FDA Releases Key Vaccine Documentation on Black Friday

FDA Vaccine Chief Claims Child Deaths from COVID-19 Shots, Experts Question Evidence

The head of the FDA’s vaccine division has sparked controversy with claims that “at least 10 children” died due to COVID-19 vaccination, using this assertion to justify significant regulatory changes. However, health experts are questioning the validity of these claims, citing insufficient information to verify them.

In a leaked email sent to staff on November 28, Dr. Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), wrote that career staff had found that “at least 10 children have died after and because of receiving COVID-19 vaccination.” Prasad described this as a “profound revelation,” stating it marked the first time the FDA would acknowledge that COVID-19 vaccines had killed American children.

The email provided no specific details about the cases, including ages, causes of death, or which vaccines were administered. While Prasad mentioned myocarditis – a known rare side effect of COVID-19 vaccines that causes heart inflammation – he did not explicitly link the reported deaths to this condition.

Health experts have expressed significant skepticism about the claims. Dr. Anna Durbin of Johns Hopkins Bloomberg School of Public Health called the memo “factually incorrect, misleading and disingenuous,” adding that Prasad “has not provided any evidence to support his conclusion that the vaccine caused the deaths yet asserts he knows the vaccine caused them.”

The FDA has promised to make a report publicly available by the end of December, but has not provided additional information when questioned by news outlets.

Prasad’s email indicated that the investigation began when Dr. Tracy Beth Høeg, then an FDA adviser and now acting director of the FDA’s drug evaluation center, started examining reports in the Vaccine Adverse Event Reporting System (VAERS). This system accepts unverified reports from anyone and is designed as an early warning system, not a definitive source for determining causality.

Dr. Kathryn Edwards, a retired Vanderbilt University vaccinologist who served on CDC and FDA vaccine advisory panels, noted it is “impossible to tell from the comments of Prasad any details of the cases and whether they have been comprehensively reviewed.” She added that while it’s “conceivable” some vaccine-related deaths occurred, “we have not seen the science to confirm this.”

Extensive research and safety monitoring in the U.S. and globally have consistently shown COVID-19 vaccines to be remarkably safe, including for children. While serious side effects can occur, they are exceedingly rare, and numerous studies have found no evidence that the vaccines increase overall mortality risk.

Using the alleged deaths as justification, Prasad outlined broad changes to FDA vaccine approval processes, including no longer accepting antibody data (immunobridging) as a proxy for efficacy when evaluating vaccines. He also called for revising the framework for approving seasonal influenza vaccines, which he termed “an evidence-based catastrophe.”

Twelve former FDA commissioners responded critically to Prasad’s proposals in a December 3 New England Journal of Medicine perspective. They argued his changes would “impede the ability to update vaccines,” “suppress innovation and competition,” and ultimately disadvantage Americans. The commissioners noted that previous death reports “had been carefully reviewed by FDA staff, who drew different conclusions.”

The context of these developments is significant. Prasad was installed as CBER director in May after his predecessor said Health and Human Services Secretary Robert F. Kennedy Jr. forced him to resign. Kennedy has long been critical of vaccines.

Meanwhile, CDC data shows that COVID-19 has killed approximately 2,000 children in the United States, with 90 confirmed deaths between July 2024 and July 2025 alone – a figure the agency considers an undercount. At one point, COVID-19 was the eighth leading cause of death in people 19 and younger and the leading cause of infectious disease deaths in this age group.

As the FDA prepares to release its official report, the medical and scientific communities continue to emphasize that the benefits of COVID-19 vaccination significantly outweigh the risks, even in younger populations.