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5d ago

FDA Ends Routine COVID-19 Vaccine Approvals for Healthy Americans Under 65

New policy requires clinical trials for younger, healthier populations while maintaining streamlined approvals for high-risk groups.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
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Overview

  • The FDA announced it will no longer routinely approve annual COVID-19 booster shots for healthy individuals aged six months to 64 without randomized, controlled trials demonstrating clinical benefits.
  • Vaccines for adults aged 65 and older, as well as individuals with underlying health conditions, will continue to be approved based on immunogenicity data.
  • FDA Commissioners Marty Makary and Vinay Prasad detailed the changes in an editorial in the New England Journal of Medicine, citing a need for evidence-based recommendations.
  • The new framework aligns U.S. vaccine policy more closely with European standards, which prioritize older and high-risk groups for booster access.
  • Experts warn the stricter requirements may limit vaccine availability for some groups and raise concerns about implementation and insurance coverage.