Autoimmune Disorders Reported Following COVID-19 Vaccination: A Disproportionality Analysis Using the WHO VigiBase

Abstract

Abstract Purpose: Owing to autoimmune disorders (AIDs) and coronavirus disease (COVID-19) vaccines sharing common biological mechanisms, identifying the risk of AIDs associated with COVID-19 vaccines remains a critical unmet need. We aimed to assess the potential safety signals for 16 AIDs and explore co-reported adverse events (AEs) and drugs using the global database of the World Health Organization, VigiBase. Methods: We assessed the occurrence of 16 AIDs following COVID-19 vaccination through the Standardised MedDRA Queries group “Immune-mediated/Autoimmune Disorders” from MedDRA and performed a disproportionality analysis using reporting odds ratio (ROR) and information component (IC) with 95% confidence intervals (CIs). Results: We identified 25,219 AIDs associated with COVID-19 vaccines in VigiBase and detected four autoimmune safety signals following COVID-19 vaccination, including ankylosing spondylitis or psoriatic arthritis (ROR 1.86; 95% CI 1.53-2.27), inflammatory bowel disease (ROR 1.77; 95% CI 1.60-1.96), polymyalgia rheumatica (ROR 1.42; 95% CI 1.30-1.55), and thyroiditis (ROR 1.40; 95% CI 1.30-1.50), with positive IC025 values. The top co-reported AEs were musculoskeletal disorders, and immunosuppressants were the most representative co-reported drugs. Although rare, four AIDs showed disproportionality in reporting. Conclusion: In response to the need to understand AID following COVID-19 vaccination using WHO-UMC VigiBase, four AIDs were identified in this study. Thus, our study highlights the need for active safety surveillance to detect potential AIDs and monitor the safety of the COVID-19 vaccination.