The U.S. Food and Drug Administration has announced significant changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.

What Happened: The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad in the New England Journal of Medicine, reported Reuters.

“At-risk Americans can be reassured that they will be covered by such approvals. At the same time, we want more evidence at the U.S. Food and Drug Administration,” Prasad told FDA scientists during a live-streamed presentation on Tuesday. “We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose.”

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