FDA Panel Endorses Limited Use of Pfizer Booster Shot

On Sept. 17, a key advisory panel to the U.S. Food and Drug Administration (FDA) issued a limited endorsement of Pfizer vaccine boosters. The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to endorse a booster shot of the Pfizer-BioNTech COVID-19 vaccination for two categories of people: those 65 and older, and those 16 and older who are at high risk of severe COVID-19. The recommended booster is to be given at least six months after completion of the primary series. 

According to the committee, the recommendation is based on available scientific evidence — including the safety and effectiveness data from clinical trial — that the known and potential benefits outweigh the known and potential risk of such a booster administered under these conditions. However, the committee voted 16-2 against endorsing a booster shot more broadly applicable to individuals 16 and older, concluding that the safety and effectiveness data do not support a booster for that population at this time. 

The committee’s endorsements are non-binding, and the FDA still needs to amend the emergency use authorization to approve any booster shot for the Pfizer-BioNTech vaccine. No recommendations or endorsements have been made to date for the Moderna or J&J/Janssen vaccines.