Sunday, October 17, 2021

FDA meeting puts Biden’s plan to fight virus at risk

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A key part of President Joe Biden’s plan to combat Covid is in jeopardy as a Food and Drug Administration vaccine advisory committee meets Friday to discuss and vote on Pfizer and BioNTech’s request to offer injections of reinforcement to the general public.

The agency’s Vaccine and Related Biologicals Advisory Committee vote, scheduled for around 2:30 p.m. ET, comes as some scientists, including at least two from the FDA, say they are not entirely convinced of all the Americans who have received the Pfizer vaccine. you need additional doses at this time.

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

It sets the stage for a tense meeting on Friday, as the Biden administration has said it wants to begin offering booster injections to the general public starting next week, pending clearance from the FDA. The move is part of the administration’s broader plan to tackle increased numbers of Covid cases in the US fueled by the fast-spreading delta variant.

The nation’s top 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 endorsed Biden’s backup plan in August. While the FDA has not always followed the advice of its committee, it often does. The agency surprised investors and the public earlier this year when it deviated from the advice of its independent panel of outside experts to approve the Alzheimer’s drug Biogen.

If the committee does not cast a favorable vote, it could force the Biden administration to change course in its plan, perhaps limiting third shots to certain groups of Americans, such as those 65 and older who are known to be at higher risk. of suffering from serious illnesses. disease, said Lawrence Gostin, director of the World Health Organization’s Center for National and Global Health Law.

The FDA group could give Biden’s booster plan a “good reception,” Gostin said. “While there is good evidence for a possible decrease in vaccine immunity, two doses of mRNA hold up strongly in preventing serious illness, hospitalizations and deaths.”

The vote puts the committee in an “awkward position” as the administration has already announced that it would begin distributing boosters the week of Sept. 20, said Dr. Bruce Farber, Northwell Health’s chief of infectious diseases.

“I am sure that they are not going to be unanimous in what they have said because we already know that they are not unanimous,” he said.

Scientists and other health experts had already criticized Biden’s decision to push all Americans 16 and older when senior health officials outlined the plan last month. Scientists and other experts said the data federal health officials cited was unconvincing and characterized the administration’s push by the boosters as premature.

Outlining plans to begin distributing boosters starting next week, administration officials cited three CDC studies that showed vaccine protection against Covid declined over several months. The administration’s plan calls for people to receive a third dose of the Pfizer or Moderna vaccine eight months after their second injection. Since then, Biden has said that scientists were reviewing whether to increase the third shot in three months. US health officials said they need more data on the Johnson & Johnson vaccine before they can recommend boosters for those vaccines.

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

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

A leading group of scientists published an article Monday in the medical journal The Lancet saying that available data shows that the vaccine’s protection against severe disease persists, even as efficacy against mild disease diminishes over time. The authors, including two departed senior FDA officials and several World Health Organization scientists, said that widely distributing the booster vaccines to the general public is “not appropriate” at this time.

There is currently no consensus in the biomedical community on boosters for the general public, said Dan Barouch, an immunologist at Harvard Medical School. “There are high-level experts who fall on different sides of the debate.”

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

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

Akiko Iwasaki, an immunologist at Yale School of Medicine, disagrees with the widespread distribution of boosters in the U.S. She said we should focus on giving everyone else around the world the first shots before moving on to the first ones. booster dose.

Still, he said, booster shots are needed for some more vulnerable people right now, as breakthrough cases are leading to serious illness and hospitalizations.

These severe cases are “mainly in older people and older adults like 65 and older,” he said. “I think giving it to older people really makes sense to me right now.”

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