Novavax Receives U.S. FDA Approval for COVID-19 Vaccine Targeting At-Risk Populations
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 COVID-19 vaccine intended for adults aged 65 and over, as well as individuals aged 12 to 64 who have at least one underlying health condition that increases the risk of severe COVID-19.
The approval allows access to a protein-based, non-mRNA vaccine option for those considered most vulnerable to serious outcomes from the virus.
This regulatory milestone has triggered a milestone payment of $175 million to Novavax from Sanofi under their collaboration agreement signed in May 2024. Sanofi will lead the commercialisation of the vaccine in the United States starting this year. Novavax is set to receive ongoing tiered royalties from future sales of the stand-alone COVID-19 vaccine.
The FDA’s decision was based on data from pivotal Phase 3 clinical trials, which demonstrated that Nuvaxovid is both safe and effective in preventing COVID-19. As part of its postmarketing obligations, Novavax has also been asked to carry out a new Phase 4 clinical trial to assess the vaccine’s efficacy and safety in individuals aged 50 to 64 who do not have high-risk health conditions. Planning for this trial is underway in collaboration with Sanofi.
Looking ahead, Novavax expects to be ready for commercial delivery of the updated COVID-19 vaccine for the 2025–2026 season in the U.S., pending guidance from the FDA’s Vaccines and Related Biological Products Advisory Committee, scheduled to meet on 22 May 2025.
Source: novavax.com
