TruthArchive.ai - Tweets Saved By @eh_den

Saved - December 14, 2023 at 8:45 PM
reSee.it AI Summary
COptiGate is a thread discussing the potential risks of codon optimization in COVID-19 vaccines. The thread highlights concerns about protein misfolding, immunogenicity, and the lack of testing by regulators. It also questions the stability and safety of the Pfizer vaccine used in Israel. The author emphasizes the need for risk assessment and transparency in vaccine development. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

COPTIGATE - THE WORST DESIGN FLAW IN HUMAN HISTORY THAT IS IMPACTING YOUR HEALTH. (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) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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... #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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! #COpiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. https://doi.org/10.1038/nm1211-1536 #COptiGate

Breaking the silence - Nature Medicine Scientists had long assumed that any genetic mutation that does not alter a protein sequence should have no impact on human health. But recent research has shown that such synonymous DNA changes can trigger disease in a number of ways. Alla Katsnelson talks to scientists and biotech companies who are speaking up about 'silent' mutations. nature.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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 wouldnโ€™t be seen until late-stage clinical trials or even after approval". #OptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"The changed form could cause immunogenicity, for example, which wouldnโ€™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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"codon optimization can lead to alterations in protein conformation and functionโ€ฆ. and increase immunogenicityโ€ฆ.some of these elements can โ€ฆ alter protein folding, and lead to changes in protein conformation and post-translational modifications.โ€ (Vincent P. Mauro) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Protein misfolding "has been linked with neurodegeneration in Alzheimer and Parkinson disease, and many other pathologies." https://pubmed.ncbi.nlm.nih.gov/28441058/ #COptiGate

Protein Misfolding Diseases - PubMed The majority of protein molecules must fold into defined three-dimensional structures to acquire functional activity. However, protein chains can adopt a multitude of conformational states, and their biologically active conformation is often only marginally stable. Metastable proteins tend to popula โ€ฆ pubmed.ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"The data confirm that protein misfolding resulting in intracellular PAO accumulation is sufficient to cause cardiomyocyte death and heart failure." https://pubmed.ncbi.nlm.nih.gov/18612262/ #COptiGate

Protein misfolding and cardiac disease: establishing cause and effect - PubMed Numerous neurodegenerative diseases are characterized by the accumulation of misfolded amyloidogenic proteins. Recent data indicate that a soluble pre-amyloid oligomer (PAO) may be the toxic entity in these diseases and the visible amyloid plaques, rather than causing the disease, may simply mark th โ€ฆ pubmed.ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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" https://doi.org/10.22541/au.161668243.35142344/v1 #COptiGate

Open Research Collaboration and Publishing - Authorea Authorea is the leading platform to write, cite, collaborate, host data, and publish. authorea.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620378/

Gamma-Glutamyltransferase: A Predictive Biomarker of Cellular Antioxidant Inadequacy and Disease Risk Gamma-glutamyltransferase (GGT) is a well-established serum marker for alcohol-related liver disease. However, GGT's predictive utility applies well beyond liver disease: elevated GGT is linked to increased risk to a multitude of diseases and conditions, ... ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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" #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

Video Transcript AI Summary
Current optimization, often considered harmless, can actually have negative effects. Synonymous mutations, which don't change the translated amino acid, have been linked to diseases. The reasons behind this association are often unknown, but factors like translation rate and RNA structure have been implicated. Since many synonymous mutations have been associated with disease, it is possible that codon optimization, which involves multiple substitutions, could also have an impact. This has been extensively reviewed.
Full Transcript
Speaker 0: I wanna go back to, the effects of, the effects of current optimization. We, although most people think of them think of current optimization as harmless, it has been shown in several there have been several reports showing that a single synonymous mutation may be associated with disease. And in many cases, the reason is unknown. In other cases, the rate of translation has been implicated or the RNA structure has been implicated. But the fact is that a lot of synonymous mutations, and that's a mutation that does not change the amino acid that's being translated. A lot of these anonymous mutations have been associated with disease. So you can think that if one can cause disease, well, if you codon optimize a gene and you have now multiple, substitutions, then there is a good chance that you may have an effect. And this has all been reviewed several times. So what we

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

Video Transcript AI Summary
The speaker asks the regulator if they would request sponsors to conduct intensive analysis to anticipate any immunogenicity issues when reviewing dossiers with extensive optimization. The regulator responds that they understand the burden and do not require specific assays, but they do ask for protein characterization and perform an in silico analysis. If they identify any red flags, they may request further analysis. They generally ask for standard characterization and may increase scrutiny if adverse events specific to optimized proteins arise. The conversation ends with a thank you.
Full Transcript
Speaker 0: Very interesting talk. I have a question for the regulator. So when you see, dossier and you review dossier and you see this kind of very intensive kind of optimization, would you be asking the sponsor say we are R and D, would you be asking the sponsor to go into this kind of analysis to try by an anticipate any immunogenicity issue. Speaker 1: So, no. So far, I mean, we understand that it's a huge burden to try to get that level of detail. We would I mean, We always ask to just to characterize your protein as as well as, you know, as as the sponsor can. We don't ask For specific assays, we we leave it up to the sponsor. We're not against cohort optimization. We know it's dossier We know that we wouldn't have all these drugs that we have if, you know, if you were always using the native product, which sometimes it's hard to express. A dossier, but it's we, we always ask for, you know, the the sequence. We do an in silico analysis is in our part. If we identify a specific, you know, issue that we think that's a red flag, we may go back and say, well, you know, Have you you know, could you try and do that? But otherwise, like, you know, we we ask for everything, you know, the standard characterization that we ask for non quarter optimized proteins. And, you know, we ask a lot of details there too. We do not add an an extra level of detail, but, You know, if, hopefully, it won't happen, but if we start seeing adverse events specific to codon optimized proteins, We might have to, increase our scrutiny. Speaker 0: Thank you. Speaker 1: Yeah. Just, continuing

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

This topic was first discussed in my blog. You can find more information on the topic. Please join my telegram channel t.me/eh_den To those who contacted me and asked how they can support my work - thank you! I'll publish it soon! https://senseofawareness.com/2021/08/09/variantology-the-deadly-optimization-no-one-talks-about/ #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

BONUS (cont) 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"? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Protein folding is governed by Gibbs Free Energy (ฮ”ฮ”G). Protein stability seems to plays a vital role in the evolution of SARS-CoV-2. Dominant variants were found to exhibit significantly lower ฮ”ฮ”G, with HIGHER THAN EXPECTED protein stability. #COptiGate https://www.biorxiv.org/content/10.1101/2021.06.25.449882v1.full.pdf

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Just 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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

(cont): "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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"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. #COptiGate https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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". #OptiGate https://sciencewithdrdoug.com/2021/02/15/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 Part 2- Will an RNA Vaccine Permanently Alter My DNA? sciencewithdrdoug.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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 !!! #COptigate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. (cont) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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 some MOST because AstraZeneca didn't... Problems solved, right? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

When you look at the actual reporting to EMA, you see that Moderna and Janssen (Ad26.COV2.S) reported the use of S-2P, AstraZeneca confirmed it doesn't... and Pfizer described the multiple modifications, and nobody raised it as a risk. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

The regulator DOES NOT HAVE a guidance with regard to the genetic sequencing, does not have a process & toolset to measure the risks, and therefore, is unable to develop a Risk Management Program to address the probability & magnitude of future adverse events. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

And again, as I said before, we have multiple substations that are right now being kept together by two proline molecules unstable and difficult to produce reliably, and in the case of AZ, not even held at all. Does this makes you feel secure? #COptiGate https://science.sciencemag.org/content/369/6510/1501

