Covid News Watch
NIH Advisers Urge Tighter Oversight of Experiments on Deadly Viruses + More
NIH Advisers Urge Tighter Oversight of Experiments on Deadly Viruses
Biosecurity advisers to the federal government are calling for tighter scrutiny of experiments with potentially dangerous viruses and other pathogens, reflecting an ongoing debate within the scientific community over the benefits and risks of such laboratory research. This contentious issue has become even more rancorous amid speculation that some kind of “lab leak” might have played a role in the origin of the coronavirus.
The draft recommendations from members of the National Science Advisory Board for Biosecurity, which met Wednesday to discuss the policies, do not address the pandemic’s origin. Nor is there any direct reference to the coronavirus. But the first recommendation clearly carries the signature of the pandemic: The external advisers urge the government to broaden its definition of the kinds of experiments that require special reviews and safety measures.
Current policies cover pathogens that are “likely highly virulent” — that is, extremely deadly. But the advisers say this fails to cover pathogens that don’t meet that threshold of deadliness, yet “pose a severe threat to public health or national security if the pathogen was capable of wide and uncontrollable spread in human populations.” That is a fair description of the novel coronavirus, SARS-CoV-2, which is far less lethal than viruses such as Ebola but is extraordinarily transmissible.
During a brief period for public comment on Wednesday, Rutgers University professor Richard H. Ebright provided a litany of what he said were defects in the existing policies, including a lack of transparency, a failure to review many risky experiments and a lack of enforcement. Research conducted by privately funded institutions is not covered by the policies, he noted.
Just in Time for Fall, There’s a Brand-New COVID Variant Making Headway in the U.S.
A new COVID strain started to create waves among virus trackers this week, outpacing nearly all other variants of interest scientists are tracking in the U.S. this autumn.
The Omicron spawn, which scientists have named BF.7 — short for BA.5.2.1.7 — comprised 1.7% of sequenced infections last week in the U.S., according to new data from the U.S. Centers for Disease Control and Prevention. Other variants jockeying for the top spot right now — held by BA.5, at 85% — include BA.4.6, which comprised 10.3% of infections, and BA.2.75, which comprised 1.3%.
Scientists are taking notice of BF.7 because it’s making headway in an increasingly crowded field of Omicron subvariants. For months they’ve watched BA.2.75 — dubbed Centaurus by the Twitterverse — as a variant of interest with the potential to surge this fall. But this week, BF.7 surpassed it.
So far Belgium has seen the lion’s share of BF.7 cases identified globally: 25%. Denmark, Germany and France have each seen 10% of the world’s identified cases so far, according to cov-lineages.org, a COVID data repository updated daily by contributors from universities in England, Scotland and Australia, among others.
The COVID Emergency May End, but There’s No Rule to Say When the Pandemic Is Over
President Joe Biden lit a firestorm of controversy this week when he said in an interview that “the pandemic is over”: Is it really over? How do we know? Who gets to decide?
Pandemics don’t have hard edges. Knowing where they start or stop is a judgment call, and there isn’t a clear authority that gets to make that decision.
Because a pandemic is a global event, no single country or leader can decide it’s over, said J. Alex Navarro, assistant director of the Center for the History of Medicine at the University of Michigan Medical School.
The world will probably have to reach a consensus, and that’s something that may come as a kind of acknowledgment from the World Health Organization — or it might not.
Pfizer Agrees to Supply Millions of Paxlovid Courses to Global Fund
Pfizer announced on Thursday it has reached an agreement to supply up to six million courses of its COVID-19 antiviral Paxlovid to the Global Fund to get treatment to low and middle-income countries.
The company said it expects the supply of Paxlovid to become available sometime this year. The Paxlovid courses will be sold according to Pfizer’s tiered pricing model, with low-income countries paying not-for-profit prices and upper-middle-income countries paying according to the tiered approach.
