Low-Interventional Cohort Study of Myocarditis/Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age

Study on Heart Inflammation in Young People After Investigational COVID-19 Vaccine

R
R. Mark Payne, MD

Primary Investigator

Enrolling By Invitation
21 years or below
All
Phase N/A
4 participants needed
1 Location

Brief description of study

The main reason for this research study is to learn more about myocarditis and pericarditis (called myocarditis in this document) following vaccination with the Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY). Myocarditis is inflammation of the muscle of the heart, and pericarditis is inflammation of the tissue that forms a sac around the heart. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants in all cohorts will be those who present to participating medical centers for care. Enrollment will include approximately 300 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).  This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)'s Pediatric Heart Network (PHN) and Pfizer. 

Detailed description of study

This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.

To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 7 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment.

To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows:

Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or

Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled > 2 weeks after hospital discharge. Participants can be retrospectively 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, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myocarditis, Riley
  • Age: 21 years or below
  • Gender: All

Inclusion Criteria:

  • Cohort 1/2:
    1. Age <21 years.
    2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
    3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
    4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
    5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
  • Cohort 3:
    1. Age <21 years.
    2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
    3. COVID-19-related disease
      1. Acute COVID-19 infection OR
      2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
    4. Probable or confirmed myocarditis/pericarditis* not temporally related to vaccination with COMINARTY
      1. Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:
        • Elevated troponin above upper limit of normal
        • Abnormal ECG or rhythm monitoring finding consistent with myocarditis
        • Abnormal cardiac function or wall motion abnormalities on echocardiogram
        • cMRI findings consistent with myocarditis OR
      2. Confirmed myocarditis/pericarditis as defined by:
        • Histopathologic confirmation of myocarditis OR
        • Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
    5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.

Exclusion Criteria:

  1. A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.
  2. Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of:
    1. Bicommissural aortic valve with < trivial stenosis and/or insufficiency
    2. Mitral valve prolapse with < trivial insufficiency
    3. Hemodynamically insignificant atrial septal or ventricular septal defects.
  3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).

This study investigates myocarditis and pericarditis in people under 21 who received the Pfizer-BioNTech COVID-19 vaccine. Myocarditis is when the heart muscle becomes inflamed, and pericarditis is when the sac around the heart gets inflamed. The study aims to see if these conditions are related to the vaccine or COVID-19 itself.

Participants will undergo cardiac imaging tests and follow-up visits over time. The study will compare those with vaccine-associated heart inflammation to those with COVID-19-related heart inflammation, including a condition called MIS-C, which is a serious inflammatory condition.

  • Who can participate: Participants must be under 21 with myocarditis or pericarditis after receiving the investigational COVID-19 vaccine or due to COVID-19. They must have been evaluated in an emergency room or hospitalized and meet CDC definitions for these conditions.
  • Study details: Participants will have regular heart imaging tests to monitor their condition and track their health over time to understand the long-term effects. No specific treatment will be provided as part of the study.
  • Study timelines: The study will last up to 5 years.
Updated on 06 Mar 2026. Study ID: PCTR-HEALTHCORE-CAMP, 16384
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only