Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
A panel of experts that advise the US Food and Drug Administration (FDA) on its regulatory decisions voted against approving third doses of Pfizer’s Cominarty mRNA COVID-19 vaccine for Americans over the age of 16 — but they may still debate boosters for older adults.
The vote by the FDA’s Vaccines and Related Biological Products Advisory Committee was split, with 16 members saying there was not enough evidence to support approval of third doses, and 2 members voting in favor of approval.
The FDA is now revising the question posed to the committee, and preparing to take another vote after a short break.
The revised question will specify support for third doses for people over the age of 65 and anyone who is at high risk because of their occupation — such as healthcare workers or because of underlying disease.
This is a developing story and will be updated with the results of further deliberations by the committee.
Medscape Medical News © 2021 WebMD, LLC
Send comments and news tips to [email protected].
Cite this: FDA Panel Rejects Pfizer’s Bid for Booster Shots for 16 and Over – Medscape – Sep 17, 2021.