FDA, CDC greenlight updated boosters

On Sept. 12, the CDC director delivered the final stamp of approval to XBB.1.5-focused COVID-19 boosters, which could be available to the public later this week.

Hours before the director's ruling, a CDC committee panel voted 16-0 to recommend the shots for most people 6 months and older. The FDA approved and authorized the new formulas from Pfizer and Moderna on Sept. 11. 

The FDA approved the boosters for people 12 and older, and it gave the new boosters emergency use authorization for those between 6 months and 11 years old. 

In 2022, the updated vaccine boosters were bivalent, or focused equally on the original strain and the sister variants BA.4 and BA.5. The new shots are monovalent because they exclusively aim at XBB.1.5. Approval for the bivalent vaccines is now nullified, according to the FDA. 

A few experts said the CDC's recommendation should have been for at-risk populations, such as older and immunocompromised people, but the CDC's Advisory Committee on Immunization Practices voted only on whether to recommend the shots for all people 6 months and older.

 

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars