FDA knew there were serious health issues with COVID vaccines but approved them anyway without transparency
Since these EUA “vaccines” are a medical intervention, the transparency of the supporting data is necessary to the informed consent principle, to assist medical providers and individuals in making sound choices for their bodies and their future. If there was a shred of scientific integrity in our government institutions, then the clinical data should have been shared with the public before the vaccines were released, and independent researchers and scientists should have been allowed to review and analyze the data.
However, these Pfizer and FDA documents were not made available to the public before the rollout of the vaccines. In fact, the documents weren’t made available until a judge ordered the FDA and Pfizer to release them after a Freedom of Information Act (FOIA) lawsuit was filed against the FDA. Now, 800 days after the FDA approved the “safe and effective” COVID-19 vaccines, the documents are finally available to the public for review.
Now, independent scientists and researchers can see exactly what FDA regulators saw when they made their decision to push out the COVID vaccines onto the public. Take into consideration: During that time, governments were using bio-terror propaganda, false imprisonment (through lockdowns and unlawful quarantines) to coerce the public to take these experimental vaccines in order to “return to normal.”
Not only were there serious safety signals with these experimental vaccines – including platelet disorders, heart inflammation and vaccine-associated enhanced disease (VAED) – but there were also indications that the government regulators knew that these problems were going to be significant and the adverse event reporting systems were incapable of quantifying the issue in the population. Their concerns were concealed, as the population was essentially poisoned by a harmful and ineffective product. In the documents, the FDA indicated that they knew its own safety monitoring system was “not sufficient” for assessing the risk of heart conditions associated with Pfizer’s COVID-19 vaccines.
FDA knew their surveillance system was incapable of identifying subclinical myocarditis cases
Embedded in the 51,893 Pfizer documents is an FDA memo that addresses the agency’s inability to evaluate the risk for myocarditis and pericarditis after COVID-19 vaccination. The memo refers to the CBER Sentinel Initiative, which is the FDA’s national electronic system intended to monitor the “safety of its regulated products.”
“The CBER Sentinel Program is NOT sufficient to assess the serious risks of myocarditis and pericarditis, and sub-clinical myocarditis associated with COMIRNATY (BNT162b2) in lieu of PMR safety studies under FDAAA [Food and Drug Administration Amendments Act].
The warning continues: “At the time of BLA [Biologics License Application] approval, the data sources in the CBER Sentinel Program are not sufficient to identify the outcomes due to lack of sufficient power to assess the magnitude of risk in patients 12-30 years of age. In addition, CBER Sentinel Program is not sufficient to follow up cases for recovery status and long-term sequelae, or for identification and characterization of subclinical myocarditis cases.”
The FDA’s adverse events surveillance system was unable to assess the risks of heart inflammation in the population, and there was plenty of evidence in the clinical studies to suggest that the vaccines would end up causing these adverse events en masse. According to the BLA Clinical Review Memorandum dated August 23, 2021, there were MORE instances of tachycardia and cardiac disorders in trial participants who received the vaccine compared to the placebo group. There were nearly twice as many cardiac deaths in the vaccinated group 15 to 81 days after the study. Somehow, the FDA still stands as the gatekeeper for mass medical malfeasance and crimes against humanity carried out under "vaccine" programs.
Sources include:
ICanDecide.org [PDF]
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