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Agency leaders said they wanted to restore trust in the shots with further studies. But the proposed criteria may reduce access to the vaccines for many people who want them.
The Food and Drug Administration may require data from additional clinical trials before approving updated Covid-19 vaccines for healthy Americans younger than 65, according to new rules detailed on Tuesday by agency officials.
New doses of the vaccines offer “uncertain” benefit to those under 65 who have previously been vaccinated or have had Covid, the officials said in The New England Journal of Medicine.
Citing low uptake of recent Covid shots, “the American people, along with many health care providers, remain unconvinced,” wrote Dr. Vinay Prasad, the F.D.A.’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner.
During the pandemic, both officials sharply criticized vaccine mandates and other public health measures intended to turn back the coronavirus.
“The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” Dr. Prasad and Dr. Makary wrote.
Robert F. Kennedy Jr., the health secretary, is a prominent vaccine skeptic who spent years campaigning against the Covid shots. Under his leadership, the Department of Health and Human Services has taken a more critical view of vaccines in general, raising questions about their safety and whether they should be so widely administered.