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22h ago

FDA Shifts COVID-19 Vaccine Policy to Focus on High-Risk Groups

New guidelines limit annual boosters to adults 65 and older and individuals with underlying conditions, requiring clinical trials for healthy populations.

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, controlled clinical trials for approving COVID-19 boosters for healthy individuals aged 6 months to 64 years.
  • Annual COVID-19 boosters will remain available for adults 65 and older and those with high-risk conditions, using streamlined immunobridging studies.
  • This policy aligns U.S. vaccine recommendations with those of other high-income nations, moving away from universal booster availability.
  • Critics warn the changes may reduce vaccine access and raise questions about insurance coverage and eligibility determination.
  • The FDA's decision, published in a medical journal rather than through standard procedures, has drawn scrutiny for bypassing traditional public comment processes.