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Vials with labels for the Pfizer-BioNTech vaccine and the coronavirus disease (COVID-19) are shown in this illustration taken on March 19, 2021.
given by ruvich | Reuters
The U.S. Food and Drug Administration on Friday added a warning to its patient and provider fact sheets about the Pfizer and Modern-19 vaccines to indicate a rare risk of heart infection.
For each vaccine, the fact sheets were reviewed to include a warning about myocarditis and pericarditis after the second dose and with symptoms appearing within a few days after receiving the vaccine.
Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the tissues surrounding the heart. Health officials said the benefits of receiving the vaccine still outweigh any risk.
“The risk of developing myocarditis and pericarditis appears to be very low given the number of doses of the vaccine taken,” Janet Woodcock, acting commissioner of the Food and Drug Administration, said in a statement.
“The benefits of the Covid-19 vaccine still outweigh the risks, given the risk of developing Covid-19 diseases and associated complications, which can be serious,” she said.
The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee that met Wednesday.
There have been more than 1,200 cases of myocarditis or pericarditis, most of them in people younger than 30 who received the injections, according to presentation slides from the CDC meeting.
About 300 million shots have been given as of June 11, according to the CDC. There were only 12.6 cases of carditis per million combined doses of the two vaccines.
CNBC’s Berkeley Lovelace Jr. contributed to this report
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