FDA’s Vinay Prasad Links 10 Child Deaths to COVID-19 Vaccines, Calls for Stricter Review Guidelines

Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, sent a memo stating that COVID-19 vaccines caused at least 10 deaths among children and called for stricter vaccine regulatory measures.12

The memo ties some deaths to myocarditis, an inflammation of the heart muscle, which is a recognized but rare risk associated with Pfizer and Moderna COVID-19 vaccines.2

FDA's analysis reviewed 96 deaths reported in VAERS between 2021 and 2024, conservatively attributing at least 10 deaths to COVID-19 vaccines; the actual number may be higher according to Prasad.1

The memo has been met with skepticism by outside experts who criticize the lack of detailed data and peer-reviewed publication backing these claims.12

Prasad also advocates for reassessment of vaccine mandates and the vaccine schedule, including concerns about co-administration of multiple vaccines in children.1

There is disagreement and concern from experts regarding the public health implications and scientific rigor of Prasad’s claims, with calls for independent review by bodies such as the National Academies of Sciences.1

The FDA memo notes prior research showing myocarditis risks in adolescents but understates COVID-19 risks to children, who still face a notable mortality burden from the virus.1

No specific details on ages, preexisting conditions, or methodology for linking deaths to vaccines were disclosed in the memo or subsequently.2

Sources:

1. https://www.statnews.com/2025/11/29/covid-vaccine-deaths-fda-memo-vinay-prasad/

2. https://www.cbsnews.com/news/food-drug-administration-covid-19-vaccines-pediatric-deaths/