Moderna’s internal documents regarding their COVID vaccine trials, obtained via a Freedom of Information Act request by Judicial Watch, show that most of their studies submitted for approval to the FDA were “irrelevant” and did not follow Good Laboratory Practices (GLP), according to a former pharma executive.
The 700 pages contain a portion of the formal Biologics Licensing Application (BLA) package that a manufacturer is required to submit to the FDA for approval.
Four hundred of these pages were on non-Spikevax products.
The documents have not been made public, but were analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times.
‘Ignore the Cargo, Focus on the Vehicle’
Moderna’s nonclinical program consisted of studies of “irrelevant” and unapproved mRNAs, which are completely different chemical entities from Spikevax, Latypova told The Epoch Times.
“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,” she said.
“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.”
“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,” Latypova added.
Latypova has worked in more than 60 pharmaceutical companies, mainly focusing on creating and reviewing clinical trials, many of which were submitted to the FDA.
According to her research, Moderna skipped entire categories of safety and toxicology testing.
The FDA approval document released in January acknowledges that the toxicity test done on the correct mRNA (1273) is non-GLP.
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