11:33 AM EDT, 05/20/2025 (MT Newswires) -- US Food and Drug Administration Commissioner Martin Makary and FDA Center for Biologics Evaluation and Research Director Vinay Prasad on Tuesday laid out the agency's new regulatory framework with respect to Covid-19 vaccination boosters.

"For all healthy persons -- those with no risk factors for severe Covid-19 -- between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted," Makary and Prasad said in a piece published by The New England Journal of Medicine.

"Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment," Makary and Prasad said.

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