FDA Panel Rejects Pfizer Vaccine Booster for All Americans, Recommends for 65+

Pfizer's COVID-19 vaccine / Getty Images
September 17, 2021

By Manojna Maddipatla and Michael Erman

(Reuters) — A panel of expert outside advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers.

The White House earlier on Friday said it was ready to roll out boosters of the Pfizer/BioNTech vaccine next week if health officials approve them. But Friday's vote if followed by the FDA would represent a more modest rollout of booster shots than outlined by the Biden administration, which called for their widespread use six months after people received their first round of shots.

Panel members rejected Pfizer's request for full approval for booster shots for those aged 16 and older. Instead, the advisory panel's recommendation was for an emergency use authorization for the narrower group.

Panel members unanimously approved the recommendation for a third dose for older Americans, and were convinced by evidence showing these individuals were at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots.

The FDA will take the panel's recommendation into consideration in making its final decision on the boosters.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York, and Julie Steenhuysen in Chicago. Editing by Caroline Humer and Bill Berkrot.)