A scientific advisory committee to the Food and Drug Administration on Friday overwhelmingly recommended against approving a booster shot of the Pfizer-BioNTech coronavirus vaccine for people 16 and older.
The committee voted 16 to 3 after holding an intense daylong public discussion on whether booster shots are necessary and if so, for whom. The Biden administration has been hoping the F.D.A. would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.
The vote came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe Covid-19 disease and hospitalization, at least in the United States.
“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.
It was not immediately clear whether a second vote, on whether booster shots should be approved for older people, who are more vulnerable to severe Covid-19, would follow the first.
The recommendation was the latest in a series of setbacks for President Biden’s booster plan since he first announced it a month ago. Mr. Biden said at the time that he wanted most adults who had gotten a second Pfizer or Moderna vaccine at least eight months ago to start receiving booster shots the week of Sept. 20.
FDA-No to booster
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