Interim Analysis of Myocarditis and Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  COMIRNATY
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN01) covid-19, RNA-based vaccine

  covid-19, RNA-based vaccine

Population studied

• Short description of the study population:
  This study uses data from three cohorts of participants in the ongoing C4591036 study:; ; Cohort 1: Prospectively ascertained cases of probable or confirmed ; myocarditis/pericarditis associated with COMIRNATY, i.e., participants enrolled ; under the protocol during hospitalization or ≤ 2 weeks after hospital discharge.; ; Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis /; pericarditis associated with COMIRNATY, i.e., participants enrolled >2 weeks after ; hospital discharge (combination of retrospective data collection from electronic ; medical records (EMRs) and prospective data from the time that the participant signs ; informed consent/assent). Participants can be retrospectively or prospectively ; ascertained and enrolled at any time from their COMIRNATY-associated ; myocarditis/pericarditis.; ; Cohort 3: Comparator cohort of COVID-19-related myocarditis/pericarditis, including ; MIS-C. Participants can be retrospectively or prospectively ascertained and enrolled ; at any time from their COVID-19 or MIS-C-associated myocarditis/pericarditis. ; Cohort 3 participants will not be separated into COVID-19-associated ; myocarditis/pericarditis with or without MIS-C because of the rarity of myocardial ; involvement in children with acute severe COVID-19.

Study design details

• Study design:
  This is an interim analysis based on data from the ongoing C4591036 study, “Low- interventional Study of Myocarditis and Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age.”
• Main study objective:
  Primary objective: ; The primary objective of this study is to characterize the potential long-term sequelae associated with myocarditis/pericarditis following COMIRNATY vaccination in persons <21 years old.; ; Secondary objectives:; 1) To characterize the acute course (hospital admission/emergency room (ER) evaluation to discharge) of COMIRNATY-associated myocarditis/pericarditis in persons <21 years old.; 2) To compare acute and long-term cardiac outcomes of COMIRNATY-associated myocarditis/pericarditis with those of myocarditis/pericarditis associated with COVID-19, including the multisystem inflammatory syndrome in children associated with COVID-19 in persons <21 years old (MIS-C).; 3) To identify possible sociodemographic and medical risk factors, such as age, sex assigned at birth, race, ethnicity, insurance, and zip code, for greater frequency and severity of long-term cardiac sequelae in persons <21 years old.