The Food and Drug Administration will no longer approve COVID-19 booster shots for healthy adults and children without new clinical trials proving that 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 the agency approves updated immunizations each season for those between 6 moths and 64 years old.

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COVID booster vaccines for adults over age 65 and those at high-risk of developing severe symptoms will not require such extensive studies.

This is a developing story and will be updated.