FDA Ties 10 Child Deaths to COVID Vaccine: Report

A nurse prepares a dose of a Covid-19 vaccine.

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By Jasmine Laws

US News Reporter

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A Food and Drug Administration (FDA) memo has reported that the COVID-19 vaccine contributed to the deaths of at least 10 children.

Following the release of the Friday memo, which was obtained by Reuters and other outlets, FDA chief medical and scientific officer Vinay Prasad also told reporters that the agency would be changing its vaccine approval process.

Newsweek contacted the FDA via the Department of Health of Human Services (HHS) outside of regular working hours via email for comment.

Why It Matters

The Trump administration, particularly Health Secretary Robert F. Kennedy Jr, has been vocal in its skepticism of the COVID vaccine.

Kennedy has previously made debunked claims about the vaccine, even falsely attributing it to the death of baseball player Hank Aaron, and more broadly has been clear on the sweeping changes he intends to make to child vaccination, which included overhauling the immunization schedule.

The memo also builds on previous concern raised about the vaccines by the FDA. Earlier this year, the agency said that the main manufacturers of the vaccines, Pfizer and Moderna, would have to update their information about the chances of myocarditis and pericarditis, after cases of the two heart conditions were reported in young men who had taken the vaccine.

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What To Know

The memo, which appears to have been shared on social media, reads that it has been found "at least 10 children have died after and because of receiving the COVID-19 vaccination." It added that the number is "certainly an underestimate due to underreporting, and inherent bias in attribution."

The memo, which has not been peer-reviewed, does not appear to specify how the FDA came to its conclusion that the vaccine caused the deaths of the children. It only states that "initial analysis" of 96 deaths between 2021 and 2024 concluding that "no fewer than 10 are related."

The memo added: "Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death."

It also reads: "It is horrifying to consider that the U.S. vaccine regulation, including our actions, may have harmed more children than we saved," although it does state that the agency "does not have reliable data estimating the absolute benefit" regarding vaccine receipt.

Dr. Krutika Kuppalli, vice chair of the IDSA Global Health Committee and clinical professor at Stanford University, wrote in a post on X: "There is NO evidence linking COVID-19 vaccines to deaths in children. There IS evidence that COVID causes serious harm—including long COVID, MIS-C, cardiac complications and diabetes. This administration’s actions are dangerous, and the damage to the public and children may be irreversible."

Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at the Children's Hospital of Philadelphia, told Newsweek the FDA needs to "push forward the data that backs up" its claim, in order to make such an announcement.

"What an irresponsible thing to do," he said. "So [Prasad] scares people without showing people the data."

Offit said the sort of data needed to make this kind of claim is also "not easy to come by," as the FDA would have to have autopsy data showing that it was presumably myocarditis that caused the child's death, and no other factor, and that the child had an immune response to the SARS-CoV-2 spike protein, and not to any other proteins, which would suggest they'd had a response to "the natural virus."

The FDA would also have to prove that the children had not had an immune response to any other virus as well, he said, as he added that there are "a lot of viruses that can cause myocarditis."

What People Are Saying

FDA chief medical and scientific officer Vinay Prasad said on Friday, according to CNN: "I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product. The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm."

Lucky Tran, director of science communications at Columbia University wrote in a post on X: "In a new leaked memo, the FDA outlined plans to make it much harder to get new vaccines approved, claiming, without sharing evidence, that COVID vaccines have killed at least 10 kids. This is so reckless. The science shows us that COVID vaccines have saved millions of lives."

What Happens Next

It is not yet clear what the FDA's announced changes to its vaccine approval process will be.

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