FDA Limits COVID Boosters to Over-65, High-Risk Americans

The U.S. Food and Drug Administration (FDA) has decided to limit COVID-19 booster shots primarily to individuals aged 65 and older and those at high risk of severe illness, moving away from broader booster recommendations for healthy individuals under 65. This shift aligns U.S. policy more closely with European countries like the UK, France, and Germany, which restrict boosters to the elderly and people with underlying conditions. FDA leaders, including Commissioner Martin Makary and Vinayak Prasad, emphasized that while early vaccination efforts were successful, the benefits of repeated boosters in low-risk groups remain uncertain, prompting the need for new placebo-controlled trials to justify boosters for healthy people aged six months to 64 years. The FDA will continue approving boosters for high-risk groups based on immune response data but requires randomized controlled trials to demonstrate clinical benefits in healthy populations. The broad definition of high risk includes common conditions such as obesity, asthma, diabetes, cancer, and mental health issues, meaning between 100 million and 200 million Americans will likely remain eligible for boosters. This policy aims to generate more evidence on the efficacy of repeated boosters while maintaining protection for vulnerable populations.