Pfizer and its German partner BioNTech failed to thoroughly examine biodistribution and pharmacokinetics issues related to their experimental gene therapy injection prior to submitting it to the European Medicines Agency (EMA) for review, we now know.
Biodistribution studies are designed to test where an injected compound travels throughout the body upon release, particularly with regards to vital organs and tissues. The purpose is to determine where a vaccine ends up so we know how people will react to it.
Instead of conducting a real one, though, Pfizer cut corners and used a "surrogate" mRNA injection that produces the luciferase protein rather than the BNT162b2 variety actually being administered to the public.
"No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2," the EMA reviewers admitted about Pfizer's fraudulent actions.
Regulatory documents also reveal that Pfizer failed to follow industry-standard quality management protocols during preclinical toxicology studies of its injection. These key studies did not meet good laboratory practice (GLP).
"Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies used as the basis for research or marketing permits for products regulated by government agencies," explains The Defender, a newsletter of Children's Health Defense (CHD).
"The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products."
TrialSite founder and CEO Daniel O'Connor says that Pfizer was basically trying to accelerate the vaccine development timeline to get its injection on the market as quickly as possible. This is what was expected from Donald Trump's "Operation Warp Speed" program.
"The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on the pressures of the pandemic," O'Connor is quoted as saying.
"The challenge is that the processes, such as Good Laboratory Practices, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling."
Even generic repurposed drugs that have an established history of safety and effectiveness for some other use must still go through "ever more studies to prove their worth," O'Connor says. Pfizer, however, was given "even more discretion with a radically new life science-based technology."
While it is normally standard practice for the EMA to disclose its assessment of investigational new drug submissions, Pfizer's Chinese Virus injection came with no results from the biodistribution studies that were included in its public EMA summary.
The method that Pfizer used in trials was, of course, inadequate and made it appear as though the injection's components remained in a much smaller area than they actually do in the real world. As the EMA document states:
"Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern."
This would explain why the number of reports about serious adverse effects continue to grow. People who got injected are now suffering an array of health problems that point to the injection components spreading throughout their bodies to places that were never disclosed in trial data, including in the spleen, ovaries and other organs and tissues.
More related news about Wuhan coronavirus (Covid-19) vaccine fraud can be found at ChemicalViolence.com.
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