The U.S. Food and Drug Administration on Friday added a warning to patient and provider fact sheets for the Pfizer and Moderna Covid-19 vaccines to indicate risk of heart inflammation.
As reported by GreatGameIndia earlier, the US CDC and FDA had lifted their recommended pause on use of Johnson & Johnson’s coronavirus vaccine with a condition that it should include a safety label warning that its vaccine comes with blood clot risks. Now, Moderna has also been included.
For each vaccine, the fact sheets were revised to include a warning about myocarditis and pericarditis after the second dose and with the onset of symptoms within a few days after receiving the shot.
Inflammation and swelling of the heart, a condition known as Myocarditis, has been identified in many youngsters who have received their dose of Pfizer-BioNTech COVID-19 vaccine.
Myocarditis is a heart condition that leads to the inflammation of the heart muscles. The inflammation is a result of the body’s immune response to a certain infection, which leads to weakening and swelling of the heart.
This in turn reduces your heart’s ability to pump blood and oxygen, causing rapid or abnormal heart rhythms (arrhythmias). In severe cases, myocarditis can lead to heart failure, abnormal heartbeat and sudden death.
The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday.
There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received the shots, according to presentation slides from the CDC meeting.