FDA Restricts COVID Boosters to High-Risk Groups

The U.S. Food and Drug Administration (FDA) has restricted routine approval of annual COVID-19 booster shots to adults over 65 and those with underlying health conditions, requiring large, placebo-controlled trials to justify boosters for healthy individuals under 65. The decision, detailed in the New England Journal of Medicine by FDA Commissioner Marty Makary and vaccine division chief Vinay Prasad, moves the U.S. toward a more targeted vaccination strategy similar to Europe. Critics have raised concerns about access for caregivers and others who support vulnerable people but are not classified as high-risk, as well as the lack of advisory committee input in the decision. The policy responds to declining booster uptake and questions about the necessity and benefits of repeated boosters for low-risk groups. Despite the new restrictions, 100 to 200 million Americans with qualifying risk factors remain eligible for annual COVID-19 vaccinations. The change may reduce accessibility and insurance coverage for those outside high-risk categories.