The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 infection.

WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.

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FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.”