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# Updated Covid-19 Vaccines Approved by FDA
- URL: https://www.fdaweb.com/updated-covid-19-vaccines-approved-by-fda/
- Published: 2023-09-11T12:00:00.000Z
- Updated: 2026-09-14T18:55:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155290

FDA has given the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely target currently circulating variants and to provide better protection against serious illness, including hospitalization and death. “Consistent with the [totality of the evidence](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvdmFjY2luZXMtYmxvb2QtYmlvbG9naWNzL3VwZGF0ZWQtY292aWQtMTktdmFjY2luZXMtdXNlLXVuaXRlZC1zdGF0ZXMtYmVnaW5uaW5nLWZhbGwtMjAyMz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjMwOTExLjgyNDE2NjExIn0.AX5G5HVOkt0azVVaTsJGLpxbrS9oylwU2OLIZj95AaA/s/1255931999/br/225627277326-l?ref=fdaweb.com) and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating?ref=fdaweb.com) says.

The updated vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals six months through 11 years of age. The agency says the previous bivalent Moderna and Pfizer-BioNTech Covid-19 vaccines are no longer authorized for use in the U.S.

“Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of Covid-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine,” FDA adds.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is meeting 9/12 to discuss clinical recommendations on who should receive the updated vaccines.