U.S. FDA Awards Dr. Jain $1.9 million to Support Research on COVID-19 Vaccine-Associated Myocarditis

Supriya Jain, M.D., clinical associate professor of pediatrics and of radiology and clinical education liaison at New York Medical College (NYMC), has been awarded a Broad Agency Agreement (BAA) of $1,997,031 over five years by the Food and Drug Administration (FDA) to support groundbreaking research on COVID vaccine-associated myocarditis using advanced cardiovascular imaging, including cardiac MRI (CMR). Dr. Jain will lead a collaborative research network of clinical investigators spanning more than 30 U.S. medical institutions.

“Immunizations are the most important measure against COVID-19 and are highly effective in preventing serious clinical complications. A very rare but serious adverse effect—COVID vaccine-associated myocarditis—had been reported in some patients,” said Dr. Jain, a pediatric cardiologist and a cardiac imaging specialist, who serves as director of pediatric cardiac MRI/advanced cardiovascular imaging at Maria Fareri Children’s Hospital, a major clinical affiliate of NYMC. “In June 2021, the Centers for Disease Control and Prevention (CDC) observed a rate of post-vaccine myocarditis that was higher in adolescents and young adults than the expected baseline,” said Dr. Jain. This latest study builds on earlier studies initiated and led by Dr. Jain that began with 63 patients from across 16 U.S. hospitals who were under 21 years old with a diagnosis of myocarditis following COVID-19 vaccination.

Since that time, Dr. Jain has built a large collaborative research network of clinical investigators with expertise in both cardiology and advanced cardiovascular imaging including cardiac MRI (CMR) that spans more than 30 medical institutions across the U.S. and includes more than 300 patients. As the principal investigator of the study known as MACiV: Myocarditis After COVID Vaccination, she is currently leading a larger retrospective observational study and beginning a comprehensive prospective multicenter study. The multicenter study will rigorously follow-up and monitor children, adolescents and young adults with vaccine-associated myocarditis to evaluate their long-term outcomes and compare them with other types of myocarditis, including those related to COVID-19 and especially multisystem inflammatory syndrome in children (MIS-C). “Because myocardial tissue involvement may predispose some patients to cardiac complications in the future, including heart failure, dilated cardiomyopathy and/or arrhythmias, it is important that we study these patients over a long period of time and improve our understanding into the spectrum and severity of this rare complication.”

With active endorsement from the Society of Cardiovascular Magnetic Resonance (SCMR), a professional international organization of CMR experts and support from the FDA, Dr. Jain plans to study the natural history of this condition across different groups, understand the risk factors, variations in management and outcomes along with examining factors that may influence prognosis and quality of life in these patients.