FDA

FDA approves Novavax COVID-19 vaccine, with restrictions

May 19, 2025

FDA approved Nuvaxovid (COVID-19 vaccine, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults ≥65 of age and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).

Nuvaxovid is a recombinant protein-based COVID-19 vaccine that previously had been available under emergency use authorization for individuals ≥12 years.

According to a manufacturer press release, the approval was based on phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19. Of note, FDA has requested a new postmarketing commitment (PMC) to conduct a phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals ages 50 through 64 without high-risk conditions for severe COVID-19. This PMC supplements previously agreed upon postmarketing requirements which have been commonly required for COVID-19 vaccine manufacturers.

Sources:

Nuvaxovid (COVID-19 vaccine, adjuvanted) [package insert]. Food and Drug Administration. https://www.fda.gov/media/186544/download Revised May 2025. Accessed May 19, 2025.

US FDA approves BLA for Novavax’s COVID-19 vaccine. [News release]. 2025. https://www.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine