Novavax Gains U.S. FDA Approval for COVID-19 Vaccine
Tuesday, May 20, 2025
Novavax, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nuvaxovid™, a protein-based COVID-19 vaccine. The approval covers use in adults aged 65 and above, as well as individuals aged 12 to 64 with at least one underlying health condition that increases the risk of severe illness from COVID-19, such as asthma, cancer, diabetes, obesity, or smoking history.
As part of a collaboration agreement signed in May 2024, the FDA approval has triggered a milestone payment of $175 million from Sanofi. Sanofi is also responsible for commercialising the vaccine in the U.S. beginning this year. Novavax will receive ongoing tiered royalties on sales of the stand-alone COVID-19 vaccine in future vaccination campaigns.
The approval is supported by data from Phase 3 clinical trials, which confirmed the vaccine’s safety and effectiveness. In addition to this, the FDA has asked for a new postmarketing commitment—a Phase 4 trial to evaluate the vaccine's safety and efficacy in people aged 50 to 64 without underlying health conditions. Novavax and Sanofi are currently discussing how to carry out this study, which adds to previously agreed postmarketing requirements common across COVID-19 vaccine manufacturers.
Subject to recommendations at the upcoming FDA advisory committee meeting on 22 May 2025, Novavax plans to begin commercial delivery of the 2025–2026 COVID-19 vaccine formulation in the U.S. this autumn in partnership with Sanofi.
Nuvaxovid has been available in the U.S. under Emergency Use Authorization since July 2022 and holds full market authorisation in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan, and Singapore.
Source: prnewswire.com
