Transcription – English – Maria Gutschi

19. Maria Gutschi.mp4: Video automatically transcribed by Sonix

19. Maria Gutschi.mp4: this mp4 video file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Maria Gutschi:
So what I was going to talk about is what people think the vaccine approval process is all about. Versus what really happened or partially what happened. One of the things I want to make clear is that the vaccine is not really a vaccine. Right. It is what we would call in the pharmaceutical business a drug and payload, the drug substance being the mRNA, which is really a modified version of the virus mRNA. If you give a virus the viral mRNA to a human, it will not transcribe it to make the spike protein. It has been modified to humanize it in order that our ribosomes, which are the tiny things in the mitochondria that makes the spike protein. It's also important to realize that the spike protein is really the active substance, right? That is the active part of the vaccine and the drug product is that mRNA within those lipid nanoparticles, the hard plastic particles. When they talked about the scientific approval process. That was no, that was condensed. What happened here was that instead of waiting for the entire package to arrive to the regulatory authorities and then the approval and testing occurs, both things were done at the same time. So as they were testing in animals, as they were doing the clinical trials, the data would come in and the regulators would start reviewing it and ask questions back and forth. At the same time, they were developing the drug on the manufacturing side as well. So three things were ongoing at the same time, which was probably quite intense for everybody involved.

Maria Gutschi:
This product went through the vaccine approval system at all, the major regulators in the Western world, that includes the European Medicine Association. They were the lead regulator for the Pfizer vaccine, and it would normally does this product. Does this product meet the definition of a gene therapy product according to the FDA guidelines? It certainly does because it includes nucleic acids, the ribosome. Right. The RNA, which is a nucleic acid. So that is considered a gene therapy product. The problem is, or the issue is that if the indication or the use of this product is as a vaccine for infectious diseases, it doesn't have to go through the genetic therapy process. It goes through the normal vaccine process, even though it would be considered a genetic product. If it was considered a genetic product, that would have to undergo 5 to 15 years of testing for long term problems and for issues such as autoimmune disease, neurological disease, cancer, etc. It is not that people did not know this or that the regulators or people in government did not know is that this product went through the vaccine system instead. And I think the reason for that is because it is a single dose or two doses. Most other gene therapy products or drugs are given on a chronic, continuous basis or on a regular basis. And so you are repeatedly exposed to that product. And so people are interested in what long term issues are from a repeated dosing. With vaccine, it's one or two doses and you're done supposedly.

Maria Gutschi:
What testing was done. Normal testing was done included toxicology testing, repeated dose testing, developmental and reproductive testing. But they were done in rats and they were not. Also, it was not as robust as perhaps we would like. Nor was it done in animals more than one species, for example, done in monkeys as well. There was a bio distribution study, which I think most people are familiar has been done. This was not necessary under a vaccine approval process. The regulators, the European Union did ask for it and it was done, but it was not completed. With the actual mRNA within the lipid nanoparticles. And that means we assume that the bio distribution study that was done is an accurate reflection of bio distribution in humans. It was done in animals and it wasn't exactly the mRNA was luciferase. That conclusion, in my view, cannot be done. There was also manufacturing and quality tests, and that was a big issue that I think a lot of people don't realize what testing was not done. They didn't do testing genotoxicity because it was a single dose. They didn't do carcinogen to see if it was a cause for cancer. Though they looked at the individual parts of the vaccine, they didn't look at it as a whole product because of single dose. The most important thing, though, from my point of view that was not looked at is something that we call safety pharmacology. We don't know the basic underlying pharmacology of this product. What cells are actually transfected with the lipid nanoparticles, how long the spike protein is produced? We don't know.

Maria Gutschi:
The off target effects if the spike protein is supposed to be made in our. Lymph nodes. What about the off target effects on other organs of the body that was not looked at? We don't know. It is not considered necessary to do these effects or these studies as part of a vaccine approval process because vaccines don't normally get travel throughout your body. So the missing piece is actually what the end product actually does in the body. And we know that from people have actually been looking at that and studying that on their own. But the regulatory authorities did not do it because they weren't required to. And that's not least something unusual is that normally we do drug interaction studies, not usually required for vaccines. But what's interesting is there's been several cases of people being admitted to hospital who are on Clozaril for schizophrenia because the vaccine caused them to become toxic on that drug. And the only reason why we know is because Clozaril is monitored every two weeks and there may be a whole lot more drug interactions we know nothing about. And also the regulators could use a similar product on the market in lieu of doing studies. So there is an an RNA lipid nanoparticle product on the market called Onpattro. It is not an mRNA, it's called it's a small interfering RNA. It silences a gene that makes a protein in the liver and it's for a genetic disease. So they use some of that data to cover for tests that they wouldn't necessarily have to do.

