicron, initially identified as B.1.1.529, it all happened within about two weeks.
29th Nov 2021 - STAT News


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

    View this newsletter in full

Botswana says 15 more cases of Omicron variant detected in country

Botswana's health minister Edwin Dikoloti said on Sunday the country had detected 15 more cases of the Omicron coronavirus variant, adding to the four confirmed cases it declared on Friday. The minister applauded its scientists for detecting the new variant in the country early, but stressed it did not emerge in Botswana as the four cases were found in people who travelled to the country on a diplomatic mission. He declined to comment on the nationalities of the four people saying the country "would not want to add to the seeming trend where the variant is stigmatised".
28th Nov 2021 - Reuters

S.African doctor says patients with Omicron variant have "very mild" symptoms

A South African doctor who was one of the first to suspect a different coronavirus strain among patients said on Sunday that symptoms of the Omicron variant were so far mild and could be treated at home. Dr. Angelique Coetzee, a private practitioner and chair of South African Medical Association, told Reuters that on Nov. 18 she noticed seven patients at her clinic who had symptoms different from the dominant Delta variant, albeit "very mild".
28th Nov 2021 - Reuters

Omicron coronavirus variant travel bans may be too late, experts say

The Biden administration is focusing on booster shots as a key weapon in efforts to protect the nation against a potentially dangerous coronavirus variant even as the extent of the threat remains unclear, according to three senior administration officials familiar with the plans. A group of senior health officials had a call with South African scientists Sunday to understand the latest about the new variant and to help inform next steps, according to one of the senior administration officials, who, like the other two, spoke on the condition of anonymity to describe internal discussions.
28th Nov 2021 - The Washington Post

New Coronavirus Variant a ‘Serious Concern’ in South Africa

Scientists in South Africa are studying a recently identified new coronavirus variant of concern, stoking fears the country may face a potentially severe fourth wave that could spread internationally. The new discovery, called B.1.1.529 until a Greek letter is assigned to it by the World Health Organization, carries an unusually large number of mutations and is “clearly very different” from previous incarnations, Tulio de Oliveira, a bio-informatics professor who runs gene-sequencing institutions at two South African universities, said at a briefing on Thursday.
27th Nov 2021 - Bloomberg on MSN.com

Merck’s Covid-19 Pill Was 30% Effective in Final Analysis, Company Says

Merck and Ridgeback Biotherapeutics said a final analysis of their experimental Covid-19 pill found the drug less effective than an early look, prompting U.S. health regulators to continue a staff review of the drug’s application days before an outside panel meets. The Food and Drug Administration made public Friday their initial review of the drug’s application, including an analysis of clinical-trial data for the drug, molnupiravir. Agency staff said the drug was effective at reducing the risk of hospitalization and death, but they didn’t take a position on whether the agency should authorize the drug. The agency also said no major safety concerns turned up in late-stage testing. The FDA said it is still conducting its review of molnupiravir, after the companies told the agency earlier this week the pill was 30% effective in a final analysis of the late-stage study results. After taking an early look at results, the companies had reported in October that molnupiravir was 50% effective.
27th Nov 2021 - The Wall Street Journal

Omicron Coronavirus Variant Raises Questions Among Scientists

The fast-spreading Omicron coronavirus variant recently identified in South Africa has virologists and health authorities on edge because of its many mutations, but much about its infectiousness and virulence remains unknown. Scientists said some of the roughly 50 mutations on the new variant, called B.1.1.529, could potentially render it more transmissible or reduce vaccine effectiveness. But it will take time for virologists and infectious-disease researchers to study the variant’s spread and the potential impact on vaccines and therapeutics. “There are several aspects of concern here, but there are lots of unknowns,” Sharon Peacock, director of the Covid-19 Genetics U.K. Consortium, said at a press briefing on Friday. “It’s so important to stress how much we don’t know at the moment about this new variant.”
27th Nov 2021 - The Wall Street Journal

Omicron Identified as Covid-19 ‘Variant of Concern,’ Triggering Global Fears

A fast-spreading new strain of the coronavirus first detected in southern Africa is a global “variant of concern” and might pose a higher risk of people falling ill with Covid-19 for a second time, the World Health Organization said Friday, as governments around the globe restricted travel from the region. WHO said there was also preliminary evidence that the variant, which it named Omicron after the Greek letter, was more transmissible than the Delta variant that is currently dominant world-wide, and other virus strains. Health authorities in Belgium, Israel, Hong Kong and Botswana said they had detected first cases of the variant. Although scientists were still figuring out the exact effects of the variant’s many mutations, its discovery highlights the continued threat posed by an evolving virus to the world’s emergence from the pandemic. The travel restrictions imposed by many countries, including the U.S., raised fears that there could be further setbacks to the reopening of economic and social life, including in Western countries with high vaccination rates.
27th Nov 2021 - The Wall Street Journal

Belgium Confirms Case of New Virus Strain in Unvaccinated Traveler

Belgium said it has confirmed one case of a concerning new Covid-19 variant in someone who traveled from abroad. Health Minister Frank Vandenbroucke told reporters the variant was detected in an unvaccinated person who first tested positive for Covid-19 on Nov. 22. The new strain prompted the European Union on Friday to recommend suspending air travel from the region. Belgium also Friday ordered a new set of steps to combat the spiraling growth of Covid-19 cases, including a closure of nightclubs for three weeks and restricting privately organized parties.
27th Nov 2021 - Bloomberg

Scientists Racing to Decode Omicron as Defenses Buy Time

Travel bans and other snap defenses that countries threw up against omicron, the new Covid-19 variant, are buying time for scientists to answer key questions that could prevent another wave of deaths.
27th Nov 2021 - Bloomberg on MSN.com

BioNTech Expects Data on Vaccine Versus New Variant in Two Weeks

BioNTech SE has begun studying the new Covid-19 variant that has emerged in southern Africa and expects the first data from laboratory tests about how it interacts with its vaccine within two weeks. The lab data will shed light on whether the new variant, called B.1.1.529, can elude the vaccine it makes together with Pfizer Inc., the German biotech said on Friday. Pfizer and BioNTech put plans in place months ago to be able to ship a new version of their shot within 100 days if necessary, a BioNTech spokeswoman said. “We understand the concern of experts and have immediately initiated investigations,” BioNTech said in a statement.
26th Nov 2021 - Bloomberg

Covid-19 Variant: Scientists Race to Decode Omicron as Strain Threatens World

Travel bans and other snap defenses that countries threw up against omicron, the new Covid-19 variant, are buying time for scientists to answer key questions that could prevent another wave of deaths. Labs in Europe, the U.S. and Africa are preparing for tests to see how the new variant is likely to behave in people who’ve been vaccinated or previously infected. Real-world research will be important too, as health authorities monitor the outbreak in South Africa closely to find out how much more transmissible the new variant will be as it spreads and whether it’s more dangerous or deadly.
26th Nov 2021 - Bloomberg

Paris makes mask wearing outdoors mandatory at public gatherings

Paris has made the wearing of face masks outside mandatory again at public gatherings as the COVID-19 infection rate in the French capital soars, police said. The police prefecture said in a statement that masks will have to be worn for gathering in public spaces, at festivals and spectacles, on markets and when standing in line.
26th Nov 2021 - Reuters

61 travellers from South Africa in Netherlands positive for COVID-19 -authorities

Dutch health authorities said that 61 people who arrived in Amsterdam on two flights from South Africa on Friday tested positive for COVID-19, and they were conducting further testing early Saturday to see if any of the infections are with the recently discovered Omicron coronavirus variant. Around 600 passengers arrived at Amsterdam's Schiphol Airport on the two KLM flights on Friday and then faced hours of delays and testing due to concerns over the new virus variant.
26th Nov 2021 - Reuters

Merck's COVID-19 pill significantly less effective in new analysis

Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported. The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
26th Nov 2021 - Reuters

Pfizer/BioNTech, Moderna expect data on shot's protection against new COVID-19 variant soon

BioNTech SE said on Friday it expects more data on a worrying new coronavirus variant detected in South Africa within two weeks to help determine whether its vaccine produced with partner Pfizer Inc would have to be reworked. Pfizer and BioNTech said that if necessary they expect to be able to ship a new vaccine tailored to the emerging variant in approximately 100 days. "We understand the concern of experts and have immediately initiated investigations on variant B.1.1.529," BioNTech said in a statement when asked to comment. "We expect more data from the laboratory tests in two weeks at the latest. These data will provide more information about whether B.1.1.529 could be an escape variant that may require an adjustment of our vaccine if the variant spreads globally," it added.
26th Nov 2021 - Reuters

Israel warns of looming emergency after its first case of omicron, new COVID-19 variant

Israel Prime Minister Naftali Bennett said on Friday that the country is “on the threshold of an emergency situation” after it detected its first case of omicron, the new South African strain of coronavirus. The Israeli Health Ministry said it detected the new strain in a traveler who had returned from Malawi, and that it is investigating two other suspected cases, The Associated Press reported. Bennett said the new variant is more contagious and spreads more rapidly than the delta variant. He added that authorities are still gathering data on how effective the coronavirus vaccines will be against the variant.
26th Nov 2021 - The Hill

COVID-19: New variant officially named Omicron and Health Secretary Sajid Javid warns of 'huge international concern' as first case found in Europe

A worrying new COVID strain has been classified by the World Health Organisation as a "variant of concern" - its most serious level - and officially given the Greek name Omicron. The WHO said the variant, first detected in South Africa and previously known as B.1.1.529, "has a large number of mutations, some of which are concerning" and early evidence suggested an increased risk of reinfection compared to other strains. "This variant has been detected at faster rates than previous surges in infection, suggesting that this variant may have a growth advantage," the organisation added.
26th Nov 2021 - Sky News

Moderna Edges Pfizer in Study of Five Covid Vaccines

The Moderna Inc. and Russian Sputnik V Covid-19 vaccines both edged the version from Pfizer Inc. and BioNTech SE in effectiveness in a large-scale study of five different immunization shots conducted by Hungarian researchers. Moderna’s vaccine was 88.7% effective in protecting against coronavirus infection and 93.6% effective against Covid-related mortality, compared with 85.7% and 95.4%, respectively for Sputnik, according to the paper published Wednesday on the website of the Clinical Microbiology and Infection medical journal. Pfizer came in third with 83.3% and 90.6%, respectively. The research reviewed the effectiveness of five vaccines in people at least seven days after they received their second dose. Data from more than 3.7 million vaccinated people aged 16 and over were reviewed from January to June of this year.
26th Nov 2021 - Bloomberg


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

    View this newsletter in full

South African scientists detect new virus variant amid spike

A new coronavirus variant has been detected in South Africa that scientists say is a concern because of its high number of mutations and rapid spread among young people in Gauteng, the country's most populous province, Health Minister Joe Phaahla announced Thursday. The coronavirus evolves as it spreads and many new variants, including those with worrying mutations, often just die out. Scientists monitor for possible changes that could be more transmissible or deadly, but sorting out whether new variants will have a public health impact can take time.
26th Nov 2021 - Associated Press on MSN.com

New 'Botswana' variant is most mutated version of Covid

A new variant of the coronavirus with a "constellation" of mutations has been identified in Botswana. Designated as B.1.1.529, scientists are still unclear whether existing antibodies would react well to the variant - which has 32 spike protein mutations. Tom Peacock, a virologist at Imperial College London, branded the mutations "really awful".
25th Nov 2021 - Economic Times

Africa Health Body Investigates New Covid Variant in South Africa

African health authorities plan to hold talks with their South African counterparts next week about a new coronavirus variant that has been found in the country. Data on the new variant is currently being analyzed and more information will be released after the meeting, Africa Centres for Disease Control and Prevention Director John Nkengasong said in a virtual briefing on Thursday. A new Covid-19 variant with a large number of mutations has emerged, with cases reported in Botswana, South Africa and Hong Kong, the Independent reported earlier. The B.1.1529, or so-called Botswana variant, is an offshoot of another variant called B.1.1., the London-based newspaper said.
25th Nov 2021 - Bloomberg

Novavax expected to be become fourth Covid vaccine available in UK

Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about two others. One is the vaccine developed by Janssen, approved in May, with doses due to be delivered by the end of this year, but the UK government is now planning to donate all 20m of them to developing countries, via the Covax initiative. The other is the Novavax jab; the government has ordered 60m doses and hundreds of British jobs depend on it. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks.
25th Nov 2021 - The Guardian

