Myocarditis and pericarditis associated with SARS-CoV-2 vaccines
Background: Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses. Methods: Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Universitat Autònoma de Barcelona |
| Repositorio: | Dipòsit Digital de Documents de la UAB |
| Idioma: | inglés |
| OAI Identifier: | oai:ddd.uab.cat:281771 |
| Acceso en línea: | https://ddd.uab.cat/record/281771 https://dx.doi.org/urn:doi:10.3389/fphar.2022.1038043 |
| Access Level: | acceso abierto |
| Palabra clave: | Myocarditis Pericarditis COVID-19 vaccine Adverse drug reaction Pharmacovigilance |
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Myocarditis and pericarditis associated with SARS-CoV-2 vaccinesA population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countriesBots, Sophie H.|||0000-0002-4483-5582Riera Arnau, Judit|||0000-0001-7591-0218Belitser, Svetlana V.Messina, DavideAragón, María|||0000-0002-5990-6953Alsina, EmaDouglas, Ian J.Durán, Carlos E.|||0000-0003-1853-3641García-Poza, PatriciaGini, RosaHerings, Ron M. C.Huerta, Consuelo|||0000-0003-4012-7826Sisay, Malede Mequanent|||0000-0002-8546-0959Martín-Pérez, MarMartin, IvonneOverbeek, Jetty A.Paoletti, OlgaPallejà-Millán, Meritxell|||0000-0003-1985-8894Schultze, Anna|||0000-0002-1637-837XSouverein, Patrick|||0000-0002-7452-0477Swart, Karin M. A.Villalobos, Felipe|||0000-0002-6907-8354Klungel, Olaf H.Sturkenboom, Miriam|||0000-0003-1360-2388MyocarditisPericarditisCOVID-19 vaccineAdverse drug reactionPharmacovigilanceBackground: Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses. Methods: Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare data from five European databases. Individuals were followed from 01/01/2020 until end of data availability (31/12/2021 latest). Outcome was first myo-/pericarditis diagnosis. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. Baseline incidence rates (IRs), and vaccine- and dose-specific IRs and rate differences were calculated from the cohort The SCRI calculated calendar time-adjusted IR ratios (IRR), using a 60-day pre-vaccination control period and dose-specific 28-day risk windows. IRRs were pooled using random effects meta-analysis. Findings: Over 35 million individuals (49·2% women, median age 39-49 years) were included, of which 57·4% received at least one COVID-19 vaccine dose. Baseline incidence of myocarditis was low. Myocarditis IRRs were elevated after vaccination in those aged < 30 years, after both Pfizer vaccine doses (IRR = 3·3, 95%CI 1·2-9.4; 7·8, 95%CI 2·6-23·5, respectively) and Moderna vaccine dose 2 (IRR = 6·1, 95%CI 1·1-33·5). An effect of AstraZeneca vaccine dose 2 could not be excluded (IRR = 2·42, 95%CI 0·96-6·07). Pericarditis was not associated with vaccination. Interpretation: mRNA-based COVID-19 vaccines and potentially AstraZeneca are associated with increased myocarditis risk in younger individuals, although absolute incidence remains low. More data on children (≤ 11 years) are needed.Universitat Autònoma de Barcelona 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/281771https://dx.doi.org/urn:doi:10.3389/fphar.2022.1038043reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2817712026-06-06T12:50:31Z |
| dc.title.none.fl_str_mv |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries |
| title |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines |
| spellingShingle |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines Bots, Sophie H.|||0000-0002-4483-5582 Myocarditis Pericarditis COVID-19 vaccine Adverse drug reaction Pharmacovigilance |
| title_short |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines |
| title_full |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines |
| title_fullStr |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines |
| title_full_unstemmed |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines |
| title_sort |
Myocarditis and pericarditis associated with SARS-CoV-2 vaccines |
| dc.creator.none.fl_str_mv |
