FDA Requires Trials of Covid Shots for Healthy Kids, Adults (2)

US 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.

The agency’s willingness to continue making the shots available for high-risk people with a wide range of health conditions was a relief to the ...