COVID-19: New coronavirus variant B.1.1.529 identified in Botswana as scientists play down concerns

A new variant of the coronavirus with a "constellation" of mutations has been identified in Botswana. Designated as B.1.1.529, scientists are still unclear whether existing antibodies would react well to the variant - which has 32 spike protein mutations. Tom Peacock, a virologist at Imperial College London, branded the mutations "really awful". Spike proteins are what viruses use to get into human cells, and some of the vaccines work by training the body to recognise the spikes and neutralise them. Mutations on the spike can therefore potentially prove problematic for mRNA doses, like Pfizer and Moderna. However, with only a handful of recorded cases - three in Botswana, six in South Africa and one in Hong Kong from someone who travelled from South Africa - scientists are hopeful that COVID cases caused by the new virus specimen will not be widespread.
25th Nov 2021 - Sky News

Australia will face a new wave of Covid-19 unless booster shot rates skyrocket, expert warns

Australia will face a new wave of COVID-19 cases similar to that currently being seen in Europe unless booster shot rates dramatically increase, a leading epidemiologist has warned. It comes as several European nations have reimposed restrictions and lockdowns after a spike in infections as the continent heads into winter. While case numbers were reducing in Australia as vaccination levels increase, infectious diseases expert Professor Raina MacIntyre said the country should heed the COVID situation overseas to avoid an identical situation next year.
25th Nov 2021 - Daily Mail

Reinfection from Covid-19 is rare, severe disease is even rarer, a study of people in Qatar finds

When people got reinfected with Covid-19, their odds of ending up in the hospital or dying were 90% lower than an initial Covid-19 infection, according to a new study. The study published Wednesday in the New England Journal of Medicine found that there were few confirmed reinfections among 353,326 people who got Covid-19 in Qatar, and the re-infections were rare and generally mild.
25th Nov 2021 - CNN

Pfizer sues departing employee it says stole COVID-19 vaccine secrets

Pfizer Inc has sued a longtime employee for allegedly stealing "scores" of confidential documents, including some related to its COVID-19 vaccine, as she prepared to jump to a competitor. In a complaint filed on Tuesday in San Diego federal court, Pfizer said Chun Xiao Li breached her confidentiality agreement by uploading more than 12,000 files without permission to her personal accounts and devices from her company-issued laptop. The alleged materials include a Sept. 24 "playbook" containing internal assessments and recommendations about the Pfizer/BioNTech COVID-19 vaccine, Pfizer's relationship with its German vaccine partner, and presentations related to cancer antibodies.
25th Nov 2021 - Reuters

Turkey's domestic COVID-19 vaccine applies for emergency authorisation

Turkey's domestically developed COVID-19 vaccine, Turkovac, has applied for emergency authorisation, Health Minister Fahrettin Koca said on Thursday, adding he hoped the shot would be available for use by year-end. Speaking at his ministry's budget debate in parliament, Koca said work on Turkovac was nearing completion, and added the shot would mark the first Phase III clinical research project to be fully carried out by Turkey. "I would like to share a piece of good news for our people: our domestic inactive COVID-19 vaccine Turkovac has applied for emergency authorisation as of today," Koca said.
25th Nov 2021 - Reuters

S.Africa detects new COVID-19 variant, implications not yet clear

South African scientists have detected a new COVID-19 variant in small numbers and are working to understand its potential implications, they said on Thursday. The variant - called B.1.1.529 - has a "very unusual constellation" of mutations, which are concerning because they could help it evade the body's immune response and make it more transmissible, scientists told reporters at a news conference. Early signs from diagnostic laboratories suggest the variant has rapidly increased in the most populated province of Gauteng and may already be present in the country's other eight provinces, they said.
25th Nov 2021 - Reuters

EU regulator gives go-ahead to first COVID shot for 5-11 year olds

The EU's drug regulator approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11 on Thursday, paving the way for them to be given a first shot as Europe struggles with a surge in cases. The European Medicines Agency (EMA) recommended that Pfizer-BioNTech's vaccine, approved for European Union use in teenagers between 12 and 17 years old since May, be given as an injection in the upper arm in two 10 microgram doses, three weeks apart. Adult doses contain 30 micrograms.
25th Nov 2021 - Reuters

Did AstraZeneca Keep Britain Safer From Covid Than Europe?

Pascal Soriot knows how to make a headline. The AstraZeneca Plc chief executive officer gave a rare interview to the BBC to mark the opening of a billion-pound ($1.3 billion) research facility in Cambridge. But he couldn’t resist a little plug for his vaccine, too. “If you look at the U.K., there was a big peak of infections but not so many hospitalizations relative to Europe,” he said. His suggestion — made in dulcet tones and bracketed with the caveat that more research needs to be done — is that the AstraZeneca vaccine offers more longer-term effectiveness against serious illness than rival jabs produced by Pfizer Inc. and Moderna Inc. In other words, Britain’s homegrown jab is the reason the country is faring better with the latest Covid wave than Europe.
25th Nov 2021 - Bloomberg

UK raises alarm over new COVID variant which could beat vaccines

Britain on Thursday said it was concerned by a newly identified coronavirus variant spreading in South Africa that might make vaccines less effective and imperil progress made across the world in fighting the pandemic. The UK Health Security Agency said that the variant - called B.1.1.529 - has a spike protein that was dramatically different to the one in the original coronavirus that COVID-19 vaccines are based on. Officials characterise the variant, which has double the number of mutations as the currently dominant Delta variant, as the "worst one yet".
25th Nov 2021 - Reuters

Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine

Pfizer and other drugmakers go to great lengths to protect their proprietary information. When it comes to the world's best-selling pharmaceutical product, the company's BioNTech-partnered COVID-19 vaccine, Pfizer's defense of trade secrets carries even more weight. That's why the company is working to get a handle on information allegedly stolen by a "soon-to-be former employee." In a new lawsuit filed in California, published by Bloomberg, Pfizer says an employee, Chun Xaio Li, uploaded more than 12,000 files, including "confidential Pfizer documents," to a personal Google Drive account and to personal devices. The company says it "has yet to understand the full scope" of the alleged theft thanks to the "sheer number" of documents involved. The company's lawsuit focuses on the COVID-19 vaccine, Comirnaty, and two cancer monoclonal antibodies.
24th Nov 2021 - FiercePharma

Emotional toll of COVID-19 on health workers is vast, varied

In the US study, a team led by Duke University researchers surveyed 1,344 HCWs in 2020 about their emotional state before the availability of COVID-19 vaccines. They recruited HCWs via email and social media from Apr 24 to May 30 (phase 1) and Oct 24 to Nov 30 (phase 2). In phase 1 involved 335 survey respondents of whom 32.6% were 35 to 44 years old, 86% were women, and 87.8% were White. Phase 2 included 1,009 participants, of whom 38.1% were aged 35 to 44, 90.5% were women, and 93.7% were White. Respondents included nurses, physicians, advanced practice practitioners, and chaplains. The HCWs reported emotions related to changes in family, social life, and occupational function. They expressed fear of contracting COVID-19 and spreading the infection to family and friends, stigmatization, short-staffing, and inadequate personal protective equipment (PPE).
24th Nov 2021 - CIDRAP

Virus expert Trevor Bedford on annual Covid boosters and the inevitable next pandemic

In January 2020, computational biologist Trevor Bedford told STAT’s Helen Branswell about the then-new coronavirus: “If it’s not contained shortly, I think we are looking at a pandemic.” Talk about a prediction. Last week at the 2021 STAT Summit, Branswell again caught up with Bedford, a scientist at the Fred Hutchinson Cancer Research Center and an expert on viral evolution and epidemiology. They talked about the future of the coronavirus and antigenic drift (essentially, whether the virus mutates in ways that escape the protection generated by vaccines or earlier infections), as well as what’s in store for flu season, and what might lie ahead with the next pandemic.
24th Nov 2021 - STAT News


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

    View this newsletter in full

Ecuador to administer COVID-19 booster shots to general population in 2022

Ecuador will administer booster shots against COVID-19 to the general population starting January 2022, the government said on Wednesday, acknowledging a rise in cases in the Amazon region due to difficulties in carrying out vaccinations.
25th Nov 2021 - Reuters

Novavax expected to be approved as fourth Covid vaccine in UK

Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about another jab, Novavax – even though the government has ordered 60m doses and hundreds of British jobs depend on it. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. It will bring to an end what feels like a long wait compared with the speedy development and approval of the other jabs, including for those who took part in trials.
24th Nov 2021 - The Guardian

Canada gives full approval to J&J's single-shot COVID-19 vaccine

Johnson & Johnson said Canada gave full approval to its single-shot COVID-19 vaccine for people aged 18 years and older, making it the first full approval for the vaccine globally. The vaccine was previously authorised by the country under an interim order. Canada, which is reporting 2,563 infections on average each day and has administered at least 60,101,058 doses of COVID-19 vaccines so far, gave full approval to Moderna Inc and Pfizer Inc's coronavirus vaccines in September. The country authorised the use of Pfizer's COVID-19 vaccine for children aged 5 to 11 and a booster dose for people aged 18 years and older this month
24th Nov 2021 - Reuters

Russia's Putin took part in trials of nasal form of COVID vaccine

Russian President Vladimir Putin has been revaccinated against COVID-19, Russian news agencies quoted him as saying on Sunday. Putin said in June 2021 that he had been vaccinated with Sputnik V vaccine. "Today, on your recommendation and that of your colleagues, I got another vaccination, Sputnik Light. This is called revaccination," Putin said at a meeting with the deputy director of the Gamaleya Research Centre for Epidemiology and Microbiology, which developed both vaccines.
24th Nov 2021 - Reuters

UK PM Johnson: disappointing that Valneva COVID-19 shot did not gain approval

British Prime Minister Boris Johnson said on Wednesday he was disappointed that Valneva's COVID-19 vaccine had not gained approval in Britain, two months after the government cancelled a supply deal worth 1.4 billion euro ($1.57 billion) for the shot. Health minister Sajid Javid had said commercial considerations played into the decision, but added it was clear Valneva's shot would not be approved in Britain. His statement was later corrected to say that the shot had not gained approval and may not gain it. Valneva said in a statement it hoped for approval by the end of the year and was working with the Medicines and Healthcare products Regulatory Agency (MHRA), the independent medicines regulator.
24th Nov 2021 - Reuters

South Korea's Enzychem to make Indian drugmaker Cadila's COVID-19 shot

South Korea's Enzychem Lifesciences would make at least 80 million doses of India's homegrown DNA COVID-19 vaccine from Cadila Healthcare, the Indian drugmaker said on Wednesday. As part of the deal, Cadila will transfer the DNA vaccine technology to Enzychem, which will make and sell the vaccine, ZyCoV-D, within its territory under the Cadila trademark. Cadila will get license fees and royalty payments, the company said in a filing to stock exchanges.
24th Nov 2021 - Reuters

Bharat's COVID-19 shot 50% effective at height of India infections - small study

Bharat Biotech's vaccine was only 50% effective at preventing symptomatic COVID-19 in a high-risk population during a devastating second wave of infections in India this year, data gleaned from hospital workers showed. The real world study for Covaxin, conducted April 15-May 15, compares with a 77.8% effectiveness rate in a late-stage trial of more than 25,000 participants that was conducted November 2020 to January 2021. The new data analysed just over 1,000 COVID-19 cases with a test-negative control case group, matching by age and gender, according to the study which was published in the Lancet Infectious Diseases journal.
24th Nov 2021 - Reuters

China's Homegrown Virus Pill Could Offer a Pivot From Covid Zero

Where will newly developed Covid pills be needed the most? Rather than pandemic hot spots, it’ll be a place where the virus has yet to gain a sustained foothold: China. That’s the take from Tong Youzhi, chief executive officer at Kintor Pharmaceutical Ltd., a Chinese company working on just such a product. After successfully containing the virus with mass testing, surveillance and rigid border curbs, China is now uniquely vulnerable to the novel pathogen and needs access to effective treatments if outbreaks worsen. “China is a virgin land for the virus, with so few people exposed,” Tong said in an interview with Bloomberg News. “The urgency for effective Covid drugs is no less in China than elsewhere if we want to regain our pre-pandemic life.”
24th Nov 2021 - Bloomberg