Access to coronavirus therapeutics like Paxlovid, which must be administered within five days of symptom-onset, has been limited for poorer countries. Efforts to provide access to these treatments to poorer countries have been since they were authorized.
Israel Rolls out New Omicron-Tailored COVID Vaccines
Israel on Thursday began administering doses of coronavirus vaccines tailored to fight the highly infectious Omicron variant as its health authorities urged at-risk groups and those over 65 to get the shot.
The rollout of the new vaccine follows Israel’s world-leading drive to vaccinate its population early in 2021 and marks it out as one of the first countries to start distributing Omicron-specific vaccines. Health officials are now voicing growing concerns about increased COVID-19 infections in the upcoming winter.
Israel was a world leader last year in vaccinating its population of 9.5 million against the coronavirus after it struck a deal with Pfizer to trade vaccines for medical data. It quickly vaccinated over 60% of its population with at least two doses of the Pfizer/BioNTech vaccine by last fall.
Scientists Were Worried About a Particular COVID Variant This Fall. They Didn’t Expect Its Offspring
Omicron spawn BA.2.75, dubbed “Centaurus,” seemed like the COVID variant to watch this summer — one with the potential to wreak unprecedented havoc later in the year.
Instead, one of its children, BA.2.75.2, has outcompeted it, eliminating it as a threat — but replacing it with a more formidable one.
Among BA.2.75.2’s concerning traits: Its spike protein binds to human cells tightly — better than any other variant so far, Dr. Raj Rajnarayanan, assistant dean of research and associate professor at the New York Institute of Technology campus in Jonesboro, Ark., says. By doing so, it makes it more difficult for antibodies to successfully attack.
To make matters worse, the new variant shows “extensive escape” ability, according to a new preprint paper released this week by researchers at the Imperial College in London and the Karolinska Institute in Sweden. The paper has not yet been peer-reviewed but has been widely cited by experts.
COVID Raises Risk of Long-Term Brain Injury, Large U.S. Study Finds
People who had COVID-19 are at higher risk for a host of brain injuries a year later compared with people who were never infected by the coronavirus, a finding that could affect millions of Americans, U.S. researchers reported on Thursday.
The year-long study, published in Nature Medicine, assessed brain health across 44 different disorders using medical records without patient identifiers from millions of U.S. veterans.
Brain and other neurological disorders occurred in 7% more of those who had been infected with COVID compared with a similar group of veterans who had never been infected. That translates into roughly 6.6 million Americans who had brain impairments linked with their COVID infections, the team said.
Memory impairments, commonly referred to as brain fog, were the most common symptom. Compared with the control groups, people infected with COVID had a 77% higher risk of developing memory problems.
COVID Vaccine Uptake for Young Ontario Children Lower Than Experts Had Expected
The number of children under the age of five getting vaccinated against COVID-19 in Ontario is even lower than the relatively small numbers many experts had expected.
Shots for the youngest age group have been available for two months, but only about 6% of those kids have had their first dose. Ontario’s chief medical officer of health, Dr. Kieran Moore, said that is lower than the numbers he thought he would see by this point.
Raywat Deonandan, an epidemiologist and associate professor in the faculty of health sciences at the University of Ottawa, said there are a lot of factors at play that likely feed into a low uptake, but he still would have expected a higher number by now.
The City of Toronto pulled a series of videos this week about COVID-19 vaccinations for children after one implied kids couldn’t go out to play with friends if they were unvaccinated. “This video missed the mark on that message and should not have been posted,” spokesperson Brad Ross wrote in a statement.
Pfizer Applies to Swissmedic for Authorization of Another COVID Vaccine
Pfizer said on Thursday it had submitted an application to Swissmedic for authorization of a further bivalent COVID-19 vaccine.
The ready-to-use dispersion for injection contained both messenger RNA (mRNA) from the original Pfizer/BioNTech COVID-19 vaccine and mRNA coding for the spike protein of Omicron variants BA.4 and BA.5, Pfizer said.
