FDA Extend the warning about rare heart side effect in two leading Covid vaccines | Today news

The Food and Drug Administration instructed that Pfizer and modern warning labels on their MRNA Covid-19 vaccines (comirnaty and spikevax) expand to emphasize a rare risk for myocarditis and pericarditis, which is heart inflammation, mainly in men between 16 and 25 years. The updated labels now mention a 38 cases per million doses in these demographic, higher than pre-warnings focused at the age of 12-17 (Pfizer) and 18-24 (modern). For all recipients under 65, the total risk is low in almost 8 cases per million doses. This move follows the FDA analysis of 2023–2024 security data, including insurance claims and a study that shows persistent heart-MRI abnormalities in some patients five months after diagnosis. However, the CDC maintains that such cases are scarce, typically dissolve and less severe than those caused by Covid-19 infection itself. Policy collision and political tension support new warnings. The FDA’s decision is in violation of previous CDC assessments that have not found any increased myocarditis risk in the databases for vaccine injuries since 2022. Kennedy recently replaced 17 CDC advisory panelists with appointments, including lawyers against the vaccine, and FDA commissioner Marty Makary, a critic of Covid-19 Booster mandates, limited annual shots to high-risk groups (eg senior citizens). Critics believe that the extension of the label over context overlooks: Studies confirm that Covid-19 infection has a 16-fold higher myocarditis risk as vaccination, and most cases after vaccination are light, and decide with anti-inflammatory treatment. Yale researchers notice that the inflammation is short -lived, not auto -immune, which enables full recovery. Expert setback and global security perspectives condemn medical experts to the FDA’s approach as misleading. “It’s right to suggest that we should consider myocarditis risks associated with the vaccine, but what they suggest is exactly the wrong solution,” Dr. Robert Morris of the University of Washington said. “We need to investigate who is prone to myocarditis to see if we can predict and soften the risk,” according to a report by AP.