Topline
The Food and Drug Administration’s vaccine advisory committee voted overwhelmingly against recommending the approval of a booster shot of Pfizer-BioNTech’s coronavirus vaccine for people 16 and older on Friday, but endorsed an additional dose for those most vulnerable to the virus—dealing a blow to the federal government’s plan for mass distribution of a third shot.
A vial of the Pfizer-BioNTech vaccine.
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Key Facts
The Vaccines and Related Biological Advisory Committee (VRBAC), a group of outside experts that informs the FDA’s decisions on vaccines, voted 16 to 2 against recommending the booster shots for everyone over the age of 16, arguing there is not enough evidence to show it is safe and necessary.
But the experts in a follow-up vote unanimously endorsed offering boosters to people over the age of 65 and “individuals at high risk of severe Covid-19,” a group that it did not explicitly define.
The panel’s decisions followed hours of debate about a slew of recent studies suggesting the Pfizer vaccine becomes less effective at protecting against coronavirus infection over time.
Officials from Pfizer made the case for boosters, arguing increasing “breakthrough infections” could lead to an uptick in cases of severe disease among vaccinated people, a trend experts from Israel told the committee they had noticed before introducing vaccine boosters.
But many of the committee’s experts noted there is conflicting data on the need for shots for most people, and there isn’t yet evidence concretely showing the vaccine has become less effective at preventing severe disease and death from Covid-19.
Dr. Phil Krause, the deputy director of the FDA’s Office of Vaccines Research and Review, highlighted that much of the data presented to the agency was “not peer-reviewed and has not been reviewed by the FDA,” making it difficult to assess whether models were giving “the correct results.”
Crucial Quote
“It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population,” Dr. Ofer Levy, an infectious disease specialist at Boston Children’s Hospital, said. “I just don’t think we’re there yet in terms of the data.”
What To Watch For
Though the FDA is not required to follow the committee’s recommendations, it typically doses, leaving the agency likely to extend its authorization of Pfizer’s vaccine to include boosters for only those most susceptible to the virus. Notably, the FDA’s approval would only apply to Pfizer. The vaccines made by Moderna and Johnson & Johnson will have to be considered separately.
Key Background
The Biden administration was aiming to begin the mass distribution of Covid-19 booster shots in the U.S. next week. The country’s top health officials had outlined the goal of giving additional shots of the Pfizer and Moderna vaccines to people about eight months after they received their second doses. However, the plan hit a series of road bumps, including two top FDA reviewers earlier this week signing onto an editorial arguing the push to roll out Covid-19 booster shots was not driven by science and actually served to undermine overall confidence in vaccines. This was followed by FDA scientists arguing on Wednesday that while generating a higher immunity response in recipients, booster doses may not be needed. Leaders at the World Health Organization, meanwhile, have repeatedly warned prioritizing booster shots for wealthy nations over inoculations in countries with low vaccination rates could lead to the emergence of more dangerous variants.
Further Reading
“As the F.D.A. vaccine panel considers Pfizer boosters, experts present conflicting data on the shots” (The New York Times)
