What does it mean that FDA claims Covid vaccines caused children’s deaths

The Food and Drug Administration is demanding sweeping changes to the procedures for testing vaccine safety and approving vaccines based on unproven claims that mRNA-based COVID-19 vaccines have caused the deaths of at least 10 children.

The agency detailed its plans in a memo issued to employees on November 28, 2025, which was obtained by multiple news outlets and published by The Washington Post.

The memo written by Vinay Prasad, the agency’s top vaccine regulator, cited an internal, unpublished review as the cause of the children’s deaths due to myocarditis, an inflammation of the heart muscle. And it said the deaths were reported to the Vaccine Adverse Event Reporting System, or VAERS, but provided no evidence that the vaccines caused the deaths.

Death of children due to unsafe vaccines is a serious allegation. I am a pediatric cardiologist who has studied the association between COVID-19 vaccines and cardiovascular side effects such as myocarditis in children.

To the best of my knowledge, studies to date have shown that such side effects are rare, and serious consequences are even more so. However, I am open to new evidence that may change my mind.

But without adequate justification and solid evidence, restricting access to an approved vaccine and changing well-established procedures for testing vaccines will have serious consequences. These moves will limit access for patients, create barriers for companies, and increase distrust in vaccines and public health.

In my view, it is important for people reading about these FDA actions to understand how evidence on vaccine safety is generally evaluated.

determining cause of death

The FDA memo claims that the deaths of these children were directly linked to receiving the COVID-19 vaccination.

From my perspective as a physician, it is terrible that any child should die from routine vaccination.

However, health professionals like me have a duty to the public to maintain the highest possible standards in investigating why these deaths occurred. If the FDA has evidence of something that national health agencies around the world have missed — massive child deaths due to myocarditis caused by COVID-19 vaccines — I don’t doubt that even the most pro-vaccine physicians will listen. However, no such evidence has been presented yet.

While deaths recorded in VAERS are a starting point, by themselves they are insufficient to conclude whether the death was caused by the vaccine or other medical causes were responsible.

To demonstrate a causal relationship, FDA staff and physicians must align VAERS reports with physicians’ patient assessments as well as data from other sources to monitor vaccine safety. These include PRISM, which logs insurance claims data, and Vaccine Safety Datalink, which tracks safety signals in electronic medical records.

It is known that the majority of deaths in VAERS-only children who recently received vaccines have been wrongly attributed to vaccines – either accidentally or in some cases intentionally by anti-vaccine activists.

Cardiovascular side effects of COVID-19 vaccines

In his Substack and Twitter account, Prasad has said that he believes the rate of serious cardiovascular side effects after COVID-19 vaccination has been vastly underestimated and that vaccines should be restricted far more than they currently are.

In the July 2025 presentation, Prasad cited a risk of 27 cases per million of myocarditis in young men who received the COVID-19 vaccine. A 2024 review showed that the numbers were slightly lower – about 20 cases out of 10 lakh people. But the same study found that unvaccinated people had a higher risk of heart problems after COVID-19 infection than vaccinated people. In a separate study, people who got myocarditis after COVID-19 vaccination developed fewer complications than people who did not get myocarditis after COVID-19 infection.

About the author

The existing vaccine safety infrastructure in the US successfully identifies the risks posed by vaccines – and did so during the COVID-19 pandemic. Today, most COVID-19 vaccines in the US rely on mRNA technology. But just as vaccines were first emerging during the COVID-19 pandemic, two pharmaceutical companies, Janssen and AstraZeneca, produced a vaccine that used a different technology, called a viral vector. A very rare but real safety problem was found in this type of vaccine.

VAERS, Vaccine Safety Datalink, clinical investigators in the US and their European counterparts found that these vaccines caused blood clots. In April 2021, the FDA formally recommended stopping their use, and they were subsequently removed from the market.

Death due to myocarditis from COVID-19 vaccination is extremely rare. To demonstrate that this has occurred requires proof that the person had myocarditis, proof that no other reasonable cause of death was present, and the absence of any additional cause of myocarditis. However, these factors cannot be determined from VAERS data – and to date, the FDA has presented no other relevant data.

A problematic approach to future vaccine approval

Currently, vaccines are tested by seeing how well they prevent disease and how well they generate antibodies, which are molecules that help your body fight viruses and bacteria.

Some vaccines, such as the COVID-19 vaccine and influenza vaccine, need to be updated based on new strains. The FDA typically approves these updates based on how well the new variants generate antibodies. Since previous generation vaccines were already shown to prevent infection, if the new version can generate antibodies like the previous one, researchers believe its ability to prevent infection is also comparable. Later studies could test how well the vaccines prevent severe disease and hospitalization.

The FDA memo says this approach is inadequate and argues instead to replace such studies with many more placebo-controlled trials — not just for COVID-19 vaccines but also for the widely used influenza and pneumonia vaccines.

This may seem reasonable in theory. However, this is not realistic in practice.

Today’s influenza vaccines must be changed each season to reflect mutations in the virus. If the FDA required new placebo-controlled trials every year, the vaccine being tested would be obsolete by the time it is approved. This would be a huge waste of time and resources.

Furthermore, detecting vaccine-related myocarditis at low rates would require clinical trials many times larger than those conducted to approve COVID-19 mRNA vaccines. This would cost at least millions of dollars more, and the delay in administering the vaccine would also cost lives.

Placebo-controlled trials will need to compare people who received the updated vaccine with people who have not been vaccinated. When an older version of a vaccine is already available, this means deliberately asking people to forego that vaccine and risk infection for the trial, a practice that is widely considered unethical. Current scientific practice is that only brand-new vaccines can be compared with a placebo.

While suspected vaccine-related deaths should certainly be investigated, withholding vaccines for inadequate reasons could lead to a significant decline in public confidence. It is therefore essential that any claims that a vaccine causes harm are thoroughly and transparently investigated.

vaccine vs disease

To accurately estimate the risks of a vaccine, it is also important to compare its side effects to the effects of the disease it prevents.

For COVID-19, the data consistently shows that the disease is clearly more dangerous. From August 1, 2021, to July 31, 2022, more than 800 children in the US died due to COVID-19, but very few deaths from COVID-19 vaccines have been confirmed in children around the world. Furthermore, the disease causes many more cardiovascular side effects than the vaccine.

Meanwhile, widespread evidence shows that COVID-19 vaccination reduces the risk of hospitalization by more than 70% and the risk of severe disease by 79% in teenage children. Studies also show that it dramatically reduces the risk of developing long COVID, a condition in which symptoms such as extreme fatigue or weakness persist for more than three months after COVID-19 infection.

Reporting only the risks of vaccines, not their benefits, shows only a small part of the picture.