FDA to issue warning label for mRNA vaccines due to increase in myocarditis, pericarditis cases

INDIANAPOLIS (WISH) – The Food and Drug Administration is expected to add a warning to the Centers for Disease Control and Prevention’s fact sheet about the risk of myocarditis and pericarditis following the second dose of the Pfizer and Moderna vaccine.

• Listen to this story

Myocarditis is characterized as inflammation of the heart muscle. Pericarditis is inflammation of the tissue surrounding the heart. Symptoms include chest pain, shortness of breath and heart palpitations. They typically appear within a week after the second dose of the mRNA vaccine.

The CDC is calling for more transparency about the risk of the conditions for parents, patients and health care providers prior to vaccination. FDA members say there is not enough evidence to know why the conditions are so prominent in people after receiving a second vaccine and patient follow-up after the first vaccine dose would help scientists gain this understanding. They also spoke about delaying the second vaccine dose.

However, officials stated the number of heart problems following vaccination is exceedingly small and, in most cases, the symptoms are mild and treatable. A person is more likely to get myocarditis if infected with the coronavirus and the complications are often more severe.

The CDC says 323 cases of heart inflammation have been confirmed after the second dose of the Pfizer or Moderna vaccine. More than 250 possible cases are still being investigated.