mRNA COVID-19 Vaccination and Development of CMR-confirmed Myopericarditis

  1. Tahir Kafil
  2. Mariana M Lamacie
  3. Sophie Chenier
  4. Heather Taggart
  5. Nina Ghosh
  6. Alexander Dick
  7. Gary Small
  8. Peter Liu
  9. Rob S Beanlands
  10. Lisa Mielniczuk
  11. David Birnie
  12. Andrew M Crean

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

During the process of open peer review on MedRxiv we quickly received a number of messages from reviewers concerned that there was a problem with our reported incidence of myocarditis post mRNA vaccination. Our reported incidence appeared vastly inflated by an incorrectly small denominator (ie number of doses administered over the time period of the study). We reviewed the data available at Open Ottawa and found that there had indeed been a major underestimation, with the actual number of administered doses being more than 800,000 (much higher than quoted in the paper).

In order to avoid misleading either colleagues or the general public and press, we the authors unanimously wish to withdraw this paper on the grounds of incorrect incidence data. We thank the many peer reviewers who went out of their way to contact us and point out our error. We apologize to anyone who may have been upset or disturbed by our report.

In summary, the authors have withdrawn this manuscript because of a major error pertaining to the quoted incidence data. Therefore, the authors do not wish this work to be cited as reference for the project. If you have any questions, please contact the corresponding author.

Article activity feed

  1. Version published to 10.1101/2021.09.13.21262182v2 on medRxiv
  2. ScreenIT

    SciScore for 10.1101/2021.09.13.21262182: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Institutional Review Board (IRB): This was an IRB-approved HIPPA/PHIPPA compliant study.
    Consent: The need for informed consent was waived by the IRB.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    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:
    The authors themselves raise this as a limitation of their study. Data from the Center for Disease Control (CDC) also report a lower incidence than that in our study. Using myocarditis cases reported to VAERS with onset within 7 days after dose 2 of an mRNA vaccine, crude reporting rates (i.e., using confirmed and unconfirmed cases) per million second dose recipients were calculated using national COVID-19 vaccine administration data as of June 11, 2021. The highest reporting rates were among males aged 12-17 years and those aged 18-24 years (62.8 and 50.5 reported myocarditis cases per million second doses of mRNA COVID-19 vaccine administered, respectively). We were not able to break down the denominator of all vaccinations in the Ottawa area by age. Therefore, although our patients were largely in the vulnerable 18-30 age category, our denominator included the full adult age spectrum. As such it is possible that the numbers, we quote are an underestimate of incidence for the 18-30 age group itself. In support of this, is the initial report from Israel of a 1 in 3000 to 1 in 6000 incidence of myocarditis following vaccination in young adults(9). Most reports have emphasized mild illness and brief in-hospital stay – and this was our experience also. However, one of the larger cohorts to date described the need for heart failure treatment in 40% of its myocarditis patients (despite an absence of prior heart failure episodes) and intensive care in 10%(14). That report also dem...

    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.
    • No protocol registration statement was detected.

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

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.09.13.21262182v1 on medRxiv