A pharmacoepidemiological study of myocarditis and pericarditis following mRNA COVID-19 vaccination in Europe

  1. Joana Tome
  2. Logan T. Cowan
  3. Isaac Chun-Hai Fung

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Abstract

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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  1. Version published to 10.1101/2022.05.27.22275706v2 on medRxiv
  2. ScreenIT

    SciScore for 10.1101/2022.05.27.22275706: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study is subject to certain limitations. First, we cannot directly compare the reporting rate of myocarditis or pericarditis to the incidence rate in the general EU/EEA population because they represent different measures that use different definitions of the time at risk. Consequently, whether the incidence of myocarditis or pericarditis is higher in vaccinated people than in the general population is beyond the scope of this study. Since we do not know the exact background incidence rate, which may vary substantially among different vaccine group populations, as well as knowing that the data were based on different assumptions,28 the findings should be interpreted with caution. Second, we cannot exclude the possibility of ADRs’ registration underestimation. There is a possibility of underreporting myocarditis and pericarditis, which can impose non-differential misclassification. Third, we were unable to calculate myocarditis and pericarditis incidence for each vaccine that is adjusted for demographics and other factors because the information on confounding is absent; except for sex and age group, information on other variables was missing. Fourth, the reporting rates were not standardized for age due to the unavailability of the data; therefore, we were unable to perform a stratified OE analysis. A vaccine’s safety profile may vary depending on the target population (e.g., higher risks in the youngest age groups); therefore, comparing reporting rates for age groups or ...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.

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  3. Version published to 10.1101/2022.05.27.22275706v1 on medRxiv