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

OHH.... ONE LAST THING.... Remember the report of Pfizer from Japan that showed how the vaccine lipids which contain the mRNA in them are leaving the injection site and spreading all around the body? Guess what - it's worse than you think! https://files.catbox.moe/0vwcmj.pdf #COptiGate

Catbox files.catbox.moe

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"Different cell types have drastically different coder usage, different tRNA levels, and figuring the translational kinetics in one tissue tells you NOTHING about the translational kinetics in a different tissue" (Katerina Alexaki) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Translational kinetics can lead to translational pauses, which have a role in modulating protein conformation, can lead to structural changes, increase immunogenicity and change performance. This has been reported since the 90โ€™s. Safe, right? #COptigate https://doi.org/10.1038/s41598-019-51984-2

Effects of codon optimization on coagulation factor IX translation and structure: Implications for protein and gene therapies - Scientific Reports Synonymous codons occur with different frequencies in different organisms, a phenomenon termed codon usage bias. Codon optimization, a common term for a variety of approaches used widely by the biopharmaceutical industry, involves synonymous substitutions to increase protein expression. It had long been presumed that synonymous variants, which, by definition, do not alter the primary amino acid sequence, have no effect on protein structure and function. However, a critical mass of reports suggests that synonymous codon variations may impact protein conformation. To investigate the impact of synonymous codons usage on protein expression and function, we designed an optimized coagulation factor IX (FIX) variant and used multiple methods to compare its properties to the wild-type FIX upon expression in HEK293T cells. We found that the two variants differ in their conformation, even when controlling for the difference in expression levels. Using ribosome profiling, we identified robust changes in the translational kinetics of the two variants and were able to identify a region in the gene that may have a role in altering the conformation of the protein. Our data have direct implications for codon optimization strategies, for production of recombinant proteins and gene therapies. nature.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

There is a database of 51 types of tissues with known different coder usage. NO ONE tested their product vs all the different tissue types. NO ONE knows what the impact is. THE REGULATOR MUST STOP ACTING LIKE A RUBBER STAMP. THIS IS OUR BODIES, WE DEMAND SAFETY! #COptiGate

Video Transcript AI Summary
In this video, the speaker discusses the complexity of gene therapy systems. They explain that the translational kinetics, which were previously studied in HEK293 T cells, will now start from the liver in the gene therapy era. Different tissues will result in expression from different cells with varying coding usage in their transcriptome and tRNA levels. To address this, the speaker's team has created a tissue codon usage database, which contains data for 51 different tissues. They are working on expanding it further and plan to make it available online soon.
Full Transcript
Speaker 0: Wanna bring, like, I just have 1 note on the complexity of these, systems. So the translational kinetics that I showed you were done in, HEK293 T cells. But now that we're moving into the gene therapy era, the expression is actually going to start from the liver. And if you target a different tissue, you're going to get expression from a different, from a different cell. And these cells have drastically different, coding usage in their transcriptome. And also, they may have different tRNA levels. So figuring out the translational kinetics of a protein in 1 tissue, that tells you nothing about the translational kinetics in a different tissue. So to try to tackle this, we've moved on with our codon usage database. And now we have generated this tissue codon usage database, where it has similar data as the previous one that I showed, but it has it for 51 different issues, and we're working towards expanding it. This should be available online starting next week, I think.

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

WARNING - IF YOU ARE FROM ISRAEL, YOU ARRIVED TO THE WORST PART OF THIS THREAD !!! REMEMBER: IGNORANCE IS BLISS: IF YOU CHOOSE TO CONTINUE READING, YOU WILL NEVER BE ABLE TO SEE REALITY AS BEFORE (I MEAN IT!!!) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

On the 17th of December Pfizer informed they already supplied 2.9 million dosages, have millions more doses sitting in their warehouse, and claim they can deliver 50 million more by end of 2020. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Israel started its campaign on 19 December 2020, with prime minister Benjamin Netanyahu being the first person in the country to receive the vaccine. In less than two weeks, over 10% of Israelis received their first dose. Israel's population is 9,364,000, meaning ~1M. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

On the 9th of December the EMA was hacked. On the January the information was shared online. However, before we will go to them, let us get some context. https://www.reuters.com/article/us-ema-cyber-idUSKBN28J2Q7 #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

The European Medical Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) released a report on 19 February 2021 on the Pfizer product. There is a section called "Steps taken for the assessment of the product". #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Remember this report was written 3 MONTHS after Israel already started its vaccination program. In Israel, on the 19th of February 4,280,046 got 1 shot, 2,932,180 got 2nd shot, in total 7,212,226 shots. https://datadashboard.health.gov.il/COVID-19/general #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Back to EMA report: Prizer had two processes: process 1 (clinical trial material) and Process 2 (commercial process). The two processes generated different products: "It can therefore not be concluded that identical species are obtained by the processes." #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

The product included fragmented mRNA, which expected not to cause problems: "It is likely that the fragmented species will not result in expressed proteins, due to their expected poor stability and poor translational efficiency" COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Fragments are supposed to lack segments that will allow it to be fully processed, but it's not the case. "majority of fragments...expected to be ...truncated transcripts...the results indicating a substantial proportion ... are not in agreement with this statement." #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

In summary: the product does work in the cell as it is supposed to. "most fragments would arise from premature termination in the IVT (In vitro Transcription) reaction." #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

poly(A) acts as a timer of mRNA stability, and its value was not tested for during production. "The length of the tails is important for RNA stability and translational efficiency the poly(A) tail length should be included to the active substance release testing" #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Remember the hack? One of the emails has identified โ€œa significant difference in % RNA integrity/truncated speciesโ€ between the clinical batches and proposed commercial batchesโ€”from around 78% to 55%." #COptiGate https://doi.org/10.1136/bmj.n627

The EMA covid-19 data leak, and what it tells us about mRNA instability Leaked documents show that some early commercial batches of Pfizer-BioNTechโ€™s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack.1 More than 40 megabytes of classified information from the agencyโ€™s review were published on the dark web, and several journalistsโ€”including from The BMJ โ€”and academics worldwide were sent copies of the leaks. They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation. The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. EMA scientists tasked with ensuring manufacturing qualityโ€”the chemistry, manufacturing, and control aspects of Pfizerโ€™s submission to the EMAโ€”worried about โ€œtruncated and modified mRNA species present in the finished product.โ€ Among the many files leaked to The BMJ , an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two โ€œmajor objectionsโ€ with Pfizer, along with a host of other questions it wanted addressed. The email identified โ€œa significant difference in % RNA integrity/truncated speciesโ€ between the clinical batches and proposed commercial batchesโ€”from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was โ€œyet to be defined,โ€ the email said. Ultimately, on 21 December, โ€ฆ bmj.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

MUCH, MUCH WORSE: "THE POSSIBILITY OF TRANSLATED PROTEINS OTHER THAN THE INTENDED SPIKE PROTEIN (S1S2), RESULTING FROM TRUCATED AND/OR MODIFIED mRNA SPECIES SHOULD BE ADDRESSED" In other words: THE POSSIBILITY OF MUTATIONS MUST BE ADDRESSED. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Remember Israel? 7,212,226 shots were given to 4,280,046 individuals of a product that suffered from the above manufacturing problems. PFIZER KNEW ABOUT IT. DO YOU THINK ISRAEL DIDN'T? Do you still wonder why the product is not serialized? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Reading the leaked document I quoted from (BWP Rolling Review report to ETF / CHMP, Rolling Review #2) is actually good risk measurement, it covers a lot of areas, but it does not cover Codon Optimization at all. #COptiGate https://covidvaccinereactions.com/ema-pfizer-leak/

EMA Hacked and Data Leaked โ€“ Covid-19 Vaccine Reactions covidvaccinereactions.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Manufacturers are having SO MUCH PROBLEMS to deliver a product that will be in line with cGMP requirements (which is everything above), so I understand why they want to completely ignore a huge threat landscape. But why is the regulator not demanding to check it? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

