An important part of the president Joe BidenCovid-19’s plan to fight Covid-19 is in jeopardy as a Food and Drug Administration vaccine advisory committee meets on Friday to debate and vote Pfizer and BioNTech‘s application to offer booster shots to the general public.
The vote by the Agency’s Advisory Committee on Vaccines and Related Biological Products – scheduled for about 2:30 p.m. ET – comes as some scientists, including at least two to the FDA, say they are not entirely convinced that every American who has received the Pfizer vaccine is currently in need of additional doses.
In documents released prior to the advisory committee meeting, FDA scientists have refused to take a stand on whether to support third shots, saying US regulators have not independently reviewed or verified all available data to support use of boosters. They also appeared to be skeptical of some of the data provided, including frequently quoted effectiveness figures from Israelwhere researchers have published observational studies showing that the Pfizer vaccine’s effectiveness against infections has waned over time.
It sets the stage for a tense meeting on Friday as the Biden government has announced that it will offer booster injections to the public as early as next week pending FDA approval. The move is part of the administration wider plan to counter a higher number of Covid cases in the USA, which is fueled by the rapidly spreading Delta variant.
The country’s leading health authorities, including CDC director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock and White House Senior Medical Advisor Dr. Anthony Fauci, approved Biden’s booster plan back in August. While the FDA has not always followed its committee’s advice, it often does. The agency surprised investors and the public earlier this year when it abandoned the recommendation of its independent panel of external experts to approve Biogen’s Alzheimer’s drug.
If the committee doesn’t pass a positive vote, it could force the Biden administration to postpone its plan and potentially restrict third shots to certain groups of Americans, including disease, said Lawrence Gostin, director of the World Health Organization’s Collaborating Center on National and International Global Health Law.
The FDA group could give Biden’s booster plan a “cool reception,” Gostin said. “While there is good evidence that vaccine immunity may decline, two doses of mRNA hold up robust by preventing serious illness, hospitalization and death.”
The vote puts the committee in an “uncomfortable position” as the government has already announced that it would start distributing boosters in the week of September 20, said Dr. Bruce Farber, chief of infectious diseases at Northwell Health.
“I’m sure they will disagree at all on what they said because we already know they are not unanimous,” he said.
Scientists and other health experts had already expressed their criticism Biden’s move to boost all Americans 16 and older when senior health officials outlined the plan last month. The scientists and other experts said the data cited by federal health officials are not compelling and characterize government pressure on boosters as premature.
In the outlines of the plans for launch Distribute booster next week, administrative officials cited three CDC studies showing that vaccines protection against Covid has waned over several months. The government’s plan is for people to receive or a third dose of Pfizer Modern Vaccination eight months after the second vaccination. Biden has since said that scientists are considering whether to postpone the third shot up by three months. US health officials said they needed more data Johnson & Johnsons Vaccine before they can recommend boosters of these shots.
Pfizer and Moderna each have theirs too own analyzes The incidence of breakthrough Covid cases – which occur in fully vaccinated people – was less common in clinical trial participants who were recently vaccinated, suggesting that the protection of Covid vaccines wears off over time. In separate documents released Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second shot.
Still, some scientists argue that booster vaccinations are not currently required for the general public.
A leading group of scientists published a paper Monday in the medical journal The Lancet, which said that available data shows that vaccination protection against serious illnesses remains in place even as efficacy against minor illness wears off over time. The authors, including two outgoing senior FDA officials and several World Health Organization scientists, said the widespread distribution of booster syringes 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 Harvard Medical School immunologist Dan Barouch. “There are high-level experts who fall on different sides of the debate.”
Dr. Arturo Casadevall, Chair 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 chance of breakthrough infections, including the variant strains. “With all vaccines, immunity degrades over time, and Covid-19 vaccines are no different.”
Yale School of Medicine immunologist Akiko Iwasaki contradicts the widespread distribution of boosters in the United States.
Still, she said, booster shots are currently needed for some more vulnerable people as breakthrough cases lead to serious illness and hospitalizations.
These severe cases “mostly occur in older people and older adults such as 65 years of age and older,” she said. “I think it really makes sense now to give it to the seniors.”