COPTIGATE - THE WORST DESIGN FLAW IN HUMAN HISTORY THAT IS IMPACTING YOUR HEALTHThread by @eh_den on Thread Reader App – Thread Reader Apphttps://threadreaderapp.com/thread/1426885632140394499.html#COptiGate(thread)
How come Prizer, Moderna, AstraZeneca, Janssen etc. are using a technology that both they and the regulators know will cause unknown results?
(plus a bonus)
Image
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.
Breaking the silence | Nature Medicinehttps://www.nature.com/articles/nm1211-1536
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)Protein misfolding "has been linked with neurodegeneration in Alzheimer and Parkinson disease, and many other pathologies."
Protein Misfolding Diseases - PubMedhttps://pubmed.ncbi.nlm.nih.gov/28441058/"The data confirm that protein misfolding resulting in intracellular PAO accumulation is sufficient to cause cardiomyocyte death and heart failure."
Protein misfolding and cardiac disease: establishing cause and effect - PubMedhttps://pubmed.ncbi.nlm.nih.gov/18612262/So if it is so problematic, why do manufacturers use it? because "higher levels of protein expression are required for clinical trials and commercialization, and these expression levels can sometimes be obtained by using (codon optimization)" (Vincent P. Mauro, 2018)Pfizer is the most aggressive in their genetic code optimization (as far as we know); just read the abstract from "BNT162b2 Vaccine: Possible Codons Misreading, Errors in Protein Synthesis and Alternative Splicing's Anomalies"
BNT162b2 Vaccine: possible codons misreading, errors in protein synthesis and alternative splicing's anomalies - Authoreahttps://www.authorea.com/users/348455/articles/503889-bnt162b2-vaccine-possible-codons-misreading-errors-in-protein-synthesis-and-alternative-splicing-s-anomalies?commit=c216b0c03c51c8776a81ea85c76429376b5eb3b1
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.
So Pfizer admits codon optimization can lead to elevated GTT, and "elevated GGT is linked to increased risk to a multitude of diseases and conditions, including cardiovascular disease, diabetes, metabolic syndrome (MetS), and all-cause mortality."
Gamma-Glutamyltransferase: A Predictive Biomarker of Cellular Antioxidant Inadequacy and Disease Riskhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620378/And even though Pfizer admits codon optimization impacts the safety of their product, "Safety pharmacology, genotoxicity and carcinogenicity studies have not been conducted in accordance with the 2005 WHO vaccine guideline."
How did they manage to avoid testing?
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:
https://video.twimg.com/ext_tw_video/1426852651757670404/pu/vid/640x360/tZFo5_kEIo9LcL4K.mp4?tag=12Here 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:
https://video.twimg.com/ext_tw_video/1426853749243486211/pu/vid/1280x720/lurPpwkgT-70_bdo.mp4?tag=12Here 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.THE BONUS !!!
Could it be that the "variants" that we see are a result of the misfolding of the spike protein, which is a result of the codon optimization technology used?
Could it explain the correlation between vaccinations campaigns & "new variants" outbreaks?
If codon optimization is causing "new variants" (new symptoms & sickness), than any new product (eg boosters) which will include new codon optimized genetic code, will again lead to more forms of sickness.
PS:
Where is the 3D model of the "Delta variant"?
Protein folding is governed by Gibbs Free Energy (ΔΔG). Protein stability seems to plays a vital role in the evolution of SARS-CoV-2. Dominant variants were found to exhibit significantly lower ΔΔG, with HIGHER THAN EXPECTED protein stability.
https://www.biorxiv.org/content/10.1101/2021.06.25.449882v1.full.pdfJust to explain the above, out of the variants of concern, NONE of the dominant mutations (67 of 19440 possible mutations) observed in induce a strongly destabilizing, which was significantly different to the expected 34% of possible mutations meeting this threshold.
"We suggest that protein folding calculations offer a useful tool for early identification of advantageous mutations"Could it be that manufacturers used codon optimization and protein folding calculations in order to stabilize the selected spike protein?
"hold on, that's the spike protein, that does not explain the spread of the virus. The spike protein is not supposed to replicate!"Agreed, but it does not explain IgG antibodies against the nucleocapsid in vaccinated non-infected people.
Circulating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients | Clinical Infectious Diseases | Oxford Academichttps://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075
And for anyone who is still not freaked out...I forgot to mention reverse transcription, thank you @HiveAnti for reminding me.
"Breaking Study Sheds More Light on Whether an RNA Vaccine Can Permanently Alter DNA".Breaking Study Sheds More Light on Whether an RNA Vaccine Can Permanently Alter DNA – Science with Dr. Doughttps://sciencewithdrdoug.com/2021/02/15/breaking-study-sheds-more-light-on-whether-an-rna-vaccine-can-permanently-alter-dna/COPTIGATE REDUX - MAJOR UPDATE!
The following tweets are A MAJOR REVISION / UPDATE to the story. It's darn complex.
As the doctor always says in the joke: "I've got some good news, and I've got some bad news."
Don't worry, you will get ANOTHER BONUS at the end !!!
Let's start with the GOOD news:
MOST pharmaceutical companies realized they have a problem (Actually since the MERS outbreak). The spike protein was unstable, so this time they inserted genetic code to create a supportive "skeleton" structure.
This is how it works:
They made two substitutions in the genetic code, adding two molecules of amino acid called proline, in order for it to act as an anchor to keep the protein structure in place. I say some MOST because AstraZeneca didn't... Problems solved, right?
Obviously not (BAD NEWS)!
So it seems that ALL the vaccines that are in the market who use this technology, known as S-2P or 2P, suffer from instability and it is difficult to produce reliably in mammalian cells. Just a reminder - we are (still) mammals.
Also, remember - we have TWO substitutions here. If ONE synonymous mutation can lead to a disease, what is the impact of TWO substitutions? The new suggested structure, HexaPro, uses 6 substitutions. Great for performance and stability, but what about safety?
A tak dal... Ted jsem si uvedomil ze nacpat sem cely clanek by mi trvalo cely den. Na coz nemam bunky. Takze zbytek zde:Thread by @eh_den on Thread Reader App – Thread Reader Apphttps://threadreaderapp.com/thread/1426885632140394499.html