Vinay Prasad, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), has linked at least 10 child deaths to COVID-19 vaccines, according to an internal memo released by the Washington Post on Friday. Prasad stated that these fatalities were reported through the Vaccine Adverse Event Reporting System (VAERS), which collects information on possible vaccine-related side effects from a wide range of sources including healthcare professionals and members of the public.
The FDA notes that VAERS reports alone cannot determine if a vaccine caused or contributed to an adverse event or illness. Despite this, Prasad asserted in his six-page memo that the deaths are “related to vaccination” and likely represent an undercount of safety concerns associated with COVID-19 vaccines. He attributed these deaths to “vaccine-induced myocarditis,” referring to inflammation of heart muscles.
“Young, healthy boys and men-- those least likely to experience bad covid outcomes-- bore the greatest risk,” Prasad wrote in his memo. He estimated that this risk could be as high as “~200-300 per million doses given in the highest risk demographic groups.”
“This is a profound revelation,” he continued. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
In response, Prasad announced plans for changes in how CBER reviews and regulates vaccines, aiming for what he described as a shift “towards evidence based medicine.” He specified that CBER would stop approving vaccines for use in pregnant women based solely on unproven surrogate endpoints.
Prasad also said randomized trials would be required for most new products before they reach market approval. These proposed regulatory changes may extend beyond COVID-19 vaccines; Prasad indicated pneumonia vaccine makers would need to demonstrate their products reduce actual cases of pneumonia rather than just producing antibody responses. He further criticized current practices around annual flu shots, calling them “an evidence-based catastrophe of low-quality evidence,” and said the agency would review flu vaccine safety more closely without providing details.
Addressing potential internal disagreement over his approach, Prasad wrote: “I am open to vigorous discussions and debate” about vaccine safety but added that staff who do not agree with his core principles—such as keeping debates within FDA channels—are free to resign.
