Vials of Pfizer BioNTech and Moderna Coronavirus Disease (COVID-19) vaccine labels can be seen in this illustration image taken on March 19, 2021.
Given Ruvic | Reuters
The U.S. Food and Drug Administration on Friday added a warning to patient and supplier data sheets for the Pfizer and Moderna Covid-19 vaccines to warn of a rare risk of heart inflammation.
For each vaccine, the leaflet has been revised to include a warning of myocarditis and pericarditis after the second dose and the onset of symptoms within a few days of receiving the vaccination.
Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue that surrounds the heart. Health officials said the vaccine’s benefits still outweigh the risk.
“The risk of myocarditis and pericarditis appears to be very small given the number of vaccine doses given,” Janet Woodcock, acting FDA commissioner, said in a statement.
“The benefits of the Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and the associated potentially serious complications,” she said.
The FDA update follows a review and discussion by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention on Wednesday.
According to presentation slides from the CDC meeting, there have been more than 1,200 cases of myocarditis or pericarditis, mostly in those under 30 who received the injections.
About 300 million shots had been administered by June 11, according to the CDC. For both vaccines combined, there were only 12.6 cases of heart inflammation per million doses.
– CNBC’s Berkeley Lovelace Jr. contributed to the coverage