The Food and Drug Administration on Saturday revised its Pfizer and Moderna guidance for patients and providers to include a warning about myocarditis and pericarditis.
The update follows a Wednesday meeting of the CDC’s Advisory Committee on Immunization Practices, during which the adverse event of heart inflammation was discussed.
The fact sheets for health care providers now warn about the incidents and advise medical attention for patients experiencing chest pain, shortness of breath, or fast-beating, fluttering, or pounding heart after vaccination.
Myocarditis is inflammation of the heart muscle, and is typically more common in teen boys and younger men.
Unlike myocarditis caused by the vaccines, traditional myocarditis is most often caused by viruses, such as Hepatitis C, HIV, and Influenza A. Heart inflammation can also be caused by parasitic, fungal, and bacterial agents, as well as illicit drugs, prescription medications, and immunological syndromes.
Symptoms can include chest pain, pressure or discomfort, shortness of breath, and palpitations. Traditional myocarditis can be treated with supportive care, such as oxygen or fluids, anti-inflammatory medicines, or in severe cases, with mechanical support or a heart transplant. Unlike the incidents related to the vaccines, traditional myocarditis is usually more severe. But for both cases, patients must reduce exercise for three to six months.
“There are viruses that cause myocarditis and it can be quite severe, meaning it can cause chronic disease, which can lead to a heart transplant. It can cause severe acute disease that can lead to death and ICU admission. So that’s not this,” said Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.
“The myocarditis following these MrNA vaccines … is short-lived, temporary, self-resolving, a mild inflammation of the heart that goes away. It’s not based, obviously, on viruses reproducing themselves to the heart muscle because you’re not getting the virus … So this is a very different thing.”
People who develop myocarditis after the first dose of the COVID-19 vaccine should talk to their doctors before getting the second shot.
Experts say the benefits far outweigh the risks. The overall efficacy of the MrNA vaccine is 95%. In December, there were about 250,000 COVID-19 cases and 3,000 deaths per day. By comparison, after millions of Americans were vaccinated by June, there were about 13,000 COVID cases and 300 deaths per day.