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2d ago

FDA Grants Conditional Approval to Novavax COVID-19 Vaccine with Restrictive Use Criteria

The protein-based vaccine is now approved for adults 65+ and high-risk individuals aged 12–64, with new trials required to assess heart risks and deferred pediatric studies.

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)

Overview

  • The FDA has approved Novavax's COVID-19 vaccine for adults 65 and older and individuals aged 12–64 with underlying health conditions, imposing restrictions not applied to mRNA vaccines from Pfizer and Moderna.
  • The approval requires Novavax to conduct additional postmarketing trials to evaluate potential heart-related risks and defers pediatric study submissions for children under 12.
  • This marks the first full approval for a protein-based COVID-19 vaccine in the U.S., offering an alternative to mRNA technology.
  • The decision follows a delay in the approval process, reportedly influenced by political appointees overriding FDA career staff recommendations.
  • CDC advisers are set to deliberate on whether annual COVID-19 boosters should be limited to high-risk groups, a policy direction potentially influenced by this approval.