FDA to require clinical trials for COVID boosters for healthy adults and children

The Food and Drug Administration will no longer approve COVID-19 booster shots for healthy adults and children without new clinical trials proving they are safe and effective.

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, who heads the agency’s center on vaccines, published an article in the New England Journal of Medicine on Tuesday outlining that the agency will require randomized controlled clinical trials before it approves updated immunizations each season for those between 6 months and 64 years old.