FDA Set To Include Warning Of Rare Heart Inflammation Symptom To Pfizer & Moderna Vaccines
Food and Drug Administration (FDA) said Wednesday it is preparing to add a warning about a rare heart condition as a side effect in some adolescents and young adults to fact file for the vaccines produced by Pfizer/BioNTech and Moderna.
The Centers for Disease Control and Prevention advisory groups also had a meeting to debate reported cases of heart inflammation after vaccination. The meeting ended with the conclusion that the benefits to patients clearly outweigh the risk.
The CDC said that patients with heart inflammation after vaccination generally recover from the symptoms and do well.
“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” CDC experts and other health experts said in the joint statement. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”