The FDA announced stricter approval standards for future COVID-19 vaccine boosters. For high-risk individuals (65+, or younger with underlying conditions), immunogenicity data will suffice. However, for healthy adults aged 6 months to 64 years, randomized controlled trials demonstrating reduced infections or hospitalizations will be required for approval. This change reflects a shift from relying solely on immunogenicity data, aligning with a more rigorous scientific approach. The new guidelines come amidst changes within health agencies under Secretary Robert F. Kennedy Jr.

Prepared by Olivia Bennett and reviewed by editorial team.