There are people (at least in the FDA) such as Katerina Alexaki who understand the topic and have developed a good process of validating the performance of Codon Optimization in biotherapeutics. So WHY the regulator (FDA/EMA) don't test it? #COptiGate https://www.youtube.com/watch?v=aZwYEpumQRU

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

From my professional experience, refusal to measure risk IS ALWAYS an indication that someone knows there is a real problem. ALWAYS. It ties back to #PfizerLeak: no liability for big pharma + full liability to country = no incentives to talk about the new elephant. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

I believe that the real reason why people are not acting professionally is political pressure, social pressure, and a spinning door between regulators & industry. The systems we have in place suppress honest people. This is how disasters occur. THIS NEEDS TO STOP. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

I ALMOST MISSED THE PROOF!!!! EMA was asking for: "RELEVANT PROTEIN/PEPTIDE CHARACTERIZATION DATA FOR PREDOMINANT SPECIES SHOULD BE PROVIDED, IF AVAILABLE" THE REGULATOR DON'T KNOW (or at least didn't know) WHAT THE mRNA IS CREATING, not to mention codon information. #COptiGate https://t.co/ioy65k6pco

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Beloved fellow human beings! I invite you to read this thread. Love, Ehden https://t.co/0HqelJkk7O

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

THE PIPED PIPER WITHIN US. By Ehden Biber. Both #PfizerLeak & #COptiGate are examples of negligence by our governments and our institutions to manage risks that has direct impact on us. The question is- does these people don't know that they are putting us at risk?

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Hi, If you reached so far, well done! I welcome you to read the follow up to the story - more on codon optimization, why the chances that the SARS_CoV_2 is a "product of nature" are WAY LESS than 1 in 844,596,301... and much more. #COptiGate https://t.co/V11Z6ZGF83

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

COPTIGATE - 3D CHESS EDITION How the worst design flaw in human history (that is impacting your health) is even WORSE THAN YOU THINK. (thread) #COptiGate https://t.co/taQR2KhBL5

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

@reSeeIt save thread

Saved - December 14, 2023 at 8:45 PM
reSee.it AI Summary
COptiGate is a thread discussing the potential risks of codon optimization in COVID-19 vaccines. The thread highlights concerns about protein misfolding, immunogenicity, and the lack of testing by regulators. It also questions the stability and safety of the Pfizer vaccine used in Israel. The author emphasizes the need for risk assessment and transparency in vaccine development. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

COPTIGATE - THE WORST DESIGN FLAW IN HUMAN HISTORY THAT IS IMPACTING YOUR HEALTH. (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) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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... #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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! #COpiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. https://doi.org/10.1038/nm1211-1536 #COptiGate

Breaking the silence - Nature Medicine Scientists had long assumed that any genetic mutation that does not alter a protein sequence should have no impact on human health. But recent research has shown that such synonymous DNA changes can trigger disease in a number of ways. Alla Katsnelson talks to scientists and biotech companies who are speaking up about 'silent' mutations. nature.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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 wouldnโ€™t be seen until late-stage clinical trials or even after approval". #OptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"The changed form could cause immunogenicity, for example, which wouldnโ€™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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"codon optimization can lead to alterations in protein conformation and functionโ€ฆ. and increase immunogenicityโ€ฆ.some of these elements can โ€ฆ alter protein folding, and lead to changes in protein conformation and post-translational modifications.โ€ (Vincent P. Mauro) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Protein misfolding "has been linked with neurodegeneration in Alzheimer and Parkinson disease, and many other pathologies." https://pubmed.ncbi.nlm.nih.gov/28441058/ #COptiGate

Protein Misfolding Diseases - PubMed The majority of protein molecules must fold into defined three-dimensional structures to acquire functional activity. However, protein chains can adopt a multitude of conformational states, and their biologically active conformation is often only marginally stable. Metastable proteins tend to popula โ€ฆ pubmed.ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"The data confirm that protein misfolding resulting in intracellular PAO accumulation is sufficient to cause cardiomyocyte death and heart failure." https://pubmed.ncbi.nlm.nih.gov/18612262/ #COptiGate

Protein misfolding and cardiac disease: establishing cause and effect - PubMed Numerous neurodegenerative diseases are characterized by the accumulation of misfolded amyloidogenic proteins. Recent data indicate that a soluble pre-amyloid oligomer (PAO) may be the toxic entity in these diseases and the visible amyloid plaques, rather than causing the disease, may simply mark th โ€ฆ pubmed.ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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" https://doi.org/10.22541/au.161668243.35142344/v1 #COptiGate

Open Research Collaboration and Publishing - Authorea Authorea is the leading platform to write, cite, collaborate, host data, and publish. authorea.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620378/

Gamma-Glutamyltransferase: A Predictive Biomarker of Cellular Antioxidant Inadequacy and Disease Risk Gamma-glutamyltransferase (GGT) is a well-established serum marker for alcohol-related liver disease. However, GGT's predictive utility applies well beyond liver disease: elevated GGT is linked to increased risk to a multitude of diseases and conditions, ... ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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" #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

Video Transcript AI Summary
Current optimization, often considered harmless, can actually have negative effects. Synonymous mutations, which don't change the translated amino acid, have been linked to diseases. The reasons behind this association are often unknown, but factors like translation rate and RNA structure have been implicated. Since many synonymous mutations have been associated with disease, it is possible that codon optimization, which involves multiple substitutions, could also have an impact. This has been extensively reviewed.
Full Transcript
Speaker 0: I wanna go back to, the effects of, the effects of current optimization. We, although most people think of them think of current optimization as harmless, it has been shown in several there have been several reports showing that a single synonymous mutation may be associated with disease. And in many cases, the reason is unknown. In other cases, the rate of translation has been implicated or the RNA structure has been implicated. But the fact is that a lot of synonymous mutations, and that's a mutation that does not change the amino acid that's being translated. A lot of these anonymous mutations have been associated with disease. So you can think that if one can cause disease, well, if you codon optimize a gene and you have now multiple, substitutions, then there is a good chance that you may have an effect. And this has all been reviewed several times. So what we

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

Video Transcript AI Summary
The speaker asks the regulator if they would request sponsors to conduct intensive analysis to anticipate any immunogenicity issues when reviewing dossiers with extensive optimization. The regulator responds that they understand the burden and do not require specific assays, but they do ask for protein characterization and perform an in silico analysis. If they identify any red flags, they may request further analysis. They generally ask for standard characterization and may increase scrutiny if adverse events specific to optimized proteins arise. The conversation ends with a thank you.
Full Transcript
Speaker 0: Very interesting talk. I have a question for the regulator. So when you see, dossier and you review dossier and you see this kind of very intensive kind of optimization, would you be asking the sponsor say we are R and D, would you be asking the sponsor to go into this kind of analysis to try by an anticipate any immunogenicity issue. Speaker 1: So, no. So far, I mean, we understand that it's a huge burden to try to get that level of detail. We would I mean, We always ask to just to characterize your protein as as well as, you know, as as the sponsor can. We don't ask For specific assays, we we leave it up to the sponsor. We're not against cohort optimization. We know it's dossier We know that we wouldn't have all these drugs that we have if, you know, if you were always using the native product, which sometimes it's hard to express. A dossier, but it's we, we always ask for, you know, the the sequence. We do an in silico analysis is in our part. If we identify a specific, you know, issue that we think that's a red flag, we may go back and say, well, you know, Have you you know, could you try and do that? But otherwise, like, you know, we we ask for everything, you know, the standard characterization that we ask for non quarter optimized proteins. And, you know, we ask a lot of details there too. We do not add an an extra level of detail, but, You know, if, hopefully, it won't happen, but if we start seeing adverse events specific to codon optimized proteins, We might have to, increase our scrutiny. Speaker 0: Thank you. Speaker 1: Yeah. Just, continuing

