tetano
Editor, Senior Moderator
Eur J Clin Pharmacol
. 2024 Jan 12.
doi: 10.1007/s00228-023-03618-w. Online ahead of print. Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database
Seohyun Kim[SUP] 1 [/SUP], Sungho Bea[SUP] 2 [/SUP], Seung-Ah Choe[SUP] 3 [/SUP], Nam-Kyong Choi[SUP] 4 [/SUP], Ju-Young Shin[SUP] 5 6 7 [/SUP]
Affiliations
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[SUB]025[/SUB] 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.
Keywords: Adverse events; Autoimmune disorders; Coronavirus disease (COVID-19) vaccines; Pharmacovigilance; Reporting odds ratio.
. 2024 Jan 12.
doi: 10.1007/s00228-023-03618-w. Online ahead of print. Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database
Seohyun Kim[SUP] 1 [/SUP], Sungho Bea[SUP] 2 [/SUP], Seung-Ah Choe[SUP] 3 [/SUP], Nam-Kyong Choi[SUP] 4 [/SUP], Ju-Young Shin[SUP] 5 6 7 [/SUP]
Affiliations
- PMID: 38212538
- DOI: 10.1007/s00228-023-03618-w
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[SUB]025[/SUB] 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.
Keywords: Adverse events; Autoimmune disorders; Coronavirus disease (COVID-19) vaccines; Pharmacovigilance; Reporting odds ratio.