Novavax Nuvaxovid COVID-19 Vaccine Approved for Adults 65+, Those with Underlying Conditions.

Novavax announced that the FDA has approved its Nuvaxovid 2025-2026 Formula COVID-19 vaccine for adults 65 years and older or individuals 12-64 years with at least one underlying condition. The vaccine, which is being commercialized by Sanofi, is designed to prevent COVID-19 caused by the JN.1 strain, which accounts for the majority of infections globally. Novavax is eligible for ongoing royalties from sales of the vaccine.

The U.S. Food and Drug Administration (FDA) has approved Novavax, Inc.'s 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. This approval marks a significant milestone for Novavax, as it is the first protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season [2].

Nuvaxovid targets the JN.1 variant, which accounts for the majority of COVID-19 infections globally as of July 2025 [1]. The vaccine is formulated using Novavax's unique recombinant nanoparticle technology, which creates copies of the surface spike protein of SARS-CoV-2. This non-infectious spike protein primes the immune system to recognize the virus, while the Matrix-M adjuvant enhances and broadens the immune response [2].

The approval of Nuvaxovid comes with several important safety considerations. It is contraindicated for individuals with a known history of severe allergic reactions to any component of the vaccine or those who had a severe allergic reaction following a previous dose of the Novavax COVID-19 Vaccine, Adjuvanted. Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration [1, 2]. Additionally, clinical trial data provide evidence for increased risks of myocarditis and pericarditis following administration, and there have been post-marketing reports of these conditions [1, 2].

Sanofi is leading the commercialization efforts for Nuvaxovid, and Novavax is eligible to receive ongoing tiered royalties from sales of the vaccine. This partnership aims to provide access to a protein-based, non-mRNA COVID-19 vaccine for eligible individuals this fall [2].

References:
[1] https://www.marketscreener.com/news/novavax-inc-s-nuvaxovid-2025-2026-formula-covid-19-vaccine-receives-approval-in-the-u-s-ce7c50ded081ff27
[2] https://www.morningstar.com/news/pr-newswire/20250827ph60566/novavaxs-nuvaxovid-2025-2026-formula-covid-19-vaccine-approved-in-the-us