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FDA Limits COVID-19 Vaccine Approval to High-Risk Groups

New policy restricts routine vaccine access for healthy adults and children, with CDC recommendations on fall shots expected in June.

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Overview

  • The FDA announced it will limit routine approval of COVID-19 vaccines to seniors and individuals with high-risk conditions, pending further data on healthy populations.
  • Manufacturers are now required to conduct additional clinical trials to demonstrate vaccine effectiveness in healthier groups.
  • The CDC's advisory panel is set to meet in June to decide on fall vaccine recommendations, which could influence broader access to shots.
  • Experts warn that the new FDA policy may reduce vaccine availability and lead to decreased insurance coverage for healthy adults and children.
  • COVID-19 remains a significant public health concern, with the CDC reporting 30,000 to 50,000 adult deaths and high pediatric hospitalization rates since October.