FDA Approves Novavax COVID-19 Vaccine
The company's Nuvaxovid vaccine is the only recombinant protein-based, non-mRNA COVID-19 immunization available in the US.
The FDA has approved the Biologics License Application (BLA) for Novavax’s NVX-CoV2601 (Nuvaxovid) vaccine 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 1 underlying condition that puts them at high risk for severe outcomes from COVID-19.1
"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," Novavax CEO John C. Jacobs, said in a statement. "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 availability of our protein-based vaccine option."1
What the Phase 3 Data Showed
The BLA approval was based on phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19.
Results from a phase 2/3 study of the vaccine demonstrated significant improvements in immune response, suggesting its potential as an effective booster for adults in the US. The study, which was conducted between September 2023 and January 2024, showed that NVX-CoV2601, based on a recombinant spike protein from the Omicron XBB15 variant, induced higher neutralizing antibody responses compared to the original NVX-CoV2373 vaccine.2
The study showed that NVX-CoV2601 produced a geometric mean neutralizing antibody (nAb) titer of 905.9 at day 28, compared to 156.6 for NVX-CoV2373. The geometric mean titer ratio (GMTR) between the two groups was 5.8, indicating that the new vaccine generated significantly higher levels of neutralizing antibodies. Additionally, 64% of participants in the NVX-CoV2601 group showed a seroresponse, compared to just 7% in the NVX-CoV2373 group.2
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. This PMC supplements previously agreed upon postmarketing requirements and commitments which have been commonly required for COVID-19 vaccine manufacturers.
Learn more: Novavax’s Updated COVID-19 Vaccine's Continue to Enhance Immune Response
This approval triggers a $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 commercialization 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.
Rollout for 2025-2026 Vaccine Formula
The vaccine 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.
Novavax expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the US this fall, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22.