Maria Gutschi:
Last but not least, and I think this is to me one of the most important pieces of information that most people do not know. When the clinical trials were done, the product that was made for the clinical trials was a very, very a product that was highly purified, made by hand, was very time sensitive and very close to what I would call pharmaceutical grade. But now that the product had to come and we had to give one to billions of people, they had to upregulate and make it automated and they had to scale it up to a commercial size basis. And this was this meant that they had to automate it, require large amounts of raw material. They had to ensure purity. They had several manufacturing sites that had to be done and they had to inspect and licensing it. What happened was right at the end of the authorisation process, when the clinical trial data had come in, the regulators, the European Medicine Association, got samples of these new automated, updated automated samples, and they were substandard. They only contain 50 to 60% of the mRNA. They were full of fragmented pieces of mRNA and double stranded and other impurities. And the lipids were novel agents they hadn't seen. There were particulate matter in the bottles at the very end, and so it was considered pretty well substandard drug and nowhere near the quality that was done in the clinical trials. This caused a great deal of problems for the regulator and we know from the leaked emails that they did want to restrict this until the quality got better.

Maria Gutschi:
But what ended up happening is that certain specific obligations were put, big regulatory flags were put on Pfizer to improve their manufacturing abilities. But that quality was actually passed and approved under the EUA or the conditional marketing authority in the EU. In conclusions, then, what we have here, that is the product on the market at the present time is not of the standard that we would think is a pharmaceutical standard drug. In my opinion. It doesn't have the quality of the intact mRNA. So in fact, the more. Substandard. The drug is it's probably may be the less likely you are to have spike protein made, but we don't know that for sure. We still have issues with impurities and safety and fragments and toxicity and insufficient pharmacological testing. And the quality of this product from a manufacturing standard is probably the worst I have ever seen. They have since improved. There's no doubt that we have improved that Pfizer and Moderna have worked very hard to improve their quality. But when it was first approved, it is something that I think no. Very few people knew about and was a real issue. It was for that reason that I refuse the vaccine because of the quality testing. And my husband as well, and many people thought that that was of no real clinical importance because we had real world data and clinical data that showed it was still efficacious. Thank you.

Trish Wood:
I think what you said about the quality control is really, really interesting. A guy named Hooman Noorchashm out of Harvard told me, I believe it's Harvard and he loves the vaccine. But even he is saying that there is not the kind of quality control in place. We don't know if a shipment maybe was not stored at the right temperature. And what he said to me that was really, really interesting and I thought quite telling was that they're not there. They've got this mass vaccine vaccination policy. They're not testing the people who they vaccinated to even see if they're actually having an immune response. They don't know if it's working. Right. So, so so that skews everything. It skews our old people safe who are getting the vaccine. Excuse the data coming out of the studies that are studying use in the population. Right. The whole thing seems to be skewed because nobody really wants or seems to want to know if the thing is being handled properly and if it even works.

Maria Gutschi:
Correct. So correct. And so and I think a lot of people are thinking it's due to batches. I also think it could be even at the level of the vial because of how the lipid nanoparticles work, they tend to coagulate together over time so that each vial may have a different amount of mRNA, each lipid nanoparticle, for example. Some have nun, some might have one mRNA, some may have seven. Some are filled with things we have no idea is the variability is huge. I will say though, things have gotten better over time and we have less mRNA fragments and less issues. They have improved, but those first lots must have been something else. And in addition, like you said, the handling of the how you make it and how you take it out of the vial and store and thaw out is complicated. It is complicated. I'm a pharmacist. I do this all the time. I can guarantee you people will not do it right. And we're good at it. We are good at it. And even I thought unless you went through, you actually had to do drills in order to get this right. If you didn't do drills and practice, you are going to make a mistake.

Trish Wood:
Yeah, I want to pass to the panel now.

Preston Manning:
Push the wrong button. Thank you for this presentation. I just want to go through something here. As I understand what you've said, an accelerated, shortened process was used to produce a gene therapy product. The justification for the accelerated process was that we had a health emergency.

Maria Gutschi:
Right.

Preston Manning:
Is there a precise definition of what constitutes an emergency sufficient to justify the accelerated process?

Maria Gutschi:
That is no, I am I do not have a definition for you. I do not know. It may be others might be able to tell you. I'm sorry, sir.

Preston Manning:
But that would be crucial to this, wouldn't it? The whole justification for this accelerated process depends. You wouldn't have an accelerated process if it wasn't an emergency. So. And this isn't the scientist job. This is the political people's job. You what constitutes an emergency that would justify that? This would be a good question for us to put to some of the policy makers.

Maria Gutschi:
I will tell you that what happened was that in early March, all the regulators met by Zoom with the W.H.O. and they had a plan on how they were going to regulate the vaccines. Basically an overall arching. Some of the guidelines that were put out at that time is that they have to have regulatory flexibility, that the chemistry manufacturing wasn't going to be the standard and that that was going to be okay. You're just going to push them as it goes on. It'll get better over time. So some of that was discussed at a meeting in March and with the FDA, but so that was already early at that time.

Preston Manning:
The bigger question is what constitutes a health emergency? Is, is so many deaths per thousand? Is it is it so many deaths over a specific period of time? And I don't think we have that definition of emergency duty. Yeah, okay.

Maria Gutschi:
Thanks. Good question.

Trish Wood:
Thanks, Maria, very much. Very grateful.

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