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FDA Approves Novavax COVID Vaccine, But With Restrictions

A production line of COVID-19 vaccines in vials, representing production of the newly approved Novavax COVID vaccine.
Credit: iStock.
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Following delays at the US Food and Drug Administration (FDA), Novavax has announced approval of its recombinant protein-based COVID-19 vaccination, albeit in a narrower population than intended.


The Novavax COVID-19 vaccine (Nuvaxovid™), the only non-mRNA COVID-19 vaccine available in the US, has been approved for use in adults aged 65 years and older. Individuals aged 12 through 64 who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, such as asthma, cancer or diabetes, may also receive the vaccine.


The vaccine prospects were thrown into doubt in April when the FDA’s approval decision target came and went. Novavax had confirmed at the time that it was still waiting on action from the agency, and that it believed that its vaccine was safe and ready for approval.


Reports at the time suggested political interference at the FDA had delayed the decision, despite Novavax feeling the vaccine was ready to be greenlit and its positive Phase 3 clinical trial data.


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


Alongside the new Biologics License Application approval, the FDA has requested a new postmarketing commitment to conduct a Phase 4 placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. The company is working with its partner Sanofi to assess funding and execution of this new trial.

Nuvaxovid, an alternative to existing mRNA COVID vaccines

The Novavax vaccine has been pitched as an alternative to existing mRNA COVID vaccines on offer from Moderna and Pfizer/BioNTech. In a statement, John Jacobs, Novavax’s CEO, said, “Market research and US CDC [Centers for Disease Control and Prevention] 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 vaccine uses recombinant nanoparticle technology whereby copies of the non-infectious spike protein of SARS-CoV-2 serve as the antigen that primes the immune system to recognize the COVID-19 virus. This is coupled with Novavax’s Matrix-M® adjuvant, which is designed to enhance and broaden the immune system.


Though the vaccine doesn’t target the broad population Novavax was originally hoping for, the approval is no doubt a win for the company. The approval triggers a $175 million milestone payment under the agreement between Novavax and Sanofi, signed in May 2024.


Sanofi will lead on commercialization efforts of the vaccine, with Novavax set to receive ongoing royalties from vaccine sales.


Novavax expects to be ready for the commercial delivery of the vaccine this fall, pending recommendations at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22, 2025. During the meeting, experts will define the SARS-CoV-2 strain to target in the upcoming season.