FDA adds heart inflammation warning to Moderna, Pfizer vaccines

Warning update follows an extensive review of information and discussion by CDC’s Advisory Committee.

The US Food and Drug Administration (FDA) has added a warning about the risk of heart inflammation to fact sheets for Moderna and Pfizer-BioNTech COVID-19 vaccines. The warning on Friday noted that reports of adverse events following vaccination – particularly after the second dose – suggest increased risks of myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the tissue surrounding the heart. The warning update follows an extensive review of information and discussion by the US Centers for Disease Control and Prevention (CDC’s) Advisory Committee on Immunization Practices meeting on Wednesday, the FDA said.