U.S. CDC Expects Omicron COVID Boosters for Kids by Mid-October + More
U.S. CDC Expects Omicron COVID Boosters for Kids by Mid-October
The U.S. Centers for Disease Control and Prevention expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October.
The CDC said in a document released on Tuesday that it expects to make a recommendation in early- to mid-October on the use of the new bivalent vaccines in the group if they are authorized by the U.S. Food and Drug Administration (FDA).
The vaccines, which target both the original version and the currently circulating variants of the virus, were rolled out for people 12 years or older earlier this month.
The CDC said it expects Pfizer-BioNTech’s (PFE.N), a bivalent vaccine to be available for children aged 5-11 years, and Moderna‘s (MRNA.O) vaccine for those aged 6-17 years, pending FDA authorization.
Feds Charge 47 for Allegedly Stealing $250 Million in COVID Fraud Scheme
Nearly 50 people were charged on Tuesday with carrying out a sweeping COVID-19 fraud scheme in which they allegedly stole close to $250 million from a federal program meant to feed hungry children in Minneapolis.
At a press conference, Attorney General Merrick Garland called it “the largest pandemic relief fraud scheme charged to date.”
Federal prosecutors said the 47 defendants pulled off the massive scam by taking advantage of loosened rules and oversight during the pandemic. They allegedly blew the cash meant for underserved kids on fancy cars and luxury real estate.
FDA Releasing Millions of Moderna Boosters as States Warn of Shortages
The federal government is releasing millions of Moderna booster shots that were delayed by the Food and Drug Administration as a result of a safety inspection at an Indiana packaging plant, even as states report shortages and encourage people to get Pfizer boosters instead.
The release of the withheld doses, which has not previously been reported, represents the latest wrinkle in the Biden administration’s fall booster campaign, with officials confronting slow uptake of the redesigned shots even before President Biden’s recent comment that the “pandemic is over.”
Only 34.9% of eligible Americans ages 5 and older have received a booster shot since the first batch was made available last year, according to federal data, and the White House has been encouraging Americans to seek out the updated Moderna and Pfizer shots that are targeting Omicron and its subvariants.
“On Tuesday, FDA authorized distribution of numerous batches of the updated Moderna COVID-19 Vaccine, Bivalent booster manufactured at Catalent’s facility,” FDA spokesperson Michael Felberbaum said in a statement.
Biden Clarifies COVID Comments: Pandemic ‘Basically Is Not Where It Was’
President Biden on Tuesday sought to clarify his comments from days earlier that the coronavirus pandemic “is over,” telling guests at a fundraiser that the COVID-19 situation is not as bad as it was.
Biden attended a Democratic National Committee fundraiser in New York City ahead of his speech Wednesday to the United Nations General Assembly. At one point, speaking about efforts on the pandemic, Biden referenced his comments to Scott Pelley of CBS last week in which he said the pandemic was “over.”
Biden acknowledged he was “criticized” for the remarks, adding, “But it basically is not where it was.”
Biden drew heat from public health experts and some lawmakers for his remarks to “60 Minutes” at the Detroit Auto Show last week, which was the first time the event was able to be held at full capacity since the onset of the pandemic.
Who Is Still Dying From COVID? The CDC Can’t Answer That
Earlier this week, President Joe Biden seemed to commit one of his trademark gaffes by saying “The pandemic is over.” The backlash was swift. That’s understandable, given that hundreds of people are still dying from COVID every day. But President Biden may be doing what comes naturally to many of us — judging the situation by our own experiences.
Who is dying in late 2022? Is it nursing home residents? Anti-vaxxers? Essential workers? How many of them have had the vaccine? Boosters? Did we fail them, or did they fail to take care of themselves?
When I asked the CDC for relevant statistics, they sent me a widely circulated graph that showed the rates of death were much lower for vaccinated people. But without raw numbers on these deaths, it’s still hard to know why the death toll has plateaued at such a high level.