African company works to replicate Moderna's COVID vaccine, without permission, to address unequal access

There are huge gaps in the availability of COVID-19 vaccines between different countries. Just 10% of people in Africa have received a single dose, compared to 63% across North America or 62% in Europe. CBS News correspondent Debora Patta found a start-up in South Africa that hopes to redress that imbalance by reverse engineering one of the major U.S.-made vaccines, making it easier to store, and then producing it independently. A pair of nondescript warehouses in a dusty part of Cape Town is the unlikely home of a medical revolution. Inside the airlocked, sterile rooms, Patta found a band of rebels in white lab coats who are passionate about using science to change the world.
24th Nov 2021 - CBS News


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

    View this newsletter in full

Mexico eyes COVID-19 vaccine booster shots, especially for older adults

Mexico will analyze administering booster vaccine doses against COVID-19, especially for older people, President Andres Manuel Lopez Obrador said on Tuesday, softening his previous stance on the need for a third shot. Less than two months ago, Lopez Obrador had rejected suggestions that Mexico should administer a third vaccine shot, saying experts deemed it to be unnecessary. But his government has gradually opened the door to giving more people shots, including teenagers.
23rd Nov 2021 - Reuters

Covaxin Gave Lower Protection Amid India's Deadly Delta-Led Wave

Covaxin, one of the main vaccines used in India’s coronavirus immunization drive, provides only 50% protection against symptomatic Covid-19, according to a real-world study that suggests the shot is less effective than initially thought. As India was slammed by its second-major Covid wave earlier this year, researchers at the All India Institute of Medical Sciences in Delhi analyzed data from 2,714 of the hospital’s health workers who were showing signs of infection and underwent RT-PCR testing between April 15 and May 15, according to a study published in The Lancet Infectious Diseases journal. At the start of the country’s vaccination campaign in January, staff at AIIMS had exclusively been offered Covaxin, a shot co-developed by India’s state-funded health research agency and Bharat Biotech International Ltd.
23rd Nov 2021 - Bloomberg

Biden Covid Vaccine Booster Plan May Face Resistance From CDC Panel, FDA

Medical experts who advise U.S. regulators on vaccines are chafing at what they perceive as political interference in the review process by the Biden administration. Last month, the White House announced plans to begin distributing Covid-19 booster shots to Americans Sept. 20. However, the effort still needs the Food and Drug Administration and the Centers for Disease Control and Prevention to sign off. Members of a key panel that advises the CDC on vaccines have pushed back consideration of the plan to mid-September and said this week they were concerned that politics was getting ahead of the process. It’s “very frightening to me that health-care providers are trying to do the best job that they can, and are taking guidance from HHS and the White House,” said Helen Talbot, a Vanderbilt University professor of medicine and member of the CDC’s Advisory Committee on Immunization Practices, in a meeting Monday.
23rd Nov 2021 - Bloomberg

The real risk of heart inflammation to kids is from COVID-19—not the vaccine

Elizabeth Brown, a mother of two who lives outside Denver, Colorado, had a tough decision to make when childhood COVID-19 vaccines became available. Her five-year-old was born with a congenital heart defect that required a risky surgery when he was two years old to avoid a lifelong risk of heart inflammation from infection. But Brown also knew that after getting some COVID-19 vaccines, adolescent boys are at risk of developing myocarditis, a different kind of inflammation of the heart. ”To read about children with no cardiac history having myocarditis as a pediatric vaccine complication was scary,” Brown says. “There were a lot of inflammatory headlines from the media that preyed on a parent’s fear in terms of the vaccination and very little information readily available regarding the damage COVID can do.”
23rd Nov 2021 - National Geographic

AstraZeneca chief: Our coronavirus vaccine could protect older people longer than mRNA jabs

The head of AstraZeneca has suggested that the company’s adenovirus vaccine could provide longer-lasting protection against COVID-19 especially in older people than the mRNA vaccines from BioNTech/Pfizer and Moderna. French CEO Pascal Soriot said this could be a reason why the U.K. hasn’t experienced the same high levels of hospitalizations as Europe, where cases have surged in recent months. But he said more data was needed. “It's really interesting, when you look at the U.K., there was a big peak of infections, but not so many hospitalizations relative to Europe,” he told BBC Radio 4. “In the U.K., this vaccine was used to vaccinate older people whereas in Europe initially people thought the vaccine doesn't work in older people,” he said. The pharma chief suggested that this could be because AstraZeneca’s adenovirus vaccine provides a better T cell response than mRNA vaccines. “The antibody response is what drives the immediate reaction or defense of the body when you are attacked by the virus,” Soriot said. “And the T cell response takes a little longer to come in. But it's actually more durable; it lasts longer.” The pharma chief said AstraZeneca’s adenovirus COVID-19 vaccine “has been shown to stimulate T cells to a higher degree in older people.”
23rd Nov 2021 - POLITICO.eu

The FDA will soon decide on Merck's Covid-19 antiviral pill. It shows promise, but there are also concerns

In the fall of 2015, Dr. Mark Denison was preparing for a long drive home from Alabama after making a presentation at a scientific meeting when a colleague asked him to stick around for lunch and check out some data on a potential new drug. Denison said yes, and six years later, he's very glad he stayed. Denison's colleague, George Painter, is a "drug hunter" at Emory University in Atlanta. At lunch, he showed Denison lab results he'd obtained with a new antiviral compound, now known as molnupiravir. "It just knocked my socks off," said Denison, an infectious disease specialist at Vanderbilt University Medical Center. "With increasing concentrations of the drug, the virus's ability to grow just plummeted." Painter's lab looked at the effect molnupiravir had against the influenza virus and chikungunya, a virus that's spread by mosquitos. After the Alabama meeting, Painter sent some of the compound to Denison, who tried it in his lab against the virus that causes Middle East Respiratory Syndrome.
23rd Nov 2021 - CNN

Pfizer says its Covid vaccine is STILL 100% effective in children ages 12 to 15 four months after the second dose

Pfizer-BioNTech released data on Monday from a long-term analysis of their COVID-19 vaccine in kids aged 12 to 15. There were 30 confirmed symptomatic Covid cases in the placebo group compared to none in the vaccinated group Researchers say this equates to 100% efficacy at least four months after receiving the second dose. The vaccine is currently only fully approved for those aged 16 and older but the companies plan to apply for extended approval in the 12-15 age group soon
23rd Nov 2021 - Daily Mail

Vaccines Ward Off Severe Covid in U.S., Wane Against Infections

Covid-19 vaccines remain highly effective at keeping people alive and out of the hospital, but new U.S. data add further support to the argument that the shots aren’t preventing infections as much as they once did. Unvaccinated people were about five times more likely to test positive for the virus than the vaccinated in the week starting Sept. 26, down from about 15 times more likely in May, according to the latest age-adjusted data from the Centers for Disease Control and Prevention, which were updated Monday. The new figures come shortly after the CDC approved booster shots for all adults, and could provide additional support for third doses as the U.S. heads into its traditional winter virus season. Covid-19 cases are rising across many parts of the U.S., including the Midwest and Northeast. The CDC data isn’t adjusted for time since vaccination. That means that the earliest recipients of the vaccine -- mostly senior citizens and those with pre-existing conditions -- are possibly at even greater risk.
23rd Nov 2021 - Bloomberg

Covid antivirals could be pandemic game-changers. But Americans might struggle to access them

Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool that could, perhaps, finally help life return to normal. But basic gaps in the U.S. health system could mean that two new treatments from Pfizer and Merck won’t make much of a difference after all. The companies’ treatments, which haven’t yet received emergency authorization, could make a Covid diagnosis dramatically less threatening. But in practice, before receiving the pills, patients may need to jump through a series of hoops that often prevent Americans from accessing care: Recognizing their symptoms, taking a test, getting a prescription from a clinician, and filling the prescription at a pharmacy. “Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment.”
23rd Nov 2021 - STAT News

COVID-19 tied to higher risk of stillbirth, maternal death

In the first study, the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team analyzed data from the Premier Healthcare Database Special COVID-19 Release, a large, hospital-based database from March 2020 to September 2021, a period that included the emergence and eventual dominance of Delta. Of all pregnant women in the database, 53.7% were White, 50.6% had private health insurance, 15.4% were obese, 11.2% had diabetes, 17.2% had high blood pressure, 1.8% had multiple-gestation pregnancy, 4.9% smoked, and 1.73% had COVID-19. The study authors noted that most of the women who tested positive for COVID-19 at delivery were likely unvaccinated. Among 1,249,634 deliveries at 736 hospitals, stillbirths were rare, at 0.65%, but the rate was 1.26% among 21,653 deliveries to pregnant COVID-19 patients, compared with 0.64% among 1,227,981 deliveries to non–COVID-19 patients. Stillbirths were defined as fetal deaths at 20 weeks' gestation or later.
22nd Nov 2021 - CIDRAP

Pfizer, BioNTech ace long-term test of their COVID vaccine in kids 12 to 15, setting up likely approval

Six months ago, Pfizer and BioNTech secured emergency use authorization for their COVID-19 vaccine in 12- to 15-year-olds. Now, the companies have provided long-term data that could bring a full approval in the age group. In a follow-up study of 2,228 children, the vaccine was 100% effective in preventing infection seven days to four months after the second dose. There were no serious safety concerns observed in those with at least six months of follow-up. With the results, the companies will file for full FDA approval in the age group. In August, the shot won an FDA nod in people 16 and older.
22nd Nov 2021 - FiercePharma


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

    View this newsletter in full

‘Herd immunity’ more complex than reaching 70% vaccine rate, says Oregon health expert

With COVID cases declining and the vaccine rate reaching 73%, many Oregonians are wondering when they can drop their face masks. Health experts say: not until early next year, if not longer. The COVID-19 booster is now available to all adults in Oregon. The Oregon Health Authority made the announcement Saturday, a day after the Centers for Disease Control and Prevention announced similar federal guidelines. The news comes after a weeks-long decline in COVID cases across the state. Case numbers are about half what they were at the peak of the Delta surge in September, and COVID-related hospitalizations are down to about 400 patients. By contrast, there were 1,178 COVID patients in Oregon on Sept. 1. Nonetheless, state health officials say there’s still a long road ahead.
22nd Nov 2021 - OPB News

Pfizer's Covid vaccine was 100% effective in kids in longer-term study

Pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% efficacious in preventing infections in 12- to 15-year-olds, measured from seven days to four months after administration of the second dose of the vaccine. The companies said the new data — a longer-term analysis of a Phase 3 trial conducted in 2,228 participants — will form the basis of an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license to cover youths in the age group.
22nd Nov 2021 - STAT

EU considers booster doses of J&J's COVID-19 vaccine

The European Medicines Agency says it is evaluating whether to authorize booster doses of Johnson & Johnson's single-shot COVID-19 vaccine. In a statement Monday, the EU drug regulator said it was considering an application from J&J to recommend booster doses of the J&J vaccine for adults 18 and over, at least two months after they were first immunized. Amid an explosive surge of new coronavirus infections across Europe the EMA said it expected to make a decision on this within weeks. The U.S. Food and Drug Administration gave the green light to J&J booster doses in October, both for people who initially received the J&J and vaccine and for people who got immunized with other vaccines.
22nd Nov 2021 - The Independent

Covid-19: UK will avoid European Delta surge due to vaccines and growing immunity, experts say

Coronavirus vaccinations may have prevented about 300,000 deaths in the UK, a leading scientist has claimed. Professor Sir Andrew Pollard, who helped create the Oxford/AstraZeneca vaccine, has hailed the success of the UK’s vaccination programme. He told the BBC’s Andrew Marr: “If we just look at the UK, the predictions last year were that there would be between 300,000 and 500,000 deaths. “And actually when you look at the data on lives saved so far this year, we’re actually not far off to actually think that that is the right number, that we might have been at around about 300,000 deaths by now without a vaccine.” He also said immunity is building in younger age groups due to high infection levels seen since the end of summer.
22nd Nov 2021 - iNews

Revealed: Over 600 babies born premature and needing critical care to mothers hospitalised by Covid-19

