FDA and CDC-Led Study Reveals Myocarditis Risk Following mRNA COVID-19 Vaccination in Adolescents and Young Adults
Pfizer
Pharmaceutical R&D Developer
BioNTech
Developer of Novel Biologics
FDA
U.S. Food and Drug Administration
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is an agency under the U.S. Department of Health and Human Services, with its headquarters located in Atlanta, Georgia. As a federal government administrative agency, the CDC provides reliable information to protect public health and safety. Through strong partnerships with national health departments and other organizations, it aims to enhance health-related decision-making and promote the well-being of citizens.
Emory University
Emory University is a prestigious private research university.
A latest study published in the JAMA Network, a journal under the American Medical Association, investigated the vaccination of the U.S. population.Pfizer/BioNTech (hereinafter referred to as Pfizer) and Moderna vaccines after the risk of myocarditis. The study was conducted by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), Duke University, Emory University, and other research institutions and hospitals.
The study used data obtained from the CDC's VAERS reporting system, which were cross-checked to ensure compliance with the CDC's definition of myocarditis.
The researchers pointed out that, given the passivity of the VAERS system, the number of reported incidents may underestimate the extent of the phenomenon.
The team studied 1,626 cases of myocarditis, and the results showed that the Pfizer vaccine was most strongly associated with a higher risk of myocarditis. In the 16 to 17-year-old male age group, the incidence after the second dose was 105.9 cases per million; in the 12 to 15-year-old male age group, it was 70.7 cases per million after the second dose. In the 18 to 24-year-old male age group, the incidence rates of myocarditis were also significantly higher for both the Pfizer and Moderna vaccines, at 52.4 cases per million and 56.3 cases per million, respectively.
The study found that the median time for symptom onset was two days, and 82% of the cases were male, which is consistent with previous studies. Approximately 96% of patients were hospitalized, with most patients treated with non-steroidal anti-inflammatory drugs, and 87% of hospitalized patients had symptoms resolved at discharge.
The reported symptoms include: chest pain, pressure or discomfort (89%), shortness of breath (30%), abnormal electrocardiogram results (72%), and abnormal cardiac magnetic resonance imaging results (72%).
Given a large number of studies confirming the link between vaccination and myocarditis, the CDC has begun active surveillance of adolescents and young adults to monitor the progression of heart-related events following vaccination. However, long-term outcome data is not yet available.
Meanwhile, the American Heart Association and the American College of Cardiology recommend that patients with myocarditis should avoid competitive sports for three to six months and can only resume intense exercise after obtaining normal ECG and other test results. In addition, they also suggest postponing further doses of the mRNA vaccine.BioValleyBioon.com）