The so-called "studies" that Moderna submitted to the U.S. Food and Drug Administration (FDA) were "irrelevant," discovered Judicial Watch, which filed the FOIA request. Moderna also failed to follow Good Laboratory Practices (GLP), according to Alexandra Latypova, a veteran pharmaceutical executive with knowledge of the situation.
Some 700 pages of the documents obtained by Judicial Watch show a Biologics Licensing Application (BLA) package that a drug manufacturer, in this case Moderna, is required to submit to the FDA. More than half of these pages have absolutely nothing to do with Moderna's Fauci Flu shot.
According to Latypova, who reviewed the documents, the studies Moderna inserted into the BLA pertain to unapproved mRNA (messenger RNA) technology that was not even used in Spikevax.
"Moderna claimed that the active substance mRNAs of Spikevax does not need to be studied for toxicity and can be replaced with any other mRNA without further testing," Latypova explained to The Epoch Times.
"The FDA did not push back on this preposterous claim. The company is claiming that the active drug substance of a novel medicine does not need to be tested for toxicity." (Related: Operation Warp Speed never would have been possible in the first place had Congress not redefined the word "vaccine" just prior to the launch of the plandemic.)
"This is analogous to claiming that a truck carrying food and a truck carrying explosives are the same thing. Ignore the cargo, focus on the vehicle. The claim is preposterous – the mRNAs and LNPs [lipid nanoparticles] separately and together are entirely novel chemical entities, each requiring its own Investigational New Drug [IND] application and data dossier filed with the regulators, and studies with one mRNA are no substitute for all others."
Throughout her career, Latypova has worked for more than 60 different pharmaceutical companies – so she knows a thing or two about how this process is supposed to work.
Her work primarily centered around creating and reviewing clinical trials, which is exactly what she was called upon to do with these FOIA documents. Her expert analysis proves that Moderna deceived regulators and the public.
The FDA itself is complicit as well because an approval document released back in January shows that agency knew full well that Moderna did not adhere to GLP standards for toxicity testing the correct mRNA (1273), and yet the agency accepted it regardless.
The FDA also acknowledge that "a biodistribution study was not performed with mRNA-1273 vaccine."
"[Moderna] used substitute test articles, and used other deceptive study design practices, such as stopping the studies early, while the drug was still accumulating in major organ systems and not studying the expression of the target antigen (spike protein) in the organs where the drug was being delivered," Latypova says.
Of the 29 unique studies that Moderna submitted to the FDA, only 10 of them pertained to the "correct" mRNA used in Spikevax. And only two of these were actually related to safety and toxicology – and neither of them were done in accordance with GLP standards.
These flawed tests had numerous "severe design limitations" including: not addressing important safety issues, avoiding testing, and not having adequate sample sizes, according to Latypova.
Only one of the 10 studies dealt with toxicology, or "safety." The other nine were all pharmacological in nature, meaning they dealt with the "mechanism of action" of the shot as opposed to what the shot actually does to the human body.
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