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

This topic was first discussed in my blog. You can find more information on the topic. Please join my telegram channel t.me/eh_den To those who contacted me and asked how they can support my work - thank you! I'll publish it soon! https://senseofawareness.com/2021/08/09/variantology-the-deadly-optimization-no-one-talks-about/ #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

BONUS (cont) 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"? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Protein folding is governed by Gibbs Free Energy (ฮ”ฮ”G). Protein stability seems to plays a vital role in the evolution of SARS-CoV-2. Dominant variants were found to exhibit significantly lower ฮ”ฮ”G, with HIGHER THAN EXPECTED protein stability. #COptiGate https://www.biorxiv.org/content/10.1101/2021.06.25.449882v1.full.pdf

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Just 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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

(cont): "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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"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. #COptiGate https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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". #OptiGate https://sciencewithdrdoug.com/2021/02/15/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 Part 2- Will an RNA Vaccine Permanently Alter My DNA? sciencewithdrdoug.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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 !!! #COptigate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. (cont) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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 some MOST because AstraZeneca didn't... Problems solved, right? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

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? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

When you look at the actual reporting to EMA, you see that Moderna and Janssen (Ad26.COV2.S) reported the use of S-2P, AstraZeneca confirmed it doesn't... and Pfizer described the multiple modifications, and nobody raised it as a risk. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

The regulator DOES NOT HAVE a guidance with regard to the genetic sequencing, does not have a process & toolset to measure the risks, and therefore, is unable to develop a Risk Management Program to address the probability & magnitude of future adverse events. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

And again, as I said before, we have multiple substations that are right now being kept together by two proline molecules unstable and difficult to produce reliably, and in the case of AZ, not even held at all. Does this makes you feel secure? #COptiGate https://science.sciencemag.org/content/369/6510/1501

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

OHH.... ONE LAST THING.... Remember the report of Pfizer from Japan that showed how the vaccine lipids which contain the mRNA in them are leaving the injection site and spreading all around the body? Guess what - it's worse than you think! https://files.catbox.moe/0vwcmj.pdf #COptiGate

Catbox files.catbox.moe

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

"Different cell types have drastically different coder usage, different tRNA levels, and figuring the translational kinetics in one tissue tells you NOTHING about the translational kinetics in a different tissue" (Katerina Alexaki) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Translational kinetics can lead to translational pauses, which have a role in modulating protein conformation, can lead to structural changes, increase immunogenicity and change performance. This has been reported since the 90โ€™s. Safe, right? #COptigate https://doi.org/10.1038/s41598-019-51984-2

Effects of codon optimization on coagulation factor IX translation and structure: Implications for protein and gene therapies - Scientific Reports Synonymous codons occur with different frequencies in different organisms, a phenomenon termed codon usage bias. Codon optimization, a common term for a variety of approaches used widely by the biopharmaceutical industry, involves synonymous substitutions to increase protein expression. It had long been presumed that synonymous variants, which, by definition, do not alter the primary amino acid sequence, have no effect on protein structure and function. However, a critical mass of reports suggests that synonymous codon variations may impact protein conformation. To investigate the impact of synonymous codons usage on protein expression and function, we designed an optimized coagulation factor IX (FIX) variant and used multiple methods to compare its properties to the wild-type FIX upon expression in HEK293T cells. We found that the two variants differ in their conformation, even when controlling for the difference in expression levels. Using ribosome profiling, we identified robust changes in the translational kinetics of the two variants and were able to identify a region in the gene that may have a role in altering the conformation of the protein. Our data have direct implications for codon optimization strategies, for production of recombinant proteins and gene therapies. nature.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

There is a database of 51 types of tissues with known different coder usage. NO ONE tested their product vs all the different tissue types. NO ONE knows what the impact is. THE REGULATOR MUST STOP ACTING LIKE A RUBBER STAMP. THIS IS OUR BODIES, WE DEMAND SAFETY! #COptiGate

Video Transcript AI Summary
In this video, the speaker discusses the complexity of gene therapy systems. They explain that the translational kinetics, which were previously studied in HEK293 T cells, will now start from the liver in the gene therapy era. Different tissues will result in expression from different cells with varying coding usage in their transcriptome and tRNA levels. To address this, the speaker's team has created a tissue codon usage database, which contains data for 51 different tissues. They are working on expanding it further and plan to make it available online soon.
Full Transcript
Speaker 0: Wanna bring, like, I just have 1 note on the complexity of these, systems. So the translational kinetics that I showed you were done in, HEK293 T cells. But now that we're moving into the gene therapy era, the expression is actually going to start from the liver. And if you target a different tissue, you're going to get expression from a different, from a different cell. And these cells have drastically different, coding usage in their transcriptome. And also, they may have different tRNA levels. So figuring out the translational kinetics of a protein in 1 tissue, that tells you nothing about the translational kinetics in a different tissue. So to try to tackle this, we've moved on with our codon usage database. And now we have generated this tissue codon usage database, where it has similar data as the previous one that I showed, but it has it for 51 different issues, and we're working towards expanding it. This should be available online starting next week, I think.

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

WARNING - IF YOU ARE FROM ISRAEL, YOU ARRIVED TO THE WORST PART OF THIS THREAD !!! REMEMBER: IGNORANCE IS BLISS: IF YOU CHOOSE TO CONTINUE READING, YOU WILL NEVER BE ABLE TO SEE REALITY AS BEFORE (I MEAN IT!!!) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

On the 17th of December Pfizer informed they already supplied 2.9 million dosages, have millions more doses sitting in their warehouse, and claim they can deliver 50 million more by end of 2020. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Israel started its campaign on 19 December 2020, with prime minister Benjamin Netanyahu being the first person in the country to receive the vaccine. In less than two weeks, over 10% of Israelis received their first dose. Israel's population is 9,364,000, meaning ~1M. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

On the 9th of December the EMA was hacked. On the January the information was shared online. However, before we will go to them, let us get some context. https://www.reuters.com/article/us-ema-cyber-idUSKBN28J2Q7 #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

The European Medical Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) released a report on 19 February 2021 on the Pfizer product. There is a section called "Steps taken for the assessment of the product". #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Remember this report was written 3 MONTHS after Israel already started its vaccination program. In Israel, on the 19th of February 4,280,046 got 1 shot, 2,932,180 got 2nd shot, in total 7,212,226 shots. https://datadashboard.health.gov.il/COVID-19/general #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Back to EMA report: Prizer had two processes: process 1 (clinical trial material) and Process 2 (commercial process). The two processes generated different products: "It can therefore not be concluded that identical species are obtained by the processes." #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

The product included fragmented mRNA, which expected not to cause problems: "It is likely that the fragmented species will not result in expressed proteins, due to their expected poor stability and poor translational efficiency" COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Fragments are supposed to lack segments that will allow it to be fully processed, but it's not the case. "majority of fragments...expected to be ...truncated transcripts...the results indicating a substantial proportion ... are not in agreement with this statement." #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

In summary: the product does work in the cell as it is supposed to. "most fragments would arise from premature termination in the IVT (In vitro Transcription) reaction." #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

poly(A) acts as a timer of mRNA stability, and its value was not tested for during production. "The length of the tails is important for RNA stability and translational efficiency the poly(A) tail length should be included to the active substance release testing" #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Remember the hack? One of the emails has identified โ€œa significant difference in % RNA integrity/truncated speciesโ€ between the clinical batches and proposed commercial batchesโ€”from around 78% to 55%." #COptiGate https://doi.org/10.1136/bmj.n627

