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• Posted December 2, 2025

FDA Memo Claims COVID Vaccine Tied to 10 Child Deaths

A confidential internal memo from the U.S. Food and Drug Administration (FDA) is creating new controversy around vaccine safety after an agency official said the COVID-19 vaccine may have played a role in the deaths of at least 10 children.

The memo, which was obtained by The New York Times, has not been released publicly or reviewed by outside scientists.

It also does not include important details such as the children’s ages, medical histories or how the FDA reached its conclusions about the vaccine’s role in the deaths.

Still, the memo reflects a major change in how the agency is talking about vaccine safety.

The memo was written by Dr. Vinay Prasad, head of the FDA’s vaccine division. In the note to staff, he said the deaths appeared to be tied to myocarditis, a rare type of heart inflammation that has been seen in some people after COVID vaccination.

"For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children," Prasad wrote.

He also said he plans to recommend a series of new reviews and stricter oversight for vaccines in general, although it is unclear whether the White House has been briefed on these plans. Any changes would still need to get a federal review before taking effect.

For years, public health leaders (including those from the Trump and Biden administrations) have strongly supported COVID vaccines, referring to them as lifesaving during the height of the pandemic.

Researchers note that myocarditis linked to the vaccine has typically been rare and quick to improve, especially compared with myocarditis caused by the COVID virus itself.

Infectious disease specialist Michael Osterholm said the timing of the memo — right before a major CDC vaccine meeting — appeared intentional.

“This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he said.

Other critics said the memo leaves out essential context. Dr. Paul Offit, a pediatric vaccine expert at Children’s Hospital of Philadelphia, told The Times that the memo is an example of science "by press release."

He noted that children treated for vaccine-related myocarditis at his hospital typically recovered quickly.

“On the other hand, we saw children admitted to our hospital with myocarditis from the virus,” he said. “It was quite severe and caused admissions to the intensive care unit.”

Among Prasad’s recommendations:

• Requiring vaccine trials to include all groups, including pregnant women

• Reassessing the yearly flu vaccine update process

• Asking companies to run larger studies on vaccines given at the same time (such as flu and COVID shots)

• Requiring long-term studies of pneumonia vaccines to prove they prevent disease, not only create antibodies

If adopted, these rules could make vaccine development more costly. Experts also warn this could also fuel mistrust at a time when measles, whooping cough and other illnesses are rising across the globe.

Prasad also used the memo to criticize past vaccination mandates, saying school and workplace requirements “coerced” people into receiving COVID shots.

His predecessor, Dr. Peter Marks, said the document’s tone was unusually political and that the reported cases should be carefully reviewed.

“I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex,” Marks said to The Times after reading the memo.

More information

Learn more about the role of the FDA.

SOURCE: The New York Times, Nov. 28, 2025