A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe
2023
Joana Tome | Logan T. Cowan | Isaac Chun-Hai Fung
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 COVID-19 vaccines (1 January 2021&ndash:11 February 2022) from EudraVigilance database were combined with European Centre for Disease Prevention and Control (ECDC)&rsquo: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&ndash:18.26) for CX-024414 and 8.44 (95% CI, 8.18&ndash:8.70) for TOZINAMERAN: and of pericarditis, 9.76 (95% CI, 9.06&ndash:10.51) for CX-024414 and 5.79 (95% CI, 5.56&ndash: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.
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