The Food and Drug Administration (FDA) is requiring Pfizer and Moderna to update their COVID-19 vaccine labels to include warnings about the risk of heart inflammation in adolescents and young men. The agency cited updated estimates of myocarditis cases and a post-approval study showing persistent heart abnormalities after receiving the mRNA shots.
According to the FDA, analysis of insurance claims found an incidence of 8 cases per million doses for the 2023-2024 formulas of the vaccines. The updated warnings specifically apply to males aged 16 to 25, although earlier warnings covered males 12 to 17 and 18 to 24 years old.
This expansion comes as the FDA is reviewing its regulatory approach to COVID-19 vaccines. The agency has announced plans to require more scientific studies before approving updated vaccines for healthy adults under 65. This move may limit access to the shots, mainly targeting seniors and individuals with pre-existing conditions.
In 2021, the Centers for Disease Control (CDC) noted a “likely association” between COVID-19 vaccination and myocarditis in adolescents and young adults. However, the agency also concluded that there was a benefit to getting vaccinated, especially for this age group. More recent studies have shown that cases of heart inflammation tend to resolve quickly and are associated with less severe cardiovascular events than those occurring after a COVID-19 infection.
The FDA’s labeling orders coincide with a Senate hearing on Wednesday, which is investigating whether federal health officials downplayed the risk of myocarditis after COVID-19 vaccination.
Source: https://www.axios.com/2025/05/21/fda-warnings-covid-vaccines