One reason clear data aren’t available is that the U.S. doesn’t collect that information in a uniform way, said Stephen Kissler, an infectious disease researcher at the Harvard School of Public Health. “A lot of public health happens at the city level or lower so, because of that, it’s really hard to combine data across states to assess who is ending up in the hospital or dying of COVID-19,” he said. “The mix is hard to standardize.”
U.S. Adults Should Get Routine Anxiety Screening, Panel Says
U.S. doctors should regularly screen all adults under 65 for anxiety, an influential health guidelines group proposed Tuesday.
It’s the first time the U.S. Preventive Services Task Force has recommended anxiety screening in primary care for adults without symptoms. The proposal is open for public comment until Oct. 17, but the group usually affirms its draft guidance.
The recommendations are based on a review that began before the COVID-19 pandemic, evaluating studies showing potential benefits and risks from screening.
Given reports of a surge in mental health problems linked with pandemic isolation and stress, the guidance is “very timely,” said Lori Pbert, a task force member and co-author. Pbert is a psychologist-researcher at the University of Massachusetts’ Chan Medical School.
Nearly 1 in 10 Americans Suffer From Depression, Study Says
A growing number of Americans are struggling with depression and most are not seeking treatment or are undertreated for the mental health disorder, according to a new study. A study published in the American Journal of Preventive Medicine found almost 1 in 10 Americans reported suffering from depression in 2020, with rates of the mental health disorder higher among adolescents and young adults.
Researchers from Columbia University Mailman School of Public Health and City University of New York analyzed 2015-2020 data from the National Survey on Drug Use and Health, which is a nationally representative poll of Americans aged 12 and older.
Depression, which is the most common mental disorder in the nation, was most prevalent among young adults ages 18 to 25 at more than 17%, an increase from 10.3% in 2015. Slightly under 17% of adolescents ages 12 to 17 reported having depression, up from 12.7% 7 years ago.
According to the study, most adolescents with depression did not speak with a healthcare professional about their symptoms and did not receive treatment. Researchers note the COVID-19 pandemic exacerbated rates of depression among Americans but say increases in depression were occurring long before the virus outbreak.
Moderna Exec: ‘Eager’ to Collaborate With China on Supplying COVID Vaccines
Moderna Inc. (MRNA.O) Chief Medical Officer Paul Burton said on Wednesday the company is “eager” to collaborate with China on supplying its mRNA-based COVID-19 vaccines to the country.
The comments follow those of Moderna chief executive Stephane Bancel, who last week in Tokyo said the company has held talks with the Chinese government about supplying vaccines but no decision has yet been made.
Biden: ‘The Pandemic Is Over’ + More
Biden: ‘The Pandemic Is Over’
President Biden declared the coronavirus pandemic “over” in an interview that aired Sunday, pointing to the return of large events and the lack of masking and other public health measures in place nationwide.
“The pandemic is over,” Biden told “60 Minutes” from the Detroit auto show last Wednesday, the first time the event has been held since the onset of the pandemic in 2020.
“We still have a problem with COVID. We’re still doing a lotta work on it. It’s — but the pandemic is over. if you notice, no one’s wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing. And I think this is a perfect example of it.”
The Biden administration has focused its messaging on the importance of getting vaccinated and receiving booster shots to increase immunity, as well as the wide availability of antiviral pills and other forms of treatment for those who contract the virus.
Continuing COVID Craziness Shows It Was Never About the Science
The pandemic is essentially over, right? For some, yes. For others, not so much. It was only June when unvaccinated Canadians were finally allowed to leave the country, for reasons unclear to anyone. The vaccine doesn’t prevent transmission, so how did it make sense to keep the unvaccinated behind the frozen curtain? It didn’t.
But that’s Canada. It’s completely lost the plot with COVID and chucked all its previously freedom-loving ideals out the nearest window, eh? America wouldn’t behave like that, right? Except we are.
