FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.
In particular, the agency recommended that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.
FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines will still be used for the primary series.
Moderna and Pfizer have already shared data from clinical trials featuring vaccine candidates with a BA.1 component. FDA has instructed them to submit data from those experimental products to help it evaluate modified boosters with an omicron BA.4/5 component.
The agency will also request manufacturers to conduct clinical trials with modified vaccines with an omicron BA.4/5 component.
Pfizer (NYSE:PFE) saw its share price increase almost 3% to $52.43, while its partner BioNTech (Nasdaq:BNTX) ticked up 5% to $149.10. Moderna (Nasdaq:MRNA) shares were mostly flat, ticking up 0.028% to $142.85.
Filed Under: Infectious Disease