"Shocking FDA Memo Claims COVID-19 Vaccine Linked to Child Deaths: Experts Demand Clarity and Evidence"
FDA Vaccine Regulator Claims COVID-19 Vaccine Linked to Child Deaths, Sparks Controversy
In a startling email sent to staff on Friday, Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), asserted that the COVID-19 vaccine has been linked to at least ten deaths in children. This claim has raised significant concerns among experts, who are questioning the lack of detailed data supporting such an extraordinary assertion.
Prasad’s memo, which has since been circulated by various news organizations, marks a pivotal moment in vaccine regulation. He stated, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.” The email suggests that as a result of these deaths, the FDA will heighten regulatory requirements for new vaccines, particularly those administered to children.
Regulatory Changes on the Horizon
Prasad emphasized the need for reform, stating that the agency would require more definitive data for vaccines administered during pregnancy and may reconsider the practice of administering multiple vaccines simultaneously. This could potentially disrupt the established childhood vaccination schedule, a concern echoed by public health experts.
Jeffrey Morris, a professor at the University of Pennsylvania, expressed apprehension regarding the implications of Prasad’s comments. He warned that any changes to vaccine administration protocols should be based on solid evidence rather than speculation.
Skepticism from Experts
Despite the gravity of Prasad’s claims, many experts are skeptical. They argue that the memo lacks the necessary data to substantiate such serious allegations. Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, criticized the memo as “irresponsible science” and called for an independent review by the National Academies of Sciences, Engineering, and Medicine.
Several CBER staff members, speaking anonymously, expressed concern over what they described as a “misleading” and “politically charged” email. They fear that the memo could lead to unwarranted changes in vaccine policy without adequate scientific backing.
The Role of VAERS
Prasad mentioned that he had asked the FDA’s Office of Biostatistics and Pharmacovigilance to investigate 96 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024. He claimed that “no fewer than 10 are related” to COVID-19 vaccinations, although experts caution that VAERS data can be unreliable and should not be used to draw definitive conclusions.
Kathryn Edwards, a veteran vaccine researcher, highlighted the need for transparency regarding the data sources and methodologies used to attribute these deaths to the vaccine. She pointed out that critical information, such as the specific vaccines involved and the circumstances surrounding the deaths, remains unclear.
The Broader Context of COVID-19 and Vaccination
While Prasad noted that children face a “tremendously low risk of death” from COVID-19, data indicates that the virus has still resulted in significant fatalities among this age group. A 2023 study published in JAMA reported that 821 individuals aged 19 and under died from COVID-19 in the year ending July 2022, making it the eighth leading cause of death in that demographic.
Experts have long debated the risk-benefit profile of COVID-19 vaccinations for children, particularly concerning myocarditis—a rare but serious side effect associated with mRNA vaccines. The FDA has previously stated that the incidence of myocarditis is approximately 27 cases per million doses among males aged 12 to 24.
Future Implications
As the FDA prepares for upcoming meetings, including discussions by the Advisory Committee on Immunization Practices (ACIP), the implications of Prasad’s memo could reverberate through public health policy. Experts are calling for a more rigorous examination of the data and a transparent dialogue about vaccine safety and efficacy.
Prasad’s email concludes with a call for internal discussions on vaccine policy, emphasizing that such debates should remain private until they are ready for public disclosure. This stance has raised further questions about the agency’s commitment to transparency and scientific integrity.
As the situation develops, the FDA’s next steps will be closely monitored by health professionals, policymakers, and the public alike. The ongoing discourse surrounding vaccine safety, particularly for children, remains a critical issue in the wake of the COVID-19 pandemic.