ORIGINAL RESEARCH article
Front. Cell. Infect. Microbiol.
Sec. Microbial Vaccines
Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1609409
This article is part of the Research TopicVaccine and Infectious Disease InformaticsView all 5 articles
Real-World Pharmacovigilance Reports of Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine: Insights from Disproportionality Analysis of the Vaccine Adverse Event Reporting System (VAERS)
Provisionally accepted
- Department of Pharmacology, Liaoning Cancer Hospital, China Medical University, Shenyang, China
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Background: Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine (Hep AB) was approved for use in 2001. Hep AB demonstrates satisfactory efficacy in protecting the public from hepatitis virus infections. However, there is a lack of recent real-world report on its adverse events (AEs).: We retrieved US AE reports related to Hep AB vaccination from VAERS for the period 2020-2024. We used four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-Item Gamma-Poisson Shrinkage (MGPS) to examine AE signals. The ROR and PRR algorithms have higher sensitivity but lower specificity. However, BCPNN and MGPS compensate for this limitation.Combining all four algorithms helps reduce false-positive signals. In addition to the general population, we also focused on reports stratified by gender.We retrieved 1,640 eligible reports from VAERS. In the general population, we identified two AE signals at the System Organ Classification (SOC) level. Additionally, we found 39 AE signals at the Preferred Term (PT) level. Among these, endocrine disorders were identified for the first time as AE signals. In the subsequent gender stratified analysis, more AE signals were identified in females compared to males. Notably, signals for endocrine disorders (autoimmune thyroiditis and Graves' disease) were detected in females, whereas no such signals were found in males.We conducted a comprehensive examination of the recent AE reports for Hep AB and identified unexpected AEs, particularly in females. These findings will provide valuable insights into future evidence-based surveillance strategies of Hep AB.
Keywords: Hepatitis AB vaccine1, Vaccine safety2, Surveillance3, pharmacovigilance4, VAERS5
Received: 10 Apr 2025; Accepted: 20 May 2025.
Copyright: © 2025 Zhou, Wang, Feng, Zhang, Sun and Xu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Tao Sun, Department of Pharmacology, Liaoning Cancer Hospital, China Medical University, Shenyang, China
Junnan Xu, Department of Pharmacology, Liaoning Cancer Hospital, China Medical University, Shenyang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.