Tennis player Novak Djokovic couldn’t travel to America to compete in the U.S. Open in August because he’s unvaccinated. No foreigner may enter the United States without being fully vaccinated. Unless, of course, they walk across our border. That’s right. If you’re visiting, stay away with your COVID-infested self. If you’re trying to stay here forever, bring that COVID right in.
New York City kids don’t need a COVID vaccination to attend school but do need it to play school sports. Think about this. These kids can go to school, have lunch with their friends, take school trips and play sports during gym class, but they can’t play in an after-school league.
COVID Shots for Young Kids Arrived in June. Few Have Received Them.
In June, when the Food and Drug Administration authorized emergency use of coronavirus vaccines for children younger than 5, physicians expected apprehension among parents — after all, 4 in 10 parents with young children said they would definitely not get their youngsters vaccinated, according to a July Kaiser Family Foundation survey.
But doctors and public health experts never expected there would be this little interest in vaccines for young children.
Even in places with strong pro-vaccine sentiments, few young children have received shots, including in the District, which has the highest percentage of vaccinated. In DC, barely 21% of children 6 months to 4 years old have received one shot, and just 7.5% have received both doses, according to the Centers for Disease Control and Prevention.
Just under 325,000 young children are fully vaccinated nationwide, according to the CDC. While some parents blame a lack of access, experts believe misinformation surrounding the shots for younger children is driving vaccine hesitancy.
Fauci Fears ‘Anti-Vaxxer Attitude’ Could Cause Outbreaks of Non-COVID Diseases
Anthony Fauci, the nation’s top infectious disease expert, said in a new interview that the “anti-vaxxer attitude” of some Americans risks causing non-COVID virus outbreaks in the U.S.
“I’m concerned the acceleration of an anti-vaxxer attitude in certain segments of the population . . . might spill over into that kind of a negative attitude towards childhood vaccinations,” Fauci told The Financial Times in an interview published Sunday.
Fauci, who announced his pending retirement from the government last month, said the political division is one factor driving anti-vaccine sentiment, noting how some states have not promoted COVID-19 vaccination and Congress has failed to advance billions of dollars in funding.
The World Health Organization released a report in July showing that vaccination among children declined more during the COVID-19 pandemic than at any time in the past 30 years.
America Is Skeptical of the ‘Dark Horse’ COVID Vaccine Others Abroad Can’t Get Enough of
Nearly 225 million Americans are considered fully COVID vaccinated by the U.S. Centers for Disease Control and Prevention, meaning they’ve received two or more doses of a vaccine. The number who’ve been fully vaccinated with Novavax, the latest vaccine to receive approval from U.S. health officials: a mere 6,278.
The traditional protein-based vaccine, approved by U.S. health officials in July, was intended to win the hearts and minds of Americans who were hesitant to receive mRNA COVID vaccines Pfizer and Moderna, claiming that the technology was too new to be considered safe.
But for the 20% of Americans who remain unvaccinated, hesitancy about the safety of mRNA vaccine technology was likely just an excuse, experts say, as Novavax was formulated using the same technology as the flu vaccine — and uptake is still dismal.
However hesitant Americans are about Novavax, for whatever reasons, the situation is quite the opposite elsewhere. The vaccine has been approved in 38 other countries, including Australia, France, Ireland, Italy, Korea and the U.K., according to the World Health Organization. And Japan and Australia have approved the vaccine for usage as a booster dose, according to the Journal of American Medical Association.
Brazil Approves Pfizer Vaccine for Children as Young as Six Months
Brazilian national health regulator Anvisa has approved the COVID-19 vaccine produced by Pfizer (PFE.N) and BioNTech for children aged between six months and four years, the government body said in a statement Friday night.
The move broadens the availability of the vaccine, which is sold under the brand name Comirnaty for adults and is already available in Brazil for older age groups.
