WASHINGTON – The United States Food and Drug Administration (FDA) said in an internal memo that at least 10 children may have died “because of” Covid-19 vaccinations, citing myocarditis, a form of heart inflammation, as a potential cause, the New York Times reported on Friday.
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The Department of Health and Human Services, which oversees the FDA, did not immediately respond to requests for comment. The memo, authored by FDA Chief Medical and Scientific Officer Vinay Prasad, described the findings as “a profound revelation” and indicated plans to tighten oversight of Covid vaccines, including requiring randomised studies for all subgroups.
The report did not disclose the ages, health conditions, or vaccine manufacturers involved. Prasad, an oncologist who has long been critical of Covid vaccine and mask mandates, returned to his current role at the FDA in September. He advises the FDA commissioner and senior officials on emerging medical and scientific issues affecting public health and regulatory science.
NEW: An internal F.D.A. memo said about 10 children died after getting the Covid shot. But experts want to see the data.
Dr. Vinay Prasad: “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”https://t.co/cgIJcVpy1n
— Christina Jewett (@By_CJewett) November 29, 2025
The development comes as Health Secretary Robert F. Kennedy Jr., a former vaccine critic who assumed office under President Donald Trump, has sharply restricted access to Covid vaccines, limiting them to people over 65 and those with underlying medical conditions. Kennedy has previously linked vaccines to autism and has sought to revise US immunisation policies.
During the terms of both Trump and his successor Joe Biden, US health authorities had strongly endorsed Covid vaccines as lifesaving. The FDA memo has not yet been published in a peer-reviewed journal, and the Centers for Disease Control and Prevention’s vaccine advisory committee is scheduled to meet next week to review the findings.
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Experts say the memo could significantly influence vaccine policy in the US and spark renewed debate over vaccine safety and oversight.