More than 600 babies have been born prematurely and needing critical care to mothers hospitalised by Covid-19, The Independent can reveal — as women are warned they are up to three times more likely to have an early birth with the virus. The figures, which cover 17 months of the pandemic, prompted calls for the government to make pregnant women of all ages eligible for Covid-19 booster jabs. Concern about pregnant women avoiding the vaccine has pushed chief medical officer Chris Whitty to urge mothers-to-be to get fully jabbed, with take-up rates in this group as low as 15 per cent last month.
22nd Nov 2021 - The Independent

Baidu in partnership with Sanofi to use its algorithm in mRNA vaccine, therapy development

Chinese tech giant Baidu Inc said on Monday it has licensed its algorithm for messenger RNA (mRNA) sequence to Sanofi SA for use in designing vaccine and therapeutic products, entering its first such commercial deal with a major global drugmaker. Sanofi had been one of the world's biggest vaccine makers before the pandemic, but the French firm was beaten by rivals BioNTech /Pfizer) and Moderna in developing mRNA shots against COVID-19. read more Sanofi stopped trials of its own mRNA COVID-19 shot in September, and is instead focusing on efforts with GlaxoSmithKline to bring another COVID-19 vaccine candidate to market based on the more conventional protein-based approach.
22nd Nov 2021 - Reuters

Germany promotes 'Rolls-Royce' Moderna shot to meet demand for COVID boosters

Germany will promote Moderna for Germans seeking booster shots as high demand for the BioNTech/Pfizer vaccine risks depleting stocks and derailing efforts to tame a fourth wave of the pandemic, Health Minister Jens Spahn said on Monday. Spahn warned during a news conference that some 16 million Moderna doses could expire in the first quarter of next year if unused, adding that some experts see Moderna as the "Rolls-Royce" of vaccines with BioNTech the "Mercedes". "Unfortunately the impression is we will insist on Moderna only to avoid the expiry of those vaccines in the first quarter of 2022," said Spahn.
22nd Nov 2021 - Reuters

Pfizer's COVID-19 vaccine trial data shows long-term efficacy in adolescents

Pfizer Inc said on Monday its COVID-19 vaccine provided strong long-term protection against the virus in a late-stage study conducted among adolescents aged 12 to 15 years. A two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose, the company said. The long-term data will support planned submissions for full-regulatory approval of the vaccine in the age group in the United States and worldwide.
22nd Nov 2021 - Reuters

EU says decision on J&J COVID-19 vaccine booster dose 'within weeks'

The European Union's drug regulator said on Monday it was evaluating data on booster doses of the COVID-19 vaccine by Johnson & Johnson (JNJ.N) following an application, and a decision could come "within weeks" under a speedy review. The approval sought is for use of a booster dose of the single-shot vaccine, COVID-19 Vaccine Janssen, to be given at least two months after the first dose to people aged 18 years and older, the European Medicines Agency (EMA) said.
22nd Nov 2021 - Reuters

How COVID shots for kids help prevent dangerous new variants

Cadell Walker rushed to get her 9-year-old daughter Solome vaccinated against COVID-19 — not just to protect her but to help stop the coronavirus from spreading and spawning even more dangerous variants. “Love thy neighbor is something that we really do believe, and we want to be good community members and want to model that thinking for our daughter,” said the 40-year-old Louisville mom, who recently took Solome to a local middle school for her shot. “The only way to really beat COVID is for all of us collectively to work together for the greater good.” Scientists agree. Each infection — whether in an adult in Yemen or a kid in Kentucky — gives the virus another opportunity to mutate. Protecting a new, large chunk of the population anywhere in the world limits those opportunities.
22nd Nov 2021 - The Associated Press


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

    View this newsletter in full

Pfizer to apply for EU authorization of its COVID pill on Friday

Pfizer plans to apply for a European authorisation of its experimental antiviral pill to treat COVID-19 on Friday, German weekly Wirtschaftswoche said, citing sources close to the European Medicines Agency (EMA) and the company. The paper also said that acting German health minister Jens Spahn plans to buy Pfizer's medicine. "The health ministry is in contact with Pfizer regarding a possible procurement of the antiviral drug Paxlovid," Wirtschaftswoche quoted a ministry's spokesperson as saying.
20th Nov 2021 - Reuters

China's BioKangtai begins first shipment of AstraZeneca's COVID-19 shot

AstraZeneca Plc's (AZN.L) COVID-19 vaccine partner in China, Shenzhen Kangtai Biological Products (BioKangtai) (300601.SZ), has begun its first shipment of the shot, sending more than four million doses to Indonesia, BioKangtai said on Friday. Including the first batch, BioKangtai plans to send over eight million doses of the China-made AstraZeneca shot, branded as KconecaVac, to Indonesia this month, Zhang Qian, general manager at BioKangtai's international affairs department, said in a video interview with local media.
20th Nov 2021 - Reuters

Market in China's Wuhan likely origin of COVID-19 outbreak - scientist

The first known COVID-19 case was a market vendor in the Chinese city of Wuhan, not an accountant who appeared to have no link to the market but whose case contributed to speculation the virus could have leaked from a lab, a U.S. researcher wrote in a commentary piece published on Thursday. The origin of the SARS-CoV-2 virus that causes COVID-19 remains a mystery and a major source of tension between China and the United States. The new analysis by the researcher does not provide a definitive answer to that question.
20th Nov 2021 - Reuters

Canada authorizes Pfizer Covid vaccine for ages 5-11

Canada on Friday became the latest country to authorize the Pfizer-BioNTech Covid-19 vaccine for children aged between five and 11-years-old. "After a thorough and independent scientific review of the evidence, the department has determined that the benefits of this vaccine for children between five and 11 years of age outweigh the risks," said an official statement from Health Canada. The decision follows an application by the companies submitted on October 18 after carrying out a clinical trial among thousands of children in this age group. The vaccine was found to be more than 90 percent effective at preventing Covid-19, and no serious side-effects were identified. It is dosed at 10 micrograms rather than the 30 micrograms used in older ages, and administered as two shots, three weeks apart.
20th Nov 2021 - FRANCE 24

Merck Covid pill backed for EU emergency use

The EU's drug watchdog on Friday backed Merck's anti-Covid pill for emergency use ahead of its formal authorisation and started reviewing Pfizer's antiviral treatment as cases soar across Europe. The two pills by the US pharma giants represent a potentially groundbreaking step in the fight against coronavirus as studies show they cut the risk of hospitalisation and death in high-risk patients. The European Medicines Agency (EMA) said that while the Merck pill was not yet approved, it had "issued advice" so that individual countries in the 27-nation EU could decide whether to use it in case of a surge in infections. "The medicine, which is currently not authorised in the EU, can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe Covid-19," the EMA said in a statement. "EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to Covid-19 across the EU."
20th Nov 2021 - RFI

CDC expands COVID booster jab eligibility to all US adults

The US Centers for Disease Control and Prevention (CDC) has expanded eligibility for COVID-19 booster jabs to all adults in the United States, move that paves the way for millions more Americans to receive additional protection against the virus. The CDC on Friday evening endorsed the advice of a health advisory panel, which earlier voted unanimously to recommend expanding booster eligibility to all Americans aged 18 and older who received their second dose of the Pfizer-BioNTech or Moderna vaccines at least six months earlier.
20th Nov 2021 - Aljazeera.com

Canada approves Pfizer-BioNTech jab for kids starting at age five

The vaccine is 90.7 percent effective at preventing COVID-19 in kids with no serious side effects, Health Canada said. Canada has approved the Pfizer-BioNTech coronavirus vaccine for children between the ages of five and 11. It’s the first jab to be approved for kids in that age group, Health Canada said on Friday, calling the move “a major milestone” in the fight against COVID-19. The vaccine was 90.7 percent effective at preventing COVID-19 in children five to 11 years of age, Health Canada said, and no serious side effects were identified. “After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks,” Health Canada said in a statement. Kids in Canada will receive two doses of the vaccine, at 10 micrograms each, to be taken three weeks apart. That is a lower dose than the 30 micrograms two-dose regimen authorised for people 12 years of age and older.
20th Nov 2021 - Aljazeera.com

Could this gene double your risk of dying from COVID-19?

Soon after the pandemic began, we knew that certain groups of people are more at risk of dying from COVID-19 than others. It was immediately clear that those with specific underlying health conditions such as diabetes and cardiovascular disease were at increased risk, but slowly it became evident that certain ethnic groups were also being disproportionately affected. Social factors have played an important role in why these groups have been more affected than others, but genetics may also play a part. Scientists at Oxford University have now identified a version of a gene that may be associated with doubling the risk of respiratory failure from COVID, and it could go some way to explaining why people from particular backgrounds are more likely to die from the virus. The study’s authors said that their work identifying the gene was extremely difficult because it wasn’t merely the presence of the gene they were looking for, but whether it was switched “on”, making it more high risk.
20th Nov 2021 - Al Jazeera English

How will the COVID pandemic affect flu season?

Countries in the Northern Hemisphere are facing an unpredictable winter as COVID-19 continues to spread during the flu season, experts have warned. Last year, when governments recommended a range of protective measures such as mask-wearing, social distancing and lockdowns to slow COVID-19 infections, the number of influenza cases dropped dramatically compared with the seasonal average. According to the European Centre for Disease Prevention and Control (ECDC) about 20 percent of the population catches the flu each year, but that figure fell by more than 99 percent in 2020-21. There were no hospitalised cases nor fatalities reported from influenza last season. Cases this year have remained low, according to the World Health Organization (WHO), but with COVID restrictions being lifted in many parts of the world, children back in school, and the coronavirus continuing to spread, experts are urging people to remain cautious. An uptick of influenza cases could burden health systems already facing difficulties due to outbreaks of COVID-19
20th Nov 2021 - Aljazeera.com

FDA official explains decision on 'simplified' booster shots

The U.S. government’s booster campaign got a lot simpler Friday after Food and Drug Administration officials authorized extra shots of Pfizer and Moderna COVID-19 vaccines for all adults. It replaces a complicated system in which eligibility was based on age, health conditions and other factors. “It’s simplified things, I think significantly over the situation that we had in place previously,” FDA’s vaccine chief Dr. Peter Marks told The Associated Press. The FDA action comes after months of debate among experts over whether everyone 18 and older should get an extra shot for protection.
20th Nov 2021 - The Associated Press

Research links COVID-19 in pregnancy with stillbirths

Pregnant women with COVID-19 face increased chances for stillbirths compared with uninfected women, and that risk spiked to four times higher after the delta variant emerged, new government data show. The federal Centers for Disease Control and Prevention released a report Friday that examined 1.2 million deliveries in 736 hospitals nationwide from March 2020 through September 2021. Stillbirths were rare overall, totaling 8,154 among all deliveries. But the researchers found that for women with COVID-19, about 1 in 80 deliveries resulted in stillbirth. Among the uninfected, it was 1 in 155. Among those with COVID-19, stillbirths were more common in people with chronic high blood pressure and other complications, including those in intensive care or on breathing machines.
20th Nov 2021 - The Associated Press

US opens COVID boosters to all adults, urges them for 50+

The U.S. on Friday opened COVID-19 booster shots to all adults and took the extra step of urging people 50 and older to seek one, aiming to ward off a winter surge as coronavirus cases rise even before millions of Americans travel for the holidays. Until now, Americans faced a confusing list of who was eligible for a booster that varied by age, their health and which kind of vaccine they got first. The Food and Drug Administration authorized changes to Pfizer and Moderna boosters to make it easier. Under the new rules, anyone 18 or older can choose either a Pfizer or Moderna booster six months after their last dose. For anyone who got the single-dose Johnson & Johnson vaccine, the wait already was just two months. And people can mix-and-match boosters from any company.
20th Nov 2021 - The Associated Press

Fauci overwhelmed by calls after journal published mistake over beagle experiments | TheHill

The nation's top infectious disease expert Anthony Fauci has been inundated with calls following a mistake in a scientific journal claiming that the National Institute of Allergy and Infectious Diseases (NIAID) was funding experimental research on beagles. The calls were so frequent that Fauci's assistant stopped answering the phone for two weeks in October, The Washington Post reported Friday. He received 3,600 phone calls in 36 hours. “The constant harassment in the form of ridiculous accusations and outright lies makes doing my job and that of my staff of fighting the covid-19 pandemic all the more difficult,” Fauci told the Post. “This attack on me, which clearly has political overtones to a nonpolitical scientist, I feel, is dangerous to the entire field of science and [shows] how people try to intimidate scientists.”
20th Nov 2021 - The Hill

