F.D.A. Poised to Restrict Access to Covid Vaccines

 Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many others may not be able to get the shots.

Preparing Covid vaccine doses at an outdoor mobile vaccination site in San Francisco in 2021.

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Mike Kai Chen for The New York Times

Top officials for the Food and Drug Administration laid out new standards for updated COVID shots, saying they’d continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.

But the FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. It’s a stark break from the previous federal policy recommending an annual COVID shot for all Americans six months and older. In the paper and a subsequent online webcast, the FDA’s top vaccine official said more than 100 million Americans still should qualify for what he termed a booster under the new guidance.

Dr. Vinay Prasad described the new approach as a “reasonable compromise” that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.