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Paul Offit, Philly’s Most Vocal Vaccine Advocate, on Science, Truth and Why He’s Not a Fan of the Latest COVID Boosters

The Philadelphia Inquirer reported:

Philadelphia’s most prominent immunization expert isn’t planning to get the latest COVID-19 booster shot and doesn’t think most others need to either. Paul Offit, who is among the Food and Drug Administration’s advisers on which vaccines the public should receive, disagrees with the current recommendations of the White House, FDA and Centers for Disease Control and Prevention that everyone over the age of 5 should get the new vaccine.

“This product was grossly oversold,” said Offit, who was in the minority on the FDA’s panel of independent experts who voted 19-2 in June to recommend that the COVID vaccines used for boosters should be updated to the bivalent vaccine now being offered across the nation.

The government’s handling of this new COVID-19 vaccine frustrates Offit. He believes the average healthy person who has been fully vaccinated and boosted gets increasingly minuscule benefits from additional shots and probably doesn’t need the bivalent booster.

What concerns Offit more is the federal government making a decision that isn’t backed by robust science. Evidence of the bivalent vaccines’ effectiveness, which included human trials, but with a bivalent vaccine designed for a COVID strain different than those now circulating, and tests with mice, was “underwhelming,” Offit said.

The Latest COVID Variants Can Evade Vaccine Protection, According to New Data

Time reported:

New lab data suggest that vaccines and prior infections may not offer enough protection against several new COVID-19 variants cropping up in the U.S. and around the world. Dr. David Ho, director of Columbia University’s Aaron Diamond AIDS Research Center, and his team reported the results from a set of studies published in the journal Nature. They showed how well some of the latest variants — BQ.1, BQ.1.1, XBB and XBB.1, which were all derived from Omicron — are evading both vaccine-derived and infection-derived immunity.

​​These new variants all have mutations in the region that binds to cells and infects them, which means that they’re highly transmissible, as prior Omicron variants were. BQ.1 is growing steadily in France, according to the public database of SARS-CoV-2 variants GISAID. By mid-November, European health officials expect the variant to account for 50% of cases in Europe, and to become the dominant strain in that region by early 2023.

XBB is growing quickly in Singapore and India. Both variants have spawned new strains that have each picked up an additional mutation to create BQ.1.1 and XBB.1. As of early November, BQ.1 and BQ.1.1, combined, now make up about 35% of new cases in the U.S.

Other studies have found similar drops in antibody protection against BQ.1 among vaccinated people. But Ho’s group conducted what is likely the most comprehensive look to date at BQ.1, BQ.1.1, XBB and XBB.1, and how existing immunity — from the original mRNA vaccines, the new Omicron boosters and natural infections — stands up to them.

WHO Reports 90% Drop in World COVID Deaths Since February

Associated Press reported:

The World Health Organization chief on Wednesday said a nearly 90% drop in recent COVID-19 deaths globally compared to nine months ago provides “cause for optimism,” but still urged vigilance against the pandemic as variants continue to crop up.

Director-General Tedros Adhanom Ghebreyesus said that last week just over 9,400 deaths linked to the coronavirus were reported to the WHO. In February of this year, he said, weekly deaths had topped 75,000 globally.

“We have come a long way, and this is definitely a cause for optimism. But we continue to call on all governments, communities and individuals to remain vigilant,” he said at a virtual news conference from the WHO’s Geneva headquarters.

Novavax BA.1 Booster Data Support COVID Vaccine Strain Switch, but Bivalent Fails to Bring Benefits

Fierce Biotech reported:

Novavax has generated phase 3 data to support a switch to its BA.1 variant COVID-19 vaccine. But with the original shot holding its own, and a bivalent version failing to bring benefits, the biotech is pushing the message that its existing adjuvanted recombinant protein vaccine remains viable.

As mRNA vaccines from Moderna and Pfizer have come to dominate the COVID-19 landscape, Novavax has tried to carve out a distinct space for its shot and make the case that its modality has benefits over the incumbent technology. Specifically, the biotech has touted the “very broad responses” in recipients of its vaccine against the ancestral strain at a time when its rivals are launching variant-specific updates.

Even so, Novavax, while continuing to tout the effectiveness of its original “prototype” vaccine, has run a phase 3 clinical trial of monovalent and bivalent shots adapted to the BA.1 Omicron subvariant. Gregory Glenn, M.D., president of R&D, framed the data as an affirmation of the original vaccine.

Novavax Cuts Full-Year Revenue Forecast Again Amid Weak Demand

Reuters reported:

Novavax Inc. (NVAX.O) cut its full-year revenue forecast on Tuesday for the second time in three months, hurt by a global supply glut in COVID-19 vaccine and waning demand.