Brazil’s vaccination rates are already among the world’s highest, with almost 90% of the population having received at least one dose, according to the Our World in Data project, which collects official numbers from governments worldwide.
Moderna Gives WHO’s mRNA Hub Some Help, Pfizer Snubs Request
Moderna Inc. has allowed its COVID-19 vaccine to be used in a World Health Organization effort to develop mRNA shots that would increase production and access for poor countries.
Afrigen Biologics & Vaccines, a South African biotechnology company working with the WHO, has used the Moderna vaccine in comparison studies in mice to test the effectiveness of its own shots, said Petro Terblanche, Afrigen’s managing director.
With Moderna’s help, Afrigen is aiming to develop a shot that may be manufactured by at least 15 production facilities around the globe under the aegis of the WHO’s mRNA Vaccine Technology Transfer Hub in Cape Town.
Moderna didn’t supply the vaccine directly. It allowed the vaccine to be provided by the French government after a request from the United Nations-backed Medicines Patent Pool, according to Marie-Paule Kieny, the pool’s chair. Pfizer Inc. refused a similar request because it didn’t regard the need as urgent, she said.
Alzheimer’s and COVID: Is There a Link? — Study Mines Electronic Health Records to Find out
Older adults with COVID-19 were more likely to have a new diagnosis of Alzheimer’s disease a year later than non-infected people, an analysis of electronic medical record (EMR) data showed.
The risk for a new diagnosis of Alzheimer’s disease in older COVID patients within 360 days after SARS-CoV-2 infection was 0.68%, according to Rong Xu, Ph.D., of Case Western Reserve University in Cleveland, Ohio, and colleagues. In a matched group of older adults without SARS-CoV-2 infection, the risk for a new Alzheimer’s diagnosis was 0.47% (HR 1.69, 95% CI 1.53-1.72), Xu and co-authors wrote in a brief communication published in the Journal of Alzheimer’s Disease.
Alzheimer’s disease takes years to develop and long-term studies to determine whether COVID plays a role in dementia are underway. “The Alzheimer’s Association’s International SARS-CoV-2 Study is a network of studies aimed at answering some of these open questions but because this virus is still relatively new, longitudinal research examining COVID-19 and dementia risk will take some time,” Snyder said.
Previous research has linked COVID with cognitive changes. In Wuhan, China, long-term cognitive decline was common a year after older adults were hospitalized with SARS-CoV-2 infection. Preliminary studies also showed COVID patients had an uptick in the same biomarkers as Alzheimer’s patients and persistent cognitive problems.
White House Pushes for Monkeypox Funding as Cases Fall
Monkeypox cases are declining in many areas of the country, but the Biden administration is warning that the virus still poses a danger and pushing for lawmakers to approve its multibillion-dollar funding request to combat it.
More than 23,000 infections have been confirmed in the U.S. during the outbreak, but the growth has slowed. Cases have dropped about 50% in the past month, according to the Centers for Disease Control and Prevention (CDC), from an average of 440 cases a day on Aug. 16 to 170 cases a day on Sept. 14.
The White House requested $4.5 billion for the monkeypox response in the upcoming government spending bill. The funding would go towards increasing access to vaccinations, testing, treatment and operational support, as well as helping to combat monkeypox globally.
Major COVID Report Suggests Virus Could Have Leaked From a U.S. Lab
Major COVID Report Suggests Virus Could Have Leaked From a U.S. Lab
The Lancet is facing a backlash after a major COVID-19 Commission report suggested the disease may have leaked from a laboratory in the United States.
Published on Wednesday, the paper said it remains “feasible” that SARS-Cov-2 emerged from either a natural spillover or a laboratory incident, and called for the introduction of more safeguards to reduce the risk of either eventuality.
But the report, the result of two years of work, also suggested that American researchers could be culpable. As well as mentioning facilities in Wuhan, it noted that “independent researchers have not yet investigated” U.S. labs, and said the National Institutes of Health has “resisted disclosing details” of its work.
