The warning update comes after an extensive review of information and discussion by the CDC advisory committee.
The U.S. Food and Drug Administration (FDA) has added a warning about the risk of heart inflammation to the fact sheets for the Modern and Pfizer-BioNTech COVID-19 vaccines.
Friday’s warning noted that reports of adverse events after vaccination, especially after the second dose, suggest an increased risk of myocarditis or inflammation of the heart muscle and pericarditis or inflammation of the tissue surrounding the heart.
The warning update comes after an extensive review of the information and debate held Wednesday by the U.S. Centers for Disease Control and Prevention (CDC) Immunization Practice Advisory Committee, 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 adverse event reporting system.
Cases appear to be markedly higher in men and in the week following the second dose of vaccine.
There have been no comments for Pfizer and Moderna yet.