FDA advisory panel to discuss Pfizer booster dose Sept. 17

The FDA said Sept. 1 that it plans to convene its vaccine advisory committee Sept.17 to discuss a third dose of Pfizer's COVID-19 vaccine for people ages 16 and older. 

The agency's Vaccines and Related Biological Products Advisory Committee will meet virtually, and the agency said it will livestream the meeting from its YouTube channel and its website. 

"A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner," Peter Marks, MD, PhD, director of FDA's Center for Biologics Research and Evaluation, said in a news release. 

Pfizer and its partner BioNTech said July 8 they plan to  seek FDA approval for a third shot of their COVID-19 vaccine. U.S. scientists and regulators told Pfizer July 12 that they needed more data and more time to determine whether COVID-19 vaccine booster shots are necessary. 

But as the delta variant has spread and preliminary studies have shown that vaccines' efficacy may wane over time, the federal government decided to begin offering boosters to immunocompromised people and has announced plans to give boosters to the general public beginning Sept. 20. 

The vaccine advisory committee is made up of a chair, members with scientific, medical and public health expertise and a consumer and industry representative. The FDA said it will make the meeting agenda and committee roster available to the public two business days before the meeting is scheduled. 

Read the FDA's full news release here.

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars