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
<b>Background</b>: 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 factor...
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2025-07-01
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| author | Laura C. Zwiers Diederick E. Grobbee Rob Schneijdenberg Corine Baljé Samantha St. Laurent Daina B. Esposito Lei Zhu Veronica V. Urdaneta Magalie Emilebacker Daniel Weibel Felipe Villalobos Carlo Alberto Bissacco Arantxa Urchueguía Fornes Juan José Carreras-Martínez Anteneh A. Desalegn Angela Lupattelli Lei Wang Jannik Wheler Vera Ehrenstein Denise Morris Catherine Fry Marjolein Jansen Brianna M. Goodale David S. Y. Ong |
| author_facet | Laura C. Zwiers Diederick E. Grobbee Rob Schneijdenberg Corine Baljé Samantha St. Laurent Daina B. Esposito Lei Zhu Veronica V. Urdaneta Magalie Emilebacker Daniel Weibel Felipe Villalobos Carlo Alberto Bissacco Arantxa Urchueguía Fornes Juan José Carreras-Martínez Anteneh A. Desalegn Angela Lupattelli Lei Wang Jannik Wheler Vera Ehrenstein Denise Morris Catherine Fry Marjolein Jansen Brianna M. Goodale David S. Y. Ong |
| author_sort | Laura C. Zwiers |
| collection | DOAJ |
| description | <b>Background</b>: 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). <b>Methods</b>: 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. <b>Conclusions</b>: 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. |
| format | Article |
| id | doaj-art-01a9cbe174d041b7bdfc84d1e76b9e7b |
| institution | Matheson Library |
| issn | 2076-393X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
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| series | Vaccines |
| spelling | doaj-art-01a9cbe174d041b7bdfc84d1e76b9e7b2025-07-25T13:38:27ZengMDPI AGVaccines2076-393X2025-07-0113775510.3390/vaccines13070755Clinical 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 SourcesLaura C. Zwiers0Diederick E. Grobbee1Rob Schneijdenberg2Corine Baljé3Samantha St. Laurent4Daina B. Esposito5Lei Zhu6Veronica V. Urdaneta7Magalie Emilebacker8Daniel Weibel9Felipe Villalobos10Carlo Alberto Bissacco11Arantxa Urchueguía Fornes12Juan José Carreras-Martínez13Anteneh A. Desalegn14Angela Lupattelli15Lei Wang16Jannik Wheler17Vera Ehrenstein18Denise Morris19Catherine Fry20Marjolein Jansen21Brianna M. Goodale22David S. Y. Ong23Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, 3584 CX Utrecht, The NetherlandsJulius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, 3584 CX Utrecht, The NetherlandsJulius Clinical, 3703 CD Zeist, The NetherlandsClin-Q B.V., 9723 DJ Groningen, The NetherlandsModernaTX, Inc., Cambridge, MA 02142, USAModernaTX, Inc., Cambridge, MA 02142, USAModernaTX, Inc., Cambridge, MA 02142, USAModernaTX, Inc., Cambridge, MA 02142, USAModernaTX, Inc., Cambridge, MA 02142, USAVaccine Monitoring Collaboration for Europe (VAC4EU), 1000 Brussels, BelgiumFundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), 08029 Barcelona, SpainFundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), 08029 Barcelona, SpainVaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO—Public Health), 46020 Valencia, SpainVaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO—Public Health), 46020 Valencia, SpainPharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, 0313 Oslo, NorwayPharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, 0313 Oslo, NorwayDepartment of Clinical Epidemiology, Aarhus University Hospital and Aarhus University, 8200 Aarhus, DenmarkDepartment of Clinical Epidemiology, Aarhus University Hospital and Aarhus University, 8200 Aarhus, DenmarkDepartment of Clinical Epidemiology, Aarhus University Hospital and Aarhus University, 8200 Aarhus, DenmarkDrug Safety Research Unit, Southampton SO31 1AA, UKDrug Safety Research Unit, Southampton SO31 1AA, UKJulius Clinical, 3703 CD Zeist, The NetherlandsJulius Clinical, 3703 CD Zeist, The NetherlandsJulius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, 3584 CX Utrecht, The Netherlands<b>Background</b>: 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). <b>Methods</b>: 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. <b>Conclusions</b>: 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.https://www.mdpi.com/2076-393X/13/7/755myocarditispericarditisvaccinationCOVID-19 vaccinessafety |
| spellingShingle | Laura C. Zwiers Diederick E. Grobbee Rob Schneijdenberg Corine Baljé Samantha St. Laurent Daina B. Esposito Lei Zhu Veronica V. Urdaneta Magalie Emilebacker Daniel Weibel Felipe Villalobos Carlo Alberto Bissacco Arantxa Urchueguía Fornes Juan José Carreras-Martínez Anteneh A. Desalegn Angela Lupattelli Lei Wang Jannik Wheler Vera Ehrenstein Denise Morris Catherine Fry Marjolein Jansen Brianna M. Goodale David S. Y. Ong 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 myocarditis pericarditis vaccination COVID-19 vaccines safety |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | myocarditis pericarditis vaccination COVID-19 vaccines safety |
| url | https://www.mdpi.com/2076-393X/13/7/755 |
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