FDA vaccine chief signals major overhaul after internal memo on child deaths

US Food and Drug Administration staff are bracing for a sweeping shift in vaccine oversight after Vinay Prasad, head of the agency’s Center for Biologics Evaluation and Research (CBER), said the agency will regulate vaccines in the same way it regulates other drug classes.

The internal note, prompted by an analysis he says ties at least ten child deaths to COVID-19 shots, marks the most dramatic intervention by a senior official since Robert Kennedy Jr became Health and Human Services Secretary (HHS) in January.

In the memo, Dr Prasad claimed that “no fewer than 10” deaths among 96 reports submitted to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 were related to vaccination, while arguing the true total could be higher. He offered no clinical details, timelines or manufacturer information, and the findings have not been peer-reviewed.