
A top Food and Drug Administration (FDA) official called for introspection, humility and transformation at the agency in an email obtained by the Daily Caller News Foundation (DCNF) following a report by career staff that the deaths of ten children may be attributed to the COVID-19 vaccine.
“At least 10 children have died after and because of receiving COVID-19 vaccination,” FDA Chief Medical Officer and Center for Biologics Evaluation and Research Director Vinay Prasad said in an email sent to staff Friday afternoon.
“For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad said. “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. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.”
The finding — and the fact it would not have been uncovered without President Donald Trump’s appointee, FDA Commissioner Marty Makary, at the helm — provokes important questions about the direction and culture of the agency, wrote Prasad, Makary’s handpicked deputy.
“Why did it take until 2025 to perform this analysis, and take necessary further actions? Deaths were reported between 2021 and 2024, and ignored for years,” he wrote.
The report on suspected COVID vaccine deaths in children has not been released. An HHS spokesperson did not immediately respond to a DCNF request for comment.
Earlier this year Prasad assigned career staff at the FDA Office of Biostatistics and Pharmacovigilance (OBPV) to assess reports to the Vaccine Adverse Event Reporting System (VAERS), a surveillance program tracing vaccine side effects, according to the email. Prior to joining the FDA, Makary and Prasad tracked reports of vaccine-induced myocarditis — inflammation of the heart muscle — which occurs most frequently in young, healthy boys and men.
FDA officials assessed whether the COVID vaccine caused the deaths reported in VAERS against a subjective scale ranging from certain to unlikely, Prasad wrote. The ten detected deaths had “likely, probable or possible” attribution. Only highly motivated physicians complete the tedious process to submit VAERS reports, thus the figure is likely an underestimate, Prasad said. The COVID-19 vaccine manufacturers were due to conduct more safety studies, but FDA has not enforced its own requirements.
“I suspect the answer is cultural and systemic,” he continued. “I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product. The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm. The same is true for vaccines.”
Prasad said the FDA should not lower its standards with the goal of further incentivizing the growth of the $30 billion vaccine market, pointing to the enormous profits of the COVID-19 vaccines and the fact that vaccines do not face generic competition.
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