(296) Study of Myocarditis and Pericarditis Following Vaccination with COMIRNATY in Persons Under 21 Years of Age

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1341

Presenting Author(s)

Cynthia De Luise, MPH, PhD
– Pfizer Inc, New York, New York, United States

Co-Author(s)

Stephan Lanes, PhD, MPH
– Principal Scientist, Safety and Epidemiology, HealthCore, Inc., Wilmington, DE, United States
Julia Coleman, BA
– Project Manager Senior, Clinical Research, HealthCore, Inc, Andover, MA, United States
Bing Cai, PhD
– Sr. Director, Biostatistics, Vaccine Clinical Research and Development, Pfizer, Inc, Collegeville, PA, United States
Brian Harty, MA
– Senior Research Scientist/Biostatistician, Clinical Research, HealthCore, Inc, Andover, MA, United States
Julie E. Miller, MPH, PMP
– Staff Vice President, Clinical Research, HealthCore, Inc, Andover, MA, United States
Devon Payne, BA
– Clinical Study Team Lead, Global Product Development, Pfizer, Inc., Seattle, WA, United States
Katie Kendrick, MPH
– Project Manager, Safety Surveillance Research, Pfizer, Inc., United States
Gail Pearson, MD, ScD
– Associate Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (NHLBI)/NIH, Bethesda, MD, United States
Dongngan Truong, MD, MS
– Associate Professor of Pediatrics, Division of Pediatric Cardiology University of Utah/Primary Children’s Hospital, Salt Lake City, UT, United States
Jane Newburger, MD, MPH
– Commonwealth Professor of Pediatrics, Dept of Cardiology, Boston Children's Hospital, Dept of Pediatrics, Harvard Medical School, Boston, MA, United States

Background: While available short-term data for myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines are reassuring, the potential long-term sequelae associated with myocarditis/pericarditis following mRNA vaccination are unknown.

Objectives: To evaluate the clinical course, long-term sequelae, risk factors, time to resolution and impact on quality of life of myocarditis/pericarditis associated with BNT162b2 in persons less than 21 years of age.

Methods: This cohort study seeks to identify 300 cases of myocarditis/pericarditis following BNT162b2 vaccination in persons less than 21 years at approximately 30 centers of the Pediatric Heart Network (PHN), a National Heart, Lung, and Blood Institute-funded consortium of research hospitals in the US and Canada. PHN investigators have already confirmed 131 cases of post-BNT162b2 myocarditis/pericarditis at 26 PHN centers. To assist in understanding possible long-term sequelae, the PHN will conduct follow-up of these as well as new cases. Cases of post-BNT162b2 myocarditis/pericarditis will be compared to myocarditis/pericarditis associated with COVID-19 disease, including the Multi-system Inflammatory Syndrome in Children (MIS-C). All participants will be followed in person through a 6-month visit (longer if symptoms persist) with electrocardiograms, echocardiograms, exercise stress tests, and ambulatory monitoring. Annual medical history forms and patient-reported outcome measures to assess quality of life factors will be obtained for up to 5 years after illness onset. Data from cardiac magnetic resonance imaging (cMRI) will be collected when ordered as part of routine clinical care. Electrocardiographic, echocardiographic, and cMRI Core Labs will perform standardized evaluations of the cardiac tests. Data analyses for this study will be descriptive, and no formal hypotheses will be tested.

Results: Most of the 131 cases of myocarditis already identified in persons < 21 years following vaccination with BNT162b2 have had a mild clinical course with rapid resolution of symptoms despite all having laboratory evidence of myocardial injury and the majority having abnormal cardiac MRIs. Follow-up of these cases along with the collection of additional cases of myocarditis/pericarditis following vaccination with BNT162b2 will continue for up to 5 years or resolution.

Conclusions: This will be the first multi-center study to use standardized assessments to evaluate the clinical spectrum of myocarditis/pericarditis after vaccination with BNT162b2 and will provide critical information on the timing of resolution of myocardial injury, long-term outcomes and impact on quality of life.