dc.contributor
[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
dc.contributor
Departament de Salut
dc.contributor.author
Zwiers, Laura
dc.contributor.author
Grobbee, Diederick
dc.contributor.author
Schneijdenberg, Rob
dc.contributor.author
Baljé, Corine
dc.contributor.author
St. Laurent, Samantha
dc.contributor.author
Esposito, Daina B.
dc.contributor.author
Villalobos, Felipe
dc.contributor.author
Bissacco, Carlo Alberto
dc.date.accessioned
2025-12-19T20:47:35Z
dc.date.available
2025-12-19T20:47:35Z
dc.date.issued
2025-12-18T12:40:18Z
dc.date.issued
2025-12-18T12:40:18Z
dc.date.issued
2025-07-16
dc.identifier
Zwiers LC, Grobbee DE, Schneijdenberg R, Baljé C, St Laurent S, Esposito DB, et al. Clinical Course, Outcomes, and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA-1273 Vaccination: A Protocol for a Federated Real-World Evidence Vaccine Safety Study Using Data from Five European Data Sources. Vaccines (Basel). 2025 Jul 16;13(7):755.
dc.identifier
http://hdl.handle.net/11351/14154
dc.identifier
10.3390/vaccines13070755
dc.identifier.uri
http://hdl.handle.net/11351/14154
dc.description.abstract
Miocarditis postvacunal; Pericarditis associada a vacunes; Vacuna mRNA-1273
dc.description.abstract
Post-vaccine Myocarditis; Vaccine-associated Pericarditis; mRNA-1273 Vaccine
dc.description.abstract
Miocarditis postvacunal; Pericarditis asociada a vacunas; Vacuna mRNA-1273
dc.description.abstract
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.
dc.description.abstract
This study was performed within the VAC4EU (Vaccine Monitoring Collaboration for Europe) association and received funding from Moderna Tx.
dc.format
application/pdf
dc.relation
Vaccines;13(7)
dc.relation
https://www.doi.org/10.3390/vaccines13070755
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Vacunes d'RNA missatger
dc.subject
DISEASES::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Myocarditis
dc.subject
DISEASES::Cardiovascular Diseases::Heart Diseases::Pericarditis
dc.subject
CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNA::RNA, Messenger
dc.subject
ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::miocardiopatías::miocarditis
dc.subject
ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::pericarditis
dc.subject
COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ARN::ARN mensajero
dc.title
Clinical Course, Outcomes, and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA-1273 Vaccination: A Protocol for a Federated Real-World Evidence Vaccine Safety Study Using Data from Five European Data Sources
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