The EMA covid-19 data leak, and what it tells us about mRNA instability Leaked documents show that some early commercial batches of Pfizer-BioNTechโ€™s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack.1 More than 40 megabytes of classified information from the agencyโ€™s review were published on the dark web, and several journalistsโ€”including from The BMJ โ€”and academics worldwide were sent copies of the leaks. They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation. The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. EMA scientists tasked with ensuring manufacturing qualityโ€”the chemistry, manufacturing, and control aspects of Pfizerโ€™s submission to the EMAโ€”worried about โ€œtruncated and modified mRNA species present in the finished product.โ€ Among the many files leaked to The BMJ , an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two โ€œmajor objectionsโ€ with Pfizer, along with a host of other questions it wanted addressed. The email identified โ€œa significant difference in % RNA integrity/truncated speciesโ€ between the clinical batches and proposed commercial batchesโ€”from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was โ€œyet to be defined,โ€ the email said. Ultimately, on 21 December, โ€ฆ bmj.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

MUCH, MUCH WORSE: "THE POSSIBILITY OF TRANSLATED PROTEINS OTHER THAN THE INTENDED SPIKE PROTEIN (S1S2), RESULTING FROM TRUCATED AND/OR MODIFIED mRNA SPECIES SHOULD BE ADDRESSED" In other words: THE POSSIBILITY OF MUTATIONS MUST BE ADDRESSED. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Remember Israel? 7,212,226 shots were given to 4,280,046 individuals of a product that suffered from the above manufacturing problems. PFIZER KNEW ABOUT IT. DO YOU THINK ISRAEL DIDN'T? Do you still wonder why the product is not serialized? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Reading the leaked document I quoted from (BWP Rolling Review report to ETF / CHMP, Rolling Review #2) is actually good risk measurement, it covers a lot of areas, but it does not cover Codon Optimization at all. #COptiGate https://covidvaccinereactions.com/ema-pfizer-leak/

EMA Hacked and Data Leaked โ€“ Covid-19 Vaccine Reactions covidvaccinereactions.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Manufacturers are having SO MUCH PROBLEMS to deliver a product that will be in line with cGMP requirements (which is everything above), so I understand why they want to completely ignore a huge threat landscape. But why is the regulator not demanding to check it? #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

There are people (at least in the FDA) such as Katerina Alexaki who understand the topic and have developed a good process of validating the performance of Codon Optimization in biotherapeutics. So WHY the regulator (FDA/EMA) don't test it? #COptiGate https://www.youtube.com/watch?v=aZwYEpumQRU

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

From my professional experience, refusal to measure risk IS ALWAYS an indication that someone knows there is a real problem. ALWAYS. It ties back to #PfizerLeak: no liability for big pharma + full liability to country = no incentives to talk about the new elephant. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

I believe that the real reason why people are not acting professionally is political pressure, social pressure, and a spinning door between regulators & industry. The systems we have in place suppress honest people. This is how disasters occur. THIS NEEDS TO STOP. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

I ALMOST MISSED THE PROOF!!!! EMA was asking for: "RELEVANT PROTEIN/PEPTIDE CHARACTERIZATION DATA FOR PREDOMINANT SPECIES SHOULD BE PROVIDED, IF AVAILABLE" THE REGULATOR DON'T KNOW (or at least didn't know) WHAT THE mRNA IS CREATING, not to mention codon information. #COptiGate https://t.co/ioy65k6pco

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Beloved fellow human beings! I invite you to read this thread. Love, Ehden https://t.co/0HqelJkk7O

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

THE PIPED PIPER WITHIN US. By Ehden Biber. Both #PfizerLeak & #COptiGate are examples of negligence by our governments and our institutions to manage risks that has direct impact on us. The question is- does these people don't know that they are putting us at risk?

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

Hi, If you reached so far, well done! I welcome you to read the follow up to the story - more on codon optimization, why the chances that the SARS_CoV_2 is a "product of nature" are WAY LESS than 1 in 844,596,301... and much more. #COptiGate https://t.co/V11Z6ZGF83

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

COPTIGATE - 3D CHESS EDITION How the worst design flaw in human history (that is impacting your health) is even WORSE THAN YOU THINK. (thread) #COptiGate https://t.co/taQR2KhBL5

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate) ๐ŸŒŸ

@reSeeIt save thread

Saved - October 3, 2023 at 12:58 AM
reSee.it AI Summary
Codon optimization, known as COptiGate, is a crucial topic. Synonymous mutations impact protein structure and function, with misfolding leading to diseases like Alzheimer's and heart failure. Codon optimization alters gene sequences, enhancing protein production. However, it carries risks, such as unpredictable effects on protein structure and immune system response. Regulators lack a framework to evaluate these risks, and fast-track approval processes overlook them. The responsibility lies with individuals to question authorities and prioritize their health and safety. COptiGate aims to shed light on these risks and the need for awareness.

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

COPTIGATE - THE SUMMARY EDITION! (thread) Highlights from my writing on the topic of codon optimization, for those who have never heard about it before (or for those who wish to share it with others). #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

Before you bombard experts (e.g. @RWMaloneMD) with endless requests to comment on the validity of what I write, please read this thread, then go to the previous threads (links below), and see the references I use. There is MUCH MORE INFORMATION in my previous threads! #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

1) Inconsequential (โ€œsilentโ€) mutations are known as synonymous mutation. 2) Synonymous mutations contribute to cellular processes which are determining protein structure and function. 3) Synonymous mutations influence protein folding. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

4) Protein misfolding has been linked with neurodegeneration in Alzheimer and Parkinson disease, and many other pathologies. 5) Protein misfolding resulting in intracellular PAO accumulation is sufficient to cause cardiomyocyte death and heart failure. #COpgiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

6) For example, these misfolded proteins, known as PRIONS, cause a number of rare brain disorders, such as kuru, bovine spongiform encephalopathy (โ€œmad cowโ€ disease), and Creutzfeldt-Jakob disease. #COptiGate https://www.brainfacts.org/archives/2010/protein-folding-a-new-twist-on-brain-disease

Protein Folding: A New Twist on Brain Disease Alzheimer’s, Huntington’s, and Parkinson’s are common brain diseases — each causes a unique form of progressive brain cell death. But they may not be so different after all. brainfacts.org

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

7) The last decade has seen an exponential increase in published research on the topic of synonymous mutations. 8) Most studies that linked synonymous mutations to diseases focused on a single (or very few) nucleotide* substitutions. *nucleotide - genetic letter. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

9) codon optimization creates a large-scale alteration of the gene sequence. 10) Up until recently, codon optimization technology was only used for research and in the manufacturing of therapeutic proteins. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

11) SARS_CoV_2, as well as all its variants/mutations are called wild type (WT), which describes their original form (in nature). 12) Pfizer, Moderna, AstraZeneca, Janssen etc. all use codon optimization, on top of other elements; their products do not generate WT. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

13) There is a lack of understanding on the difference between proteins synthesized using codon optimization compared to those which did not pass a codon optimization process. 14) Using the codon optimization technology gives multiple advantages to the manufacturers. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

15) HOWEVER, Codon optimized proteins carry potential risks as their modified nucleotide sequences may have unpredictable effects on the structure and function of proteins. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

16) For example, codon optimization can achieve efficiency in creating large amounts of the required protein (eg spike), but doing so at the expense of the accuracy of the protein being manufactured, resulting in generating unknown proteins due to errors/misreading. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

17) Another example: codon optimization might change the shape of the protein, which in result will lead the immune system to be trained to detect a wrong pathogen thus greatly reducing its ability to stop the pathogen, in our case SARS_CoV_2 and its mutants. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

18) It is therefore necessary to have well qualified methods that are fit-for-purpose and can be used to evaluate the risk of codon optimization during drug development and manufacture. The regulators did not have such framework in place. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

