GAITHERSBURG, Md. — Novavax said Wednesday that the U.S. Food and Drug Administration has approved its Nuvaxovid 2025-2026 COVID-19 vaccine formula, the only protein-based, non-mRNA option available in the U.S. this season.
The vaccine is authorized for adults 65 and older, as well as individuals aged 12 to 64 with at least one underlying health condition that puts them at a higher risk of severe illness from COVID-19. Novavax noted that the updated formula targets the JN.1 strain and has been shown in clinical and preclinical data to provide protection against multiple circulating JN.1 lineage variants, which currently dominate global infections.
“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.
Sanofi will lead commercialization in the U.S., while Novavax will collect tiered royalties on vaccine sales. The company highlighted the product’s traditional vaccine technology, which utilizes recombinant nanoparticle spike proteins in conjunction with its proprietary Matrix-M adjuvant to stimulate a broad immune response. The vaccine is supplied in pre-filled syringes and can be stored under standard refrigeration conditions.
The FDA approval comes as public health officials prepare for another vaccination season, with manufacturers updating their shots to target currently circulating variants.
