Zwiers Laura C, Grobbee Diederick E, Schneijdenberg Rob, Baljé Corine, St Laurent Samantha, Esposito Daina B, Zhu Lei, Urdaneta Veronica V, Emilebacker Magalie, Weibel Daniel, Villalobos Felipe, Bissacco Carlo Alberto, Urchueguía Fornes Arantxa, Carreras-Martínez Juan José, Desalegn Anteneh A, Lupattelli Angela, Wang Lei, Wheler Jannik, Ehrenstein Vera, Morris Denise, Fry Catherine, Jansen Marjolein, Goodale Brianna M, Ong David S Y
Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, 3584 CX Utrecht, The Netherlands.
Julius Clinical, 3703 CD Zeist, The Netherlands.
Vaccines (Basel). 2025 Jul 16;13(7):755. doi: 10.3390/vaccines13070755.
: Myocarditis and pericarditis are recognised risks following COVID-19 vaccination, including the mRNA-1273 vaccine. Most cases occur shortly following the second dose of this vaccine, and incidence is highest among young males. However, little is known about risk factors beyond age and sex and about the longer-term clinical course. This study aims to identify possible risk factors for myocarditis and pericarditis following mRNA-1273 vaccination, to characterise the clinical course of myocarditis and pericarditis, both associated with mRNA-1273 vaccination and not associated with vaccination, and to identify risk factors for severe outcomes (i.e., cardiac or thromboembolic complications, severe hospital outcomes, all-cause hospital readmission, and death). : This study is being conducted within the Vaccine Monitoring Collaboration for Europe (VAC4EU) association using routinely collected healthcare data from five data sources from four European countries (Denmark, Norway, Spain, and the United Kingdom). The study is being performed using a common data model, and all analyses are performed separately in each data source in a federated manner following a common protocol. A case-cohort analysis set is identified within each data source for identifying potential risk factors for myocarditis and pericarditis following mRNA-1273 vaccination using logistic regression analysis. The clinical course of myocarditis and pericarditis is being assessed using a cohort study design and describes all cases (i.e., cases associated with mRNA-1273 and unexposed cases). Cox regression analysis is applied to assess the associations between risk factors and several follow-up outcomes. : This protocol describes the study methodology of an international collaborative initiative with the aim of assessing the risk factors and clinical course of myocarditis and pericarditis following mRNA-1273 vaccination using a federated network of five European data sources.
心肌炎和心包炎是接种新冠疫苗(包括mRNA-1273疫苗)后公认的风险。大多数病例在接种该疫苗第二剂后不久出现,且发病率在年轻男性中最高。然而,除年龄和性别外,对于其他风险因素以及长期临床病程知之甚少。本研究旨在确定接种mRNA-1273疫苗后心肌炎和心包炎的可能风险因素,描述与接种mRNA-1273疫苗相关以及与接种疫苗无关的心肌炎和心包炎的临床病程,并确定严重后果(即心脏或血栓栓塞并发症、严重住院结局、全因再次入院和死亡)的风险因素。 本研究在欧洲疫苗监测协作组织(VAC4EU)内开展,使用来自四个欧洲国家(丹麦、挪威、西班牙和英国)五个数据源的常规收集的医疗保健数据。该研究使用通用数据模型进行,所有分析按照通用方案以联邦方式在每个数据源中单独进行。在每个数据源中确定一个病例队列分析集,使用逻辑回归分析确定接种mRNA-1273疫苗后心肌炎和心包炎的潜在风险因素。使用队列研究设计评估心肌炎和心包炎的临床病程,并描述所有病例(即与mRNA-1273相关的病例和未暴露病例)。应用Cox回归分析评估风险因素与几个随访结局之间的关联。 本方案描述了一项国际合作倡议的研究方法,旨在使用五个欧洲数据源的联邦网络评估接种mRNA-1273疫苗后心肌炎和心包炎的风险因素及临床病程。