COPTIGATE - THE WORST DESIGN FLAW IN HUMAN HISTORY THAT IS IMPACTING YOUR HEALTH
How come Prizer, Moderna, AstraZeneca, Janssen etc. are using a technology that both they and the regulators know will cause unknown results?
Let's start with a thought experiment: If an engineering design flaw exists and no one measures it, can it really injure people or kill them?
Making a new vaccine is hard. Making a new vaccine that uses a new technology is even harder, because you need to prove safety. Luckily, when it comes to COVID, the vaccines have been tested and shown to be safe, right?
Well, they might have forgotten one thing...
Trying to tell your body to generate proteins is hard for many reasons. One of them is the fact that when you try to run the protein information via ribosomes which process that code and generate the protein, it can be very slow or can get stuck during the process.
Luckily, scientists found a way to overcome this problem, by doing code substitution: instead of using the original genetic code to generate the protein, they changed the letters in the code so the code would be optimized. This is known as Codon Optimization.
Codons are three nucleotides; nucleotides are the building blocks of your DNA. Here is an example of Codon Optimization: 60% of the codons were altered, 22% of the nucleotides were altered. And yet the end result is that the
ribosomes generate the same protein!
Same? Well, not so much. In 2011
Nature Medicine magazine published an article called "Breaking the Silence". It described how codon optimization, which uses this synonymous DNA changes, can trigger disease in a number of ways.
Turns out the protein which was manufactured when codon optimization has different ways it folds and a different 3D shape, and it "could cause immunogenicity, for example, which wouldn’t be seen until late-stage clinical trials or even after approval".
"The changed form could cause immunogenicity, for example, which wouldn’t be seen until late-stage clinical trials or even after approval."
(Chava Kimchi Sarfaty, FDA)
This statement relates to the NORMAL approval cycle. The COVID vaccines went via an accelerated one.
"Codon optimization can lead to alterations in protein conformation and function…. and increase immunogenicity…. some of these elements can … alter protein folding, and lead to changes in protein conformation and post-translational modifications.”
(Vincent P. Mauro)
Do they mention it to the regulator? no. Here is Pfizer BNT162b2/Comirnaty Risk Management Plan for the EMA. Variant V8 & V9 were tested, only difference was codon optimization, V8 had elevated levels of gamma-glutamyl transferase (GTT), V9 didn't.
The WHO 2005 document states that such tests normally not needed for the FINAL vaccine formulation. This is because in a NORMAL vaccine approval pharmacology, genotoxicity and carcinogenicity studies are done during ANIMAL STUDIES, which were practically skipped here.
Even though EMA states: "It is important to investigate the potential for undesirable pharmacological activity in appropriate animal models and, where necessary, to incorporate particular monitoring for these activities in the toxicity studies and/or clinical studies"
Back to sequencing: this concern was reported in 2006, published in 2007, and "breaking the silence" was published in Nature Medicine magazine in 2011, the FDA or its equivalent in Europe (EMA) STILL THEY DO NOT HAVE a guidance with regard to the genetic sequencing.
Here is Katerina Alexaki from the FDA explaining how a SINGLE synonymous mutation (mutation that doesn't impact the protein but its 3D object & folding) can result in a disease and that if you have multiple substations there is a good chance it may have an effect:
Here is again Katerina Alexaki, this time answering the question whether the regulator demand the manufacturers to test for the impact of their codon optimization. The answer is "no":
Here is a slide from a workshop given to the EMA in 2016, by FDA employee ("Immunogenicity of Biological Therapeutics Product Quality Attributes") Construct design affects product quality and "Codon optimization and protein folding" are mentioned.
The manufacturers knows about the potential risk. The regulators knows about the potential risk. Yet regulators don't test V products as gene therapy, and do not put in place codon optimization risk mitigation plan. IF YOU DON'T MEASURE RISK IT DOESN'T GO AWAY.
) mechanism of actions and how this could possibly lead to cancer risk in the long term... Oh goody! I'm sure it has got more nasty tricks up its sleeve so I wouldn't trust it.
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