The report comes as controversy swirls around the commission chair, the economist Prof Jeffrey Sachs. At a conference in Madrid earlier this year, he said he was “pretty convinced” that SARS-Cov-2 “came out of a U.S. lab of biotechnology, not out of nature” — a claim that has since been widely promoted by Chinese diplomats.
New Study Finds Organ Recipients Rejecting Transplant After Receiving COVID Vaccine
Some transplant recipients are rejecting their new organ and scientists say the coronavirus vaccine may be to blame.
According to a new study published in the Journal of Clinical Medicine, acute corneal allografts are being rejected by immunized patients who’ve undergone the procedure. Researchers say the underlying cause could be tied to a systemic inflammatory response elicited by the shot post-jab.
Japanese researchers compiled data from 23 studies. A total of 23 eyes from 21 patients who had undergone corneal graft procedures were assessed. Graft rejection occurred anywhere from one day to six weeks after vaccination in all patients — some who underwent the procedure as far back as 20 years ago.
Among the list of emerging complications linked to the vaccine are blood clots, heart inflammation and Guillain-Barre syndrome.
Laval University Professor Suspended for Child COVID Vaccination Criticism Faces New Disciplinary Threat
A Quebec university professor of infectious diseases who was suspended during the summer for calling into question the need to vaccinate children against COVID-19 is facing a new disciplinary threat for similar comments he made on a radio show while under suspension.
Patrick Provost, a full professor at the Department of Microbiology and Immunology at Laval University, was suspended for eight weeks without pay in June by his employer for comments he made in December 2021.
Provost had said during a public event that the risks of vaccinating children against COVID-19 were greater than the benefits. While on suspension in mid-July, Provost made similar comments during an interview with Quebec radio station CHOI 98.1 Radio X.
Following Provost’s radio appearance, an individual submitted a complaint through the university’s security denunciation portal, according to files obtained by The Epoch Times.
France’s Health Body Warns of Resurgence of COVID Virus in the Country
France’s national health body warned on Friday of a resurgence of COVID-19 cases in the country and urged people to continue to get vaccinated to protect themselves against the virus.
The Sante Publique France (SPF) body said that during the week of Sept. 5-Sept. 11, there had been 186 confirmed COVID cases for every 100,000 people in France — a figure up 12% versus the previous week — representing an average of around 18,000 new cases per day.
Vax Protection Fades Fast Against BA.4/5-Related Hospitalizations — South African Study Makes the Case for More Frequent Boosters
Vaccine protection against hospitalization from the latest Omicron subvariants deteriorates rapidly, even after a third dose, new data from South Africa indicated, suggesting that annual boosters might not cut it for high-risk people.
With the primary two-dose series of Pfizer‘s mRNA vaccine, effectiveness against BA.4/5-related hospitalization slipped from 47.4% after 3 to 4 months (95% CI 19.9-65.5) to just 19.3% at 9 months and beyond (95% CI 6.3-30.5), according to Glenda Gray, MBBCh, of the South African Medical Research Council in Cape Town, and co-authors, writing in correspondence to the New England Journal of Medicine.
“Evidence of rapid waning of durability indicates the need for regular boosting as early as 4 months after the last dose or the need for vaccines to incorporate variants of concern to maintain protection,” Gray and co-authors said.
WHO ‘Strongly Advises Against’ Use of Two COVID Treatments
Two COVID-19 antibody therapies are no longer recommended by the World Health Organization (WHO), on the basis that Omicron and the variant’s latest offshoots have likely rendered them obsolete.
The two therapies — which are designed to work by binding to the spike protein of SARS-CoV-2 to neutralize the virus’ ability to infect cells — were some of the first medicines developed early in the pandemic.