19) Prior to COVID19, the use of gene therapy was extremely limited, so even though regulatory agencies were well aware of the need for methods and processes, the limited use and the long review process deemed sufficient to identify codon optimization side effects. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

20) Because in 2020 the WHO has declared COVID19 as a pandemic, and since governments across the world followed happily by implementing emergency regulations, the medical regulators had been instructed to get vaccines approved as fast as possible. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

21) All the gene therapies which were introduced as vaccines to the SARS_CoV_2 virus and it's variants went via a fast-track process such as the FDA's Emergency Use Authorization (EUA) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

22) The use of the fast-track approval process created a gap where the assumption that codon optimization side effects will be able to be identified as part of the review process, as there was no regulatory process to review risks related to codon optimization. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

23) HOWEVER, since the fast-track process has been chosen, the risks which were usually being measured as part of the normal process were not measured. 24) The codon optimization related risks are not even required to be measured in the FDA's BLA for Pfizer vaccine. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

25) The fact manufacturers use a technology which they are fully aware of is problematic, and the fact regulators are fully aware of it but do not even have a process to review it, tells you everything you need to know about the validation process and it's value. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

26) Not measuring a risk does not make it go away, just makes it become invisible. 27) The only one who takes the risk is YOU, because all the countries in the world have signed a full indemnity to manufacturers and anyone who administers their products (#PrizerLeak). #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

28) The purpose of the #COptiGate threads was to help people realize the risks related to codon optimization, which no one seems to have bothered to tell them that they exist. 29) The silence of the scientific community and media on the matter is a huge disgrace. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

30) One's education does not make them a scientist. One's position of power (government or academia) does not make them trustworthy. PLEASE, STOP TRUSTING "AUTHORITIES". It is YOUR health, it is YOUR safety, it is YOUR life. YOU HAVE THE RIGHT TO QUESTION EVERYTHING! #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

THREADS TO READ # 1 COPTIGATE - THE WORST DESIGN FLAW IN HUMAN HISTORY THAT IS IMPACTING YOUR HEALTH. (use "Show replies" multiple times to expand) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

THREADS TO READ # 2 COPTIGATE - 3D CHESS EDITION (use "Show replies" multiple times to expand) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

THREADS TO READ # 3 REVERSE ENGINEERING: WHAT DO WE KNOW ABOUT THE GENETIC CODE WITHIN THE PFIZER VACCINE? (use "Show replies" multiple times to expand) #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

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@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

Antibody-dependent Enhancement (ADE) & Codon Optimization: 31) ADE: antibodies generated as a result of the vaccine response recognize and bind to SARS_CoV_2 virus, but they are unable to prevent infection, because they were trained badly. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

32) Not only the S-2P design of the spike protein generated by Moderna, Pfizer and Janssen is faulty, introducing codon optimization on top of that might lead to errors in the RBD domain on the generate spike protein can further increase the risk of ADE. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

33) The reason for the S-2P prefusion design was "to provoke stronger immune response...but it can also means the spike protein lingers in the plasma membrane bound to ACE2 receptors because of impaired fusion capabilities" https://dpbh.nv.gov/uploadedFiles/dpbhnvgov/content/Boards/BOH/Meetings/2021/SENEFF~1.PDF #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

34) HOWEVER, as the Salk institute has shown, if the spike protein is binding to ACE2 it disrupts the ACE2โ€™s molecular signaling to mitochondria, causing the mitochondria to become damaged and fragmented. https://www.salk.edu/news-release/the-novel-coronavirus-spike-protein-plays-additional-key-role-in-illness/ #COptiGate

The novel coronavirusโ€™ spike protein plays additional key role in illness - Salk Institute for Biological Studies LA JOLLAโ€”Scientists have known for a while that SARS-CoV-2โ€™s distinctive โ€œspikeโ€ proteins help the virus infect its host by latching on to healthy cells. Now, a major new study shows that the virus spike proteins (which behave very differently than those safely encoded by vaccines) also play a key role in the disease itself. salk.edu

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

35) Antibody production against S-2P spike bind with soluble /plasma ACE-2 (shedding) can cause: coryzal symptoms; shortness of breath; abnormal liver function; LOST OF TASTE; Lymphopenia; Renal failure; ARDS; Kawasaki; myocarditis; and stoke. https://www.frontiersin.org/articles/10.3389/fimmu.2021.582166/full #COptiGate

COVID-19โ€”A Theory of Autoimmunity Against ACE-2 Explained The COVID-19 pandemic caused by the coronavirus SARS-COV-2 has cost many lives worldwide. In dealing with affected patients, the physician is faced with a very unusual pattern of organ damage that is not easily explained on the basis of prior knowledge of viral-induced pathogenesis. It is established that the main receptor for viral entry into tissues is the protein angiotensin-converting enzyme-2 (โ€œACE-2โ€, 1). In a recent publication (2), a theory of autoimmunity against ACE-2, and/or against the ACE-2/SARS-COV-2 spike protein complex or degradation products thereof, was proposed as a possible explanation for the unusual pattern of organ damage seen in COVID-19. In the light of more recent information, this manuscript expands on the earlier proposed theory and offers additional, testable hypotheses that could explain both the pattern and timeline of organ dysfunction most often observed in COVID-19. frontiersin.org

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

Source: "Effects of codon optimization on coagulation factor IX translation and structure: Implications for protein and gene therapies" (Aikaterini Alexaki et al., 2019) #COptiGate https://t.co/GwDCQ7yLai

Saved - October 2, 2023 at 9:31 PM

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

EXPLOSIVE!!! 1) ISRAEL MINISTRY OF HEALTH ADMITS THAT #MYOCARDITIS (WITH OR WITHOUT #PERICARDITIS) OCCURS IN 1 IN 6637 YOUNG PEOPLE BETWEEN THE AGES OF 16 TO 19 WHO GOT #COVID19 VACCINES! 2) THEY ADMIT THAT ADVERSE EVENTS ARE MORE COMMON WITH YOUNG PEOPLE!!! 1/THREAD #mRNAGate

Saved - September 10, 2023 at 9:55 PM
reSee.it AI Summary
In July 2021, I exposed the genuine PfizerBioNTech manufacturing and supply agreement with Brazil, which revealed that all countries worldwide committed to the same terms. Recently, the South Africa contact was exposed, confirming the truth of my previous claims. As an information security expert, I verified the authenticity of the Brazilian contract, facing professional consequences for my actions. It's important to note that governments were aware of the potential harm caused by the PfizerBioNTech shots. The use of deadly mRNA technology was revealed through PfizerLeak. #PfizerLeak #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

1/4 IMPORTANT REMINDER: I EXPOSED ON JULY 2021 the #Pfizer/#BioNTech manufacturing and supply agreement with Brazil, PROVED IT WAS 100% GENUINE, and provided evidence that ALL THE COUNTRIES AROUND THE WORLD COMMITTED TO THE SAME TERM. #PfizerLeak https://t.me/eh_den/775

Ehden's Channel REMINDER: I EXPOSED ON JULY 2021 the Pfizer/BioNTech manufacturing and supply agreement with Brazil, PROVED IT WAS 100% GENUINE, and provided evidence that ALL THE COUNTRIES AROUND THE WORLD COMMITTED TO THE SAME TERM. (#PfizerLeak). https://ehden.substack.com/p/pfizerleak-exposing-the-pfizer-manufacturing-and-supply-agreement-the-brazilian-job-day-56 t.me

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

2/4 The South-Africa contact which just been exposed via court order only proves that everything I've written was true & in line with the testimony of the head of Pfizer in Latin America, which I reported on on July 2021. Here's the testimony: #PfizerLeak https://t.me/eh_den/653

