FDA Grants Novavax COVID-19 Vaccine Full Approval for High-Risk Groups
Nuvaxovid (NVX-CoV2373) is indicated for those aged ≥65 years and aged 12 to 64 years with at least one condition that puts them at high risk for severe infection.
The FDA has fully approved Novavax's Biologics License Application (BLA) for Nuvaxovid (NVX-CoV2373), making it the only non-mRNA, protein-based COVID-19 vaccine available in the US, according to a company statement. The approval comes with caveats, however, with the approved indication restricted to adults aged 65 years and older, plus individuals 12-64 years with underlying conditions that increase their risk for severe COVID-19 outcomes.1
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NVX-CoV2373 has been available under Emergency Use Authorization in the US since July 2022. The FDA did not provide details on reasons for the restrictions on the May 19 approval.
"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," John C Jacobs, Novavax president and CEO said in the 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."1
The FDA has requested a new postmarketing commitment (PMC) requiring Novavax to conduct a phase 4 randomized, placebo-controlled efficacy trial in adults aged 50 to 64 without high-risk conditions, Novavax said in the statement. The company is working with vaccine development partner Sanofi on plans for the PMC. The commitment is in addition to standing postmarketing requirements levied on all COVID-19 vaccine manufacturers, according to Novavax.1
NVX-CoV2373 utilizes Novavax's recombinant nanoparticle technology to create copies of the SARS-CoV-2 spike protein, paired with the company's proprietary Matrix-M® adjuvant to enhance immune response. The vaccine requires standard refrigeration (2-8°C), allowing distribution through existing cold chain infrastructure.1
Data for the original BLA and on which the FDA based the EUA came from the phase 3 randomized, placebo-controlled PREVENT-19 clinical trial with approximately 30 000 adults (median age, 47 years; 12.6% aged 65 years and older). Overall, NVX-CoV2373 was 90.4% effective (95% CI 82.9-94.6), with 77 cases of laboratory-confirmed SARS-CoV-2: 63 in the placebo group and 14 in the vaccine group. All cases in the vaccine group were defined as “mild” by the trial protocol.2 The company expanded PREVENT-19 to assess efficacy, safety, and immunogenicity of the vaccine in approximately 3000 adolescents aged 12 to 17 years.3 In August 2024, the FDA granted emergency use authorization for an updated version of NVX-CoV2373 that includes a monovalent component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.4
The vaccine's safety profile includes warnings for myocarditis and pericarditis, similar to other COVID-19 vaccines. Clinical trials documented common adverse reactions including injection site tenderness, fatigue, headache, and muscle pain, according to the company statement.1
Novavax expects to deliver its 2025-2026 COVID-19 formula in the US this fall following strain recommendations at the FDA's Vaccines and Related Biological Products Advisory Committee meeting scheduled for May 22, 2025.
"This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option," Jacobs stated.1
