June 24, 2021 (LifeSiteNews) — The Food and Drug Administration (FDA) will place a heart inflammation warning label on fact sheets for COVID-19 vaccines made by Pfizer/BioNTech and Moderna, the agency announced on Wednesday.
Dr. Doran Fink, deputy director of the FDA’s vaccine division, told an expert panel of the Centers for Disease Control and Prevention (CDC) that the FDA plans to “move rapidly” to add the new warnings in light of increased reports of post-vaccine heart issues.
The CDC’s Advisory Committee on Immunization Practices (ACIP) convened on Wednesday to discuss data on higher-than-expected cases of heart inflammation among people who received doses of either the Pfizer or Moderna shot, both of which rely on messenger RNA technology. The CDC had planned an emergency meeting to address the reports last week, though that meeting was scrapped due to Juneteenth.
“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. “We anticipate that following today’s ACIP meeting we would move rapidly to update the fact sheets with this information,” he added.
The warnings “would likely include information stating
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