Warnings about the rare risk of developing inflammatory heart conditions will soon be added to Moderna and Pfizer vaccines, Politico reported Thursday.
A Food and Drug Admiration warning will likely will note that there may be a risk of developing myocarditis or pericarditis within a week after receiving a second dose of either the Pfizer or Moderna shots, and that most cases appear to resolve themselves, said the outlet. Long-term effects are still unclear.
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Myocarditis is inflammation of the heart muscle and pericarditis involves inflammation of the membrane surrounding the heart, according to the Mayo Clinic.
So far, the conditions are rare, with around 1,200 cases under investigation as of June 11 among more than 150 million people who have received either the Pfizer or Moderna vaccine, said Politico. According to NPR, there have been just 323 confirmed cases.
An FDA official said the administration would work rapidly to add warning fact sheets about the side effect Wednesday during a Centers for Disease Control and Prevention advisory meeting, according to Politico.
"Based on the available data, a warning statement in the fact sheets for both health care providers and vaccine recipients and caregivers would be warranted in this situation," said Doran Fink, deputy director of FDA's vaccines division, according to Politico.
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Analysis presented at the meeting showed that a CDC safety panel determined there is a “likely association” between the two vaccines – both two-dose mRNA vaccines – and cases of myocarditis as well as pericarditis.
According to Politico, an FDA advisory committee also discussed the link between the vaccines and inflammatory heart conditions earlier this month and health officials are particularly focused on cases seen in people 30 and younger.
If people think they may be experiencing myocarditis or pericarditis after receiving a COVID-19 vaccine, they should contact their doctor or visit an emergency room, Dr. Kristen Sexson Tejtel, a cardiologist at Texas Children's Hospital, told NPR.