Pfizer-BioNTech, Moderna Covid-19 Boosters for All Adults Backed by FDA, CDC

Booster shots from Pfizer Inc and partner BioNTech and Moderna Inc. MRNA will be available to all adults after the Centers for Disease Control and Prevention endorsed the extra doses for people at least six months after their second shot. The signoff Friday by CDC Director Rochelle Walensky will lead to a significant widening of the U.S. booster campaign that health officials hope will remove confusion and offer people more protection ahead of holiday gatherings and travel as new daily Covid-19 cases are beginning to rise again. “Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays,” Dr. Walensky said.
20th Nov 2021 - The Wall Street Journal

Merck’s Covid Pill Can Be Used to Treat Adults, EU Regulator Says

Merck & Co.’s antiviral pill for Covid-19 can be used to treat adults in the European Union, the bloc’s drug regulator said, giving countries another weapon to use as a fourth wave of the pandemic sweeps the continent. Merck’s Lagevrio pill, known generically as molnupiravir, is still under review and hasn’t been formally authorized for sale. But until then, it can be used to treat adults who don’t need oxygen therapy and face an increased risk of developing severe Covid, the European Medicines Agency’s human medicines committee said on Friday. National authorities may decide to use the pill in emergency settings “in light of rising rates of infection and deaths due to Covid-19 across the EU,” the regulator said. Austria imposed a nationwide lockdown on Friday, and German authorities said they wouldn’t rule out a similar move, as cases rise and intensive care facilities fill up.
20th Nov 2021 - Bloomberg

Delta variant dangerous during pregnancy, CDC reports say

Once the delta variant took hold in the United States, pregnant individuals and their fetuses or babies faced increased risks from coronavirus infections, according to two new reports released Friday by the Centers for Disease Control and Prevention. One report found that 15 pregnant patients died of covid-related causes between March 2020 and early October, including nine who died after delta became the most prominent strain. All but one of the women who died had underlying health conditions, and none had been fully vaccinated. The second report found that the risk of stillbirth increased about fourfold for women with covid-19 as delta surged. The reports’ authors emphasize the importance of preventive measures including vaccination, which the CDC recommends for pregnant people. Only about 30 percent of pregnant Americans are vaccinated, a rate far lower than the population as a whole.
20th Nov 2021 - The Washington Post

Hong Kong Approves Sinovac Vaccine for Children Ages 3-17

Hong Kong approved lowering the age of eligibility for the Covid-19 vaccine from China’s Sinovac Biotech Ltd. to three years old, down from 18 years old. The city’s Secretary for Food and Health said adolescents from 12-to-17 years will be accorded priority to receive the vaccine, “with a view to extending to children of a younger age group at a later stage,” according to a statement on Saturday. Experts serving on panels for the Centre for Health Protection had earlier backed the new age limit. The expansion of the eligible population comes as Hong Kong’s immunization campaign hits a wall. Vaccine hesitancy is ripe especially among the elderly population, many of whom refuse to even get one dose. Since the effort began in February, about 60% of residents have been fully vaccinated, according to Bloomberg’s Vaccine Tracker.
20th Nov 2021 - Bloomberg

EU recommends Merck COVID-19 pill for adults at risk of severe illness

The European Union's drug regulator on Friday advised that an experimental COVID-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening. The European Medicines Agency (EMA) said the pill, developed along with Ridgeback Biotherapeutics, should be taken twice a day for five days, but advised against use during pregnancy for in women who plan to get pregnant.
20th Nov 2021 - Reuters

U.S. expands COVID-19 booster eligibility to all adults

U.S. regulators expanded eligibility for booster shots of COVID-19 vaccines to all adults on Friday, allowing millions more Americans to get additional protection against the virus amid a recent rise in infections. The director of the Centers for Disease Control and Prevention, Rochelle Walensky, signed off on the expanded eligibility on Friday evening after the U.S. Food and Drug Administration broadened its authorization of booster doses to all adults who had received their second shot of either the Pfizer/BioNTech or Moderna Inc vaccine at least six months prior.
20th Nov 2021 - Reuters

Hong Kong Approves Sinovac Vaccine for Children Ages 3-17

The city’s Secretary for Food and Health said adolescents from 12-to-17 years will be accorded priority to receive the vaccine, “with a view to extending to children of a younger age group at a later stage,” according to a statement on Saturday. Experts serving on panels for the Centre for Health Protection had earlier backed the new age limit. The expansion of the eligible population comes as Hong Kong’s immunization campaign hits a wall. Vaccine hesitancy is ripe especially among the elderly population, many of whom refuse to even get one dose. Since the effort began in February, about 60% of residents have been fully vaccinated, according to Bloomberg’s Vaccine Tracker. That compares with over 80% in Singapore, its rival financial hub in Asia.
20th Nov 2021 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Nov 2021

    View this newsletter in full

Canada to authorize use of Pfizer's COVID-19 vaccine for children -source

Canada will announce as expected on Friday it is authorizing the use of Pfizer Inc's COVID-19 vaccine for children aged 5 to 11, a government source said on Thursday. The decision will make it the first shot for young children in Canada. Officials had made clear for weeks that the decision would be favorable, noting that incidences of COVID-19 are now highest in those under 12. Prime Minister Justin Trudeau said last month that Ottawa had signed a deal with Pfizer to quickly receive 2.9 million doses of the vaccine once it was approved.
18th Nov 2021 - Reuters

‘Zero-Covid is not going to happen’: experts predict a steep rise in US cases this winter

A steep rise in Covid-19 cases in Europe should serve as a warning that the US could also see significant increases in coronavirus cases this winter, particularly in the nation’s colder regions, scientists say. However, there is more cause for optimism as America enters its second pandemic winter, even in the face of likely rises in cases. Evidence shows vaccine-conferred protection against hospitalization and death remains high several months after inoculation, vaccines for children older than five can reduce Covid transmission, and new antiviral medications hold the promise of making Covid-19 a treatable disease.
18th Nov 2021 - The Guardian

AstraZeneca's antibody drug over 80% effective at preventing Covid, trial shows

The data showed that patients given a single injection of the antibody treatment were 83% less likely to develop symptomatic cases of the coronavirus than participants who were given a placebo. Around 2% of the world’s population is thought to be at risk of not responding well to Covid-19 vaccines, according to AstraZeneca. In a separate trial, patients with mild-to-moderate Covid-19 who were given one dose of AZD7442 within three days of developing symptoms had their risk of developing severe disease reduced by 88%.
18th Nov 2021 - CNBC

Pfizer, U.S. ink $5.29 deal over possible COVID-19 treatment

The U.S. government will pay drugmaker Pfizer $5.29 billion for 10 million treatment courses of its potential COVID-19 treatment if regulators approve it. Pfizer asked the Food and Drug Administration on Tuesday to authorize the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The FDA is already reviewing a competing pill from Merck and will hold a public meeting on it later this month. The price for Pfizer’s potential treatment amounts to about $529 per course. The U.S. has already agreed to pay roughly $700 per course of Merck’s drug for about 1.7 million treatments.
18th Nov 2021 - The Independent

Moderna seeks U.S. authorization of COVID-19 booster shots for all adults

Moderna Inc said on Wednesday it had applied with the U.S. Food and Drug Administration for authorization of its COVID-19 booster vaccine for all adults aged 18 and older. The FDA has cleared booster shots of COVID-19 vaccines for people who are immunocompromised, those aged 65 and older and for individuals at high risk of severe disease or who are regularly exposed to the virus. Moderna is seeking authorization for a 50-microgram booster dose, half the strength of its original vaccine given in two shots about four weeks apart.
18th Nov 2021 - Reuters

UK study suggests Delta subvariant less likely to cause symptoms

A subvariant of Delta that is growing in Britain is less likely to lead to symptomatic COVID-19 infection, a coronavirus prevalence survey found, adding that overall cases had dropped from a peak in October. The Imperial College London REACT-1 study, released on Thursday, found that the subvariant, known as AY.4.2, had grown to be nearly 12% of samples sequenced, but only a third had "classic" COVID symptoms, compared with nearly a half of those with the currently dominant Delta lineage AY.4. Two-thirds of people with AY.4.2 had "any" symptom, compared with more than three-quarters with AY.4.
18th Nov 2021 - Reuters

Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills

Pfizer Inc said the U.S. government would pay $5.29 billion for 10 million courses of its experimental COVID-19 antiviral drug, as the country rushes to secure promising oral treatments for the disease. The deal is for around twice as many treatment courses as Merck & Co Inc has agreed to supply the United States under its contract. The price for the Pfizer pill is nearly 25%lower at roughly $530 per course, compared with about $700 for Merck's.
18th Nov 2021 - Reuters

AstraZeneca's preventative COVID-19 shot shown to work longer-term

AstraZeneca cemented its lead in bringing a preventative COVID-19 shot to market, saying its antibody cocktail offered 83% protection over six months, providing another possible weapon in the fight against the pandemic. The therapy, called AZD7442 or Evusheld, had previously been shown to confer 77% protection against symptomatic illness after three months, in an earlier readout of the late-stage PROVENT trial in August.
18th Nov 2021 - Reuters

EU assesses GSK-Vir COVID-19 antibody therapy for authorisation

European health regulator said on Thursday it was assessing a marketing authorisation application for GSK-Vir Biotechnology's, monoclonal antibody treatment for COVID-19 and could give its opinion within two months. The drug, sotrovimab, branded as Xevudy was already under a speedy review by the European Medicines Agency (EMA), and GSK's application makes the drug the fourth application currently under EU lenses for the treatment of COVID-19.
18th Nov 2021 - Reuters

Antibody protection after mild COVID-19 may not last; an estimated 100 mln people have had long COVID

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. Antibody protection from mild COVID-19 may not last Nearly everyone who had a mild case of COVID-19 still has antibodies to the coronavirus a year later, but that might not protect them from new variants, a small study suggests. Among 43 Australians who dealt with mild COVID-19 early in the pandemic, 90% still had antibodies 12 months later.
18th Nov 2021 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Nov 2021

    View this newsletter in full

Moderna seeks U.S. authorization of COVID-19 booster shots for all adults

Moderna Inc said on Wednesday it had applied with the U.S. Food and Drug Administration for authorization of its COVID-19 booster vaccine for all adults aged 18 and older. The FDA has cleared booster shots of COVID-19 vaccines for people who are immunocompromised, those aged 65 and older and for individuals at high risk of severe disease or who are regularly exposed to the virus. Moderna is seeking authorization for a 50-microgram booster dose, half the strength of its original vaccine given in two shots about four weeks apart. The filing comes a week after Pfizer Inc applied for a similar clearance for the booster doses of the vaccine it has developed with German partner BioNTech.
18th Nov 2021 - Yahoo News UK

Atrial fibrillation significantly increases a person’s risk of serious complications and death from COVID-19

A new study from researchers at Intermountain Healthcare in Salt Lake City finds that patients with atrial fibrillation, the most common type of heart arrhythmia in adults, are at significantly higher risk to experience serious complications from COVID-19 illness. The study found that patients with a history of atrial fibrillation who have COVID-19 illness are not only more likely to need hospitalization, ICU and ventilator support, but nearly 62% more likely to suffer a major cardiovascular event, such as a heart failure hospitalization, and 40% more likely to die than individuals who don’t have a history of atrial fibrillation.
17th Nov 2021 - EurekAlert!

