Global Estimates of Vaccine-Associated Hepatic Autoimmune Disorders and Their Related Vaccines, 1968-2024: An International Analysis of the WHO Pharmacovigilance Database.

Abstract

Introduction: Previous studies have suggested an association between vaccines and autoimmune diseases, but they were limited by their narrow focus and timeframe.

Methods: This study conducted the first large-scale international analysis to investigate the impact of various vaccines on autoimmune liver diseases. Utilizing WHO's VigiBase data from 1968 to 2024, and the study identified 1,083 (0.012%) cases of vaccine-associated hepatic autoimmune disorders out of 8,562,584 reported vaccine adverse events.

Results: The vaccines with the highest risk of hepatic autoimmune disorders were the hepatitis B vaccine (reporting odds ratio [ROR], 3.52; 95% CI, 2.50-4.95), COVID-19 mRNA vaccines (ROR, 2.95; 95% CI, 2.73-3.18), and papillomavirus vaccines (ROR, 2.13; 95% CI, 1.45-3.13). Additionally, when vaccine-associated hepatic autoimmune disorders occurred, hepatobiliary adverse events were frequently observed to occur concurrently.

Conclusions: This study suggests that vaccines may induce hepatic autoimmune disorders and highlights the need for enhanced monitoring before and after vaccination. Additionally, it proposes implementing pre-vaccination screening protocols and postvaccination monitoring to address this concern.