Food and drug management ordered that Pfizer and Modernism expand the warning labels on their MRNA COVID-19 (Comirnaty and Spikevax) vaccines to emphasize the rare risk of myocarditis and pericarditis, which are conditions of heart inflammation. Updated labels now report an incidence of 38 cases per million doses in this demographic group, from previous warnings aimed at 12-17 years (Pfizer) and 18-24 (Moderno).
For all recipients under 65 years of age, the total risk remains low in almost 8 cases per million doses. This step is governed by FDA 2023-2024 analysis data on the safety of the vaccine, including insurance claims and a study showing the persistent MRI cardiac abnormality in some patients five months after diagnosis. However, CDC claims that such cases are rare, usually they are distinguished rapidly and are less severe than the cases caused by the COVID-19 infection itself.
Political clash and political tension support new warnings
The FDA decision is contrary to previous CDC evaluations that have not detected an increased risk of myocarditis in the databases of the vaccine injury since 2022. It also copes with the wider efforts of Minister of Health Robert F. Kennedy Jr. Kennedy has recently replaced all 17 CDC advisors, including Anti-Vakcine advocates, and FDA Commissioner Marty Makara, critics of COVID-19 strengthening mandates, reduced annual missiles to high-risk groups (eg seniors).
Critics claim that etiquette expansion overlooks the context: Studies confirm that COVID-19 infection is 16 times the risk of higher myocarditis than vaccination, and most cases after vaccine are mild and distinguish with anti-inflammatory treatment. Scientists Yale will notice that inflammation is transient, not autoimmune, allowing complete recovery.
Will expert and global security perspective
Medical experts condemn the FDA approach as misleading. “They have the right to propose that we must consider the risks of myocarditis associated with the vaccine, but what they suggest is exactly a bad solution,” Robert Morris of the University of Washington. “We should examine who is susceptible to myocarditis to see if we can predict and alleviate this risk,” according to the AP report.
(tagstotranslate) myocarditis risk
