FDA to not hold advisory committee meeting on Pfizer, Moderna Omicron updated COVID shots
Sarah Silbiger

The U.S. Food and Drug Administration's (FDA) commissioner Robert Califf on Thursday said the agency will not hold a vaccines advisory committee meeting on Moderna (NASDAQ:MRNA) and Pfizer's (NYSE:PFE) emergency use requests for their Omicron subvariant-modified bivalent COVID-19 shots.
Pfizer (PFE) and German partner BioNTech (NASDAQ:BNTX) on Monday submitted an application for an emergency use approval to the FDA for their Omicron-specific bivalent COVID shot, while Moderna (MRNA) followed suit on Tuesday.
"FDA will not hold a VRBPAC meeting about these submissions, as the agency feels confident in the extensive discussion that was held in June," the commissioner said on Twitter, referring to the Vaccines and Related Biological Products Advisory Committee.
"VRBPAC voted overwhelmingly to include an omicron component in COVID-19 boosters. FDA has no new questions that warrant committee input," Califf said.
"Bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients," the commissioner added, and said that the agency has extensive experience with reviewing strain changes in vaccines, as it does with the annual flu shot.
An advisory committee on immunization to the Centers for Disease Control and Prevention are likely to discuss the submissions at a two-day meeting next week, the New York Times reported.
Moderna (MRNA) and Pfizer (PFE) have already signed deals with the U.S. government to deliver 175M doses of the updated COVID-19 vaccines for use in September's immunization campaign.
Pfizer (PFE) shares were slightly lower at $47.39, while Moderna (MRNA) stock was down 1.1% at $139.86 in afternoon trading.