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2w ago

FDA Grants Conditional Approval to Novavax COVID-19 Vaccine

The protein-based shot is now fully approved for older adults and high-risk groups, with additional trials mandated and pediatric use deferred.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022. REUTERS/Frank Simon/File Photo
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)
Vials of Novavax Covid-19 vaccines arranged at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.

Overview

  • The FDA has fully approved Novavax’s COVID-19 vaccine for adults aged 65 and older, as well as individuals aged 12–64 with underlying health conditions that increase their risk of severe illness.
  • Pediatric studies for children under 12 have been deferred, as the necessary data has not yet been submitted.
  • The approval requires Novavax to conduct post-marketing trials, including studies on potential heart inflammation risks and the effectiveness of boosters in certain adult age groups.
  • Novavax’s vaccine, the only protein-based COVID-19 shot in the U.S., had previously been available under emergency use authorization since 2022.
  • This decision reflects a shift in regulatory policy under HHS Secretary Robert F. Kennedy Jr., contrasting with the broader approvals granted to mRNA vaccines from Pfizer and Moderna.