Assessment of risk factors for Myocarditis in the United States (US) using Electronic Health Records and Claims data

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  COMIRNATY
• Medical condition to be studied:
  Myocarditis

  COVID-19

  COVID-19 immunisation

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  Assess and compare demographic, medical history, and comorbidities that may be risk factors for myocarditis.
• Outcomes:
  To assess and compare demographic, medical history, and comorbidities that may be risk factors for myocarditis in each of three cohorts: 1) Myocarditis after mRNA COVID-19 vaccine, 2) Myocarditis after SARS-CoV-2 infection (2020-2022), or 3) Acute/viral myocarditis prior to the COVID-19 era (pre-2020). 1. To examine the risk factors in each myocarditis cohort stratified by age group at diagnosis, sex, time period and follow-up time (years). 2. To assess and compare the validity of myocarditis diagnosis case definitions in administrative data for each cohort, via calculating the PPV(Positive predictive value) using electronic medical record review.
• Data analysis plan:
  In primary analyses, descriptive statistics will be presented to characterize myocarditis patients in terms of demographic and clinical characteristics as of the index date,Additionally, we will examine clinical characteristics, including patient’s history for myocarditis pre-2020, post SARS-CoV-2 infection, and post mRNA COVID-19 vaccine cohorts, through utilization of logistic regression models will be used to estimate odds ratios (ORs) and 95% CIs of associations between demographics, clinical characteristics, and empirical model identified risk factor and myocarditis