Novavax announced that the U.S. Food and Drug Administration has approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

"With today's approval, we will work with our partner Sanofi to provide access to a protein-based, non-mRNA COVID-19 vaccine for eligible individuals this fall," said John C. Jacobs, President and Chief Executive Officer, Novavax.

Clinical and preclinical data have previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19.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.3

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