The Trump administration is casting more doubt on the safety of vaccines, with an internal memo from the Food and Drug Administration linking the deaths of at least 10 children to the Covid vaccine and proposing new regulatory measures as a result.
The memo was obtained by The New York Times and not publicly released. It did not provide details such as the ages of the children, whether they had any health problems or how the agency determined the vaccine-death link. Nor did it disclose the maker of the vaccines involved.
The findings have not been published in a peer-reviewed medical journal, drawing suspicion from some critics of Health Secretary Robert F. Kennedy Jr., who has repeatedly criticized the Covid shots as deadly despite the scientific consensus that they are safe.
The memo was written by Dr. Vinay Prasad, the director of the F.D.A.’s vaccine division. He sent it to agency staff members on Friday, outlining findings from a review of reports concerning childhood deaths and attributing them to myocarditis, or inflammation of the heart muscle.
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“This is a profound revelation,” Dr. Prasad wrote in a memo to staff members. “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”
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Michael Osterholm, a critic of Mr. Kennedy’s health agency oversight and an infectious disease expert at the University of Minnesota, said he believed the memo was intentionally released before the meeting.
“This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he said.
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Dr. Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia and a critic of Mr. Kennedy’s vaccine policies, called the memo an example of science “by press release.”
He said it was missing context such as the number of deaths from the virus itself among vaccinated and unvaccinated children.
Dr. Offit said children with vaccine-related myocarditis showed up at the hospital with cases that resolved 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.”
