FDA Official Calls for Change After COVID-19 Vaccine Deaths Report
A senior official at the Food and Drug Administration (FDA) has urged a reevaluation of the agency’s approach in light of a report suggesting that up to ten children might have died due to the COVID-19 vaccine, according to an email obtained by a news outlet.
Vinay Prasad, the FDA’s Chief Medical Officer, indicated in his email that, “At least ten children have died from receiving the COVID-19 vaccination.” This email was shared with FDA staff on Friday afternoon.
“For the first time, the US FDA will admit that COVID-19 vaccines have resulted in the deaths of American children,” he stated. Prasad emphasized that healthy children, who were at minimal risk of dying from COVID-19, were pressured by mandates from the Biden administration to take a vaccine that could potentially lead to death. “It is troubling to see cases where kids aged 7 to 16 may have lost their lives due to these vaccines,” he added.
Prasad pointed out that this alarming finding—and its revelation thanks to the leadership of FDA Commissioner Marty Makary—raises significant questions about the agency’s culture and direction.
He questioned, “Why did it take until 2025 to conduct this critical analysis and take necessary steps? Reports of deaths surfaced between 2021 and 2024 yet went largely ignored for years.”
The report linking COVID vaccine deaths in children has not yet been officially released, and a spokesperson from the Department of Health and Human Services (HHS) did not respond to a request for comment.
Prasad described the report as an essential wake-up call and called for a pivotal shift in the mission of his center, though he acknowledged this may meet considerable resistance from the pharmaceutical industry and some of the agency’s long-time reviewers.
“Never again will the US FDA commissioner have to discover deaths in children for staff to take notice,” he wrote, adding a direct challenge to those who disagree. “If you don’t align with these core principles, feel free to submit your resignation.”
This year, Prasad directed the FDA’s Office of Biostatistics and Pharmacovigilance (OBPV) to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS), which monitors vaccine side effects. Before the FDA, both Prasad and Makary had been tracking reports of myocarditis linked to vaccines, which mainly affects young boys and men.
In his assessment, Prasad reported that the ten deaths had a “likely, probable or possible” connection to the vaccine, noting that the number may actually be an underestimate since only highly motivated physicians typically complete the VAERS reporting process. He mentioned that while vaccine manufacturers should conduct more safety studies, the FDA has not enforced these requirements adequately.
Prasad expressed concern about the FDA’s lack of reliable data that would allow it to determine whether more healthy children were harmed than helped by the COVID-19 vaccine. He said, “We simply don’t know if we saved lives on balance.” He highlighted the disturbing possibility that the agency’s regulatory actions might have harmed more children than they saved, calling for humility and self-reflection.
He acknowledged that many vaccines have undoubtedly saved millions globally, but cautioned that like any medical product, vaccines can also cause harm if not administered properly. “I believe in approving products that have benefits outweighing their risks,” he stated.
Looking ahead, Prasad indicated that future changes will focus on vaccine approvals for pregnant women, necessitating more clinical trials instead of relying on lab studies, and re-evaluating the annual flu vaccine rollout.
His email also revealed a strong critique of his predecessor, Peter Marks, who had advocated for granting early approval of COVID boosters for younger populations and full authorization of the COVID vaccines, contributing to the issuance of mandates from the Biden administration. This approach resulted in the resignation of two top vaccine reviewers, Marion Gruber and Philip Krause, who described feeling pressure to compromise standards.
Prasad’s proactive changes aim to restore public trust in the FDA, which, according to recent polls, remains low. A mere 37% of Americans expressed confidence in the FDA’s independence, and just 27% rated its work positively.
His path forward, however, isn’t without challenges, as he faces pushback from both agency staff and biotech investors wary of more stringent regulations.
Prasad’s time at the FDA has seen interruptions, including his brief firing amid media scrutiny. Despite initial setbacks, he was reinstated after advocacy from key figures within the government.
While the FDA has not withdrawn a certain gene therapy from the market, the drug now carries serious warnings about its use.
Additionally, Prasad has contended with leaks impacting his initiatives. An investigation into VAERS reports by one of his senior advisors revealed the deaths connected to the COVID vaccine were indeed legitimate; however, subsequent details were leaked, leading to misunderstandings about the intentions behind the investigation.
“While those who leak information may believe they are acting rightly, it is both unethical and illegal,” he commented, expressing frustration over the breach of trust.
