FDA Knew Safety Monitoring System Was 'Not Sufficient'
Federal health agencies claim COVID-19 vaccines are part of the “most intensive vaccine safety monitoring effort in U.S. history,” with “continuous” and “robust” safety monitoring that helps ensure that the vaccine's benefits outweigh any risks. Yet the final documents released from Pfizer’s biologic product file reveal the agency knew its safety monitoring program was not sufficient to assess the serious risks of myocarditis and pericarditis associated with Pfizer’s COVID-19 vaccine.
Cardiac Disorders Higher in Vaccine Trial Group
According to an Aug. 23, 2021, BLA Clinical Review Memorandum, there were more cardiac disorders in trial participants who received Pfizer’s COVID-19 vaccine compared to the placebo group and more instances of tachycardia in the younger vaccinated age group.
Cardiac conditions were reported as the cause of death in nine participants 25 to 128 days after having received at least one dose of Pfizer’s COVID-19 vaccine, including seven cases of cardiac arrest, one case of cardiovascular disease, and one case of congestive heart failure.
Five cardiac-related deaths in the placebo group occurred 15 to 81 days after having received a placebo, including two cases of myocardial infarction, one aortic rupture, and two cardiac arrests.
“Because COVID-19 mRNA and its Spike protein are found in the human heart at autopsy causing inflammation and heart damage, it is incontrovertible that the COVID-19 vaccines are cardiotoxic,” cardiologist Dr. Peter McCullough told The Epoch Times in an email.
“Younger individuals with healthy hearts take up more of the damaging vaccine into the cardiac tissue resulting in symptoms of chest pain, palpitations, fluctuations in blood pressure, dizziness, and sadly, some, end up with cardiac arrest either during exercise or in the early morning waking hours. At both time periods, an internal surge of adrenalin appears to be the trigger for the fatal arrhythmia in those with COVID-19 vaccine myocarditis,” he added.
Despite nearly double the number of reported cardiac events in vaccine recipients versus placebo recipients, the FDA concluded the deaths were “unlikely to be related to vaccination.”
JewsAintHonkies -1 points 4 months ago
Dr. Fauci needs to meet the exact same fate as Mussolini for the exact same reasons. We should’ve interned that cracker-ass tribe along with the Japs during World War II. Japs are dishonorary crackers for their alliance with krauts and wops. Between the three of them, the wops are the worst because at least the krauts have Gay marriage now. That still doesn’t bring Ricky Schroder’s cock any closer to my asshole, but it showed which of them is serious about repentance for crimes against actual human beings.