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
Bots, Sophie H; Riera-Arnau, Judit; Belitser, Svetlana V; Messina, Davide; Aragón, Maria; Alsina, Ema; Douglas, Ian J; Durán, Carlos E; García-Poza, Patricia; Gini, Rosa; Herings, Ron M C; Huerta, Consuelo; Sisay, Malede Mequanent; Martín-Pérez, Mar; Martin, Ivonne; Overbeek, Jetty A; Paoletti, Olga; Pallejà-Millán, Meritxell; Schultze, Anna; Souverein, Patrick; Swart, Karin M A; Villalobos, Felipe; Klungel, Olaf H; Sturkenboom, Miriam C J M
(2022) Frontiers in Pharmacology, volume 13, pp. 1 - 12
(Article)
Abstract
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
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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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Keywords: Adverse drug reaction, COVID-19 vaccine, Myocarditis, Pericarditis, Pharmacovigilance
ISSN: 1663-9812
Publisher: Frontiers Media S.A.
Note: Funding Information: The project received support from the European Medicines Agency (EMA/2018/23/PE). Publisher Copyright: Copyright © 2022 Bots, Riera-Arnau, Belitser, Messina, Aragón, Alsina, Douglas, Durán, García-Poza, Gini, Herings, Huerta, Sisay, Martín-Pérez, Martin, Overbeek, Paoletti, Pallejà-Millán, Schultze, Souverein, Swart, Villalobos, Klungel and Sturkenboom.
(Peer reviewed)