The U.S. Food and Drug Administration on June 25 announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines in light of new evidence suggesting increased risks of myocarditis and pericarditis following vaccination.

These revisions follow a discussion by the CDC Advisory Committee on Immunization Practice (ACIP) on June 23 which thoroughly reviewed existing scientific evidence and determined a "likely association" between the two mRNA vaccines and cases of myocarditis and pericarditis. Over 150 million people have received either the Pfizer or Moderna vaccine, with the rare 1,200 plus cases predominantly occurring in males under 30 following the second dose of an mRNA vaccine. Of these cases, most involved symptoms appearing within a few days of vaccination and resolving on their own.

The updated fact sheets state that vaccine recipients should seek medical attention immediately if they experience "chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination." The FDA stated that, alongside the Centers for Disease Control and Prevention, it is continuing to monitor longer term outcomes and collecting data. No orders to stop vaccine administration due to the reports have been made.

"The ACC encourages all eligible people to get the COVID-19 vaccine as soon as possible and strongly agrees that the benefits of the vaccine, both for the individual and greater public good, far outweigh any risks," said ACC President Dipti Itchhaporia, MD, FACC, and Eric Stecker, MD, MPH, FACC, chair of ACC's Science and Quality Committee. "The FDA's new warning statement on the Moderna and Pfizer COVID-19 vaccines on potential risk for myocarditis should not overly alarm those being vaccinated and parents determining whether to vaccinate their children. Myocarditis is a very rare and treatable condition from which most patients fully recover with minimal treatment. While no one wants exposure to a potential complication, the risks from vaccination are much lower than remaining unvaccinated. Unvaccinated individuals, including adolescents, are at risk of not only myocarditis, but also more serious complications that can lead to hospitalization and death. As ever-more-infectious variants arise and pandemic fatigue sets in, the role of vaccination has become critical. We encourage everyone with concerns to consult with their health care clinicians, but we would provide maximum reassurance. After millions of adolescents and many tens of millions of adults have received COVID vaccination, the data are clear; the vaccine is safe and effective, will save lives, and can end the COVID-19 pandemic."

The College continues to provide information and analysis on the latest COVID-19 clinical and policy guidance on ACC's COVID-19 Hub at ACC.org/COVID19.

Clinical Topics: Cardiovascular Care Team, COVID-19 Hub, Heart Failure and Cardiomyopathies, Pericardial Disease, Prevention

Keywords: Coronavirus, ACC Advocacy, COVID-19, Advisory Committees, Pandemics, Myocarditis, United States Food and Drug Administration, RNA, Messenger, Vaccination, Vaccines, Immunization, Pericarditis, Delivery of Health Care, Chest Pain, Hospitalization, Centers for Disease Control and Prevention, U.S., Policy, Dyspnea

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