Nuvaxovid 2025-2026 Formula COVID-19 vaccine approved in the U.S – Novavax

Novavax, Inc. announced that the FDA has approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years – 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Clinical and preclinical data have previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19.

(See citations) Both clinical and preclinical data from Nuvaxovid confirm that the JN.1 strain vaccination induces immunity across currently circulating JN.1 lineage strains, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7 and XEC. As of July 2025, the vast majority of COVID-19 infections globally are caused by variants within the JN.1 strain.

Sanofi is leading commercialization efforts for Nuvaxovid and Novavax is eligible to receive ongoing tiered royalties from sales of the vaccine.