Fact Check: FDA Memo Claims COVID Vaccines Killed 10 Children

The Black Friday Memo

On November 28, 2025, Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), sent a 3,000-word memo to staff that was subsequently leaked to the press. The memo claimed that analysis of 96 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 determined that 'no fewer than 10' were 'related' to COVID-19 vaccination. Prasad also suggested the 'real number is higher.' The memo did not include patient ages, medical histories, vaccine manufacturers, timelines, or any methodology for how causation was determined—information scientists say is essential for peer review.

Why VAERS Cannot Prove Causation

COVID-19 Impact on Children (2020-2024)

The Vaccine Adverse Event Reporting System is a passive surveillance system co-managed by the CDC and FDA. Anyone—doctors, patients, family members—can submit a report. The system's own guidance explicitly states: 'For any reported event, no cause-and-effect relationship has been established.' A VAERS report confirms only that an adverse event occurred sometime after vaccination, not that the vaccine caused it. The system is designed to detect potential safety signals that warrant further investigation through more rigorous systems like the Vaccine Safety Datalink (VSD). Using VAERS data alone to claim causation is what experts have called 'the zombie practice that keeps coming back.'

Expert Pushback

The memo drew immediate criticism from vaccine safety experts across the scientific community. Dr. Anna Durbin, a vaccine researcher, called the memo 'factually incorrect, misleading and disingenuous,' noting that Prasad 'has not provided any evidence' while claiming certainty about causation. Dr. Kathryn Edwards emphasized that 'it is impossible to tell' whether cases have been 'comprehensively reviewed and other causes excluded.' Dr. Paul Offit of the University of Pennsylvania questioned why Prasad is asking people to trust assertions about serious matters without data transparency. Dr. Amesh Adalja of Johns Hopkins warned the statement would 'increase anti-vaccine sentiment and further politicize an issue.'

The Policy Implications

Beyond the death claims, the memo proposes sweeping changes to FDA vaccine approval processes. Prasad calls for eliminating the use of antibody data as a proxy for efficacy, requiring manufacturers to demonstrate actual disease reduction for new vaccines. He questions the practice of simultaneous vaccination with multiple shots. Former FDA commissioners warned these changes would 'slow' vaccine updates, 'increase prices,' and 'delay arrival of better-matched vaccines.' The memo was reportedly written with the expectation it would be leaked, according to experts who spoke with STAT News.

Context: Pediatric COVID Deaths vs. Vaccine Safety

To put the claimed 10 deaths in context: CDC data shows over 1,300 children aged 0-19 have died from COVID-19 itself (as the underlying cause) through 2024. A peer-reviewed American Academy of Pediatrics study found COVID-19 killed an estimated 1,086 children ages 1-17 between 2020-2022, making it the seventh leading cause of death in that age group. Meanwhile, comprehensive safety monitoring through systems like the Vaccine Safety Datalink—which can actually assess causation—has consistently shown COVID vaccines are remarkably safe for children. Studies of millions of vaccinated people have identified only rare vaccine-related myocarditis cases, with the vast majority fully recovering.

What Would Proper Evidence Look Like?

For such extraordinary claims to be credible, scientists would expect: (1) Individual case reports with patient ages, medical histories, and underlying conditions; (2) Clear methodology for how causation was determined versus correlation; (3) Identification of vaccine types and manufacturers involved; (4) Timeline data showing proximity of deaths to vaccination; (5) Peer review and publication in a scientific journal; (6) Comparison to background mortality rates in unvaccinated populations. None of this was provided. Without it, the scientific community cannot independently verify or replicate the claimed findings—a fundamental requirement of evidence-based medicine.