What official CDC and FDA investigations have concluded about deaths reported after childhood vaccination since 2020?

Checked on December 1, 2025
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Executive summary

Federal agency reviews since 2020 have generally found that reports of deaths after childhood vaccination are rare and mostly not causally linked to vaccines, though recent internal FDA analyses claim a small number of pediatric deaths may be attributable to COVID‑19 vaccines. Career FDA/CDC surveillance reviews and peer‑reviewed analyses emphasize no population‑level mortality signal, while a 2025 internal FDA memo asserts at least 10 child deaths were “after and because of” COVID‑19 vaccination based on a review of VAERS‑linked cases [1] [2].

1. What CDC and FDA say in public surveillance and early pandemic reports

Throughout the vaccine rollout, CDC and FDA monitoring reported reassuring safety profiles and treated death reports as rare events to be investigated: early FDA/CDC monitoring during the December 2020–January 2021 rollout concluded safety signals were limited and deaths reported in passive systems mostly reflected background mortality in elderly and frail populations rather than vaccine causation (MMWR/FDA described monitoring as “reassuring”) [1]. CDC and FDA jointly run VAERS and explicitly caution that reports to VAERS do not mean vaccines caused the event; the agencies have said the “vast majority” of deaths reported were not attributable to vaccination after review [3] [4].

2. Independent literature and reviews: no broad mortality signal found

Systematic reviews and epidemiologic work have not shown higher non‑COVID mortality among vaccine recipients; for example, evidence reviews and integrated health‑system analyses found no signal of sudden death linked to COVID‑19 vaccines and in some studies suggested lower mortality rates among vaccinated groups, while clinical trials did not indicate excess deaths in vaccine arms [5]. Independent analyses using VAERS or other passive data may spark hypotheses but cannot by themselves establish causality without medical records, autopsies and formal case reviews [6] [5].

3. The FDA internal memo and its claims: at least 10 pediatric deaths linked

In late 2025, an internal FDA memo authored by a senior official asserted that agency staff review of roughly 96 deaths between 2021–2024 “concludes that no fewer than 10” were related to COVID‑19 vaccination and referenced myocarditis as a suspected mechanism; the memo reportedly did not publish underlying data, ages, medical histories or manufacturers in its circulation [2] [7]. Multiple outlets reported the memo and that the FDA planned to present analyses to CDC advisers, but the findings were not peer‑reviewed and agency staff and outside experts urged transparency and full case documentation [2] [8].

4. How agencies and experts have pushed back or cautioned

Career scientists, outside experts and organizations have cautioned against over‑interpreting VAERS‑driven signals and criticized the lack of published clinical data underlying the memo’s conclusions; critics note VAERS is an unverified passive system and that definitive attribution requires review of death certificates, autopsies and medical records [9] [10]. Fact‑checking and agency statements have repeatedly emphasized that mandated reporting to VAERS inflates counts of deaths temporally associated with vaccination and that most such reports are not shown to be caused by vaccines [3] [4].

5. Conflicting narratives and political context matter

Reporting around these reviews occurred amid a politically charged restructuring of HHS and vaccine advisory bodies; several outlets document how leadership changes and public messaging shifts have created competing narratives about vaccine risks, with some officials calling for stricter vaccine approval standards and others warning that these moves mirror anti‑vaccine talking points [11] [12]. That context affects how internal analyses are framed, released and received by clinicians, public health bodies and the public [11] [12].

6. What the available sources do not settle and what remains to be produced

Available sources do not publish the full case‑level evidence (autopsies, medical records, timelines, manufacturer data) underlying the FDA memo’s claim that at least 10 child deaths were caused by COVID‑19 vaccines; several news reports note the memo lacked those details and the analysis has not appeared in peer‑reviewed literature [2] [7]. Formal, transparent case reviews—ideally published with methods and clinical documentation—are required before independent researchers can confirm or refute causation [10] [9].

7. Bottom line for readers

Public CDC/FDA monitoring and peer‑reviewed analyses to date have not found a broad signal that childhood vaccines increased mortality; recent internal FDA staff assertions claim a small number of COVID‑vaccine‑linked pediatric deaths but have not released case‑level evidence for external review. Readers should weigh agency surveillance statements and peer‑reviewed studies (no population‑level mortality signal) against recent internal claims that remain unpublished and contested in the sources summarized here [1] [2] [5].

Want to dive deeper?
What did CDC and FDA autopsy or medical reviews find in child deaths reported after vaccination since 2020?
How do CDC and FDA determine causality between vaccines and reported deaths in children?
What vaccines were most frequently associated with death reports in children to VAERS since 2020?
Have CDC or FDA updated vaccine recommendations or safety warnings for children based on death investigations since 2020?
Where can I find official CDC and FDA reports or datasets on post-vaccination deaths in children since 2020?