Maria Gutschi, a pharmacist based in Ontario, made a scientific and technical presentation on the Covid “vaccine” approval process. She corrected “vaccine” to explain that what we are dealing with is a drug with a payload. This mRNA product meets the FDA’s definition of a gene therapy product. However, if used for vaccinal purposes, it does not have to go through the gene therapy approval process, which can last 15 years. Most other gene therapy drugs are given on a chronic or continuing basis, rather than one or two doses (we are already being told to take even more), hence it was slotted into the vaccine review process. General toxicity testing was not done, nor was it analyzed for any carcinogenic properties, and we do not know the underlying pharmacology (which cells are affected, for how long the spike protein is produced, how long it lasts). It is not considered necessary to do these tests for the vaccine approval process, because normally vaccines do not diffuse throughout the body. There were no drug interaction studies. However, people on Clozaril have significant toxic reactions, and that is known because they are tested every two weeks. When the clinical trials were done, the product made for the clinical trials was almost purified, virtually made by hand—but after production had to be scaled up, processes had to be automated, large volumes of ingredients had to be managed, etc., the quality of the product changed. The new samples were substandard compared to the what was submitted for trial, containing contaminants, 60% of the mRNA, double-stranded DNA, and particulate of various kinds.
The product on the market does not meet the pharmaceutical standard. Issues with impurities, toxicity, and safety continue. “The quality of the product is probably the worst I have ever seen”. For that reason, she and her husband refused the “vaccine”.
In response to questions, Gutschi says there may be problems with batches, or even with vials, and in some cases contents have started to coagulate. The process for extracting the contents to prepare an injection are also complex, and there are many steps during which mistakes could be made. What justified the accelerated process for approving the product? She was not sure, and deferred to others. “What constitutes a health emergency,” is a question the panel wants to plant as a central one to ask.