FDA promises quick review of Pfizer booster for all adults, CDC meets Friday

The U.S. Food and Drug Administration (FDA) said on Tuesday it would review Pfizer Inc's request to authorize booster doses of COVID-19 vaccine in all adults "as expeditiously as possible," with the New York Times reporting that the regulatory nod could come as soon as Thursday.
17th Nov 2021 - Reuters

Pfizer files for U.S. authorization of promising COVID-19 antiviral pill

Pfizer Inc said on Tuesday it is seeking U.S. authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial. Pfizer said it completed submission of its application for emergency use authorization of the drug, Paxlovid, with the U.S. Food and Drug Administration, including data from the drugmaker's clinical trial.
17th Nov 2021 - Reuters

Philippines approves emergency use of Novavax COVID-19 vaccine

The Philippines has approved the emergency use of a COVID-19 vaccine by Novavax Inc, its food and drug agency chief said on Wednesday, the ninth vaccine approved in the Southeast Asian country. The nanoparticle vaccine, under the brand name Covovax, will be manufactured by Serum Institute of India, and is approved for use on adults 18 and above, the agency's chief Rolando Enrique Domingo told a public briefing. Covovax, which had efficacy of 89.7% in clinical trials, will be administered in two doses not less than 21 days apart, Domingo added.
17th Nov 2021 - Reuters

EU regulator expects decision on Novavax COVID-19 shot in weeks

The European Union's drug regulator said on Wednesday it could decide on Novavax's COVID-19 vaccine approval "within weeks" if the data it has received from the drugmaker was sufficient to prove the shot's effectiveness. The protein-based vaccine, branded Nuvaxovid, has been under a rolling review since February, the European Medicines Agency (EMA) said. Such reviews allow for a speedy approval.
17th Nov 2021 - Reuters

Roche walks away from Atea partnership to develop COVID-19 pill

Roche Holding AG has ended a partnership with Atea Pharmaceuticals Inc to jointly develop a COVID-19 antiviral pill, the Swiss drugmaker said on Tuesday, a month after the drug failed to help patients in a small study. Boston-based Atea's shares fell 11% to $10.08 in extended trading, set to add to the 72% slump this year. Many companies are racing to develop an oral pill as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalizations and deaths, a promising new weapon in the fight against the pandemic.
17th Nov 2021 - Reuters

U.S. secures GSK-Vir COVID-19 antibody therapy doses worth $1 bln

The United States has signed contracts worth about $1 billion for doses of the antibody-based COVID-19 treatment from Britain's GSK and U.S.-based Vir Biotechnology, as countries seek to secure promising options beyond vaccines. The drugmakers said on Wednesday the U.S. orders bring the total number of doses to be supplied to more than 750,000 globally, without specifying how many doses of the treatment, sotrovimab, the U.S. government had signed up for.
17th Nov 2021 - Reuters

COVID-19: More infectious variant of Delta virus accounts for 1 in 10 COVID cases in England

Professor Paul Elliott, director of the REACT programme at Imperial College London, said the strain "seems to be less symptomatic" than the original Delta virus - adding this is a "good thing" as it "may be spreading less far in distance" when people are coughing.
17th Nov 2021 - Sky News

Could this gene double your risk of dying from COVID-19?

Soon after the pandemic began, we knew that certain groups of people are more at risk of dying from COVID-19 than others. It was immediately clear that those with specific underlying health conditions such as diabetes and cardiovascular disease were at increased risk, but slowly it became evident that certain ethnic groups were also being disproportionately affected. Social factors have played an important role in why these groups have been more affected than others, but genetics may also play a part. Scientists at Oxford University have now identified a version of a gene that may be associated with doubling the risk of respiratory failure from COVID, and it could go some way to explaining why people from particular backgrounds are more likely to die from the virus. The study’s authors said that their work identifying the gene was extremely difficult because it wasn’t merely the presence of the gene they were looking for, but whether it was switched “on”, making it more high risk.
17th Nov 2021 - AlJazeera

GlaxoSmithKline and Vir finally score $1B supply deal for COVID antibody—6 months after FDA nod

It was a long time coming but GlaxoSmithKline and Vir Biotechnology have finally secured a supply deal with the United States for their COVID-19 antibody treatment—six months after it scored an FDA emergency authorization. The U.S. will pay $1 billion to expand access to sotrovimab throughout the country. While the green light for sotrovimab—known commercially as Xevudy—came in May, the therapy has been available in more than half of the states in the U.S., which were free to make separate deals to acquire it. GSK said it will supply the contracted doses by Dec. 17. There is an option for the U.S. to purchase additional doses by March 2022. GSK did not reveal how many doses are included in the agreement but said it has now secured contracts to sell more than 750,000 doses worldwide. Japan, Australia and Canada are among the countries that have inked supply deals for sovrotimab.
17th Nov 2021 - FiercePharma

Johnson and Johnson’s new vaccines leader talks Covid-19, pipeline plans, and ‘a golden opportunity’ for clinical trials

There’s a changing of the guard at Janssen, Johnson & Johnson’s vaccines division. In June, the company announced that Penny Heaton, formerly the founding CEO of the Bill and Melinda Gates Medical Research Institute, was joining Janssen as the global therapeutic area head for vaccines, taking over from Johan Van Hoof, who retires at the end of 2021. Heaton’s CV shows her chops. She also previously worked for Merck, Novartis, and Novavax, and earlier in her career at the Centers for Disease Control and Prevention. As she faces her first J&J Pharma Day on Wednesday — actually a two-day event for analysts — STAT caught up to Heaton to ask her about her plans for Janssen’s vaccines division. We discussed the company’s Covid-19 vaccine, made with an adenovirus 26 delivery system that is also used in its Ebola vaccine, which has been licensed in Europe. We also talked about Janssen’s promising vaccine to protect adults against respiratory syncytial virus or RSV, now in a Phase 3 clinical trial, and other things in its pipeline.
17th Nov 2021 - STAT News

With 128 Covid vaccines in clinical development, we don’t know if the approved/authorized ones are the best ones

Pfizer/BioNTech. Moderna. Johnson & Johnson. AstraZeneca. These are the marquee names that spring to mind when you think of the vaccine companies at the forefront of the global fight against Covid-19. And for good reason: together they have manufactured the majority of the estimated 7 billion-plus Covid vaccine doses administered to date around the world. But as regulators in the U.S., Europe, and around the world mull the most responsible way to expand vaccine eligibility to an even larger share of their populations — including to younger children, as the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) have done this month by greenlighting Pfizer’s vaccine for kids 5 to 11 years of age — it’s time to confront an uncomfortable reality: The global health community still doesn’t know which of the hundreds of Covid vaccines currently in clinical and preclinical development are truly “the best.” That’s a shortcoming governments and the global health system need to address if they are to ensure that the next pandemic doesn’t knock the world on its heels to the extent the novel coronavirus has done.
17th Nov 2021 - STAT News

Pfizer agrees to allow generic versions of its COVID pill

Pharmaceutical giant Pfizer has signed a deal enabling the production and supply of its experimental COVID anti-viral drug in dozens of lower- and middle-income countries. The agreement between the US company and the UN-backed international public health group Medical Patent Pool (MPP) would allow producers to manufacture and supply generic versions of the drug in 95 countries without the threat of patent infringement.
16th Nov 2021 - Aljazeera.com


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

    View this newsletter in full

Pfizer Asks F.D.A. to Authorize Covid Pill For Unvaccinated People

Pfizer has applied to the Food and Drug Administration to authorize its antiviral pill to treat unvaccinated people with Covid-19 who are at high risk of becoming severely ill, the company said on Tuesday. The drug, which will be sold under the brand name Paxlovid, could become available within weeks if authorization is granted. It is meant to be dispensed by pharmacies and taken at home. Paxlovid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that are expected to reach far more patients than other drugs that are typically given by infusion.
16th Nov 2021 - The New York Times

Pfizer Submits Covid-19 Pill for FDA Authorization

Pfizer Inc. said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year. Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease. “There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bourla said Thursday. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”
16th Nov 2021 - The Wall Street Journal

Why Impact of 'Long Covid' Could Outlast the Pandemic

Millions of people who have gotten Covid-19 and survived are finding that a full recovery can be frustratingly elusive. Weeks or even months after seemingly recovering from even a mild case, many patients still confront a wide range of health problems. As researchers try to measure the duration and depth of what’s being called “long Covid,” specialized, post–acute Covid clinics are opening to handle the patients. The scale of the pandemic and persistence of some of Covid’s disabling effects mean the economic pain and drain on health resources could continue well after the contagion ends.
16th Nov 2021 - Bloomberg

NHS boss Amanda Pritchard reveals health service is preparing a yearly Covid booster programme

Amanda Pritchard said the NHS is putting plans in place for yearly booster jabs JCVI recommended booster programme should be extended to all over-40s Ms Pritchard urged people to take up vaccination invitations 'as soon as possible'
16th Nov 2021 - Daily Mail

Three doses of COVID-19 mRNA vaccination safe in high-risk populations

Earlier reports have suggested the high effectiveness of messenger ribonucleic acid (mRNA) coronavirus disease (COVID-19) vaccines at preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, their efficacy against mild COVID-19 disease appears to wane over time. Thus, the need for additional/booster vaccine doses is being contemplated. This retrospective study included adults within the Mayo Clinic Enterprise who were vaccinated with three doses of United States Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccines from December 1, 2020, to October 17, 2021. Participants received the first two doses of BNT162b2 or mRNA-1273 according to the emergency use authorization (EUA) protocol. The study participants were administered a third dose of the same vaccine type as the original two doses at least 28 days after the second dose. All subjects were followed up for at least 14 days after their third vaccine dose.
16th Nov 2021 - News-Medical.Net

More than 10,000 Australians have filed coronavirus vaccine injury claims

Taxpayers are facing a hefty bill for rare but significant coronavirus vaccine injuries, with at least 10,000 people planning to claim under the federal government’s no-fault indemnity scheme. Services Australia is building an online portal, to be launched next month, for uncapped claims above $5000 from those who suffered injury and loss of income due to their COVID-19 vaccine, with compensation for medical costs and lost wages to be paid by the government.
16th Nov 2021 - Sydney Morning Herald

Researchers find way to filter coronavirus particles out of the air

A study by researchers suggests that air filters can remove almost all airborne traces of COVID-19. The findings by the University of Cambridge and Addenbrooke's Hospital could not only improve the safety of "surge wards" but also opens up the possibility of setting standards for cleaner air to reduce the risk of indoor transmission. With fears growing of another potential wave this winter, the discovery could allow hospitals to better manage their repurposed "surge wards" which can often lack the ability to change the air with a high frequency.
16th Nov 2021 - Sky News

Jabs have given us a tactical advantage over Covid-19 – squandering it now would be reckless in the extreme

Now the spectre of Christmas cancelled is raised, an attempt to jolt millions out of complacency and into action. In other European countries – notably Austria, Netherlands, France, Italy and Germany – Covid-19 infections are climbing. Here in Britain, we have relied on high vaccination rates to keep hospitalisations and deaths low, even when infections have spiked. Squandering that tactical advantage over Covid-19 would be reckless in the extreme. From next week, booster jabs will be offered to eight million over-40s. Third doses cut the risk of infection by more than 80 per cent. So far the middle-aged are not coming forward in the numbers needed. While three-quarters of eligible over-70s have had their booster, just half of those in their 50s have taken up the offer.
16th Nov 2021 - iNews

How food can help recovery from Covid-19

Eating advice for people recovering from Covid-19 is now available online. The Recovery Knowledge Hub, external, launched by the University of Plymouth, asks people about their current diet and offers tips and ideas to improve it. The hub is aimed at everyone who wants advice, from the public to professionals and it is free, said the university. "Eating the right diet is crucial to keep well physically and mentally, and a key part of recovery from Covid-19 is to make sure your diet is healthy," said Mary Hickson, professor in dietetics at the university.
16th Nov 2021 - BBC News

COVID-19: Boosters not only replenish immunity against transmission but lift it too, new data shows

These two types of protection - against transmission and against severe disease - are both very important, but they are also quite different. Just because a particular vaccine is good at one thing doesn't necessarily mean it's equally good at the other thing. Just because a particular vaccine's effectiveness at preventing transmission is waning doesn't necessarily mean its effectiveness at preventing serious disease is diminishing at the same rate. I say all of this not just because the two types of protection are often conflated (though they are) but because keeping this distinction under your hat is quite important when navigating all the data around COVID and vaccines.
16th Nov 2021 - Sky News

Moderna says EU to donate over 70 mln doses of its COVID-19 vaccine

Moderna Inc said it signed an agreement that enables European Union and European Economic Area countries to donate over 70 million doses of its COVID-19 vaccine to the COVAX vaccine sharing scheme for low-and-middle income countries.
16th Nov 2021 - Reuters

AstraZeneca-Oxford COVID-19 vaccine supply hits two billion doses

Two billion doses of the AstraZeneca-Oxford University COVID-19 vaccine have been supplied worldwide, the Anglo-Swedish drugmaker and its partner said on Tuesday, in just under a year since its first approval. The shot, which is the biggest contributor to the COVAX vaccine sharing scheme backed by the World Health Organization, is being made in 15 countries for supply to more than 170 countries, London-listed AstraZeneca and Oxford University said in a joint statement. AstraZeneca in June last year signed on India's Serum Institute, the world's biggest manufacturer of vaccines by volume, to help double the vaccine's manufacturing capacity to two billion doses.
16th Nov 2021 - Reuters

