A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe.

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 COVID-19 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.