An intriguing memo from the Food and Drug Administration (FDA) Chief Medical and Scientific Officer Vinay Prasad was recently sent to various media outlets.
Dr Prasad also serves as the Director of the Center for Biologics Evaluation and Research (CBER). In the memo, Prasad asserts that an internal review conducted by FDA staff members concluded that at least 10 children died “after and because of receiving” a Covid‑19 vaccine.
The 3,000-word memo, obtained by NBC News, was written by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research. In it, Prasad claims that agency staff determined that “no fewer than 10” of 96 child deaths reported to the Vaccine Adverse Event Reporting System, or VAERS, between 2021 and 2024 were “related” to Covid vaccination. He said the true numbers could be higher, accusing the agency of ignoring the safety concerns for years.The memo, sent Friday, did not include the children’s ages or medical histories, timelines or documentation for the deaths he references and does not identify the manufacturer of the vaccine. The FDA’s findings have not been published in a peer-reviewed journal.
While a direct link to the memo was not available via the media outlets at the time of the report, a copy appears to be available via X.com. The report is intended for members of the Center for Biologics Evaluation and Research (CBER). The full memo can also be found on the Brownstone Institute website.
Prasad states that the Office of Biostatistics and Pharmacovigilance (OBPV) career staff reviewed 96 VAERS reports of child deaths after COVID-19 vaccination (2021–2024) and concluded that “no fewer than 10” deaths were related to vaccination, with underreporting and conservative coding likely making the actual number higher. He notes that this will be the first time the FDA acknowledges that these vaccines killed American children and describes the finding as a profound revelation demanding introspection and reform.
The memo added: “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”It also reads: “It is horrifying to consider that the U.S. vaccine regulation, including our actions, may have harmed more children than we saved,” although it does state that the agency “does not have reliable data estimating the absolute benefit” regarding vaccine receipt.
I have often noted the troubling reports about post-vaccination myocarditis, especially in young men. In this analysis, Prasad disputes the claim that COVID-19 infection causes more myocarditis than vaccines, arguing existing studies are biased toward sicker patients, ignore age balance (e.g., young adults getting many doses), and use flawed denominators. He says no analysis has correctly compared myocarditis after infection versus vaccination in the key young-age cohorts and that the FDA has not adequately enforced post‑marketing safety commitments, including systematic myocarditis surveillance.
Prasad’s assessment on this subject is damning.
A perennial argument is that COVID 19, the virus, causes more myocarditis than COVID-19 vaccines. In fact, I heard this argument made inside CBER recently when one company submitted their PMC. Here is why that argument is wrong.In order to study how often people have myocarditis after the virus, you would want to collect everyone who got covid, and see how many get myocarditis. Yet, studies on this topic don’t do this. They take people who presented to health care systems and had covid-19 and ask how many have myocarditis. But we all know most people who get covid simply recover at home. People who seek medical care are the sickest ones. These studies use a false denominator.Second, the demographic matters. I have no doubt COVID vaccines were life saving for an 80 year old who never had COVID, but should a 20 year old get his 6th dose this fall? These studies often fail to look at the balance in younger people.
Of course, the elite media is quick to trot out their preferred “experts” to dispute the memo.
His predecessor, Dr. Peter Marks, who led the F.D.A. division during the pandemic, said he was taken aback by the “clearly political tone of the communication.” He agreed that the case reports of childhood deaths needed to be opened to further scrutiny to determine whether they were caused by the vaccines.“I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex,” Dr. Marks said after reading the memo.
In a nutshell, Prasad argues that existing data on COVID-19 vaccination in children are too limited and methodologically biased (especially observational studies and myocarditis analyses) to reliably quantify benefits, compare risks with infection, or determine whether the vaccination program saved more children than it harmed. He also contends that VAERS underreporting, subjective causality judgments, and poor enforcement of post‑marketing studies mean current official conclusions understate vaccine‑related harms and overstate certainty about safety.
His memo is not the ranting of an “anti-vaxxer”, but a sound review by someone well credentialed to make a judgment on the information available. No wonder the elite media is making it challenging to find.
In the wake of the memo, the FDA is set to impose stricter guidelines.
The guidelines, obtained by The New York Times, could also impact vaccinations for other illnesses and viruses, including the FDA’s standards for annual flu shots and if Americans should receive multiple vaccines at a time. The memo also states that shots for pregnant women could be limited, and manufacturers will be required to conduct larger studies before seeking approval for vaccines.
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