Bots, Sophie H.|||0000-0002-4483-5582 Riera Arnau, Judit|||0000-0001-7591-0218 Belitser, Svetlana V. Messina, Davide Aragón, María|||0000-0002-5990-6953 Alsina, Ema Douglas, Ian J. Durán, Carlos E.|||0000-0003-1853-3641 García-Poza, Patricia Gini, Rosa Herings, Ron M. C. Huerta, Consuelo|||0000-0003-4012-7826 Sisay, Malede Mequanent|||0000-0002-8546-0959 Martín-Pérez, Mar Martin, Ivonne Overbeek, Jetty A. Paoletti, Olga Pallejà-Millán, Meritxell|||0000-0003-1985-8894 Schultze, Anna|||0000-0002-1637-837X Souverein, Patrick|||0000-0002-7452-0477 Swart, Karin M. A. Villalobos, Felipe|||0000-0002-6907-8354 Klungel, Olaf H. Sturkenboom, Miriam|||0000-0003-1360-2388 |
| author |
Bots, Sophie H.|||0000-0002-4483-5582 |
| author_facet |
Bots, Sophie H.|||0000-0002-4483-5582 Riera Arnau, Judit|||0000-0001-7591-0218 Belitser, Svetlana V. Messina, Davide Aragón, María|||0000-0002-5990-6953 Alsina, Ema Douglas, Ian J. Durán, Carlos E.|||0000-0003-1853-3641 García-Poza, Patricia Gini, Rosa Herings, Ron M. C. Huerta, Consuelo|||0000-0003-4012-7826 Sisay, Malede Mequanent|||0000-0002-8546-0959 Martín-Pérez, Mar Martin, Ivonne Overbeek, Jetty A. Paoletti, Olga Pallejà-Millán, Meritxell|||0000-0003-1985-8894 Schultze, Anna|||0000-0002-1637-837X Souverein, Patrick|||0000-0002-7452-0477 Swart, Karin M. A. Villalobos, Felipe|||0000-0002-6907-8354 Klungel, Olaf H. Sturkenboom, Miriam|||0000-0003-1360-2388 |
| author_role |
author |
| author2 |
Riera Arnau, Judit|||0000-0001-7591-0218 Belitser, Svetlana V. Messina, Davide Aragón, María|||0000-0002-5990-6953 Alsina, Ema Douglas, Ian J. Durán, Carlos E.|||0000-0003-1853-3641 García-Poza, Patricia Gini, Rosa Herings, Ron M. C. Huerta, Consuelo|||0000-0003-4012-7826 Sisay, Malede Mequanent|||0000-0002-8546-0959 Martín-Pérez, Mar Martin, Ivonne Overbeek, Jetty A. Paoletti, Olga Pallejà-Millán, Meritxell|||0000-0003-1985-8894 Schultze, Anna|||0000-0002-1637-837X Souverein, Patrick|||0000-0002-7452-0477 Swart, Karin M. A. Villalobos, Felipe|||0000-0002-6907-8354 Klungel, Olaf H. Sturkenboom, Miriam|||0000-0003-1360-2388 |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Universitat Autònoma de Barcelona |
| dc.subject.none.fl_str_mv |
Myocarditis Pericarditis COVID-19 vaccine Adverse drug reaction Pharmacovigilance |
| topic |
Myocarditis Pericarditis COVID-19 vaccine Adverse drug reaction Pharmacovigilance |
| description |
Background: Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses. Methods: Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare data from five European databases. Individuals were followed from 01/01/2020 until end of data availability (31/12/2021 latest). Outcome was first myo-/pericarditis diagnosis. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. Baseline incidence rates (IRs), and vaccine- and dose-specific IRs and rate differences were calculated from the cohort The SCRI calculated calendar time-adjusted IR ratios (IRR), using a 60-day pre-vaccination control period and dose-specific 28-day risk windows. IRRs were pooled using random effects meta-analysis. Findings: Over 35 million individuals (49·2% women, median age 39-49 years) were included, of which 57·4% received at least one COVID-19 vaccine dose. Baseline incidence of myocarditis was low. Myocarditis IRRs were elevated after vaccination in those aged < 30 years, after both Pfizer vaccine doses (IRR = 3·3, 95%CI 1·2-9.4; 7·8, 95%CI 2·6-23·5, respectively) and Moderna vaccine dose 2 (IRR = 6·1, 95%CI 1·1-33·5). An effect of AstraZeneca vaccine dose 2 could not be excluded (IRR = 2·42, 95%CI 0·96-6·07). Pericarditis was not associated with vaccination. Interpretation: mRNA-based COVID-19 vaccines and potentially AstraZeneca are associated with increased myocarditis risk in younger individuals, although absolute incidence remains low. More data on children (≤ 11 years) are needed. |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2 2022-01-01 2022 2022-01-01 |
| dc.type.none.fl_str_mv |
Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
https://ddd.uab.cat/record/281771 https://dx.doi.org/urn:doi:10.3389/fphar.2022.1038043 |
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https://ddd.uab.cat/record/281771 https://dx.doi.org/urn:doi:10.3389/fphar.2022.1038043 |
| dc.language.none.fl_str_mv |
Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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application/pdf |
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reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona |
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