FDA acknowledges for first time that COVID vaccines caused at least 10 infant deaths, internal memo says
The document signed by Dr. Vinay Prasad, current director of FDA's Center for Biologics Evaluation and Research (CBER), represents the first time the agency has officially acknowledged that COVID vaccines caused deaths in minors.
COVID-19 vaccine vials (Archive) (Photo by BAY ISMOYO / AFP)
An internal memo from the U.S. Food and Drug Administration (FDA) obtained by NBC News, states that at least 10 children died "after and because of receiving” vaccination against the COVID-19 between 2021 and 2024.
The 3,000-plus-word document, signed by Dr. Vinay Prasad-current director of the FDA's Center for Biologics Evaluation and Research (CBER), represents the first time the agency has officially acknowledged that COVID vaccines caused deaths in minors.
According to the text, of the 96 pediatric deaths reported to the VAERS (Vaccine Adverse Event Reporting System) system in that period, FDA staff determined that "no fewer than 10" were causally related to vaccination. Prasad warns that the actual number could be higher and accuses the agency of ignoring safety signals for years.
The memo does not include specifics: exact ages, medical histories, dates, manufacturers involved or documentation to support each case. Nor have the findings been published in peer-reviewed scientific journals.
Strong rejection by experts
Several specialists consulted by NBC News called the memo "irresponsible" and "dangerous.” The main argument is the misuse of the VAERS system, a passive, voluntary database that accepts reports from anyone and, by design, does not verify causality.
"This is sort of science by press release," stated Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia.
For his part, Dr. Peter Marks, former director of the FDA's office of vaccines (ousted this year by Health Secretary Robert F. Kennedy Jr.), claimed the agency is reexamining old reports and reclassifying them now as vaccine-related, something he considers "tergiversation."
Radical changes proposed
In addition to child deaths, Prasad's memo includes a tone critical of past FDA and CDC decisions. He calls the vaccination mandates "coercive,” slams previous agency statements as "dishonest" and goes so far as to suggest that the COVID vaccine regulation "may have harmed more children than we saved."
The measures it announces are
- Complete review of the annual flu vaccine approval process, which it calls a “evidence-based catastrophe of low quality evidence.”
- Requirement of pneumococcal vaccine manufacturers to demonstrate actual reduction in pneumonia (not just antibody titers) in post-marketing studies.
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