Former Senior FDA Official: Manufacturers, FDA Negligent In Not Investigating Covid-19 Vaccine Risks To Heart Health
By: David Gortler
February 10, 2022
From day ,one the U.S. Food and Drug Administration knew the Covid-19 vaccine was linked to serious heart trouble in recipients. The FDA medical officer review of Pfizer’s original Covid-19 application notes “clinically important serious adverse reactions [included] anaphylaxis and myocarditis/pericarditis”—that is, severe allergic reactions and inflammation of the heart and or the sac containing the heart, respectively. As of this writing, FDA has not released its review of the Moderna “Spikevax” mRNA vaccine application despite having granted emergency use authorization well more than a year ago and full approval late last month.
The Vaccine Adverse Event Reporting System (VAERS), jointly run by FDA and the Centers for Disease Control, lists a long and impersonal number of cardiovascular-related events in young, healthy people. Without reading the underlying narratives submitted with the reports, it’s hard to establish the precise causal links regarding these adverse events. Still, there are thousands of reports of heart attacks, myocarditis, and pericarditis in the United States alone, which should have spurred manufacturers and the FDA into full investigation mode.
Studies acknowledged by FDA officials show that the FDA’s various safety databases only collect an estimated 1 to 13 percent of all adverse events that occur. Multiple FDA drug safety epidemiologists have stated during official FDA presentation that it only takes a single well-documented adverse event to justify a safety signal investigation and in turn to warn the American public of the potential risk.
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https://thefederalist.com/2022/02/10/former-senior-fda-official-manufacturers-fda-negligent-in-not-investigating-covid-19-vaccine-risks-to-heart-health/
