Reuters reports that the U.S Food and Drug Administration (FDA) will move forward to include a warning concerning what at least initially include rare cases of heart inflammation observed in adolescents and young males to the pharmaceutical company fact sheets, including Pfizer-BioNTech and Moderna. TrialSite reported on a CDC warning involving myocarditis after the mRNA-based jabs and, based on other intelligence, TrialSite suspects further warnings could follow in the weeks and months to come.
Due to the recent CDC safety panel action assessing the “likely association” between the mRNA-based vaccines authorized on an emergency use basis and myocarditis and pericarditis in predominantly younger males, the FDA plans to “move rapidly” to insert a warning sheet to help protect the public
TrialSite has put forth the case that perhaps regulators should consider cutting back mRNA-based doses to just one. A majority of adverse events, occurring after the second jab, but as described in this article the data reveals that the two-shot regimen reflected a specific way the trial data was presented. Would one dose have been sufficient?
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