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FDA meeting endangers Biden plan to fight virus

A key part of President Joe Biden’s plan to fight Covid is threatened as a Food and Drug Administration vaccine advisory committee meets Friday to debate and vote on Pfizer and BioNTech’s request to offer injections of reminder to the general public.

The agency’s Vaccines and Related Biologics Advisory Committee vote – scheduled for around 2:30 p.m. ET – comes as some scientists, including at least two at the FDA, say they’re not fully convinced of all Americans who received the Pfizer vaccine. needs additional doses at this time.

In documents released ahead of the advisory committee meeting, FDA scientists declined to take a position on whether to support third shots, saying U.S. regulators have not independently reviewed or verified all available data. to support the use of boosters. They also seemed skeptical of some of the data provided, including the widely cited efficacy figures from Israel, where researchers published observational studies there showing that the effectiveness of the Pfizer vaccine against the infection worsened over time. .

This sets the stage for a tense meeting on Friday as the Biden administration said it wanted to start offering booster shots to the general public as early as next week, pending FDA clearance. The move is part of the administration’s broader plan to deal with a higher number of Covid cases in the United States fueled by the fast-spreading delta variant.

The country’s leading health regulators, including CDC Director Dr Rochelle Walensky, Acting FDA Commissioner Dr Janet Woodcock and White House Chief Medical Advisor Dr Anthony Fauci, have already approved Biden’s recall plan in August. While the FDA hasn’t always followed the advice of its committee, it often does. The agency surprised investors and the public earlier this year when it backed away from the advice of its independent panel of external experts to approve Biogen’s drug for Alzheimer’s disease.

If the committee does not deliver a favorable vote, it could force the Biden administration to shift gears on its plan, possibly limiting third shots to certain groups of Americans, such as those aged 65 and over who are known to be at higher risk for serious illness, said Lawrence Gostin, director of the World Health Organization’s Center on National and Global Health Law.

The FDA group could give Biden’s stimulus package a “cool reception,” Gostin said. “While there is good evidence for potentially waning vaccine immunity, two doses of mRNA hold up strongly in preventing serious illness, hospitalizations and death.”

The vote puts the committee in an “awkward position” as the administration has already announced it will begin handing out boosters the week of September 20, said Dr Bruce Farber, head of infectious diseases at Northwell Health.

“I’m sure they won’t be at all unanimous in what they said because we already know they are not unanimous,” he said.

Scientists and other health experts had previously criticized Biden’s decision to boost all Americans 16 and older when senior health officials presented the plan last month. Scientists and other experts said the data cited by federal health officials was unconvincing and called the administration’s recall request premature.

Outlining plans to start giving out boosters as early as next week, administration officials cited three CDC studies that showed vaccine protection against Covid declined over several months. The administration plan calls for people to receive a third dose of Pfizer or Moderna vaccine eight months after their second injection. Biden has since said scientists are considering whether to move the third shot by three months. U.S. health officials have said they need more data on Johnson & Johnson’s vaccine before they can recommend boosters of those injections.

Pfizer and Moderna also each published their own analyzes showing that the incidence of cases of rupture of Covid, which occur in fully vaccinated people, was less common in clinical trial participants who were more recently inoculated, suggesting that the protection of Covid vaccines decreases over time. In separate documents released on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine six months after a second injection restores protection against infection to 95%.

Still, some scientists argue that booster shots for the general public are not needed at this time.

A leading group of scientists published an article in the medical journal The Lancet on Monday saying that available data shows vaccine protection against serious illnesses persists, even though effectiveness against mild illnesses declines over time. The authors, including two senior FDA officials and several scientists from the World Health Organization, said the large-scale distribution of recalls to the general public was “not appropriate” at this time.

There is currently no consensus in the biomedical community on boosters for the general public, said Dan Barouch, immunologist at Harvard Medical School. “There are seasoned experts on different sides of the debate. “

Dr Arturo Casadevall, president of molecular microbiology and immunology at the Bloomberg School of Public Health at Johns Hopkins University, supports boosters for the general public.

He said a third shot would boost immunity and reduce the likelihood of breakthrough infections, including variant strains. “For all vaccines, immunity wanes over time and Covid-19 vaccines are no different,” he added.

Akiko Iwasaki, an immunologist at the Yale School of Medicine, does not agree with the large-scale distribution of the boosters in the United States. She said we should focus on giving everyone the first shots before moving on to the booster doses.

Still, she said, booster shots are needed for some more vulnerable people right now as groundbreaking cases lead to serious illness and hospitalizations.

These serious cases are “mainly in the elderly and those aged 65 and over,” she said. “I think giving it to the elderly really makes sense to me right now.”