FDA Adds Heart Inflammation Warning to Moderna, Pfizer Vaccines | Coronavirus pandemic News
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Update of the notice The CDC Advisory Committee has conducted an extensive review of the information and discussion.
The U.S. Food and Drug Administration (FDA) has added a warning about the risk of heart inflammation to the data sheets of Moderna and Pfizer-BioNTech COVID-19 vaccines.
It was warned on Friday that reports of adverse events after the vaccine (especially after the second dose) suggest a risk of myocarditis or inflammation of the heart muscle and pericarditis or inflammation of the tissues surrounding the heart.
The warning update was reviewed and discussed at a meeting of the U.S. Centers for Disease Control and Prevention (CDC) Immunization Practice Advisory Committee on Wednesday, the FDA said.
By the end of the second week of June, more than 1,200 cases of myocarditis or pericarditis had been reported to the U.S. vaccine reporting system.
The cases appear to be significantly higher in men and in the week following the second vaccine dose.
No comments have yet been made for Pfizer and Modern.
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