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4w ago

FDA Memo Says Covid Shots Were Linked to 10 Child Deaths as Agency Plans Tougher Vaccine Rules

The unpublished VAERS-based memo faces immediate pushback over evidence standards.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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Overview

  • In an internal email, vaccine division director Vinay Prasad wrote that “no fewer than 10” of 96 pediatric deaths reported to VAERS from 2021–2024 were related to Covid vaccination, with myocarditis suggested as a mechanism.
  • The memo, obtained by outlets including NBC News, did not include ages, medical histories, timelines or vaccine manufacturers and the findings have not been published in a peer‑reviewed journal.
  • Prasad proposed stricter oversight such as pre‑market randomized trials measuring clinical endpoints for most products, tighter criteria for vaccines in pregnancy, a review of the annual flu‑shot process and a re‑evaluation of giving multiple vaccines at the same visit.
  • Experts including Paul Offit and former FDA vaccine chief Peter Marks criticized using VAERS reports to assert causation and called the memo’s release irresponsible, while HHS did not immediately comment.
  • The memo surfaces ahead of a CDC vaccine advisory meeting next week on immunization policy, following HHS moves this year to limit Covid vaccination to people 65 and older and younger patients with certain conditions.