The Food and Drug Administration (FDA) has required Pfizer and Moderna to expand the warning labels on their mRNA COVID-19 vaccines to highlight the risk of myocarditis and pericarditis, cardiac inflammation conditions, mainly found in males between the age of 16-25.
The updated incidence is 38 cases per million doses, up from previous alerts focusing on younger age groups 12–17 (Pfizer) and 18–24 (Moderna).
This update comes after FDA analysis of 2023–2024 data, including insurance claims and research showing several patients with previous cardiac MRI changes five months following the diagnosis.
The CDC further mentioned that the number of cases remains low, which is usually mild, and less severe as compared to the conditions caused by COVID-19 itself.
This significant change underscores efforts by Health Secretary Robert F. Kennedy Jr.’s administration to restrict vaccine oversight.
To note, Kennedy recently replaced all CDC advisory panel members with leading intellectuals.
The FDA Commissioner has also limited the annual vaccine shots for vulnerable people.
Critics claim the warnings omit critical context, highlighting evidence that COVID-19 infection consists of a significantly increased myocarditis risk 16-fold greater.
Furthermore, health experts, including Dr. Robert Morris, issued a warning for the FDA’s latest approach and stressed the need for more research to identify the vulnerable population instead of broad label changes.
