Fraenza Federica, Cagnotta Cecilia, Gaio Mario, Sportiello Liberata, Scavone Cristina, Capuano Annalisa, Trama Ugo
Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Sci Rep. 2025 Apr 27;15(1):14740. doi: 10.1038/s41598-025-98313-4.
The safety profile of COVID-19 vaccines is well-established, yet the widespread immunization campaign has led to an increase in reported cases of Immune-Mediated and Rheumatic Diseases (IMDRs). This study aimed to assess the reporting of Adverse Events Following Immunization (AEFIs) related to IMDRs after COVID-19 vaccination. We analyzed all individual case safety reports (ICSRs) related to COVID-19 vaccines authorized in the European Union (i.e., tozinameran, elasomeran, ChAdOx1-S NCoV-19, and Ad26.Cov2.S) registered in the EudraVigilance (EV) database from January 1, 2021, to October 23, 2023. Our analysis identified ICSRs with events indicative of IMDRs and conducted disproportionality analysis (i.e., Reporting Odds Ratio (ROR) with 95% CI) to examine the frequency of different IMDR types linked to each vaccine. In total, 45,352 ICSRs reported at least one AEFI associated with rheumatic or autoimmune conditions, with 54% of them implicating tozinameran as the suspected vaccine. More than half of the reported AEFIs were classified as serious, with approximately 45% remaining unresolved. The most frequently reported conditions were other immune-mediated diseases, followed by arthritis, vasculitis, systemic lupus erythematosus, and tendinopathies. Our disproportionality analysis suggested that mRNA vaccines may be more frequently associated with new autoimmune rheumatic diseases. Stratified analysis revealed significant associations for ChAd, particularly in vasculitis and tendinopathies, only when compared to Ad26.Cov2.S. Real-world pharmacovigilance data suggest that autoimmune and rheumatic diseases may be under-reported following COVID-19 vaccination, highlighting the need for further research to better understand the underlying mechanisms. The findings from this disproportionality analysis suggest the need for further studies to investigate these results in greater depth.
2019冠状病毒病疫苗的安全性已得到充分证实，但广泛的免疫接种运动导致免疫介导和风湿性疾病（IMDR）报告病例有所增加。本研究旨在评估2019冠状病毒病疫苗接种后与IMDR相关的免疫接种后不良事件（AEFI）报告情况。我们分析了2021年1月1日至2023年10月23日在欧洲药品管理局药物警戒（EV）数据库中登记的所有与欧盟授权的2019冠状病毒病疫苗（即托珠单抗、艾拉莫德、ChAdOx1-S NCoV-19和Ad26.Cov2.S）相关的个体病例安全报告（ICSR）。我们的分析确定了有IMDR相关事件的ICSR，并进行了不成比例分析（即报告比值比（ROR）及95%置信区间），以检查与每种疫苗相关的不同IMDR类型的发生频率。总共45352份ICSR报告了至少一种与风湿或自身免疫性疾病相关的AEFI，其中54%认为托珠单抗是可疑疫苗。报告的AEFI中超过一半被归类为严重，约45%仍未解决。报告最频繁的疾病是其他免疫介导疾病，其次是关节炎、血管炎、系统性红斑狼疮和肌腱病。我们的不成比例分析表明，mRNA疫苗可能更常与新发自身免疫性风湿性疾病相关。分层分析显示，仅与Ad26.Cov2.S相比时，ChAd有显著关联，特别是在血管炎和肌腱病方面。真实世界的药物警戒数据表明，2019冠状病毒病疫苗接种后自身免疫性和风湿性疾病可能报告不足，这突出了进一步研究以更好地了解潜在机制的必要性。这项不成比例分析的结果表明需要进一步研究以更深入地调查这些结果。
