Experts warn the memo lacks context and could damage vaccine trust during rising disease outbreaks<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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TUESDAY, Dec. 2, 2025 (HealthDay News) \u2014 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.<\/p>\n
The memo, which was obtained by The New York Times<\/em>, has not been released publicly or reviewed by outside scientists.<\/p>\n It also does not include important details such as the children\u2019s ages, medical histories or how the FDA reached its conclusions about the vaccine\u2019s role in the deaths.<\/p>\n Still, the memo reflects a major change in how the agency is talking about vaccine safety.<\/p>\n The memo was written by Dr. Vinay Prasad<\/a>, head of the FDA\u2019s 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.<\/p>\n “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad wrote.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n Infectious disease specialist Michael Osterholm<\/a> said the timing of the memo \u2014 right before a major CDC vaccine meeting \u2014 appeared intentional.<\/p>\n \u201cThis is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,\u201d he said.<\/p>\n Other critics said the memo leaves out essential context. Dr. Paul Offit<\/a>, a pediatric vaccine expert at Children\u2019s Hospital of Philadelphia, told The Times<\/em> that the memo is an example of science “by press release.”<\/p>\n He noted that children treated for vaccine-related myocarditis at his hospital typically recovered quickly.<\/p>\n \u201cOn the other hand, we saw children admitted to our hospital with myocarditis from the virus,\u201d he said. \u201cIt was quite severe and caused admissions to the intensive care unit.\u201d<\/p>\n Among Prasad\u2019s recommendations:<\/p>\n Requiring vaccine trials to include all groups, including pregnant women<\/p>\n<\/li>\n Reassessing the yearly flu<\/a> vaccine update process<\/p>\n<\/li>\n Asking companies to run larger studies on vaccines given at the same time (such as flu and COVID shots)<\/p>\n<\/li>\n Requiring long-term studies of pneumonia<\/a> vaccines to prove they prevent disease, not only create antibodies<\/p>\n<\/li>\n<\/ul>\n If adopted, these rules could make vaccine development more costly. Experts also warn this could also fuel mistrust at a time when measles<\/a>, whooping cough and other illnesses are rising across the globe.<\/p>\n Prasad also used the memo to criticize past vaccination mandates, saying school and workplace requirements \u201ccoerced\u201d people into receiving COVID shots.<\/p>\n His predecessor, Dr. Peter Marks<\/a>, said the document\u2019s tone was unusually political and that the reported cases should be carefully reviewed.<\/p>\n \u201cI would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex,\u201d Marks said to The Times <\/em>after reading the memo.<\/p>\n More information<\/strong><\/p>\n Learn more about the role of the FDA<\/a>.<\/p>\n\n