FDA wants new heart damage warnings added to COVID-19 vaccines
The U.S. Food and Drug Administration (FDA) is urging both Pfizer and Moderna to add expanded warning labels on their COVID-19 vaccines to highlight the risks of myocarditis and/or pericarditis that could potentially lead to long-term myocardial injuries. The focus of these changes is the risks seen in young men who receive a COVID vaccine.
The FDA wrote both companies about this change in April, though the letters were only recently made available online. When explaining its position, the agency pointed to data from the Biologics Effectiveness and Safety System as well as a 2024 study funded by the FDA and published by Jain, et al. in eClinicalMedicine.[1]
Acute myocarditis and other related conditions have been seen in a small number of patients after receiving a COVID-19 vaccination. The long-term impact of this risk has been the subject of countless studies, debates and even arguments over the years.
While the American College of Cardiology, American Heart Association and other U.S. healthcare organizations have consistently supported patients being vaccinated, especially after vaccines first started gaining approval and the pandemic was still at its peak, some critics have remained adamant that even the smallest risk of side effects is still too high.
What the FDA wants the new labeling to say
The FDA is asking that these companies make several different changes to the packaging of these vaccines. Moderna, for instance, has been told that at package insert should be changed from this:
Myocarditis and pericarditis following SPIKEVAX and Moderna COVID-19 vaccines have occurred most commonly in males 18 years through 24 years of age.
To this:
Based on available data, the estimated rate of myocarditis and/or pericarditis from 1 through 7 days after getting a dose of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 per million doses in people 6 months through 64 years of age; the highest estimated rate was in males 16 through 25 years of age (approximately 38 cases of myocarditis and/or pericarditis per million doses).
The FDA also wants this information to be added to that insert:
In a study, follow-up information was collected on people who developed myocarditis after receiving the original formula of a COVID-19 vaccine; most , people had received an mRNA COVID-19 vaccine. Some people in the study reported having heart symptoms approximately 3 months after developing myocarditis. Some people in the study had heart MRIs (scans that show detailed images of the heart muscle) initially after developing myocarditis and again approximately 5 months later. The initial and follow-up heart MRIs commonly showed signs of injury to the heart muscle, with improvement over time in most people. It is not known if these heart MRI findings might predict long-term heart effects of myocarditis. Studies are underway to find out if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine.
Are the labeling changes mandatory?
According to the FDA’s letters, Pfizer and Moderna had 30 calendar days to either tell the agency it was making these changes or submit a rebuttal statement. It is unclear at this time how the companies responded.
The letter to Moderna can be read here. The letter to Pfizer is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.