Novavax’s COVID-19 Jab Gets FDA Approval
The recombinant protein-based, non mRNA vaccine has been granted full marketing approval to prevent COVID-19 in adults aged 65 years and older and patients aged 12–64 years who are at risk of severe infection due to underlying conditions.
The U.S. FDA has approved Novavax’s biologics license application (BLA) for its recombinant protein-based, non-messenger RNA (mRNA) COVID-19 vaccine, NVX-CoV2705 (Nuvaxovid) (1). The vaccine has been approved for use in adults aged 65 years or older and in patients aged 12–64 years who have at least one underlying condition that increases their risk for severe outcomes from COVID-19.
“[This] 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, in a company press release about the approval (1). “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.”
As a result of this regulatory decision and under the terms of a collaboration and license agreement signed in May 2024, a milestone payment of USD 175 million will be paid by Sanofi to Novavax. The agreement between Sanofi and Novavax provides further value for the vaccine developer, which will be eligible to receive tiered royalties from Sanofi’s vaccine commercialization efforts (2).
FDA’s decision to approve the BLA was based on Phase III clinical trial data, which demonstrated the safety and efficacy of NVX-CoV2705 when used as a preventative treatment for COVID-19. The regulatory body has requested further post-marketing commitment from the company, comprising a Phase IV prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50–64 years who do not have high-risk conditions for severe COVID. Novavax and Sanofi will work closely together in relation to the potential funding and execution of the post-marketing commitments required by FDA.
NVX-CoV2705 is a protein-based vaccine that has been updated to target the Omicron variant JN.1 strain of COVID-19. The vaccine, which is made by creating copies of the surface spike protein of the virus that causes COVID-19, is delivered using recombinant nanoparticle technology and incorporates a proprietary adjuvant, Matrix-M, which enhances and broadens the immune response.
A prototype of the vaccine, NVX-CoV2373, was approved for emergency use authorization by the FDA in July 2022 (3). The vaccine formulation was updated in 2024 and is available as a ready-to-use liquid formulation. Additionally, the updated vaccine (NVX-CoV2705) has also received full marketing authorization for use in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan, and Singapore (1).
References
Novavax. U.S. FDA Approves BLA for Novavax’s COVID-19 Vaccine. Press Release, May 19, 2025.
Sanofi. Sanofi and Novavax Announce Co-Exclusive Licensing Agreement to Co-Commercialize COVID-19 Vaccine and Develop Novel Flu-COVID-19 Combination Vaccines. Press Release, May 10, 2024.
Novavax. U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over. Press Release, July 13, 2022.