Pfizer to allow generic versions of its COVID pill in 95 countries

Pfizer Inc said it will allow generic manufacturers to supply its experimental antiviral COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP). The voluntary licensing agreement between Pfizer and the MPP will allow the UN-backed group to grant sub-licences to qualified generic drug manufacturers to make their own versions of PF-07321332. Pfizer will sell the pills it manufactures under the brand name Paxlovid.
16th Nov 2021 - Reuters

Racial disparities in kids’ vaccinations are hard to track

The rollout of COVID-19 shots for elementary-age children has exposed another blind spot in the nation’s efforts to address pandemic inequalities: Health systems have released little data on the racial breakdown of youth vaccinations, and community leaders fear that Black and Latino kids are falling behind. Only a handful of states have made public data on COVID-19 vaccinations by race and age, and the federal Centers for Disease Control and Prevention does not compile racial breakdowns either. Despite the lack of hard data, public health officials and medical professionals are mindful of disparities and have been reaching out to communities of color to overcome vaccine hesitancy. That includes going into schools, messaging in other languages, deploying mobile vaccine units and emphasizing to skeptical parents that the shots are safe and powerfully effective.
16th Nov 2021 - The Associated Press

Pfizer, like Merck, inks deal to license COVID-19 pill and boost global supply

With its highly anticipated COVID-19 oral treatment seemingly on a fast track to approval, Pfizer already is lining it up to be manufactured as a generic by countries in need. Under an agreement with the Medicines Patent Pool (MPP), Pfizer will license Paxlovid to facilitate affordable global access. The deal will allow sub-licensees to supply 95 countries that account for 53% of the world's population, Pfizer said. The arrangement mirrors the one made by Merck and Ridgeback with the MPP three weeks ago, allowing for needy countries to manufacture those drugmakers' COVID-19 pill molnupiravir. Molnupiravir also is expected to be endorsed by the FDA in the coming weeks. Both deals are contingent upon regulatory authorizations or approvals. An FDA advisory group will meet on Nov. 30 to discuss Merck's application for molnupiravir.
16th Nov 2021 - FiercePharma


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

    View this newsletter in full

U.K. Expands Covid-19 Booster Program to People in Their 40s

The U.K. is expanding its Covid-19 booster program to younger people as the country seeks to head off another wave of infections this winter. A third vaccine dose will be available to people aged 40 to 49 starting six months after their second shot, the government said Monday. Previously, only those over 50 and other vulnerable groups were eligible. So far, more than 12 million people have received a booster. The government is also recommending a second shot of the Pfizer Inc.-BioNTech SE vaccine for 16 and 17-year-olds. That inoculation will be given at least 12 weeks after the initial dose or a Covid infection, whichever is later.
15th Nov 2021 - Bloomberg

Novavax: SK Bioscience Submits BLA For COVID-19 Vaccine Candidate, NVX-CoV2373, To South Korea' MFDS

Novavax Inc. (NVAX) said that SK bioscience has summited a biologics license application for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate, to South Korea's Ministry of Food and Drug Safety. NVX-CoV2373 is Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant. In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to South Korea's Ministry of Food and Drug Safety in April of this year. The completion of a BLA submission to the agency marks the final review stage for authorization of NVX-CoV2373 in Korea.
15th Nov 2021 - Business Insider

Spain's Hipra gets green light for Phase II COVID vaccine trials

Spain's medicines agency has authorised Catalonia-based pharmaceutical group Hipra to test a COVID-19 vaccine it is developing on more than 1,000 volunteers, Prime Minister Pedro Sanchez said on Monday. Hipra will carry out the so-called Phase II trial - the second stage of a three-round trial process - on volunteers at 10 hospitals around Spain, Sanchez said. Speaking at an event to present how European Union recovery funds will be channelled into health investments, Sanchez described the vaccine development as "extraordinary news".
15th Nov 2021 - Reuters

Why two emergency physicians’ kids took part in the Pfizer vaccine trials

Cue the collective sigh of relief from many parents across the country. While the Pfizer-BioNTech Covid-19 vaccine has been available for children ages 12 and up since mid-September, as of now 28 million even younger school-age children between the ages of 5 and 11 are eligible to receive it. As an emergency medicine physician and a parent, that reassures me. As a member of the global community, it gives me hope we’ll soon return to some level of normalcy. I acknowledge the personal decision of some parents who don’t want their kids to be vaccinated. Yet as someone whose own children were part of the vaccine’s clinical trials, I feel compelled to share the story of why my wife and I felt confident making that decision with them, and what vaccinating younger children will mean for the fate of the pandemic.
15th Nov 2021 - STAT News

8 lingering questions about the new Covid pills from Merck and Pfizer

The past two months have brought extremely good news in the fight against Covid-19. Two different oral treatments have proved effective at both preventing people newly diagnosed with Covid-19 from entering the hospital and from dying. “We’re accelerating our path out of this pandemic,” President Biden said after data on the second Covid pill became available. The wide availability of oral drugs could make Covid-19 less lethal, making it less risky for people to return to in-person work and to their normal lives. The first results, from Merck and Ridgeback Therapeutics, were released in October and will be considered by an advisory panel to the Food and Drug Administration in December. That could lead to an emergency use authorization in the U.S. by the end of the year. That drug, molnupiravir, reduced hospitalizations by 50% and prevented deaths entirely a large randomized clinical trial when it was given within five days of when symptoms began. The pill is given as a five-day course during which patients take a total of 40 pills.
15th Nov 2021 - STAT News

Non-White race tied to higher risk for COVID infection, severity

A US meta-analysis and systematic review of data on 4.3 million patients analyzed in 68 cohort and cross-sectional studies shows that, relative to White people, Black, Hispanic, and Asian populations were at higher risk for COVID-19 infection and admission to an intensive care unit (ICU) but were less likely to die of the disease. The study, published yesterday in JAMA Network Open, was designed to uncover the link between socioeconomic determinants of health and racial disparities in COVID-19 outcomes. A team led by University of California at San Diego researchers searched for COVID-19 studies that included data on race and rates of infection, disease severity, and socioeconomic status published from Jan 1, 2020, to Jan 6, 2021, well before the more transmissible Delta (B1617.2) variant was predominant in the United States.
12th Nov 2021 - CIDRAP

GlaxoSmithKline, Vir target emergency authorization for intramuscular COVID-19 antibody drug with new trial win

GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody drug sotrovimab already bears an FDA emergency use authorization (EUA) as an infusion. Now, the pair hopes to win the same status for an intramuscular formulation. The latest plan comes as a phase 3 trial showed sotrovimab, also known as Xevudy, delivered similar efficacy between intramuscular and intravenous administration routes in nonhospitalized mild to moderate COVID patients who are at high risk of disease progression. The IM administration group recorded a 2.7% rate of progression to hospitalization for over 24 hours or death through Day 29 of the trial versus 1.3% in the IV arm, the two companies reported Friday from the COMET-TAIL study. The adjusted difference of 1.07% falls within the noninferiority bar GSK and Vir previously set with the FDA.
12th Nov 2021 - FiercePharma

Late to the party: Europe on the verge of approving Roche and Celltrion antibodies for COVID

Nearly a full year after the U.S. gave Regeneron’s antibody cocktail for COVID-19 patients emergency authorization, Europe is on the verge of approving the monoclonal antibody duo. The European Medicines Agency's (EMA's) committee for human medicines also has recommended another antibody treatment for approval, Celltrion’s regdanvimab. The EMA's Committee for Medicinal Products for Human Use has passed the recommendations to the European Commission for approval. The Regeneron cocktail of casirivimab and imdevimab, which is marketed outside of the U.S. by Roche and known commercially as Ronapreve, is recommended for COVID-19 patients who do not require supplemental oxygen and are at risk to progress to a severe form of the disease. It also is recommended for use as post-exposure prophylaxis. While the recommendations cover all adults, they also include adolescents 12 years or older weighing at least 40 kilograms, or roughly 88 pounds.
12th Nov 2021 - FiercePharma


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

    View this newsletter in full

Bahrain authorizes AstraZeneca's anti-COVID drug for emergency use

Bahrain has approved the emergency use of AstraZeneca's (AZN.L) anti-COVID drug Evusheld, the state news agency reported on Sunday. Bahrain has become the first country to authorize the drug, which will be limited to adults who suffer from immunodeficiency or who are taking immunosuppressants, as well as individuals with occupations that put them at risk of transmission, the news agency said.
15th Nov 2021 - Reuters

More than 10,000 COVID-19 booster breakthroughs - cause for concern?

The Pfizer vaccines were not evaluated for preventing infection, but rather symptomatic or severe disease and death. And when it comes to these statistics at least for now, the vaccines seem to be doing their job. The percentage of people testing positive for the virus has declined from an aveage of more than 5% to just 0.56%. And hospitalisations have gone down too, hitting only 200 people on Friday with 20% of the patients in only a mild condition.
13th Nov 2021 - The Jerusalem Post

Covaxin, India’s homegrown COVID jab, ‘highly efficacious’: Study

Covaxin, the first COVID-19 vaccine developed in India, is “highly efficacious” and presents no safety concerns, according to a study published in the medical journal Lancet. Covaxin gained emergency approval from the World Health Organization last week, the eighth jab to be given the green light by the health body. The vaccine has already been cleared for use in 17 countries. Known by the code BBV152, Covaxin is an inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The WHO has described it as “extremely suitable for low- and middle-income countries due to easy storage requirements”. Some of the other approved vaccines must be stored at very low temperatures, which throws up logistical and cost problems.
12th Nov 2021 - Al Jazeera English

The Valneva COVID-19 vaccine: Why it might be a game-changer

French pharmaceutical company Valneva is throwing its hat into the vaccine ring, but it has a vaccine with a difference. Rather than induce an immune response that targets just the spike protein of the coronavirus, the Valneva vaccine, also known as VLA2001, stimulates an immune response to the entire virus, and that might just give it an edge over its competitors. It is different in that it uses the tried and tested method of taking the whole of the coronavirus and inactivating it so that it can no longer cause illness. It then combines with an adjuvant, a substance that helps it enter human cells effectively.
12th Nov 2021 - Al Jazeera English

WHO eyes meeting to set guidelines on COVID-19 pills

World Health Organization (WHO) officials said on Friday they were hoping to convene a meeting soon to set guidelines on the use of COVID-19 antiviral pills, saying they offered "very attractive" new prospects for clinical care. Britain became the first country to approve one of the potentially game-changing pills earlier this month. Janet Diaz, the WHO's top official for clinical care responses, said that a meeting of its guidelines development group would consider the question of COVID pills in a forthcoming meeting in three weeks. Another WHO official Mike Ryan said preliminary findings on the pills was "very, very welcome", adding that a "careful process" was not required before the therapies should be expanded more broadly.
12th Nov 2021 - Reuters

GSK-Vir COVID-19 antibody works as shot in the arm as well as infusion

Britain's GSK and partner Vir said on Friday their antibody-based COVID-19 drug was shown in a trial to work as well when given as a shot in the arm awhen administered via the standard infusion, potentially offering more convenience. GSK said it would now speak to global regulators, including the U.S. Food and Drug Administration, about potential approval for the new method of administration, known as intramuscular injection, which can be carried out by family doctors and spare patients a trip to hospital.
12th Nov 2021 - Reuters

Patients with Covid history contributing to diabetes case burden, says hospital

Experts at the hospital said inflammatory reactions after Covid could include, hypoxia, weakness, weight loss, hair loss, myocarditis, thyroid and diabetes which is being reported as one of the most common diseases.
12th Nov 2021 - Hindustan Times


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

    View this newsletter in full

Covid Pills May Save Lives, But They Won’t End the Pandemic

The promise of new Covid-19 pills from Pfizer Inc. and Merck & Co. gives rise to the hopeful question: Is this how the pandemic ends? The best answer anyone can muster is “maybe.” No matter how effective the antiviral pills are, it will be months before we can say we’re near the end. The pills have been shown in studies to substantially reduce the chances that a high-risk, unvaccinated person with Covid will need hospitalization. The results rightly raised hopes. Pfizer’s drug was 89% effective, and Merck’s succeeded in about 50% of patients—potentially powerful scientific breakthroughs
11th Nov 2021 - Bloomberg