Ehden's Channel The Negotiations (#PfizerLeak) An overview of the way Pfizer conducted their negotiations worldwide, while clarifying the timeline of the negotiations that took place in Israel. Revised twitter thread from 2022-12-26. https://ehden.substack.com/p/the-negotiations-pfizerleak t.me

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

3/4 As an information security expert, I knew that the fact the Brazilian contact was digitally signed meant IT WAS 100% authentic and I had the credentials to prove it. I've paid a heavy professional price exposing this agreement. I still do: #PfizerLeak https://t.co/WO5uCqylhd

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

Today I've been assulted, abused, and discriminated by #MetroBank. It frozen my account bdecause I travelled to #Moscow (#Russia) to visit my son who almost died earlier this year, and who was missing me. AS A FORMER HEAD OF INFORMATION SECURITY OF THE BANK I know I don't poseโ€ฆ

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

4/4 To those who only start to wake up to the betrayal of their government that signed this contract with #Pfizer/#BioNTech: THEY KNEW THE SHOTS WILL HARM YOU! #PfizerLeak led me to expose the use of a deadly technology in #mRNA shots. READ #COptiGate! https://t.co/sjSQOM2Tgw

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

1/ #COptiGate, 2022 Xmas Edition. Following the news about UK-#Moderna partnership, this THREAD is about a key technology used IN ALL mRNA "vaccines" (and IN ALL gene therapy technologies), which is carrying SEVERE HEALTH RISKS that our health regulators decided to ignore.

Saved - September 10, 2023 at 9:53 PM
reSee.it AI Summary
COptiGate reveals the risks of codon optimization in mRNA vaccines. Health regulators ignored the potential health hazards associated with this technology. Codon optimization alters genetic sequences, potentially affecting protein structure and function. Protein misfolding can lead to diseases like Alzheimer's and heart failure. The use of N1methylpseudouridine and codon optimization impacts ribosomes and mRNA secondary structures. Low tRNA availability can pause spike protein creation, affecting proper folding. Regulators failed to address translation accuracy and immune system confusion. Partnership with Moderna raises concerns about the UK's safety assurance process. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

1/ #COptiGate, 2022 Xmas Edition. Following the news about UK-#Moderna partnership, this THREAD is about a key technology used IN ALL mRNA "vaccines" (and IN ALL gene therapy technologies), which is carrying SEVERE HEALTH RISKS that our health regulators decided to ignore.

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

2/ The UK-#Moderna partnership is so that the #NHS will "have access to a UK-made supply of COVID-19 jabs as well as cutting-edge vaccines developed for other respiratory diseases, such as flu and respiratory syncytial virus (RSV)". Sounds great, no? NO! https://www.gov.uk/government/news/uk-cements-10-year-partnership-with-moderna-in-major-boost-for-vaccines-and-research

UK cements 10-year-partnership with Moderna in major boost for vaccines and research Moderna to invest in mRNA research and development (R&D) in the UK, and build a state-of-the-art vaccine manufacturing centre with the ability to produce up to 250 million vaccines a year. gov.uk

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

3/ Last year, starting Aug 2021, I've published a series of threads I entitled #COptiGate. Until that point of time it was unknown to the most of the public that all the COVID19 shots were using a technology that had a negative impact on their safety. Let's start with a recap.

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

4/ Codon Optimization is a method to use an alternative genetic sequence to produce the same protein (in the case of COVID19, the spike protein). There were known risks related to the technology, which health authorities knew of for many years, butโ€ฆ #COptigate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

5/ Health regulators from around the world (e.g., FDA, EMA), which were aware of the multiple risks associated with the codon optimization technology, decided to simply ignore them when it came to the COVID19 shots. The betrayal of the public was covered in #COptigate threads.

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

6/ The body has defence mechanisms against viral replication in its cells. To bypass it and increase the number of spike proteins produced inside the cells, two major changes were done: the introduction of N1-methylpseudouridine, and Codon Optimization. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

7/ First, N1-methylpseudouridine: If you wish to understand why manufacturers such as #Pfizer & #Moderna use it, as well why replacing specific genetic letters with it is a bad idea to our health, I invite you to read my article, linked below: #PrizerLeak https://ehden.substack.com/p/deadly-substitution-and-farewell

Deadly Substitution, and Farewell to Andrew New article shed more light on the problematic usage of N1-methylpseudouridine in the mRNA experimental gene therapy ("vaccine"). Here is a summary of the article, plus a farewell to one of my heroes. ehden.substack.com

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

8/ For now, let's focus on Codon Optimization: 1) a "codon" is 3 adjacent genetic letters (or nucleotides). It either encodes information to produce a specific amino acid or serves as a stop signal to terminate translation. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

9/ 2) Codon Optimization is a technology in which genetic letters (nucleotides) are being substituted by other letters, thus creating a new codon, while not impacting the proteins that ribosomes produces. This technology creates inconsequential (โ€œsilentโ€) mutations. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

10/ 3) Inconsequential (โ€œsilentโ€) mutations are known as synonymous mutation. 4) Synonymous mutations contribute to cellular processes which are determining protein structure and function. 5) Synonymous mutations influence protein folding. #COptiGate

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

11/ 6) Protein misfolding been linked to Alzheimer, Parkinson disease, and many other pathologies. 7) PROTEIN MISFOLDING resulting in intracellular PAO accumulation IS SUFFICIENT TO CAUSE CARDIOMYOCYTE DEATH & HEART FAILURE. #COptiGate https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2559970/

Protein Misfolding and Cardiac Disease: Establishing Cause and Effect Numerous neurodegenerative diseases are characterized by the accumulation of misfolded amyloidogenic proteins. Recent data indicate that a soluble pre-amyloid oligomer (PAO) may be the toxic entity in these diseases and the visible amyloid plaques, rather ... ncbi.nlm.nih.gov

@eh_den - Ehden (#PfizerLeak/#MonkeyBusiness/#COptiGate)

12/ 8) For example, these misfolded proteins, known as PRIONS, cause several rare brain disorders, such as kuru, bovine spongiform encephalopathy (โ€œmad cowโ€ disease), and Creutzfeldt-Jakob disease. Notice, this article is from 2010! #COptiGate https://www.brainfacts.org/archives/2010/protein-folding-a-new-twist-on-brain-disease

Protein Folding: A New Twist on Brain Disease Alzheimer’s, Huntington’s, and Parkinson’s are common brain diseases — each causes a unique form of progressive brain cell death. But they may not be so different after all. brainfacts.org

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13/ 9) ALL COVID19 "vaccines" uses large-scale alteration of the gene sequence of the spike protein via codon optimization. They carry potential risk: the modified nucleotide sequences may have unpredictable effects on the structure and function of proteins. #COptiGate

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14/ 10) This is a real problem. 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. In the mRNA "Vaccines" all is synonymous! https://t.co/ky0eOxZzI7

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15/ If you want to understand the risks that were created as a result of it, as well as the decision of health authorities to ignore it, I invite you to read this #COptiGate summary thread. At the end there are links to the original threads on the topic. https://t.co/RJGb9c04sn

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16/ Here is the first thread I've written on the topic, which I entitled "COPTIGATE - THE WORST DESIGN FLAW IN HUMAN HISTORY THAT IS IMPACTING YOUR HEALTH." I've published it on Aug 15, 2021. A lot has happened ever since, so let's start! #COptiGate https://t.co/sR5RjJJnKB

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17/ OK, I hope I got everyone on board now, so we can progress to what was discovered ever since I've published my #COptiGate articles (threads). First of all, huge thanks to @Kevin_McKernan for his work on the topic.

