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3w ago

FDA Memo Alleges At Least 10 Child Deaths Linked to Covid Vaccines, Prompting Push for Stricter Rules

Experts question the unreviewed VAERS-based analysis that the FDA’s vaccine chief is using to justify tighter approval standards.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Mary Ngim (right) of San Jose holds her daughter Emerson Ng (center), 3, on her lap as Ng receives a COVID-19 vaccine in San Jose, in 2022. An internal memo at the FDA reportedly suggested that officials said, without evidence, that COVID vaccines are harmful to children.
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File photo: a nurse prepares a dose of a Covid-19 vaccine.

Overview

  • An internal memo by Dr. Vinay Prasad says FDA staff found “no fewer than 10” of 96 child deaths reported to VAERS from 2021–2024 were related to Covid vaccination, with myocarditis suggested as a cause.
  • The document provides no ages, timelines, medical histories, autopsy findings, or vaccine manufacturers, and the review has not been published or peer reviewed.
  • Vaccine experts, including Dr. Paul Offit and former FDA vaccine chief Dr. Peter Marks, argue the memo misuses VAERS data and call the move irresponsible without transparent, case-level evidence.
  • Prasad outlines broad changes to vaccine oversight, including larger randomized studies across subgroups, stricter criteria for use in pregnancy, a reappraisal of the annual flu-shot framework, and a re-evaluation of guidance on giving multiple vaccines at one visit.
  • The memo surfaces as HHS under Robert F. Kennedy Jr. has already narrowed Covid vaccine eligibility, and the CDC’s advisory committee is scheduled to meet next week to discuss the childhood schedule and hepatitis B timing.