Scientific advisers to the U.S. Food and Drug Administration (FDA) voted not to recommend a third injection of the Pfizer vaccine for Americans age 16 and older, a potentially significant blow to the Biden administration after it announced a plan to “stimulate” adults ahead of the warning. the committees had the opportunity to review the scientific evidence in public.
The committee chairman, Dr. Arnold Monto, an epidemiologist at the University of Michigan, said he planned to continue deliberations after the vote. Sixteen of the 18 advisers opposed the proposal, even though some members believed there was “a role” for a third dose.
The decision of the advisory committee on vaccines and related biologics is not binding, but the FDA generally follows its advice.
The decision was made after major public scientific disagreement regarding a third dose of the vaccine. Much of the data in favor of a third dose comes from Israel, while data is sparse on whether a booster could help protect people against hospitalization and death.
“There are too many questions for me to feel comfortable saying ‘yes’ to this,” said A Oveta Fuller, fellow and associate professor of microbiology and immunology at the University of Michigan School of Medicine, summarizing the views of several voting members.
Another committee member, Dr. Eric Rubin, Harvard assistant professor of microbiology and molecular genetics, said he suspects “strongly” that the vaccine will be low-risk, “but we don’t have that right now, and I don’t think I do.” I would feel comfortable giving it to a 16-year-old for all the reasons that everyone has raised. “
The decision calls into question the Biden administration’s plan to “push” or provide a third Pfizer injection to fully vaccinated Americans over 16, an effort the administration had said would begin on September 20.
The scientists said they had “trouble” supporting the Pfizer application for booster doses for reasons including the risk of myocarditis or inflammation of the heart, especially in young men; the lack of evidence that the drivers would significantly slow the direction of the pandemic; and questions about whether reinforcements should be limited to older Americans.
Much of the debate centered on how vaccines elicited immunity: does decreased immunity in mild and moderate disease, which requires circulating antibodies, indicate that there would be a decrease in immunity to severe disease requiring hospitalization, which depends on from a different part of the immune system?
Several members considered that there was insufficient evidence to answer the question.
However, not all voting members agreed.
“Immunity clearly seems to wane over time,” said Dr. Jay Portnoy of Children’s Mercy Hospital in Kansas City, a committee member who said he was already prescribing a third dose of the Pfizer vaccine.
“Do we want to wait until more previously vaccinated people get sick before we prevent them from getting sick?” Portnoy said. “I prefer not to contract Covid disease.”