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

• Main Authors: Sophie H. Bots (Author), Judit Riera-Arnau (Author), Svetlana V. Belitser (Author), Davide Messina (Author), Maria Aragón (Author), Ema Alsina (Author), Ian J. Douglas (Author), Carlos E. Durán (Author), Patricia García-Poza (Author), Rosa Gini (Author), Ron M. C. Herings (Author), Consuelo Huerta (Author), Malede Mequanent Sisay (Author), Mar Martín-Pérez (Author), Ivonne Martin (Author), Jetty A. Overbeek (Author), Olga Paoletti (Author), Meritxell Pallejà-Millán (Author), Anna Schultze (Author), Patrick Souverein (Author), Karin M. A. Swart (Author), Felipe Villalobos (Author), Olaf H. Klungel (Author), Miriam C. J. M. Sturkenboom (Author)
• Format: Book
• Published: Frontiers Media S.A., 2022-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

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.

Item Description

1663-9812
10.3389/fphar.2022.1038043