Novavax, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for Nuvaxovid. The vaccine is approved for active immunisation against COVID-19 caused by SARS-CoV-2.

It is intended for adults aged 65 and older, and for individuals aged 12 to 64 with at least one underlying health condition that increases their risk of severe COVID-19, such as asthma, cancer, diabetes, obesity, or smoking.

This US license approval has also triggered a USD 175 million milestone payment from Sanofi.

John C. Jacobs, President and Chief Executive Officer, Novavax said, “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.”

He further added, “Market research and US 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 the availability of our protein-based vaccine option.”

The approval triggers a USD 175 million milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in May 2024. The agreement has layers of value for Novavax. Sanofi is leading on commercialisation efforts starting this year, and Novavax is eligible to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons.

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, randomised, 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. This PMC supplements previously agreed-upon postmarketing requirements and commitments, which have been commonly required for COVID-19 vaccine manufacturers.

Novavax expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the US this fall in partnership with Sanofi, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22, 2025.

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