Controversy Erupts Over FDA Official’s Claims of COVID-19 Vaccine-Related Child Deaths

A recent memo from the FDA’s top vaccine regulator claiming that at least ten children died from COVID-19 vaccines has sparked intense scientific debate and criticism, revealing deep divisions in how vaccine safety data is interpreted and communicated to the public.

The controversy began when Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), asserted in a November 28 internal memo that his team had analyzed 96 reported deaths between 2021 and 2024, concluding that “no fewer than 10 are related” to COVID-19 vaccines. Prasad further claimed this represented “conservative coding” and that “the real number is higher.”

The memo was subsequently leaked to the press, drawing immediate scrutiny from the scientific community. Critics noted that Prasad, a known vaccine skeptic appointed during the Trump administration, provided no methodological details to support his conclusions.

Twelve former FDA commissioners responded with a sharply worded perspective in the New England Journal of Medicine, questioning the validity of Prasad’s analysis. They emphasized that the data source – the Vaccine Adverse Event Reporting System (VAERS) – collects unverified reports that cannot, on their own, establish causation.

“VAERS data have well-recognized challenges, including reporting bias and a lack of control groups,” the former commissioners wrote, adding that the system’s primary purpose is to flag potential safety signals that must then be evaluated through “carefully designed investigations.”

Perhaps most damning, a December 5 follow-up memo from FDA scientists reportedly contradicted Prasad’s claims. According to Harvard Medical School professor Jeremy Faust, who obtained information about this memo from agency insiders, FDA scientists actually determined that “the actual number of deaths linked to Covid-19 vaccines in the United States is somewhere between zero and seven.”

The December 5 report, which has not yet been made public, reportedly indicates that using the established World Health Organization framework, zero deaths were deemed “certain” to have been caused by COVID-19 vaccines, two were judged “probable/likely,” and five were considered “possible” – meaning the vaccine was, at most, equally likely to be responsible as other causes.

An HHS spokesperson confirmed to Faust that “the FDA’s investigation into deaths caused by Covid vaccines is still ongoing and there’s no final count yet of those deaths.”

The dispute highlights the critical importance of determining accurate risk-benefit ratios for vaccines. While myocarditis (heart inflammation) is a known rare side effect of mRNA vaccines, the death rate from this complication is extremely low in adults. By contrast, myocarditis resulting from COVID-19 infection itself carries a significantly higher mortality risk.

The claim that children face negligible COVID-19 risk, which Prasad asserted in his memo, has also been challenged. Hundreds of young children have died from COVID-19 during the pandemic, making accurate risk assessment crucial for public health decision-making.

This controversy comes on the heels of a landmark French study, the largest and longest of its kind, which found that COVID-19 vaccination was associated with a 25% lower overall mortality rate and a 74% lower death rate from severe COVID-19 among adults aged 18-59. The study, which followed 22.7 million vaccinated individuals versus 5.9 million unvaccinated controls for a median of 45 months, provides strong evidence for the vaccines’ safety in adults, though it did not include children.

Vaccine safety remains a contentious topic that often becomes entangled with political positioning. Alex Berenson, a former New York Times reporter and prominent vaccine skeptic, helped amplify Prasad’s claims through his Substack newsletter, demonstrating how scientific debates about vaccine safety frequently extend beyond medical journals into the public sphere, where they can be influenced by political leanings.

As this controversy unfolds, it underscores the necessity of rigorous scientific methodology in evaluating vaccine safety claims, particularly when they could influence public health decisions and perception. The scientific community continues to emphasize that valid evidence, not political or emotional considerations, must drive vaccine risk-benefit analyses.