The original headline reflected a real statement by an FDA official in November 2025, but the evidence requires more qualification than that statement suggests. A later, publicly released FDA review distinguishes probable and possible vaccine-related deaths from cases where causation could not be established.
What the November email said
In an email dated 28 November 2025, Vinay Prasad told FDA colleagues that an initial review linked at least 10 children’s deaths to COVID-19 vaccination. He referred to 96 reported deaths following vaccinations given during 2021–2024 and grouped different levels of causal attribution together. The original article attributed its coverage to Reuters.
What the subsequent review adds
The FDA’s December 2025 review, released publicly through Senator Ron Johnson’s office in May 2026, assessed 96 US paediatric death reports recorded by 14 August 2025. It classified two as probably related to vaccination and five as possibly related. None was classified as certain; 62 were considered unlikely to be related and 27 could not be assessed.
“Possible” allows an alternative explanation. “Probable” indicates a stronger assessment, while still leaving uncertainty. Therefore, these findings do not establish 10 confirmed vaccine-caused deaths. They also should not be described as proof that no child could have died because of vaccination.
The review treated five possible or probable deaths involving myocarditis as important new safety information about potentially fatal outcomes. Those concerns deserve transparent investigation and clear communication.
A recognised risk that should not be minimised
Myocarditis is inflammation of the heart muscle; pericarditis affects its surrounding lining. FDA labelling has warned about these conditions after mRNA COVID-19 vaccination since 2021.
A June 2025 warning update reported approximately 27 myocarditis or pericarditis cases per million doses among males aged 12–24 during days 1–7 after the 2023–2024 vaccine formulation. This was an unadjusted incidence estimate from insurance data, not a death rate or an estimate applicable to every formulation and age group. FDA also described persistent MRI abnormalities in some affected patients, with uncertain long-term significance.
How to use this information
Reports to VAERS are valuable warning signals, but a report alone does not establish cause. Missing information, reporting patterns and the lack of an appropriate comparison group limit what a raw count can tell us.
For a personal vaccination decision, discuss the relevant product, age, health history, previous reactions and current recommendations with a clinician. New persistent chest pain, shortness of breath or a racing heartbeat warrants prompt medical assessment, especially after vaccination. Severe symptoms require emergency care.
Original accompanying image retained for historical context:
References
- FDA: Vinay Prasad’s email of 28 November 2025.
- FDA: December 2025 review of paediatric death reports, publicly released May 2026 — Executive summary, pages 3–4; results, page 8.
- FDA: Updated myocarditis and pericarditis warning, 25 June 2025.
- VAERS: Data and interpretation limitations.
- WHO: Questions and answers on myocarditis and COVID-19 vaccines.
- FDA: Current COVID-19 vaccine information.
- Reuters: US FDA memo links 10 child deaths to COVID vaccines, 29 November 2025 — Original post named Reuters without a link; syndicated reporting retained here for attribution, with primary documents used for the updated assessment.
