How many VAERS death reports after COVID-19 vaccines were confirmed as causally linked by CDC or FDA as of 2024?
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Executive summary
Available reporting shows an internal FDA review of 96 pediatric death reports to VAERS from 2021–2024 concluded at least 10 of those reports met criteria for “likely, probable, or possible” causal links to COVID-19 vaccination [1] [2]. Major outlets and follow-ups note experts’ skepticism, emphasize VAERS is a passive signal system, and report that CDC/FDA had not previously publicly confirmed a specific, final tally of vaccine-caused deaths as of these stories [3] [4] [2].
1. What the agencies’ internal review reportedly found
A memo circulated inside FDA’s vaccine center describes an Office of Biostatistics and Pharmacovigilance review of 96 death reports in VAERS (2021–2024) and states at least 10 pediatric deaths were judged by staff to be related to COVID-19 vaccination with classifications like “likely, probable, or possible” [1] [2]. Multiple news outlets subsequently reported those same numbers after obtaining the internal memo [5] [3].
2. How the agencies themselves have (or haven’t) presented this
Reuters and other outlets characterized the finding as based on an initial, internal analysis that has not been published in a peer‑reviewed journal and did not disclose detailed clinical data, vaccine product, or case-level information in the memo summary [2]. STAT and The Atlantic reported the FDA’s claim but emphasized the agency had not released full data publicly and that the assertion was conveyed in an internal email from a senior FDA vaccine official [3] [4].
3. What VAERS is — and what it is not
VAERS is a passive, open surveillance system co‑sponsored by CDC and FDA that collects reports of adverse events after vaccination; anyone can submit a report [6]. Experts quoted in the coverage underline that VAERS signals require careful follow-up because reports alone do not establish causation [3]. The internal FDA review described in reporting represents staff-level causality assessments applied to a small, selected set of reports — not a population-level, adjudicated, peer‑reviewed epidemiologic study [2] [3].
4. Why experts expressed skepticism
Stat and The Atlantic documented expert skepticism rooted in the lack of published case details and the known limitations of VAERS, noting previous CDC slides that reported “no increased risk of death following mRNA COVID-19 vaccines” in some age ranges for earlier periods [3] [4]. Those critics stressed extraordinary claims require transparent data; the media pieces framed the FDA staff finding as preliminary and in need of external validation [3].
5. How other outlets treated the same memo
Newsrooms ranged from careful to more assertive in headline framing: Reuters and FactCheck.org described the analysis as an internal finding of “no fewer than 10” child deaths possibly linked to vaccination [7] [2]. NTD and SAN reproduced the memo’s language and emphasized the agency staff’s conclusion that at least 10 of the 96 cases met causal criteria, sometimes adding commentary about undercounting in VAERS [1] [5].
6. What remains unreported or uncertain
Available sources do not present complete case‑level clinical data, autopsy reports, manufacturer breakdowns, or the formal, public CDC/FDA adjudication that would allow independent verification of the causal determinations [2] [3]. Reporters note the analysis has not been peer reviewed and that agency-wide release of methods and case details had not occurred in the cited stories [2] [3].
7. Wider epidemiologic context
CDC reporting highlights that COVID-19 itself has caused substantial pediatric hospitalizations and deaths in recent seasons; CDC analyses and MMWR pieces stress vaccines’ role in preventing COVID-associated severe outcomes even as safety surveillance continues [8]. This context matters because risk‑benefit calculations for pediatric vaccination rest on both vaccine safety signal assessment and the burden of disease [8].
8. Bottom line for readers
Based on available reporting, an internal FDA staff review of 96 VAERS pediatric death reports concluded at least 10 could be related to COVID-19 vaccination, but the analysis remains internal, not peer‑published, and lacks publicly released case details and methods for independent review [1] [2] [3]. Journalistic and scientific outlets quoted experts urging caution: VAERS reports are hypothesis‑generating and require transparent, rigorous follow-up before drawing definitive causal conclusions [3] [6].