How many vaccine-related deaths have CDC and FDA confirmed through 2024, and how were they classified?
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Executive summary
The FDA’s internal review of 96 child deaths reported to VAERS from 2021–2024 concluded “no fewer than 10” were related to COVID-19 vaccination, with agency staff characterizing those attributions as “likely/probable/possible” and noting myocarditis as a suspected mechanism in some cases [1] [2]. Multiple news outlets and the FDA memo itself say the analysis is preliminary, not peer‑reviewed, and omits detailed case data; public‑health experts and reporting outlets have expressed skepticism and called for fuller, transparent data and independent review [3] [4] [5].
1. What the FDA memo actually says — a narrow, internal finding
An internal FDA memo circulated by CBER director Vinay Prasad reported that an Office of Biostatistics and Pharmacovigilance review of 96 deaths reported to VAERS between 2021 and 2024 “concludes that no fewer than 10 are related” to COVID-19 vaccination, and described staff coding of those cases as “likely/probable/possible” attributions [1] [2]. The memo links several pediatric deaths to presumed heart inflammation (myocarditis) in its narrative, but it does not provide full case‑level detail or methods in the circulated excerpts [1] [6].
2. How the FDA classified those deaths — conservative attribution language
Reporting emphasizes that the FDA staff used graded terminology — likely, probable, possible — rather than a single definitive causation label; those phrases appear in the memo’s description of staff coding [1] [4]. Several outlets quote Prasad’s statement that the coding was “conservative” and that the “real number is higher,” language originating from the same internal memo rather than a published adjudication [4] [7].
3. The data source: VAERS and its limits
The cases the FDA analyzed were drawn from VAERS, a passive reporting system that accepts submissions from clinicians, families and the public; CDC and independent experts routinely caution that VAERS reports are not verified proof of causation and are designed for signal‑detection rather than definitive causal adjudication [8]. Multiple news outlets note experts’ skepticism because the agency has not published the detailed methods, autopsy findings, or peer‑reviewed case series that would allow independent assessment [3] [4].
4. Public‑health context: deaths averted vs. rare risks
Major outlets and CDC reports cited alongside the memo place the FDA finding within broader vaccine benefit data: analyses and CDC reporting show substantial reductions in COVID‑19 hospitalizations and deaths from vaccination, including studies finding vaccine effectiveness in children and estimates of many lives saved by COVID vaccines globally and domestically [9] [10]. Several commentators warn that focusing only on harms without contextualizing lives saved can mislead public understanding [10].
5. Expert reaction and demand for transparency
Scientists and vaccine experts widely called the memo’s claim “extraordinary” without accompanying, detailed evidence, urging publication of methods and case details or submission to peer review; former FDA officials and clinicians criticized both the sampling and the lack of transparent adjudication [3] [4] [5]. News organizations report the findings have not been published in a peer‑reviewed medical journal and that CDC and FDA prior reviews reached different conclusions on reported deaths [4] [1].
6. What we do and do not know from available reporting
Available sources consistently state the FDA’s internal analysis tied at least 10 pediatric deaths to vaccination among 96 VAERS reports, using conservative attribution language, but they also agree the review is preliminary, lacks peer‑reviewed detail, and has prompted calls for wider, independent analysis [1] [2] [3]. Available sources do not mention comprehensive case‑level data, the full criteria used for causal assignment, or a completed public report that reconciles these findings with prior CDC/FDA reviews [4] [11].
7. Stakes and possible agendas to watch
The memo immediately precipitated regulatory proposals to tighten vaccine approval standards; critics warn those policy changes could reflect the personal and political views of senior officials as much as new science, while proponents frame them as necessary safety reforms [4] [1]. Readers should note outlets cite both the memo’s claims and substantial expert skepticism; divergent interpretations partly reflect differing priorities — rapid transparency and caution about vaccine harms versus preserving well‑established pathways that enabled timely vaccine access and demonstrated population benefits [4] [10].
Limitations: this account uses only the provided reporting. It does not assess case files or unpublished FDA documents; available sources do not include the memo’s full dataset or peer‑reviewed analyses that would permit independent verification [2] [4].