Low Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age \<21 years. 2. Have 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 7 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Are 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. 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.
• Cohort 1/2:
‣ Age \<21 years.
⁃ Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
⁃ Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
⁃ Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
⁃ 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:
‣ Age \<21 years.
⁃ Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
⁃ COVID-19-related disease
• Acute COVID-19 infection OR
∙ Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
⁃ Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY
• 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
∙ Confirmed myocarditis/pericarditis as defined by:
‣ Histopathologic confirmation of myocarditis OR
⁃ Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
⁃ 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.