May 28, 2025- The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, limiting them to older adults and those at risk of developing severe illness, according to Reuters. Vaccine manufacturers will need to conduct randomized controlled trials before the FDA will approve future applications to give shots to all healthy persons between the ages of 6 months and 64 years old, according to CBS News. Details of the new rules for COVID-19 vaccine approvals were also outlined in an article published by The New England Journal of Medicine, authored by Prasad and FDA Commissioner Dr. Martin Makary.