FDA Approves Novavax COVID-19 Shot But With Unusual Restrictions

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The Food and Drug Administration has given its long-awaited approval for Novavax’s COVID-19 vaccine, but with some unusual restrictions in place.

Novavax’s vaccine, which is the only traditional protein-based coronavirus vaccine in the nation, was previously authorized for emergency use in individuals aged 12 and older. However, the FDA’s full approval now limits its use to adults aged 65 and older, as well as individuals aged 12 to 64 who have underlying health conditions that put them at higher risk from COVID-19.

In contrast, vaccines from Novavax’s competitors Pfizer and Moderna are fully licensed for use in individuals aged 12 and older, with authorization extending to children as young as 6 months.

This decision comes ahead of a meeting next month where CDC advisers will discuss whether yearly COVID vaccines should be recommended for everyone or only certain high-risk groups. The restrictions imposed by the FDA on Novavax’s vaccine suggest that the Trump administration may have already made a decision on this matter.

Food and Drug Administration commissioner Martin Markary speaks during an event in the Roosevelt Room at the White House, Monday, May 12, 2025, in Washington. (AP Photo/Mark Schiefelbein)

Novavax’s CEO, John C. Jacobs, expressed his satisfaction with the licensure, highlighting the company’s commitment to providing a protein-based vaccine option to older individuals and those with underlying health conditions.

The FDA’s approval letter did not provide specific reasons for the restrictions, but they may be influenced by skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump administration officials.

Initially, Novavax demonstrated the safety and efficacy of its vaccine in a 30,000-person clinical trial. While the FDA was expected to grant full approval without restrictions by April 1, the company was later asked to conduct additional trials post-approval, including studies on potential heart conditions and the benefits of continued vaccination in certain age groups.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.