Published On: Wed, Jun 23rd, 2021

Heart Inflammation Warning to Be Added to mRNA Vaccine Fact Sheet: FDA

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The Food and Drug Administration (FDA) said on Wednesday that it will add a warning of heart inflammation to the fact sheet for the Pfizer and Moderna mRNA COVID-19 vaccines that are given to patients prior to vaccination. At a meeting of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), Dr. Doran Fink, deputy director of the FDA’s vaccines division told the committee that the FDA will “move rapidly to update the fact sheets” to ensure transparency surrounding identified risks, no matter how rare. “We do agree that, based on the available data, a warning statement in the fact sheets for both healthcare providers and vaccine recipients and caregivers would be warranted in this situation,” Fink said. Fink added that the warning statements “would likely include information stating that these events have occurred in some vaccine recipients, particularly following dose two of mRNA vaccines, …

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