On Aug. 27, 2025, Novavax announced that the U.S. Food and Drug Administration (FDA) 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. 

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.

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

Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or 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.

Nuvaxovid is formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M^® adjuvant enhances and broadens the immune response. The vaccine is packaged in pre-filled syringes and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.