4.BREAKING: FDA Launches Investigation Into COVID-Era
The Food and Drug Administration has launched a sweeping new investigation into whether COVID‑19 vaccines may be linked to deaths across multiple age groups, including adults and children, marking a dramatic shift in federal vaccine oversight.
This probe follows the circulation of an internal November memo from Dr. Vinay Prasad, the FDA’s lead vaccine regulator, that directly informed agency staff that about 10 children’s deaths were linked to COVID‑19 shots after initial analysis of reported fatalities.
According to a Department of Health and Human Services spokesman, Andrew Nixon, the investigation will be “thorough” and examine the safety of the COVID‑19 vaccines across all age groups—not just those under 18—reflecting growing concern about vaccine safety.
Prasad’s memo revealed that the FDA had examined roughly 96 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) and determined at least 10 could be related to COVID‑19 vaccination, a conclusion many observers say demands transparency and accountability.
The memo stated in blunt terms that “healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death,” laying blame on federal policy rather than parental choice.
The memo quoted CNN when characterizing the serious concern that vaccines were being administered to children who faced minimal risk from COVID‑19 itself, especially given what Prasad described as comparisons to typical respiratory viruses.
No details have been publicly released regarding the identities of the deceased, including which vaccine manufacturers were involved, the ages of the children, or whether preexisting conditions played a role, leaving crucial questions unanswered.
Prasad’s internal communication also revealed that as a direct result of these troubling findings, the FDA plans to overhaul its vaccine approval process, requiring significantly more evidence of safety and efficacy before new vaccines can be marketed to the public.
In a historic move earlier this fall, the Centers for Disease Control and Prevention updated its immunization schedule to remove the COVID‑19 vaccine as a recommended shot, shifting toward “individual‑based decision making” for adults and children alike.
This policy change was adopted to align with recommendations from the CDC’s Advisory Committee on Immunization Practices, and it reflects growing acknowledgement within federal public health agencies that the blanket COVID‑19 vaccine mandate approach may not be sustainable or appropriate.
In the wake of the memo, twelve former FDA commissioners published a response in the New England Journal of Medicine criticizing the agency’s new stance and warning that dramatic shifts in vaccine policy could “undermine the public interest.”
The former commissioners wrote that the FDA’s assertions about vaccine safety and planned regulatory changes “undermine the public interest” and jeopardize the established model designed to ensure safe and effective vaccines are available when needed.
Prasad’s memo did not stop with the pediatric cases. It also signaled that the FDA will take a closer look at adult deaths potentially linked to COVID‑19 vaccination, expanding the scope of the investigation beyond children.
In a separate report covered by UPI, Prasad stated that his team’s review of VAERS data from 2021 to 2024 found that at least ten child deaths were directly related to COVID‑19 vaccines, a conclusion that had never before been officially acknowledged by the FDA.
“This is a profound revelation,” Prasad wrote in the memo obtained by NBC News. “For the first time, the U.S. FDA will acknowledge COVID‑19 vaccines have killed American children.”
Prasad alleged that the FDA has ignored vaccine safety concerns for years and hinted that the actual number of vaccine‑related deaths could be higher than currently recognized, because not all events are reported or adequately analyzed.
One of the causes of death cited in the investigation was myocarditis, an inflammation of the heart that has been associated in rare cases with mRNA vaccines. Prasad indicated that myocarditis was the cause behind some of the fatalities under review.
Critics of Prasad’s memo immediately weighed in. Renowned pediatrician Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, dismissed the memo as “science by press release” and “dangerous,” arguing that it lacked the necessary rigorous evidence to support its claims.
Offit and other vaccine specialists argue that a memo circulated internally is not the same as peer‑reviewed science and say it is irresponsible to draw conclusions about causality without thorough research published in established scientific journals.
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Even so, the presence of this memo and the FDA’s decision to expand the probe are themselves historic developments that point to serious internal concern about vaccine safety monitoring, transparency, and public confidence.
Public health advocates and conservative voices alike are now calling for a full public briefing from the FDA, including transparent release of data, methods, and criteria used to establish the preliminary links outlined in Prasad’s memo.
