UPDATE: The FDA has just announced a significant shift in vaccine oversight, linking the deaths of at least 10 children to COVID-19 vaccines and proposing urgent regulatory measures. This shocking revelation comes from an internal memo obtained by The New York Times, raising serious concerns about vaccine safety and regulatory processes.
Dr. Vinay Prasad, head of the FDA’s vaccine division, detailed these findings in a memo sent to agency staff on October 15, 2025. The memo attributes these tragic incidents to myocarditis, a severe inflammation of the heart muscle, potentially connected to the vaccines. However, critical details remain unclear, including the ages of the children involved and the specific vaccines linked to these incidents.
The implications of this announcement are profound. Prasad stated, “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.” This statement contradicts the long-held belief among public health officials that vaccines are safe and necessary for preventing COVID-19, a virus that has claimed over 1 million lives in the United States alone.
The FDA’s proposed measures aim to tighten the oversight of vaccine trials, suggesting that future studies must include diverse populations, such as pregnant women. This initiative comes at a critical time, just days before a major meeting of the Centers for Disease Control and Prevention (CDC), where vaccine schedules and the safety of vaccines for newborns will be discussed.
Prasad’s memo could profoundly impact vaccine manufacturers, as new requirements may lead to increased costs and more extensive studies before vaccines can be deemed safe. Critics, including Michael Osterholm, an infectious disease expert, argue that the memo’s timing appears strategic, designed to sway discussions at the upcoming CDC meeting. “This is an irresponsible way to deal with a very critical public health issue,” Osterholm stated.
Moreover, public health experts warn that such high-profile announcements could further erode vaccine confidence amidst rising cases of preventable diseases like measles and whooping cough. Dr. Paul Offit, a prominent vaccine expert, emphasized the need for context, noting that the number of deaths from COVID among vaccinated children is significantly lower compared to unvaccinated peers.
The FDA’s announcement is part of a broader shift under the leadership of Health Secretary Robert F. Kennedy Jr., who has publicly expressed skepticism about vaccine safety and has been criticized for promoting policies that limit access to COVID-19 shots for certain age groups. His controversial stance continues to fuel the debate over vaccine safety in the United States.
As the situation develops, all eyes will be on the CDC’s vaccine committee meeting next week, where the implications of this memo and the future of vaccine policy in the U.S. will be at stake. What happens in the coming days could redefine public trust in vaccines and alter the landscape of immunization strategies nationwide.
Stay tuned for further updates as this developing story unfolds.
