The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

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.

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Filed Under: Infectious Disease
Tagged With: BA.4, BA.5, BioNTech, coronavirus, covid-19, COVID-19 vaccines, FDA, Moderna, Pfizer, VRBPAC
 

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