12/03/2025
A senior FDA official, Dr. Vinay Prasad, has stated in an internal memo that COVID-19 vaccines are linked to the deaths of at least 10 children, calling it a "profound revelation" and asserting that the U.S. FDA will "acknowledge that COVID-19 vaccines have killed American children" for the first time.
The memo, dated November 28, 2025, attributes the deaths to vaccine-induced myocarditis and calls for significantly stricter review standards for all vaccines, including requirements for randomized trials and proof of clinical benefit beyond antibody production.
The claims are based on an initial review of 96 deaths reported to the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system that collects reports from the public and healthcare providers but cannot establish causation.
Prasad stated that the 10 deaths are "related to vaccination" and are "certainly an underestimate" of the safety concerns, though he did not provide detailed medical data on the children, such as ages or medical histories.
The proposed changes include ending approvals for vaccines in pregnant women based on surrogate endpoints, requiring larger and longer-term trials for new vaccines, and re-evaluating the annual flu vaccine framework.
The memo has sparked significant controversy, with public health experts criticizing it as lacking context and potentially damaging public trust in vaccines during a time of rising infectious disease outbreaks.
The memo was shared with agency staff and later obtained by media outlets, but it has not been publicly released or reviewed by independent scientists.
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Any policy changes would require federal review and approval.