The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Novavax Inc.’s Nuvaxovid for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older 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. Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi.

“Today’s approval solidifies a pathway for Americans aged 65 and older and those aged 12 through 64 with an underlying condition that puts them at high risk for severe outcomes from COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine,” said John C. Jacobs, President and CEO, Novavax. “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.”

The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19. In addition, the 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 aged 50 through 64 without high-risk conditions for severe COVID-19. Novavax is working closely with Sanofi to assess funding and execution of this new trial.

Novavax expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall in partnership with Sanofi.

Nuvaxovid has been available for use in the U.S. under Emergency Use Authorization since July 2022 and has full market approvals in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan and Singapore.