FDA acknowledges COVID-19 vaccine linked to child deaths: “A significant and sobering admission”

FDA acknowledges COVID-19 vaccine linked to child deaths: “A significant and sobering admission”

A statement from the Food and Drug Administration’s top medical official has raised major concerns about the federal government’s vaccination policies during the COVID-19 pandemic — particularly those that affected American children.

During the pandemic, millions of Americans were told that receiving the newly authorized mRNA COVID-19 vaccines was the price of keeping their jobs, attending school, dining out, or visiting loved ones. Government leaders, major news outlets, and pharmaceutical companies repeatedly assured the public that the shots were “safe and effective,” and critics of the vaccines were frequently censored or dismissed.

However, months after the Department of Health and Human Services concluded that mRNA technology carried more risks than benefits for respiratory viruses, the FDA has now internally acknowledged that a number of children died as a result of receiving the vaccine.

Internal FDA analysis: At least 10 child deaths linked to vaccination

Dr. Vinay Prasad, the FDA’s chief medical officer and a director at the Center for Biologics Evaluation and Research, informed agency staff on Friday that analysts in the Office of Biostatistics and Pharmacovigilance identified a minimum of 10 deaths in children that they concluded occurred after — and because of — receiving a COVID-19 vaccine.

According to the email, reviewed by multiple news organizations and first highlighted by the Washington Post, FDA analysts reviewed 96 pediatric deaths from 2021 to 2024 and determined that at least 10 had a clear connection to vaccination. Prasad emphasized that these findings likely represent a conservative estimate, noting that ambiguous cases often result in vaccines being cleared of blame rather than implicated.

He added that underreporting and the difficulty of confirming causality mean the real number of vaccine-related deaths is “certainly higher.” Prasad called the newly recognized safety signal one with “far-reaching consequences for American families, the country’s pandemic strategy, and the FDA itself.”

Officials promoted shots for children despite minimal COVID risk

Throughout 2021 and 2022, federal health leaders such as Dr. Anthony Fauci and CDC Director Rochelle Walensky strongly encouraged childhood vaccination, even though healthy children faced extremely low rates of severe illness from COVID-19.

On Nov. 2, 2021, the Biden administration gave final approval for Pfizer’s vaccine for children ages 5–11, calling it a major milestone in defeating the virus. Vaccination for children under 5 began in June 2022, with President Biden insisting the shots were “safe, highly effective,” and offered parents reassurance.

Despite emerging evidence suggesting elevated myocarditis risk in boys and young men, Prasad wrote that federal officials failed to act quickly by adjusting vaccine schedules, modifying dosages, or skipping doses for those who already had COVID — mitigation strategies that could have reduced harm.

He noted that the FDA did not acknowledge the myocarditis safety signal until after expanding authorization to boys ages 12–15, a delay he said likely exposed more children to unnecessary risk.

“A profound revelation” for the agency

Prasad described the confirmation of child deaths from the vaccine as “a profound revelation.” He noted that the agency — which rescinded emergency-use authorization for COVID-19 vaccines earlier this year — is now officially acknowledging for the first time that the vaccines resulted in fatalities among American children.

“Healthy young children who faced almost no risk of dying from COVID were pressured — through school policies, workplace mandates, and government messaging — to take a vaccine that carried the potential for serious harm,” Prasad wrote. “In many instances, these mandates were damaging.”

Not everyone at the FDA welcomed Prasad’s candor. Peter Marks, who previously held Prasad’s position, told The New York Times that he believed the letter carried a “political tone” and that some of the case attributions may be debatable due to the complexity of medical circumstances.

FDA leadership signals shift in approach

FDA Commissioner Dr. Marty Makary addressed the issue during an appearance on Fox & Friends, saying the agency will no longer “rubber-stamp” approvals without solid data. He added that the past practice of green-lighting boosters for young, low-risk children amounted to “a mockery of science” during the Biden administration.