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...

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Autores: 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
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
Descripción
Sumario: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.

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