FDA Limits COVID-19 Vaccine Approvals to Older, High-Risk Groups

The U.S. Food and Drug Administration (FDA) has announced a significant policy change restricting future COVID-19 vaccine approvals mainly to adults aged 65 and older and individuals aged 6 months to 64 years with underlying health conditions that increase their risk of severe disease. This move, detailed in a New England Journal of Medicine article by FDA Commissioner Marty Makary and Dr. Vinay Prasad, requires randomized, placebo-controlled clinical trials demonstrating clinical outcomes before approving vaccines for healthy individuals aged 6 months to 64 years. The policy aligns the United States with other countries like the UK, Canada, and Australia, which have adopted risk-based COVID-19 vaccine recommendations rather than universal coverage. The change aims to balance regulatory flexibility with scientific rigor, reflecting the widespread immunity in the population from prior doses and infections, and could limit vaccine availability for millions of healthy Americans. While annual boosters will remain streamlined for high-risk groups, experts express concerns about potential challenges in vaccine access and insurance coverage for those outside these categories. The FDA's new framework follows recent scrutiny of COVID-19 vaccine use and precedes advisory committee votes on vaccine strain formulations.