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18/ Let's start with "Differences in Vaccine and SARS-CoV-2 Replication Derived mRNA: Implications for Cell Biology and Future Disease" of @Kevin_McKernan & @P_McCulloughMD & Anthony Kyriakopoulos #COptiGate

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19/ Here the authors have used the known genetic code that #Pfizer & #Moderna has used, and they analysed it to see if there were any alterations in the secondary structures of mRNAs in SARS-CoV-2 vaccines due to the use of codon optimization. #COptiGate

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20/ What are secondary structures? Well, a protein is a 3D object, and its interaction with the body is based on it. Since the spike protein which the mRNA was supposed to create has been codon optimized, it meant that it looked differently if you could see it with your eyes. https://t.co/chkOVNWNlD

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21/ Ribosome, the cell unit which is supposed to process the genetic code, is impacted by the changes in the structure. It impacts the transcription, the translation and the replication of the genetic code. #COptiGate

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22/ On top of of that, there are the problems that were created as a results of using N1-methylpseudouridine (from now on: m1ฮจ). It increase base stacking, RNA stability and melting temperatures compared to uracil, the original genetic letter that it substituted. #COptiGate

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23/ What causes the change in the way ribosomes process genetic data is the emerges of G-quadruplexes. What are they? Because codon optimization increases the GC content of synthetic mRNAs, there can be an enrichment of G-quartets which potentially form G-quadruplex structures. https://t.co/tcGesH6Plk

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24/ I will stop here. #COptiGate will continue tomorrow. Hopefully it would allow people to catch up, as I know many never even heard about Codon Optimization before. Tomorrow there will be much moreโ€ฆ Please use the "Show replies" if you don't see anythingโ€ฆ Thanks, Ehden

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25/ #COptiGate, 2022 Xmas Edition - PART 2! Thanks for your comments and your DM! I understand that for a some this topic of "Codon Optimization" might seems a bit confusing. This part will start by (hopefully) clarifying things to those who feel slightly lostโ€ฆ

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26/ Let's start with the basic building blocks of genetic code: the 4 nucleotide letters โ€“ A, C, G, & T/U. In the COVID19 shots, the manufacturers has used a modified uridine (N1-methylpseudouridine) to replace uridine (U) which appears in the original spike protein. #COptiGate

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27/ Remember that a codon are 3 letters, right? This means 64 combinations (4*4*4). However, there is something really interesting: a mRNA with CGA codon and a CGG codon will both will result in adding an Arginine nucleotide to the protein it manufacture. Why? #COptiGate

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28/ During the process of translation, ribosomes rely on tRNA (Transfer RNA), located in the cell plasma w/cloverleaf structure, to bring the right amino acid element to add to the ribosomes. The tRNA contains a 3-nucleotide codon that anticodon (inverse match) of the mRNA code. https://t.co/TKq9qQP0yj

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29/ Different species and even different cell types (lungs, shoulder muscles etc.) have different availability of different tRNA, therefore a successful human respiratory virus will be evolutionary optimized, in terms of its code to humans and to the human lung cells. #COptiGate

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30/ Since the production of the protein in the ribosome is dependant on the availability of tRNA, if you change the codon to a synonymous codon that has a higher probability of matching the available tRNA in the cell, it should improve the throughput of your product. #COptiGate

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31/ This brings us to the next quick overview - the 3-D structure of the protein, which seems to confuse a lot of people. There are FOUR levels in describing a protein structure, or four levels of organization: Primary. Secondary. Tertiary. Quaternary. #COptiGate https://t.co/3bSXgMfgrx

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32/ Primary (1D): the amino acid sequence. "formula". Secondary (2D): amino acids linked by peptide bonds (oxygen attached to carbon, nitrogen attached to hydrogen). Oxygen & hydrogen can bond. Interactions of adjacent amino acids can form folding: ฮฑ-helices and ฮฒ-plated sheets. https://t.co/Ejr95AYGFJ

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33/ Tertiary (3D): an attraction between ฮฑ-helices and ฮฒ-plated causes the protein to fold. Quaternary (4D): multiple amino acid chains connect together. https://t.co/QYgBJRtJpt

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34/ An adverse result of low tRNA is ribosomal pausing, which in the case of the COVID19 mRNA "vaccines" means that the spike protein creation will be paused significantly enough to impact proper spike protein folding, which, as I've mentioned before, is not good. #COptiGate

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35/ I hope that now, when you look at this image of the "three different Spike Protein Sequences (Moderna (left), Pfizer (middle), SARs-CoV-2(right)) analyzed with RNAfold" I've mentioned above, you can understand there might be structure differences. https://t.co/L3xdaucJX9 https://t.co/1dxrPipcvG

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36/ As the researchers have written, "Not only are the secondary structures of the mRNA noticeably different, of note, is the increased number of quadruplex G formations in the codon optimized mRNA vaccines". If the secondary structures are different, so does the Tertiary (3D)!

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37/ I've posted a thread last year on the topic, entitled "REVERSE ENGINEERING: WHAT DO WE KNOW ABOUT THE GENETIC CODE WITHIN THE PFIZER VACCINE?", and in it I looked at an analysis done on the #Pfizer and #Moderna genetic code. #COptiGate https://t.co/y7eCIeELD3

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38/ In the analysis, performed by @XuhuaX who reviewed the genetic sequence used by #Prizer and #Moderna, he stated that: "THE CODON OPTIMIZATION โ€ฆ SUFFERS FROM LACK OF CONSIDERATION FOR TRANSLATION ACCURACY". They were focused on throughput! #COptiGate https://t.co/6tA9eY64Gq

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39/ From the same review: "IT IS IMPORTANT FOR VACCINE mRNA TO BE TRANSLATED ACCURATELY BECAUSE MISINCORPORATION OF THE WRONG AMINO ACIDS WOULD CONFUSE OUR IMMUNE SYSTEM IN TARGET RECOGNITION". Mis-incorporation can also cause prion proteins. #COptiGate https://t.co/uL0BXBrrif

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40/ As you can see, the regulators (here the #FDA) has never asked manufacturers about their codon optimization decisions. #Pfizer and #Moderna mRNA products and the health implication of their codon optimization were not challenged because regulators have no process to do so! https://t.co/p614geY4MY

Video Transcript AI Summary
The regulator is asked if they would require sponsors to conduct intensive analysis to anticipate immunogenicity issues when reviewing dossiers. The regulator responds that they do not ask for such analysis, but rather request sponsors to characterize their proteins and perform in silico analysis. They acknowledge the necessity of codon optimization and only intervene if there are red flags or adverse events related to codon optimized proteins. They emphasize the importance of standard characterization and may increase scrutiny if adverse events arise.
Full Transcript
Speaker 0: Very interesting talk. I have a question for the regulator. So when you see a dossier and you review a dossier and you see this kind of very intensive kind of optimization, would you be asking the sponsor say, we are IND, would you be asking the sponsor to go into this kind of analysis to try and anticipate any immunogenicity issue? Speaker 1: So no. So far I mean, we understand that it's a huge burden to try to get that level of detail. We would I mean we always ask to just to characterize your protein as as well as, you know, as as the sponsor can. We don't ask for specific assays. We we leave it up to the sponsor. We're not against codon optimization. We know it's necessary. We know that we wouldn't have all these drugs that we have if you were always using the native probably, which sometimes it's hard to express, but So we, we always ask for, you know, the the sequence. We do an in silico analysis in our part. If we identify a specific, a dossier issue that we think that's a red flag, we may go back and say, well, could you try and do that. But otherwise, like, you know, we asked for everything, you know, the standard characterization that we asked for non color optimized proteins. And, you know, we ask a lot of details there too. We do not add an an extra level of detail. But, Hopefully, it won't happen, but if we start seeing adverse events specific to codon optimized proteins, we might have to increase, are screwing me. Yes.

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41/ END OF PART 2! PART 3 will cover research published since my #coptigate publications last year. I leave you with a question: How can the UK go into partnership with #Moderna who depend on codon optimization while having no process in place to assure its use is safe? ๐Ÿ’– Ehden

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