The U.S. Food and Drug Administration said that at least 10 children had likely died “because of” COVID-19 vaccinations, citing myocarditis, or heart inflammation, as a possible cause, the New York Times reported on Friday.

The Department of Health and Human Services, which includes the FDA, did not immediately respond to a Reuters request for comment on the report outside business hours. But FDA Commissioner Marty Makary on Saturday confirmed the report during a TV interview.

“There were, it appears, 10 deaths of children from the COVID shots,” he told Fox News’ “Fox & Friends” weekend show, citing data gathered during the Biden administration.

Health Secretary Robert F. Kennedy Jr. has sharply changed government policy on COVID vaccines, limiting access to them to people 65 and older,

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