A confidential internal memo from the U.S. Food and Drug Administration has raised new controversy about the safety of COVID‑19 vaccines in children.
The memo, which was obtained by The New York Times but has not been publicly released or reviewed by independent scientists, suggests that the COVID‑19 vaccine may have played a role in the deaths of at least ten children.
Because the memo has not been shared in full, many important details remain unclear, including the ages of the children, their medical histories, the timeline of their symptoms, and how the FDA concluded that the vaccine may have contributed to their deaths.
Still, the language used in the memo marks a major shift in how the agency communicates about vaccine safety.
The memo was written by Dr. Vinay Prasad, the new head of the FDA’s vaccine division. In the document, he wrote that the deaths appeared linked to myocarditis, a rare type of heart inflammation that can occur after infection or vaccination.
Myocarditis has been known as a very uncommon side effect of mRNA COVID vaccines, mostly affecting teenage boys and young adult men. In most reported cases worldwide, symptoms were mild and patients recovered quickly. However, the possibility of fatal cases—especially in children—has brought renewed attention to how the FDA monitors vaccine safety.
For the last several years, leaders in public health from both Republican and Democratic administrations have widely supported COVID vaccines, saying they saved many lives during the pandemic.
They have consistently noted that the risks from the COVID virus itself, including heart inflammation caused by the infection, were much higher than any risks linked to vaccination. Many experts worry that the memo may be misinterpreted, especially because it lacks full scientific context.
Some infectious‑disease specialists and vaccine experts were critical of how the memo was presented. Michael Osterholm, a well‑known epidemiologist, said releasing information like this without full detail or scientific review was irresponsible.
He noted that the memo came just before a major CDC vaccine meeting, which made it appear political rather than scientific. Pediatric vaccine expert Dr. Paul Offit told The New York Times that the memo resembled “science by press release,” meaning its claims cannot be fully evaluated without data.
He added that children treated at his hospital for vaccine‑related myocarditis typically recovered quickly, while myocarditis from COVID infection itself was often much more severe and sometimes required intensive‑care treatment.
In the memo, Dr. Prasad recommended several changes to how vaccines are studied and approved. These included requiring vaccine trials to include pregnant women, reviewing the yearly flu vaccine update process, asking companies to run larger studies on vaccines given at the same time, and requiring long‑term studies of pneumonia vaccines to show they prevent illness rather than simply increasing antibodies.
Supporters say these ideas could improve transparency, but critics warn they might slow vaccine development and increase costs. Many experts also worry that this could feed public mistrust at a time when preventable diseases like measles and whooping cough are rising again.
The memo also criticized past vaccine mandates in schools and workplaces, saying they “coerced” people into receiving COVID shots. This political tone concerned several former FDA officials, including Prasad’s predecessor Dr. Peter Marks, who said that these cases need careful review because vaccine‑related deaths are extremely difficult to confirm.
He noted that many medical events in children have multiple possible causes, and determining whether a vaccine truly caused harm requires detailed, rigorous investigation.
When reviewing the situation, it becomes clear that the memo raises questions but does not provide enough information for firm conclusions. The fact that it was not publicly released or peer‑reviewed means its claims should be interpreted carefully.
The scientific community generally agrees that myocarditis after mRNA vaccination is rare and usually mild, and that the risk of myocarditis from COVID infection itself is significantly higher.
The memo may be an early signal of the FDA’s desire to change how it evaluates vaccine safety, but without data, it cannot be taken as evidence that the vaccines caused the reported deaths. More transparent information, independent analysis, and scientific review will be essential for understanding what really happened and for maintaining public trust in vaccines.
If you care about COVID, please read studies about vitamin D deficiency linked to severe COVID-19, death, and how diets could help manage post-COVID syndrome.
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