FDA advisory panel rejects widespread Pfizer booster shots

A U.S. Food and Drug Administration advisory committee on Friday voted to reject COVID-19 vaccine booster shots for most Americans, but authorized them for people 65 and over and those who are at high risk for severe COVID-19. The votes came amid division among scientists inside and outside the FDA as to whether booster shots are necessary for people who are not immunocompromised, and who should receive them.

The vote against boosters of the Pfizer-BioNTech vaccine for anyone 16 and older who had received two earlier shots was 16-2. The FDA doesn’t have to follow the committee’s recommendation, but it usually does. The vote Friday, 16-2, was a blow to the Biden administration’s effort to shore up people’s protection against the virus amid the highly contagious Delta variant. The proposal was submitted by Pfizer and backed by President Joe Biden’s administration, to fully approve boosters to everyone aged 16 and over.
The decisions came after a day-long meeting full of data presentations and at times charged debate that was convened by the Food and Drug Administration (FDA). Tens of millions of Americans will soon be eligible for a third shot. The panel — which included vaccinologists, infectious disease researchers, and epidemiologists — concluded that the benefit-risk balance differed for younger people, especially males at risk for myocarditis. A clinical trial for the booster involved just over 300 people, which they felt was too small to be able to draw firm conclusions about safety. The panel voted 16-2 against granting a third dose full approval.