The virus has since evolved, and mounting evidence from lab tests suggests the two therapies — sotrovimab as well as casirivimab-imdevimab — have limited clinical activity against the latest iterations of the virus. As a result, they have also fallen out of favor with the U.S. health regulator.
On Thursday, WHO experts said they strongly advised against the use of the two therapies in patients with COVID-19, reversing previous conditional recommendations endorsing them, as part of a suite of recommendations published in the British Medical Journal.
COVID Home Test Kits Less Effective With Omicron Variant: Study
U.S. News & World Report reported:
Rapid at-home COVID tests have become less reliable with the emergence of the Omicron variant, new research suggests.
Only one of three widely used rapid antigen tests met World Health Organization (WHO) standards for accuracy, Dutch researchers report.
For the study — published Sept. 14 in The BMJ — they tested nearly 6,500 people with COVID symptoms who visited one of three test sites in the Netherlands between late December and early February.
Researchers found that the sensitivity of three rapid antigen tests — the ability to correctly identify a true positive sample — declined as Omicron became the dominant variant.
EU Regulator Backs Wider Use of AstraZeneca COVID Therapy
Europe’s medicines regulator has backed using AstraZeneca‘s (AZN.L) preventative COVID-19 therapy as a treatment for the disease and also endorsed another medicine as a preventative option for another common virus.
AstraZeneca said on Friday that the European Medicines Agency (EMA) had backed Evusheld as a treatment for adults and adolescents with COVID who do not need supplemental oxygen and who are at increased risk of their disease worsening.
Last month, Japan became the first country to approve the long-acting antibody as a treatment for COVID — making Evusheld the first such therapy authorized for both prevention and treatment of the viral disease.
Racing Moderna, Pfizer Starts Phase 3 Trial of mRNA Flu Vaccine
Pfizer has begun a phase 3 clinical trial of its mRNA-based influenza vaccine, keeping it tucked in behind Moderna in the race to upend the seasonal flu market using the technology that defined the response to COVID-19.
Moderna dosed the first participants in the phase 3 clinical trial of its flu vaccine candidate, mRNA-1010, in June, activating sites in the Southern Hemisphere to get data to support a potential accelerated approval while preparing to run a larger confirmatory study in the Northern Hemisphere in the 2022-23 flu season. Pfizer, taking a different approach, has made a 25,000-subject U.S. phase 3 the focus of its program.
The investigators have now dosed the first participants with Pfizer’s quadrivalent modified RNA influenza vaccine. Through the trial, which is enrolling people aged 18 years and older, Big Pharma is aiming to show the efficacy, safety, tolerability and immunogenicity of the vaccine.
White House Launches Monkeypox Research Agenda
The White House on Thursday announced a round of new research commitments aimed at better understanding how to diagnose, treat and prevent monkeypox, with new clinical trials being done both in the U.S. and in countries where the virus is endemic.
During a press briefing, chief White House medical adviser Anthony Fauci acknowledged there are “a number of unanswered questions” when it comes to the monkeypox response.
There are currently no treatments approved by the Food and Drug Administration (FDA) specifically meant to treat and prevent monkeypox. The treatments that have been utilized throughout the outbreak — mainly the Jynneos vaccine and the antiviral tecovirimat, or TPOXX — are both approved to treat and prevent smallpox infections.
Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases (NIAID), further noted the importance of developing better diagnostic methods for the monkeypox virus. Current monkeypox tests can only be used once lesions have formed on the skin that can then be swabbed.
U.S. Seeing Decline in Monkeypox New Case Growth, CDC Says
U.S. Centers of Disease Control and Prevention (CDC) Director Rochelle Walensky said on Thursday she was cautiously optimistic over a decline in the growth of new monkeypox cases, but that some areas of the country are still experiencing a rise in infections.
She also said during a White House briefing that the agency was taking steps to address racial and ethnic disparities in the distribution of monkeypox vaccines.
Nearly 23,000 cases of monkeypox have been identified across the United States as of Sept. 14, Walensky told reporters.
