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Analysis of Myocarditis Among 252 Million mRNA-1273 Recipients Worldwide

Walter Straus1, Veronica Urdaneta1, Daina B Esposito1

  • 1Clinical Safety and Pharmacovigilance, Moderna, Inc., Cambridge, Massachusetts, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|June 6, 2022
PubMed
Abstract

Insights

Myocarditis risk following mRNA-1273 COVID-19 vaccination is rare overall but elevated in young males after dose 2. This study analyzed global safety data to assess these rare myocarditis/myopericarditis events.

Area of Science:

  • Cardiology
  • Immunology
  • Public Health

Background:

  • Growing evidence links SARS-CoV-2 infection to myocarditis.
  • Myocarditis is a rare safety event post-mRNA COVID-19 vaccination, especially in young males after the second dose.
  • This study investigates myocarditis/myopericarditis reports in mRNA-1273 vaccine recipients.

Purpose of the Study:

  • To evaluate the risk of myocarditis/myopericarditis following mRNA-1273 vaccination.
  • To compare observed myocarditis rates with expected population rates.
  • To identify specific demographic groups at higher risk.

Main Methods:

  • Reviewed 3017 myocarditis/myopericarditis cases from the Moderna global safety database (Dec 2020-Feb 2022).
  • Calculated reported rates by age and sex after mRNA-1273 (Moderna) vaccine doses.
  • Compared observed rates to population-based incidence rates, calculating observed-to-expected rate ratios (RRs).

Main Results:

  • Overall myocarditis/myopericarditis reporting rate (9.23/100,000 person-years) was similar to the expected rate (9.0/100,000 person-years).
  • Males aged 18-24 years showed a higher observed rate (53.76/100,000 person-years; RR 3.10) compared to expected rates.
  • Most cases in this demographic occurred within 7 days after the second mRNA-1273 vaccine dose.

Conclusions:

  • Myocarditis/myopericarditis rates are not elevated overall in mRNA-1273 recipients.
  • A higher-than-expected rate of myocarditis/myopericarditis was observed in males aged 18-24 years.
  • The elevated risk in young males is primarily associated with the second dose, occurring within 7 days post-vaccination.
Keywords:
COVID-19SARS-CoV-2myocarditispharmacovigilancevaccination

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