Novavax, Inc. announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (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 (e.g. asthma, cancer, diabetes, obesity, smoking). Achievement of the US 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 chief executive officer, Novavax. ""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.""
The 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.
The BLA approval was based on pivotal phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of Covid-19.2,3 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. 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.
Nuvaxovid is a vaccine indicated for active immunization to prevent Covid-19 caused by 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.
Nuvaxovid (NVX-CoV2705) is an updated version of Novavax's prototype Covid-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes Covid-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
Matrix-M is Novavax's proprietary adjuvant that can be added to a vaccine or medicine to stimulate a stronger immune response and is currently used in globally approved vaccines. It is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile and allows use of a lower dose of antigen that is still effective. Matrix-M is sustainably harvested and manufactured and has the potential to enhance existing and new vaccines. When combined with the company's recombinant, protein-based nanoparticles, this technology platform is the basis of Novavax's expanding pipeline.
Novavax, Inc. tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant.
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