The company now expects annual revenue to be near the low end of its prior forecast range of between $2 billion and $2.3 billion.

The company is now “pushing forward” on developing a vaccine targeting Omicron subvariants BQ.1 and BQ.1.1 which they would also formulate as a bivalent vaccine with another coronavirus strain, Filip Dubovsky, Novavax’s chief medical officer, said on a conference call with investors.

Novavax plans to have that ready in the second quarter of next year, in time for a potential surge of cases in the southern hemisphere, Dubovsky added.

People With Long COVID Face Barriers to Government Disability Benefits

Kaiser Health News reported:

When Josephine Cabrera Taveras was infected with COVID-19 in the spring of 2020, she didn’t anticipate that the virus would knock her out of work for two years and put her family at risk for eviction.

Like many others with long COVID, Taveras has fallen through the cracks of a system that was time-consuming and difficult to navigate even before the COVID pandemic.

People are facing years-long wait times, insufficient legal support and a lack of clear guidance on how to prove they are disabled — compounded by the challenges of a medical system that does not have a uniform process for diagnosing long COVID, according to health experts and disability attorneys.

The Biden administration promised support to people with long COVID, but patient advocates say many are struggling to get government help.

COVID: Evusheld Protects the Most Vulnerable Patients, Analysis Shows

The BMJ reported:

The antibody drug Evusheld is effective for protecting clinically extremely vulnerable people from COVID-19, including its Omicron variants, a preprint study has reported.

The prophylactic treatment, manufactured by AstraZeneca, is a combination of two long-acting antibodies (tixagevimab and cilgavimab). It is given as two separate, sequential intramuscular injections in the same session and can be administered in the community.

A research team, led by the University of Birmingham alongside academics from King’s College London and the U.K. Health Security Agency, carried out a systematic review and meta-analysis to examine its effectiveness in immunocompromised patients.

Overall, it reported that the treatment was 86% (95% confidence interval 6.2% to 99.7%; P=0.04) effective for preventing COVID-specific death, 88% (47.1% to 98.7%; P<0.001) effective in preventing intensive care admission, 69% (50.8% to 81.6%; P<0.001) effective in preventing hospital admission and 40% (29.8% to 49.7%; P<0.001) effective in preventing SARS-CoV-2 infection.

Telemedicine Has Improved Healthcare Access. Let’s Keep It That Way

The Washington Post reported:

Telemedicine has emerged as one of the several crucial innovations coming out of the coronavirus pandemic, making it easier for many people to access healthcare. But as the crisis phase of the pandemic comes to an end, these gains could be rolled back. Policymakers should try to preserve them.

Before the pandemic, virtual medical visits were somewhat of a novelty. Telemedicine was mainly envisioned as a service for patients living in remote areas who couldn’t travel to see a specialist physician.

The ability to continue virtual visits is tied to the federal government’s public health emergency for the pandemic. While there are bipartisan efforts to continue telehealth flexibilities once the emergency ends, policy analysts have expressed concern that reimbursing providers the same amount for virtual as in-person visits could make healthcare spending harder to rein in.

U.K. Approves Pfizer-BioNTech’s COVID Booster Targeting Omicron BA.4/5

Reuters reported:

Britain’s health regulator on Wednesday approved the country’s first two-pronged COVID-19 booster targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine from Pfizer (PFE.N) and partner BioNTech (22UAy.DE) was approved for use as a booster in people 12 years and older after it was found to meet safety, quality and effectiveness standards.

Britain had already approved so-called bivalent vaccines targeting the Omicron BA.1 sub-variant from Pfizer-BioNTech and rival Moderna (MRNA.O) but now has added a first against BA.4/5 in its arsenal with the latest authorization.

The regulator on Wednesday also approved Novavax‘s (NVAX.O) COVID-19 shot as a booster for adults.

CanSino’s Inhalable COVID Vaccines to Be Available in Tianjin From Nov. 10

Reuters reported:

Chinese pharmaceutical company CanSino Biologics (6185.HK) said on Wednesday its inhalable COVID-19 vaccines will be available in China’s northern city of Tianjin from Nov. 10, a statement on its WeChat account said.

Last week, the Tianjin-based company said it did not expect its inhaled COVID vaccine to significantly boost financial results, based on the current immunity strategy and domestic booster vaccination rates.

China’s financial hub Shanghai and 13 cities in eastern Jiangsu province have already introduced CanSino’s inhalable vaccines as a booster for their citizens, CanSino said.