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Summary
This study on vaccine-associated hepatic autoimmune disorders used corrected data from the WHO Pharmacovigilance Database. Findings on vaccine-associated hepatic autoimmune disorders should be interpreted cautiously.
Area of Science:
- Immunology
- Hepatology
- Pharmacovigilance
Background:
- The article "Global Estimates of Vaccine-Associated Hepatic Autoimmune Disorders and Their Related Vaccines, 1968-2024" by Jeong et al. has undergone corrections.
- Corrections were made following communication with the Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring) regarding dataset accuracy and data use policies.
Purpose of the Study:
- To update and ensure the accuracy of the reported global estimates of vaccine-associated hepatic autoimmune disorders.
- To clarify the methodology and data sources used in the analysis of the WHO Pharmacovigilance Database.
Main Methods:
- The Vigibase database size was corrected from "over 140 million cases" to "over 35 million cases."
- Ethical approval statement was clarified to reflect IRB approval from Kyung Hee University Medical Center and data access from the Uppsala Monitoring Centre.
- The study utilized disproportionality analysis on spontaneous adverse event reports, not for estimating incidence or prevalence.
Main Results:
- The authors confirm that the corrections do not alter the main results, interpretations, or conclusions of the original study.
- The terminology 'vaccine-associated' was clarified to indicate signal detection through disproportionality analysis, not implying causality.
Conclusions:
- Findings regarding vaccine-associated hepatic autoimmune disorders should be interpreted with caution due to the nature of spontaneous reporting data.
- The study emphasizes that the terminology used does not imply causality or serve as a basis for clinical decision-making.