FDA Approves Seasonal Covid-19 Vaccines From Moderna, Pfizer, BioNTech, Novavax — Update

By Elias Schisgall

The Food and Drug Administration approved new seasonal Covid-19 vaccine formulas made by Moderna, Pfizer and BioNTech, and Novavax.

The agency gave a green light to supplemental biologics license applications for the 2026-2027 formulas to the Comirnaty vaccine, made by Pfizer and BioNTech, Moderna's mNexspike and Spikevax shots, and Novavax's Nuvaxovid vaccine. The new formulas are designed to target the XFG variant of Covid-19.

Pfizer and BioNTech said the new formulation of its vaccine would begin shipping immediately for use beginning in the fall. Sanofi, which commercializes Nuvaxovid in most major markets through a partnership with Novavax, and Moderna both said their respective vaccines will be available in the coming days.

All three vaccines were approved for adults 65 years of age and older. The FDA also approved the shots for individuals younger than 65 whose underlying conditions put them at high risk for severe outcomes from Covid-19. Those approvals extend as young as 12 years old for mNexspike and Nuvaxovid, five years for Comirnaty, and six months for Spikevax.

"Our updated COVID-19 vaccines help protect those at high risk of severe disease, and we are proud to help ensure Americans have access to the latest protection against currently circulating SARS-CoV-2 strains this respiratory virus season," Moderna Chief Executive Stéphane Bancel said.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

August 28, 2026 11:41 ET (15:41 GMT)