| アブストラクト | PURPOSE: Owing to adverse event following immunization (AEFI) related to autoimmune disorders and coronavirus disease 2019 (COVID-19) vaccines sharing common biological mechanisms, identifying the risk of AEFIs associated with COVID-19 vaccines remains a critical unmet need. We aimed to assess the potential safety signals for 16 AEFIs 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 AEFIs following COVID-19 vaccination through the Standardized 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 events associated with COVID-19 vaccines in VigiBase. Although rare, we detected four potential safety signals related to autoimmune disorders 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 IC(025) values. The top co-reported AEs were musculoskeletal disorders, and immunosuppressants were the most representative co-reported drugs. CONCLUSION: In addressing the imperative to comprehend AEFI related to autoimmune disorders following COVID-19 vaccination, our study identified four potential safety signals. Thus, our research underscores the importance of proactive safety monitoring for the identification of the four AEFIs following COVID-19 vaccination, considering the associated advantages. |
|---|
| ジャーナル名 | European journal of clinical pharmacology |
|---|
| 投稿日 | 2024/1/12 |
|---|
| 投稿者 | Kim, Seohyun; Bea, Sungho; Choe, Seung-Ah; Choi, Nam-Kyong; Shin, Ju-Young |
|---|
| 組織名 | Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South;Korea.;School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si,;Gyeonggi-do 16419, South Korea.;Department of Preventive Medicine, Korea University College of Medicine, Seoul,;South Korea.;Department of Health Convergence, College of Science & Industry Convergence, Ewha;Womans University, Seoul, Korea.;Korea. shin.jy@skku.edu.;Gyeonggi-do 16419, South Korea. shin.jy@skku.edu.;Department of Clinical Research Design & Evaluation, Samsung Advanced Institute;for Health Sciences & Technology, Sungkyunkwan University, Seoul, South Korea.;shin.jy@skku.edu. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38212538/ |
|---|