EU regulator backs COVID-19 drugs from Regeneron-Roche, Celltrion

Europe's drug regulator has recommended two COVID-19 antibody therapies - one from American-Swiss partners Regeneron-Roche and another from South Korea's Celltrion, as the region builds up its defence against surging cases. Approval by the European Commission would mark the first for any COVID-19 treatment on the continent since Gilead's remdesivir last year. Reuters reported earlier this week that the European Medicines Agency's (EMA) endorsement of the two drugs was imminent.
11th Nov 2021 - Reuters

EU regulator endorses COVID-19 drugs from Regeneron-Roche, Celltrion

Europe's drug regulator has recommended two COVID-19 antibody therapies - one from American-Swiss partners Regeneron-Roche and another from South Korea's Celltrion, as the region builds up its defence against surging cases. Approval by the European Commission would mark the first for any COVID-19 treatment on the continent since Gilead's remdesivir last year. Reuters reported earlier this week that the European Medicines Agency's (EMA) endorsement of the two drugs was imminent
11th Nov 2021 - Reuters

India could approve Covid pill in matter of days

Antiviral drug Molnupiravir, used for treating mild to moderate Covid-19 infections, is set to enter the Indian markets within days, an official confirmed on Wednesday. Manufactured by US drug companies Merck, Sharp and Dohme, Molnupiravir is among the first proven drugs to effectively treat the viral contagion and was originally developed to treat flu. It can be taken as a pill instead of injection or intravenous administration. It could likely enter the Indian pharmaceutical markets “within days” after receiving Emergency Use Authorisation, Dr Ram Vishwakarma,
11th Nov 2021 - The Independent

Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says

U.S. National Institutes of Health scientists played "a major role" in developing Moderna Inc's COVID-19 vaccine and the agency intends to defend its claim as co-owner of patents on the shot, NIH Director Dr. Francis Collins told Reuters on Wednesday. In a story first reported by the New York Times on Tuesday, Moderna excluded three NIH scientists as co-inventors of a central patent for the company's multibillion-dollar COVID-19 vaccine in its application filed in July.
11th Nov 2021 - Reuters

Moderna applies for COVID-19 booster shot approval from Japan's health ministry -NHK

Moderna Inc applied for approval from Japan's health ministry on Wednesday to use their COVID-19 vaccines for booster shots, broadcaster NHK reported on Thursday. Japan plans to start administering booster shots from December this year, and has already approved the use of Pfizer COVID-19 vaccines for a third round of vaccinations on Thursday. If approved, Moderna's vaccine would become the second to be approved for booster shots in Japan.
11th Nov 2021 - Reuters

Ellume's COVID-19 home test recall most serious, FDA says

The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month. Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall. A 'false positive' indicates that a person has the virus when they actually do not.
11th Nov 2021 - Reuters

UK researchers identify T-cell targets for future COVID vaccines

British researchers said on Wednesday they had identified proteins in the coronavirus that are recognised by T-cells of people who are exposed to the virus but resist infection, possibly providing a new target for vaccine developers. Immunity against COVID-19 is a complex picture, and while there is evidence of waning antibody levels six months after vaccination, T-cells are also believed to play a vital role in providing protection. The University College London (UCL) researchers examined 731 health workers in two London hospitals during the first wave of the COVID-19 pandemic, and found that many had not tested positive despite likely exposure to the original coronavirus.
11th Nov 2021 - Reuters

Moderna offers COVID-19 shot at $7 to African Union - Africa CDC head

Moderna Inc has offered to sell its COVID-19 vaccines to the African Union at $7 a shot, head of the Africa Centres for Disease Control John Nkengasong said on Thursday, half the price paid by the United States earlier in the year. It is also a substantial discount to what other buyers like the European Union have agreed this year, part of a broader trend for drugmakers to sell at lower prices to lower income countries. "I am happy to say that a dose of the Moderna vaccine will be $7. That is what is being offered to us," Nkengasong told a weekly virtual media briefing.
11th Nov 2021 - Reuters

Israel pandemic advisory panel backs COVID vaccine for young children

Israel's pandemic advisory board on Wednesday backed administering Pfizer's and BioNTech's COVID-19 vaccine to children age 5-11, health officials said, as a fourth wave of infections subsides nationwide. The Health Ministry is widely expected to accept the panel's recommendation and begin rolling out the shots this month. The U.S. Food and Drug Administration has granted emergency use authorization of the vaccine for the age group at a 10-microgram dose.
11th Nov 2021 - Reuters

Diabetes problem makes Africa more vulernable to COVID-19 death, says WHO

Death rates from COVID-19 infections are much higher in patients with diabetes in Africa, where the number of people with diabetes is growing rapidly, the World Health Organization said on Thursday. A WHO analysis of data from 13 African countries found a 10.2% case fatality rate in COVID-19 patients with diabetes, compared with 2.5% for COVID-19 patients overall. "COVID-19 is delivering a clear message: fighting the diabetes epidemic in Africa is in many ways as critical as the battle against the current pandemic," said Matshidiso Moeti, WHO Regional Director for Africa, in a statement.
11th Nov 2021 - Reuters

Sleep apnea linked to COVID-19 outcomes

Sleep apnea tied to severe COVID-19 - The risk of severe illness from COVID-19 is higher in people with obstructive sleep apnea and other breathing problems that cause oxygen levels to drop during sleep, researchers say. They tracked 5,402 adults with these problems and found that roughly a third of them eventually tested posted for the coronavirus. While periodic episodes of not-breathing while asleep - leading to low oxygen levels, or hypoxia - did not increase people's chances of being infected, sleep-related hypoxia did increase infected patients' odds of needing to be hospitalized or dying from COVID-19, Drs. Cinthya Pena Orbea and Reena Mehra of the Cleveland Clinic and colleagues reported on Wednesday in JAMA Network Open. It is not clear if treatments that improve sleep apnea, such as CPAP machines that push air into patients' airways during sleep, would also reduce the risk of severe COVID-19, said Pena Orbea and Mehra.
11th Nov 2021 - Reuters

EU authorizes 2 medicines for people at risk of severe COVID

The European Medicines Agency has recommended the authorization of two new medicines against the coronavirus for people at risk of severe disease. In a statement on Thursday, the EU drug regulator said it had concluded that the monoclonal antibody treatments — a combination of casirivimab and imdevimab, and the drug regdanvimab — have both been proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19. The EMA described the safety profile of both medicines as “favorable,” and said that despite a small number of side effects, “the medicines’ benefits are greater than their risks.” The drug combination of casirivimab and imdevimab is made by Roche; it was granted an emergency use license by the U.S. Food and Drug Administration last November.
11th Nov 2021 - The Associated Press

Merck inks yet another $1B-plus supply deal for COVID pill, this time with Japan

Merck & Co.'s positive data for oral COVID-19 antiviral molnupiravir continue to pay off in a big way. Wednesday, just a day after unveiling a $1 billion sale order to the U.S., the company disclosed another major supply deal. Japan has agreed to pay Merck and partner Ridgeback Therapeutics $1.2 billion for 1.6 million courses of the drug, or $750 per course. The deal is contingent on the antiviral winning an authorization or approval from Japan’s Pharmaceuticals and Medical Devices Agency. The deal comes a day after Merck said the U.S. government agreed to purchase another 1.4 million courses of the drug for $1 billion. Together with an earlier purchase, the order brings the United States' total supply purchase to 3.1 million courses at a cost of $2.2 billion.
11th Nov 2021 - FiercePharma


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

    View this newsletter in full

Next generation of Covid vaccines should target different part of virus, study says

A vaccine targeting Covid's replication proteins could knock all coronaviruses. Study found some NHS staff who tested negative had T cells against the virus. Current vaccines mainly target the spike protein to trigger antibody response
10th Nov 2021 - Daily Mail

Pfizer, BioNTech Ask FDA to Expand Covid-19 Booster Use to All Adults

Pfizer Inc. and partner BioNTech asked U.S. health regulators to expand the authorization of their Covid-19 booster to people as young as 18 years old, as the government explores expanding access to extra doses. The application opens the door for authorization of the extra dose potentially before the end of the year, which could provide millions of people with another layer of security as winter drives many indoors where the risk of transmission is higher. The Food and Drug Administration in September cleared a third dose of the Pfizer-BioNTech vaccine for adults who are 65 years and older or are at risk of severe disease and death, including because of their jobs or where they live.
10th Nov 2021 - The Wall Street Journal

Two Million Ellume Covid Tests Recalled on False Positive Risk

Ellume Ltd. is recalling 2.2 million at-home Covid-19 tests because they risk returning false positives, the U.S. Food and Drug Administration said. The regulator classified the action on Wednesday as a class I recall, the most serious kind, saying it has received 35 reports of false positives from the test made by the Australian company. Incorrect results could lead a person to wrongly receive Covid-19 treatments or isolate when they don’t need to, the FDA said. “The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result,” a company spokesperson said in an email. “We have and will continue to work diligently to ensure test accuracy, in all cases.”
10th Nov 2021 - Bloomberg

U.S. Spending $650 Million to Expand Rapid Confirmatory Testing

The U.S. will spend $650 million to increase production and access to rapid diagnostic tests that can confirm the results of at-home screening, part of an effort to quickly identify and treat people with Covid-19. Peope who buy over-the-counter rapid antigen tests at pharmacies may need confirmatory testing to verify the accuracy of the result, the U.S. Department of Health and Human Services said Wednesday in a statement. The funds will help ensure such tests are readily available across the country and can provide results quickly, the agency said. The investment follows the Biden administration’s commitment of more than $3 billion for rapid home tests that may need confirmation. The earlier funding aimed to quadruple the amount of rapid home tests available in the U.S. by December, to about 200 million a month.
10th Nov 2021 - Bloomberg

French company Valneva wins deal with European Commission over COVID-19 vaccines

French vaccines company Valneva's share price jumped more than 20% on Wednesday after it won European Commission approval for a deal under which it would supply up to 60 million doses of its COVID-19 vaccine candidate over two years. The eighth such deal by the European Union's executive body in the fight against rising infections is a welcome boost for Valneva as it negotiates what has been a bumpy road for its COVID-19 vaccine. "The Valneva vaccine adds another option to our broad portfolio, once it is proven to be safe and effective by the European Medicines Agency (EMA)," EU health commissioner Stella Kyriakides said.
10th Nov 2021 - Reuters

Israeli MRI study finds heart damage from COVID-19 vaccine is rare and mild

A study conducted by Beilinson Hospital in Petah Tikva, using a detailed scanning technique to examine patients with symptoms of a heart muscle condition after receiving a COVID-19 vaccine, found that damage was rare, mild, and expected to heal. The study used cardiac magnetic resonance imaging on patients diagnosed with myocarditis, a weakening of the heart muscles that has been found in a few patients after they were inoculated. A link has been seen in recent months between coronavirus vaccines using mRNA technology and very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart).
10th Nov 2021 - The Times of Israel

Pfizer asks FDA for broader authorization of vaccine booster

Pfizer and its German partner, BioNTech, on Tuesday asked the Food and Drug Administration to authorize a booster dose of its coronavirus vaccine for people 18 and older. The FDA could clear the request by the end of the month, according to health officials who spoke on the condition of anonymity because they were not authorized to discuss the issue. The officials are concerned about studies showing waning vaccine protection, as well as increased infections in parts of the United States. Currently, the government recommends the Pfizer-BioNTech booster vaccine for people 65 and older and those 18 to 64 who are at high risk of covid-19, the disease caused by the virus, because of underlying medical conditions or potential exposures at work or in their living situation.
10th Nov 2021 - The Washington Post

COVID-19 tests may be more accurate in the afternoon

A new study finds that the accuracy of reverse transcription-polymerase chain reaction (RT-PCR) COVID-19 tests follows a daily pattern. The highest number of accurate positive results occur with midafternoon tests, while evening tests increase the number of false positives. The study also suggests that midafternoon is the time of day at which both symptomatic and asymptomatic individuals are most likely to pass on the SARS-CoV-2 virus to others.
10th Nov 2021 - Medical News Today

Germany recommends only Biontech/Pfizer vaccine