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9h ago

FDA Restricts COVID-19 Vaccine Approvals to High-Risk Groups

New policy limits routine vaccine access to adults 65+ and those with underlying conditions, requiring rigorous trials for healthy populations under 65.

Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana)
People in the Phase 1B priority group wait in line to receive doses of the Moderna Covid-19 vaccine in Chula Vista, Calif., on Jan. 26, 2021.
Dr. Marty Makary, Commissioner of the U.S. Food and Drug Administration, appears before the Senate Health, Education, Labor and Pensions Committee in March.
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Overview

  • The FDA announced it will only approve COVID-19 vaccines for individuals aged 65 and older or those with high-risk conditions, impacting future vaccine eligibility.
  • Healthy people under 65 will now require robust clinical trials to access approved vaccines, a shift aimed at improving safety data and public trust.
  • The CDC must determine vaccine recommendations within the FDA’s new restrictions, potentially affecting insurance coverage and access for younger, healthy individuals.
  • The policy aligns U.S. vaccine strategy with European countries that focus annual COVID-19 shots on older and high-risk populations.
  • FDA estimates suggest over 100 million Americans will still qualify for vaccines under the revised guidelines, despite declining overall uptake in recent seasons.