The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said that “at least” 10 children have died “because of” COVID-19 shots, calling for changes to vaccine reviews and recommendations.
Prasad made these claims in an internal memo made public on Friday by the Washington Post. In it, the U.S.’s top vaccines regulator said the safety signals were reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS), the agency’s surveillance mechanism of toxicities potentially linked to vaccines.
VAERS is open to reports from “all concerned individuals,” according to the FDA’s own website for the system. This includes not just doctors, vaccine manufacturers and government bodies, but also any member of the public. Reports on the VAERS “generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness,” the FDA itself notes.
In his six-page memo, Prasad nevertheless said that the 10 deaths are “related to vaccination” and are “certainly an underestimate” of the safety concerns surrounding COVID-19 vaccines, without offering further evidence or data. The director attributed these mortalities to “vaccine-induced myocarditis,” or the inflammation of heart muscles.
“Young, healthy boys and men-- those least likely to experience bad covid outcomes-- bore the greatest risk,” Prasad insisted in his memo, adding that such risk reached as high as “~200-300 per million doses given in the highest risk demographic groups.”
“This is a profound revelation,” he wrote. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
As a result of these deaths, Prasad is looking to institute changes in the way his office reviews and regulates vaccines, moving the process “towards evidence based medicine” he wrote in his memo. Specifically, CBER will no longer approve vaccines for use in pregnant women “based on unproven surrogate endpoints.”
The agency will now also “demand” randomized trials for “most new products” before they hit the market.
These changes in framework will potentially extend beyond COVID-19 vaccination. “Pneumonia vaccine makers will have to show their products reduce pneumonia,” Prasad wrote, “and not merely generate antibody titers.” The annual flu vaccine will also be affected—Prasad called the nation’s influenza framework “an evidence-based catastrophe of low-quality evidence”—with the agency reviewing the shots’ safety, though he did not provide specifics.
Finally, Prasad addressed potential “objections” within his office regarding his new approach to regulating vaccines. The director insisted that he is “open to vigorous discussions and debate” regarding the safety of vaccines, however noting that staff who disagree with his “core principles”—such as keeping the debate private within the FDA—are free to resign.
