The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention, are investigating reports that the Moderna COVID-19 vaccine may be associated with a higher risk of a heart condition than previously thought.
According to The Washington Post, the investigation is looking at the rate at which younger adults who have been vaccinated with Moderna’s COVID-19 vaccine are developing myocarditis, an inflammation of the heart.
The Post cites two unnamed people familiar with the agencies’ ongoing review of the vaccine that gained FDA Emergency Use Authorization in December 2020.
According to the story, the review is focusing on Canadian studies that seem to suggest that myocarditis is present in young people who were given the Moderna vaccine more than in those given the Pfizer-BioNTech vaccine.
The instances of heart inflammation were seen especially in males below the age of 30.
In June, the CDC launched a review into a potential link between myocarditis and the mRNA vaccine. The FDA added a warning label about the increased risk of myocarditis to both Moderna and Pfizer’s COVID-19 vaccines.
The incidents of myocarditis are extremely rare and the condition generally clears up without complications, according to the CDC. In one study, among 2,000,287 people receiving at least one COVID-19 shot, there were 20 documented cases of myocarditis, or 1.0 cases per 100,000 vaccinations.
FDA spokeswoman Stephanie Caccomo told The Post that although the agency will not comment on internal meetings or discussions, “we can say that FDA is absolutely committed to reviewing data as it becomes available to us. We have previously communicated about myocarditis and COVID-19 vaccines and if new information changes the risk/benefit profile, we will update the public accordingly.”
The symptoms of myocarditis include chest pain, shortness of breath, feelings of having a fast-beating, fluttering or pounding heart.
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