Rafaniello Concetta, Gaio Mario, Zinzi Alessia, Sullo Maria Giuseppa, Liguori Valerio, Ferraro Marialuisa, Petronzelli Fiorella, Felicetti Patrizia, Marchione Pasquale, Marra Anna Rosa, Rossi Francesco, De Angelis Antonella, Capuano Annalisa
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.
Section of Pharmacology "L. Donatelli", Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.
Pharmaceuticals (Basel). 2022 Apr 25;15(5):525. doi: 10.3390/ph15050525.
Considering the clinical significance for myocarditis and pericarditis after immunization with mRNA COVID-19 vaccines, the present pharmacovigilance study aimed to describe these events reported with mRNA COVID-19 vaccines in the Vaccine Adverse Events Reporting System (VAERS). From 1990 to July 2021, the mRNA vaccines were the most common suspected vaccines related to suspected cases of myocarditis and/or pericarditis (myocarditis: N = 1,165; 64.0%; pericarditis: N = 743; 55.1%), followed by smallpox vaccines (myocarditis: N = 222; 12.2%; pericarditis: N = 200; 14.8%). We assessed all suspected cases through the case definition and classification of the Brighton Collaboration Group, and only definitive, probable, and possible cases were included in the analysis. Our findings suggested that myocarditis and pericarditis mostly involve young male, especially after the second dose with a brief time to onset. Nevertheless, this risk is lower (0.38/100,000 vaccinated people; 95% CI 0.36-0.40) than the risk of developing myocarditis after SARS-CoV-2 infection (1000-4000 per 100,000 people) and the risk of developing "common" viral myocarditis (1-10 per 100,000 people/year). Comparing with the smallpox vaccine, for which is already well known the association with myocarditis and pericarditis, our analysis showed a lower probability of reporting myocarditis (ROR 0.12, 95% CI 0.10-0.14) and pericarditis (ROR 0.06, 95% CI 0.05-0.08) following immunization with mRNA COVID-19 vaccines.
考虑到接种新型冠状病毒mRNA疫苗后发生心肌炎和心包炎的临床意义，本药物警戒研究旨在描述疫苗不良事件报告系统（VAERS）中报告的与新型冠状病毒mRNA疫苗相关的这些事件。1990年至2021年7月，mRNA疫苗是与疑似心肌炎和/或心包炎病例相关的最常见疑似疫苗（心肌炎：N = 1165；64.0%；心包炎：N = 743；55.1%），其次是天花疫苗（心肌炎：N = 222；12.2%；心包炎：N = 200；14.8%）。我们通过布莱顿协作组的病例定义和分类对所有疑似病例进行了评估，分析仅纳入确诊、很可能和可能病例。我们的研究结果表明，心肌炎和心包炎大多累及年轻男性，尤其是在接种第二剂疫苗后，发病时间较短。然而，这种风险（0.38/10万接种人群；95%可信区间0.36 - 0.40）低于感染严重急性呼吸综合征冠状病毒2后发生心肌炎的风险（每10万人中1000 - 4000例）以及发生“常见”病毒性心肌炎的风险（每年每10万人中1 - 10例）。与已知与心肌炎和心包炎有关联的天花疫苗相比，我们的分析显示，接种新型冠状病毒mRNA疫苗后报告心肌炎（相对危险度0.12，95%可信区间0.10 - 0.14）和心包炎（相对危险度0.06，95%可信区间0.05 - 0.08）的可能性较低。
