Key result
The Moderna mRNA COVID-19 vaccine was associated with an excess risk of myocarditis, demonstrating a standardized morbidity ratio of 22.53 compared to the lowest background incidence.
Why the study?
The study was conducted to assess the reporting rates of myocarditis and pericarditis as adverse drug reactions for mRNA COVID-19 vaccines authorized in Europe.
Does mRNA COVID-19 vaccination increase the risk of myocarditis and pericarditis in the European population?
Observational (n=557,868,504)
Yes
Does mRNA COVID-19 vaccination increase the risk of myocarditis and pericarditis in the European population?
Effect estimate: SMR 22.53 (95% CI 21.31-23.81)
Absolute Event Rate: 1269% vs 56.32%
There is an excess risk of myocarditis following the first dose of mRNA COVID-19 vaccines in Europe, with CX-024414 showing a higher reporting rate than TOZINAMERAN.
May warrant post-vaccination myocarditis monitoring in Europe; leaves open comparative risks across mRNA platforms and long-term outcomes.
Purpose To assess myocarditis and pericarditis reporting rate as adverse drug reactions (ADRs) for the messenger ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccines authorized in Europe. Methods Data on myocarditis and pericarditis related to mRNA COVID-19 vaccines (period: January 1, 2021 - February 11, 2022) were collected from the EudraVigilance database and combined with the European Centre for Disease Prevention and Control’s (ECDC) vaccination tracker database. The reporting rate was expressed as 1 million individual vaccinated-days with a corresponding 95% confidence interval (CI), and an observed-to-expected (OE) analysis was performed to check if there was an excess risk for myocarditis or pericarditis following mRNA COVID-19 vaccination. Results The reporting rate of myocarditis per 1 million individual vaccinated-days in the study period was 17.27 (95% CI, 16.34-18.26) for the CX-024414 vaccine and 8.44 (95% CI, 8.18-8.70) for TOZINAMERAN vaccine. The reporting rate for pericarditis per 1 million individual vaccinated-days in the study period was 9.76 (95% CI, 9.06-10.51) for the CX-024414 vaccine and 5.79 (95% CI, 5.56-6.01) for TOZINAMERAN vaccine. The OE analysis showed that both vaccines produced a myocarditis standardized morbidity ratio (SMR) greater than 1, with the CX-024414 vaccine having a greater SMR than TOZINAMERAN. Regarding TOZINAMERAN, SMR for pericarditis was greater than 1 when considering the lowest background incidence, but smaller than 1 when considering the highest background incidence. Conclusions Our results suggest an excess risk of myocarditis following the first dose of mRNA COVID-19 vaccine, but the relationship between pericarditis and mRNA COVID-19 vaccine remains unclear.
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Tome et al. (2022) conducted an observational in Myocarditis and pericarditis (n=557,868,504). Moderna (CX-024414) and Pfizer-BioNTech (TOZINAMERAN) mRNA COVID-19 vaccines vs. Background incidence was evaluated on Myocarditis standardized morbidity ratio (SMR) for Moderna (CX-024414) vs lowest background incidence (SMR 22.53, 95% CI 21.31-23.81). The Moderna mRNA COVID-19 vaccine was associated with an excess risk of myocarditis, demonstrating a standardized morbidity ratio of 22.53 compared to the lowest background incidence.
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