Concerns Raised Over COVID-19 Vaccine Safety for Children
Recent statements from FDA Chief Medical Officer Vinay Prasad have brought to light troubling data regarding COVID-19 vaccinations and their potential risks for children. According to Prasad, at least 10 children have died following their vaccinations.
“At least 10 children have died after and because of receiving COVID-19 vaccination,” Prasad stated in an internal email to FDA staff on Friday afternoon.
He further asserted, “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.” Prasad expressed concerns that many healthy children, facing minimal risk of severe illness from COVID-19, were pressured into getting vaccinated through mandates imposed by the Biden administration. “It is painful to see cases where kids aged 7 to 16 may have died as a result of these vaccines,” he said.
Prasad, who also directs the Center for Biologics Evaluation and Research, was appointed to his position by then-FDA Commissioner Marty Makary, who was chosen by Donald Trump.
He cautioned that the deaths he referenced might actually be an understatement due to underreporting. He believes that studies on COVID vaccinations often overlook the specifics concerning younger populations.
Prasad highlighted, “reports of vaccine-induced myocarditis” appear to predominantly affect young, healthy boys and men, a group that generally faces low risks from the virus itself.
Makary added in comments to a media outlet, “There were, it seems, 10 deaths of children from the COVID shots… This data was accumulated during the Biden administration, and we will make it available that those cases were reviewed.”
“Why did it take until 2025 to perform this analysis and take necessary actions?” Prasad questioned. “Deaths were reported between 2021 and 2024, and ignored for years.”
Prasad suggested that systemic and cultural reasons may have contributed to the failure to adequately address these tragic outcomes, pointing out contrasting approaches between current and past administrations regarding health protocols.
“The U.S. government’s coercive vaccine mandates for young people may have had negative effects,” he asserted. “In contrast, older, unvaccinated Americans benefited from early doses in 2020.”
He noted that those most likely to benefit from vaccination were often not subject to workplace mandates, which he deemed another mistake by the Biden administration.
Additionally, Prasad referenced conflicts that led to resignations among former FDA officials. The former heads of the Office of Vaccines Research and Review, Dr. Marion Gruber and Dr. Philip Krause, left due to disagreements with the previous CBER Director, Peter Marks, who advocated for mandatory annual boosters, regardless of age or risk.
Marks later submitted a Biologics License Application that Prasad criticized as enabling “unethical COVID-19 mandates.” Marks resigned in March, blaming misinformation about vaccines that he associates with Robert F. Kennedy Jr., who served under Trump.
“I support approving products that have benefits outweighing risks,” Prasad emphasized, opposing the push for products driven by financial motives.
While Prasad’s five-page message contained serious allegations and grim statistics, he hopes it acts as a wake-up call for the agency, promoting a sense of “humility and introspection” as they move forward. He also issued a warning to staff members who might jeopardize the integrity of vaccine reviews.
“Never again will the U.S. FDA commissioner have to find deaths in children for staff to recognize them,” he asserted. “Some staff may not agree with these core principles. Please submit your resignation letters to your supervisor.”
