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

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.

既往研究已提示疫苗接种与自身免疫性疾病之间存在关联，但受限于其狭窄的研究焦点和时间范围。鉴于此，本研究首次进行了大规模的国际分析，旨在探究各类疫苗对自身免疫性肝病的潜在影响。该研究利用了世界卫生组织（WHO）自1968年至2024年的VigiBase数据，从8,562,584例报告的疫苗接种不良事件中识别出1,083（占比0.012%）例与疫苗接种相关的肝性自身免疫性紊乱病例。其中，风险最高的疫苗为乙型肝炎疫苗（报告比数比[OR]，3.52；95%置信区间[CI]，2.50-4.95）、COVID-19 mRNA疫苗（OR，2.95；95% CI，2.73-3.18）以及人乳头瘤病毒疫苗（OR，2.13；95% CI，1.45-3.13）。此外，当发生与疫苗接种相关的肝性自身免疫性紊乱时，肝胆系统不良事件往往同时发生。本研究表明，疫苗接种可能诱发肝性自身免疫性紊乱，并强调了在疫苗接种前后加强监测的必要性。此外，研究还建议实施疫苗接种前的筛查协议和疫苗接种后的监测，以应对这一担忧。