Global estimates of vaccine-associated hepatic autoimmune disorders and their related vaccines, 1968-2024: An international analysis of the WHO pharmacovigilance database.

Abstract

Previous studies have suggested an association between vaccines and autoimmune diseases, but they were limited by their narrow focus and timeframe. Therefore, 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, the study identified 1,083 (0.012%) cases of vaccine-associated hepatic autoimmune disorders out of 8,562,584 reported vaccine adverse events. 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, hepato-biliary adverse events were frequently observed to occur concurrently. 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 post-vaccination monitoring to address this concern.