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A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe
Microorganisms
  • Joana Tome, Georgia Southern University, Jiann-Ping Hsu College of Public Health
  • Logan Cowan, Georgia Southern University, Jiann-Ping Hsu College of Public Health
  • Isaac Fung, Georgia Southern University, Jiann-Ping Hsu College of Public Health
Document Type
Article
Publication Date
4-22-2023
DOI
10.3390/microorganisms11051099
Disciplines
Abstract

This study assessed the myocarditis and pericarditis reporting rate of the first dose of mRNA COVID-19 vaccines in Europe. Myocarditis and pericarditis data pertinent to mRNA COVID19 vaccines (1 January 2021–11 February 2022) from EudraVigilance database were combined with European Centre for Disease Prevention and Control (ECDC)’s vaccination tracker data. The reporting rate was expressed as events (occurring within 28 days of the first dose) per 1 million individuals vaccinated. An observed-to-expected (OE) analysis quantified excess risk for myocarditis or pericarditis following the first mRNA COVID-19 vaccination. The reporting rate of myocarditis per 1 million individuals vaccinated was 17.27 (95% CI, 16.34–18.26) for CX-024414 and 8.44 (95% CI, 8.18–8.70) for TOZINAMERAN; and of pericarditis, 9.76 (95% CI, 9.06–10.51) for CX-024414 and 5.79 (95% CI, 5.56–6.01) for TOZINAMERAN. Both vaccines produced a myocarditis standardized morbidity ratio (SMR) > 1, with the CX-024414 vaccine having a greater SMR than TOZINAMERAN. Regarding TOZINAMERAN, SMR for pericarditis was >1 when considering the lowest background incidence, but <1 when considering the highest background incidence. Our results suggest an excess risk of myocarditis following the first dose of the mRNA COVID-19 vaccine, but the relationship between pericarditis and the mRNA COVID-19 vaccine remains unclear.

Comments

Georgia Southern University faculty members, Logan T. Cowan and Isaac Chun-Hai Fung co-authored A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe.

Creative Commons License
Creative Commons Attribution 4.0
Citation Information
Joana Tome, Logan Cowan and Isaac Fung. "A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe" Microorganisms Vol. 11 Iss. 5 (2023)
Available at: http://works.bepress.com/isaac_fung1/199/