22.05.2025 13:11
The FDA has requested Pfizer and Moderna to expand the warning labels for their COVID-19 vaccines. The warning states that these mRNA-based vaccines may pose a risk of inflammation of the heart lining and heart muscle, particularly in males aged 16 to 25.
The U.S. Food and Drug Administration (FDA) has requested Pfizer and Moderna to expand the warning labels for their COVID-19 vaccines. It was noted that these mRNA-based vaccines could play a role in the risk of inflammation of the heart lining and heart muscle, particularly in adolescent boys and young men. The decision was made based on the results of a study published last year and new data from the FDA.
FDA'S INSTRUCTION TO UPDATE WARNINGS
The FDA published letters dated April 17 for Pfizer-BioNTech's Comirnaty vaccine and Moderna's Spikevax vaccine on Wednesday. In these letters, both companies were instructed to update the relevant warnings.
COVERS MALES AGED 16-25
Previously, both vaccines contained warnings that they could play a role in heart conditions. In the previous labels, the risky age range was specified as 18-24 for Moderna and 12-17 for Pfizer. The new warnings have been updated to cover males aged 16-25 for both vaccines.
In the FDA's new general warning, it was stated, "After the administration of mRNA COVID-19 vaccines during the 2023-2024 period, the highest estimated incidence of myocarditis and/or pericarditis cases was detected in males aged 16-25."
8 CASES PER MILLION DOSES
According to the FDA, the incidence of these conditions in children and adults under 65 after the vaccines used last season was recorded at approximately 8 cases per million doses.