The Food and Drug Administration is seeking to drastically change procedures for testing vaccine safety and approving vaccines, based on unproven claims that mRNA-based COVID-19 vaccines caused the death of at least 10 children.
The agency detailed its plans in a memo released to staff on Nov. 28, 2025, which was obtained by several news outlets and published by The Washington Post.
Citing an internal, unpublished review, the memo, written by the agency’s top vaccine regulator, Vinay Prasad, attributes the children’s deaths to myocarditis, an inflammation of the heart muscle. And it says the deaths were reported to the Vaccine Adverse Event Reporting System, or VAERS, but provides no evidence that the vaccines caused the deaths.
The death of children due to an unsafe vaccine is a serious allegation. I am a pediatric cardiologist who has studied the link between COVID-19 vaccines and heart-related side effects such as myocarditis in children. To my knowledge, studies to date have shown such side effects are rare, and severe outcomes even more so. However, I am open to new evidence that could change my mind.
But without sufficient justification and solid evidence, restricting access to an approved vaccine and changing well-established procedures for testing vaccines would carry serious consequences. These moves would limit access for patients, create roadblocks for companies and worsen distrust in vaccines and public health.
In my view, it’s important for people reading about these FDA actions to understand how the evidence on a vaccine’s safety is generally assessed.
The FDA memo claims that the deaths of these children were directly related to receiving a COVID-19 immunization.
From my perspective as a clinician, it is awful that any child should die from a routine vaccination.
However, health professionals like me owe it to the public to uphold the highest possible standards in investigating why these deaths occurred. If the FDA has evidence demonstrating something that national health agencies worldwide have missed – widespread child deaths due to myocarditis caused by the COVID-19 vaccine – I don’t doubt that even the most pro-vaccine physician will listen. So far, however, no such evidence has been presented.
While a death logged in VAERS is a starting point, on its own it is insufficient to conclude whether a vaccine caused the death or other medical causes were to blame.
To demonstrate a causal link, FDA staff and physicians must align the VAERS report with physicians’ assessments of the patient, as well as data from other sources for monitoring vaccine safety. These include PRISM, which logs insurance claims data, and the Vaccine Safety Datalink, which tracks safety signals in electronic medical records.
It’s known that most deaths logged only in VAERS of children who recently received vaccines have been incorrectly attributed to the vaccines – either by accident or in some cases on purpose by anti-vaccine activists.
In his Substack and Twitter accounts, Prasad has said that he believes the rate of severe cardiac side effects after COVID-19 vaccination is severely underestimated and that the vaccines should be restricted far more than they currently are.
In a July 2025 presentation, Prasad quoted a risk of 27 cases per million of myocarditis in young men who received the COVID-19 vaccine. A 2024 review suggested that number was a bit lower – about 20 cases out of 1 million people. But that same study found that unvaccinated people had greater risk of heart problems after a COVID-19 infection than vaccinated people. In a different study, people who got myocarditis after a COVID-19 vaccination developed fewer complications than people who got myocarditis after a COVID-19 infection.
