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FDA Approves Novavax COVID-19 Vaccine with Restrictions

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Novavax Protein Based Covid 19 Vaccine

WASHINGTON — The Food and Drug Administration has approved Novavax‘s COVID-19 vaccine, Nuvaxoid, but with specific restrictions. This approval, announced on May 19, 2025, makes Nuvaxoid the first protein-based vaccine approved for COVID-19 in the United States.

Nuvaxoid is authorized for use in adults aged 65 and older and in individuals aged 12 through 64 who have at least one underlying health condition that increases their risk of severe outcomes from COVID-19. The vaccine previously had emergency authorization for those aged 12 and older.

John C. Jacobs, the president and CEO of Novavax, expressed optimism about the approval. He noted that market research indicates older adults and those with underlying health conditions are the groups most likely to seek COVID-19 vaccinations. “Today’s approval solidifies a pathway for access to our protein-based vaccine,” Jacobs stated in a news release.

While Moderna and Pfizer-BioNTech vaccines are available for anyone aged 12 and older without restrictions, Nuvaxoid’s specific use limitations suggest a shift in the FDA’s approach. Current CDC recommendations advise that everyone aged 6 months and older receive an updated COVID-19 vaccine.

Nuvaxoid was tested in two major clinical trials involving nearly 30,000 adults and 2,247 adolescents. In one phase 3 trial, it showed nearly 100% protection against moderate-to-severe disease and an efficacy of 92.6% against variants of concern. Another trial indicated about 79.5% efficacy in adolescents aged 12 to 17.

The FDA has also mandated a postmarketing commitment for Novavax to conduct further studies on the vaccine’s safety and efficacy in individuals aged 50 to 64 who do not have high-risk conditions. These findings may lead to broader approval in the future.

As vaccination efforts continue, pharmacists are advised to stay informed about the evolving guidelines surrounding COVID-19 vaccines. All current vaccines, regardless of their formulation, remain effective and safe.