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New FDA restrictions will make COVID-19 vaccines only available to elderly and people with medical conditions

  • On Tuesday, the FDA announced new COVID-19 booster guidelines limiting routine approvals to adults over 65 or high-risk individuals in the US.
  • This change addresses criticism of the previous U.S. Policy that uniformly advised COVID-19 booster shots for all adults, without differentiating based on age or individual risk factors.
  • Under the new framework, manufacturers must conduct fresh randomized trials to support vaccine use in healthy younger adults and children.
  • FDA officials Makary and Prasad characterized the policy change as grounded in evidence, highlighting the unclear advantages of additional boosters for healthy individuals—for example, questioning if a healthy 52-year-old who has already had multiple Covid infections and six vaccine doses would gain any benefit from a seventh.
  • This policy implies annual shots will remain widely available for 100 to 200 million at-risk people but could restrict access and insurance coverage for healthy adults seeking boosters.
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Forbes broke the news in United States on Tuesday, May 20, 2025.
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