Sistema de Salut de Catalunya
[Zwiers LC, Grobbee DE] Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Julius Clinical, Zeist, The Netherlands. [Schneijdenberg R] Julius Clinical, Zeist, The Netherlands. [Baljé C] Clin-Q B.V., Groningen, The Netherlands. [St. Laurent S, Esposito DB] ModernaTX, Inc., Cambridge, Massachusetts, USA. [Villalobos F, Bissacco CA] Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain
Departament de Salut
2025-12-18T12:40:18Z
2025-12-18T12:40:18Z
2025-07-16
Miocarditis postvacunal; Pericarditis associada a vacunes; Vacuna mRNA-1273
Post-vaccine Myocarditis; Vaccine-associated Pericarditis; mRNA-1273 Vaccine
Miocarditis postvacunal; Pericarditis asociada a vacunas; Vacuna mRNA-1273
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). Methods: 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. Conclusions: 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.
This study was performed within the VAC4EU (Vaccine Monitoring Collaboration for Europe) association and received funding from Moderna Tx.
Article
Published version
English
Miocarditis; Pericarditis; Vacunes d'RNA missatger; DISEASES::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Myocarditis; DISEASES::Cardiovascular Diseases::Heart Diseases::Pericarditis; CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNA::RNA, Messenger; ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::miocardiopatías::miocarditis; ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::pericarditis; COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ARN::ARN mensajero
MDPI
Vaccines;13(7)
https://www.doi.org/10.3390/vaccines13070755
Attribution-NonCommercial 4.0 International
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
