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6h ago

FDA Overhauls COVID-19 Booster Policy, Restricting Access for Healthy Adults Under 65

New guidelines require clinical trials for low-risk groups while maintaining streamlined approvals for high-risk populations and older adults.

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 will now require randomized, placebo-controlled trials for COVID-19 booster approvals in healthy individuals aged 6 months to 64 years, marking a shift from prior immunobridging-based approvals.
  • Annual boosters will remain available for adults aged 65 and older and individuals with underlying health conditions, with estimates suggesting 100–200 million Americans will still qualify.
  • The policy aligns U.S. vaccination guidance with European nations, moving away from broad recommendations to a more targeted, risk-based approach.
  • FDA officials Marty Makary and Vinay Prasad emphasized the need for robust clinical evidence to rebuild public trust and address declining booster uptake, which has fallen below 25% in recent years.
  • The new framework could deter vaccine manufacturers due to the high costs and logistical challenges of conducting large-scale trials for low-risk populations.