FDA to hold advisory meetings for Moderna & J&J boosters, pediatric COVID-19 vaccines

The FDA said Oct. 1 it will hold three upcoming meetings of its Vaccines and Related Biological Products Advisory Committee to review new data on COVID-19 vaccines.

Five things to know:

  1. On Oct. 14, the committee will discuss amending the emergency use authorization of Moderna's COVID-19 vaccine for the administration of a booster dose in people ages 18 and older.

  2. On Oct. 15, the committee will discuss amending the emergency use authorization of Johnson & Johnson’s COVID-19 vaccine for the administration of a booster dose in people ages 18 and older.

  3. On Oct. 15, the committee will also listen to a presentation from the National Institute of Allergy and Infectious Diseases on whether the U.S. should allow people to receive booster doses that were produced by a different drugmaker than the manufacturer of the vaccine they originally received.

  4. On Oct. 26, the committee will discuss the potential authorization of Pfizer's COVID-19 vaccine for children ages 5-11. The FDA expects to receive a request from Pfizer in the coming weeks to amend its vaccine's emergency use authorization to allow for its use in this age group.

  5. The FDA said it plans to make the background materials for each meeting available to the public, including meeting agendas and committee rosters, no later than two business days before each meeting is held. The agency also said it plans to livestream the meetings on its YouTube page and website.
 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars