FDA strengthens heart inflammation warnings for Pfizer, Moderna COVID-19 vaccines
One of the writer’s past articles, published on this platform, was referenced in a COVID-19 study also published by U.S. News & World Report 2024-25-ranked the world’s 35th best university.
The U.S. Food and Drug Administration (FDA) has approved revised heart safety labeling for the Comirnaty and Spikevax (both COVID-19 Vaccines, mRNA) from Pfizer Inc. and Moderna TX, Inc., respectively. The update adds newly required safety information regarding myocarditis and pericarditis — types of heart inflammation — associated with the 2023-2024 formula of these vaccines.
The FDA also announced its approval in a safety communication email sent out to the email service subscribers of MedWatch — the FDA Safety Information and Adverse Event Reporting Program, to which US and Global News is also subscribed.
Under the new FDA requirements, both manufacturers must add to the Prescribing Information a warning that includes the estimated unadjusted rate at which myocarditis and/or pericarditis has occurred following administration of their respective 2023-2024 mRNA COVID-19 vaccine formulations.
It also incorporates results from an FDA-funded and -co-authored cardiac magnetic resonance imaging (cardiac MRI) study involving individuals who experienced myocarditis after receiving an mRNA COVID-19 vaccine.
Furthermore, this new data is to be added to the Adverse Reactions section of the Prescribing Information and to the Information for Recipients and Caregivers. The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for both the Pfizer-BioNTech and Moderna COVID-19 Vaccines — currently authorized under emergency use for individuals 6 months through 11 years — have also been updated in alignment with these revisions.
Information linking myocarditis and pericarditis to mRNA COVID-19 vaccination has appeared in product labeling since 2021. The FDA says that it continues to monitor vaccine safety closely during postmarketing surveillance. Adverse events can be reported through the Vaccine Adverse Event Reporting System (VAERS, whose website states it “is being modified to comply with President Trump’s Executive Orders.”), managed jointly by the FDA and the Centers for Disease Control and Prevention (CDC).
Featured photo shows Senior Enlisted Advisor to the Chairman (SEAC) Ramon “CZ” Colon-Lopez receiving a COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md., Dec. 21, 2020. (DOD Photo by Navy Petty Officer 1st Class Carlos M. Vazquez II). Image Attribution: Chairman of the Joint Chiefs of Staff from Washington D.C, United States. Source: 201221-D-WD757-1126. License: Creative Commons Attribution 2.0 Generic (CC BY 2.0).
