FDA Panel Overwhelmingly Rejects Pfizer Booster for Healthy People 16 and Older

The 16 – 2 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.

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 U.S., the New York Times reported.

“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.

In a second vote, the panel voted unanimously in favor of recommending Pfizer’s third dose for people with compromised immune systems and/or people over age 65.

The issue of whether or not to approve boosters has become increasingly contentious, dividing scientists, both outside and inside the FDA, including two scientists who recently announced they are leaving the agency because of pressure from the Biden administration to approve boosters, despite the lack of data to support a third shot.

As The Hill reported, the advisory panel’s vote is not binding, so the FDA doesn’t have to accept the results. But if the agency doesn’t, it will raise significant questions of political interference and pit agency scientists against political officials who signed off on the booster plan.

On Thursday, FDA scientists had expressed skepticism about the need for Pfizer COVID vaccine booster shots in a report released Wednesday.

In the 23-page report, FDA officials said that based on their analysis of data submitted by Pfizer and BioNTech, they could not yet take a stance on whether to recommend COVID boosters for the general public.

The 23-page report analyzed data submitted by Pfizer and BioNTech as part of the drugmakers’ request for authorization for their vaccine to be given as a booster shot in people 16 years and older.