Documents obtained through a Freedom of Information Act (FOIA) request have sparked fresh debate over the presentation of data in a COVID-19 vaccine safety study conducted by researchers at the Centers for Disease Control and Prevention (CDC).
The materials, released following a 2023 lawsuit by Children’s Health Defense (CHD), include draft and final versions of a study on adverse events linked to mRNA COVID-19 vaccines. The research was eventually published in June 2022 in The Lancet Infectious Diseases.
According to CHD, the earlier draft of the study contained details that were later revised or omitted in the published version. The organization claims these changes reduced emphasis on reported deaths following vaccination while highlighting vaccine safety.
Analysis of the documents suggests that the draft version of the study was initially titled “Reactogenicity and Adverse Events,” while the final publication was renamed to focus on “Safety of mRNA vaccines.” Reactogenicity refers to side effects experienced after vaccination.
The study examined adverse event reports collected during the first six months of the U.S. vaccine rollout, drawing data from federal monitoring systems such as the Vaccine Adverse Event Reporting System (VAERS) and V-safe.
References to deaths reported in VAERS—numbering 4,496 during the study period—were removed from the study’s abstract.
A figure showing the leading causes of reported deaths following vaccination was excluded from the final publication.
A table containing similar mortality-related data was moved to supplemental materials rather than being featured prominently.
Comments within the draft documents reportedly show internal discussions about removing references to deaths from the abstract, which typically serves as the most widely read section of a scientific paper.
Karl Jablonowski, a senior research scientist with CHD, argued that the revisions “de-emphasized death” and framed the study more strongly around vaccine safety.
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The published study also noted that reports of deaths occurring shortly after vaccination followed patterns seen with other adult vaccines, though critics cited in the documents questioned whether sufficient comparative data was provided to support that claim.
Additionally, the study suggested that the clustering of adverse event reports shortly after vaccination could be influenced by reporting bias—an explanation that at least one reviewer in the draft cautioned might not fully account for the observed patterns.
The release of the FOIA documents comes amid continued scrutiny of how public health agencies handled COVID-19 vaccine data and communications during the pandemic.
Separately, Ron Johnson has called for investigations into allegations involving a former CDC official linked to vaccine safety monitoring, though those claims remain under review by relevant authorities.
The CDC study itself included a standard disclaimer stating that its findings and conclusions were those of the authors and did not necessarily represent the official positions of the CDC or the U.S. Food and Drug Administration.
Public health experts generally emphasize that reports in systems like VAERS do not establish causation but are used as early warning tools to detect potential safety signals requiring further investigation.
The CDC has not publicly detailed the rationale behind the specific revisions highlighted in the FOIA documents. The issue continues to generate discussion among researchers, policymakers, and advocacy groups about transparency, data interpretation, and public communication during health emergencies.