Health
US Will No Longer Approve Covid Boosters for Healthy Kids, Adults Without New Trials
The Food and Drug Administration expects drugmakers to do randomized, controlled trials on Covid shots before the agency approves the updated immunizations.
Photographer: Hannah Beier/BloombergUS regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly requirement for drugmakers, though they will still be available for millions of high-risk Americans.
Food and Drug Administration Commissioner Marty Makary and Vinay Prasad, who leads the agency’s vaccine division, outlined the approach they intend to take with updated versions of the immunizations in an article published Tuesday in the New England Journal of Medicine.