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Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims

Hui-Lee Wong1, Mao Hu2, Cindy Ke Zhou1

  • 1Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Lancet (London, England)
|June 12, 2022
PubMed
Abstract

Insights

COVID-19 mRNA vaccines showed a rare increased risk of myocarditis or pericarditis, particularly in young men after the second dose. The study found no statistically significant difference between Moderna (mRNA-1273) and Pfizer-BioNTech (BNT162b2) vaccines.

Area of Science:

  • Cardiology
  • Vaccinology
  • Public Health

Background:

  • Passive surveillance indicated potential myocarditis/pericarditis risks post-COVID-19 mRNA vaccination, especially in young males.
  • Active surveillance is crucial for precise risk assessment and direct vaccine comparisons.

Purpose of the Study:

  • To actively surveil and compare the risks of myocarditis or pericarditis following mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccinations.
  • To quantify and directly compare risks using large healthcare databases.

Main Methods:

  • Retrospective cohort study using US health plan claims data (ages 18-64).
  • International Classification of Diseases codes identified myocarditis/pericarditis events within 1-7 days post-vaccination.
  • Multivariate Poisson regression and meta-analyses compared incidence rates and incidence rate ratios (IRRs) between mRNA-1273 and BNT162b2.

Main Results:

  • 411 events observed among over 25 million vaccine doses administered.
  • Highest pooled incidence rate in males aged 18-25 after the second dose: 1.71/100,000 person-days for BNT162b2 and 2.17/100,000 person-days for mRNA-1273.
  • Pooled IRR was 1.43 (95% CI 0.88-2.34), indicating no statistically significant difference, though a slight excess risk for mRNA-1273 was noted.

Conclusions:

  • An elevated risk of myocarditis/pericarditis exists post-COVID-19 mRNA vaccination, most pronounced in young males after dose two, but remains rare.
  • No statistically significant risk difference was detected between mRNA-1273 and BNT162b2, though a potential difference cannot be excluded.
  • The study supports the continued use of both mRNA vaccines, considering their overall benefit-risk profile.

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