The New York Times has reported that an internal memo from the U.S. Food and Drug Administration (FDA) suggests at least 10 children “likely died” in cases the agency is reviewing for a possible link to COVID-19 vaccines, with myocarditis (heart inflammation) mentioned as a potential factor.

The report states that the memo was written by FDA Chief Medical and Scientific Officer Vinay Prasad. However, the document did not disclose the ages, medical history, or vaccine manufacturers involved in the cases, and the findings have not been published in any peer-reviewed medical journal.

The U.S. Department of Health and Human Services (HHS), which oversees the FDA, has not yet issued a comment. Reuters also reported that the agency did not respond to requests made outside business hours.

Health Secretary Robert F. Kennedy Jr., a longtime critic of vaccines and now part of the Trump administration, recently changed national policy to restrict COVID-19 vaccine eligibility to Americans aged 65 and older or those with underlying health risks. Kennedy has previously promoted debunked claims linking vaccines to autism, drawing widespread criticism from medical experts.

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The New York Times further reported that Prasad called the memo findings “a profound revelation” and suggested stricter oversight for COVID-19 vaccines, including randomized trials for specific age groups.

The U.S. Centers for Disease Control and Prevention (CDC) advisory committee is expected to review vaccine safety data in a meeting scheduled next week.

Prasad, known for opposing COVID-19 vaccine and mask mandates during the pandemic, returned to his senior FDA post in September, advising on scientific and public-health issues.