The FDA has approved Novavax’s Nuvaxovid vaccine, which includes a proprietary adjuvant for prolonged immunization and response against severe acute SARS-CoV-2 based on study data that were captured from approximately 17,000 adults.
The approval was based on data from a combination of placebo-controlled, phase 3 trials (NCT04611802, NCT04368988, NCT05463068, NCT05372588), which demonstrated that the vaccine safely and effectively prevented COVID-19.1 The approval applies to adults aged 65 years and older and individuals aged 12 through 64 years who have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19, including asthma, cancer, diabetes, obesity, or smoking.
Nuvaxovid (NVX-CoV2705) is an updated version of Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) 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.
Reference
- Novavax. US FDA approves BLA for Novavax’s COVID-19 vaccine [press release]. Novavax. May 19, 2025. Accessed July 8, 2025. https://ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine