A Food and Drug Administration official proposed new vaccine measures after linking the deaths of at least 10 children to the COVID-19 vaccine, according to an internal memo dated Friday and published by The Washington Post.
“These deaths are related to vaccination (likely/probable/possible attribution made by staff),” wrote Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research. “That number is certainly an underestimate due to underreporting, and inherent bias in attribution.”
Prasad told staff that FDA senior advisor (and COVID-19 vaccine critic) Tracy Beth Høeg began an investigation over the summer into deaths of children that were reported to the federal Vaccine Adverse Event Reporting System (VAERS). The Centers for Disease Control notes on the VAERS website that “anyone” can submit a report to the system’s database, so it ”may contain information that is incomplete, inaccurate, coincidental, or unverifiable.”
Prasad said he directed FDA staff to analyze 96 deaths reported between 2021 and 2024, and that the analysis found “no fewer” than 10 were related to the COVID-19 vaccine.
Prasad called the findings “a profound revelation,” noting that “for the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
“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. In many cases, such mandates were harmful,” Prasad said in the memo.
“I want to outline a path forward,” he wrote, saying he plans to “direct
vaccine regulation towards evidence based medicine.”
His plan includes examining whether Americans should be receiving multiple vaccines at the same time and revising the “annual flu vaccine framework,” which he described as “an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.”
Prasad also said the agency will have more stringent requirements for authorizing vaccines for pregnant women.
Pneumonia vaccine makers will also have to show that their products reduce pneumonia rather than generate antibodies, according to the memo.
The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a request for comment from JS.
In the memo, Prasad also criticized staff who may leak information to the media.
“I have no doubt that individuals who are providing media outlets with slides, emails and personal anecdotes believe they are doing the right thing,” he wrote. “Unfortunately, this behavior is both unethical, illegal, and, as this case illustrates, factually incorrect.”
Dr. Paul Offit, a pediatrician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told NPR that Prasad had not provided any evidence that COVID-19 vaccines had actually killed 10 children, and that “all this will do is scare people unnecessarily.”
“At the very least, he should provide all the evidence he has so that experts in the field can review it and decide whether he has enough data to prove his point,” Offit said.
