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 Administration warning will likely 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. That comes among more than 150 million people who have received either the Pfizer or Moderna vaccine, said Politico.
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," Doran Fink, deputy director of FDA's vaccines division, told 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.
Children's Hospital Colorado Pediatric Cardiologist Dr. Pei-Ni Jone told the American Heart Association that if someone endures chest pain within the first few days of getting the COVID-19 vaccine, they should go to the emergency room.
She also still independently recommended vaccination.
"Getting COVID or MIS-C is a lot worse than myocarditis/pericarditis from the vaccine," Dr. Jone said.
The KYW Newsradio staff contributed to this report.