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<\/a><\/p>\nThe German Corona Extra-Parliamentary Inquiry Committee was launched by Dr. Reiner Fuellmich on July 10, 2020. Dr. Fuellmich LL.M. (UCLA) is an attorney at law, authorized to represent at all courts in the US federal state of California. He has been a consumer protection trial lawyer in California and Germany for 26 years.<\/p>\n
The Corona Investigative Committee has been listening to a large number of international scientists and expert testimony since its inception. Class-action lawsuits are being prepared in the US and Canada. Lawsuits are also being prepared in Germany. Germany does not permit class-actions so the process is being prepared differently there. The committee is also working on the creation of legal guidelines and data caches that attorneys around the world will be able to use to file their own lawsuits.<\/p>\n
On 30th January 2021 the German Corona Extra-Parliamentary Inquiry Committee interviewed Dr. Vanessa Schmidt-Kruger, a cell biologist with over 20 years\u2019 experience in molecular medicine working at the Max Delbr\u00fcck Center for Molecular Medicine.<\/p>\n
This is her evidence presented at the 37th Hearing of the German Corona Extra-Parliamentary Inquiry Committee on 30th January 2021.<\/p>\n
RF = Dr. Reiner Fuellmich
\nVSK = Dr. Vanessa Schmidt-Krueger
\nVF = Viviane Fischer
\nMT = Marcel Templin
\nDr. H. = Dr. Holzeisen (Italy)<\/p>\n
RF<\/strong>: Dr. Schmidt-Krueger conducts research on cardiovascular disease and will explain the mechanism and risks of the vaccine.<\/em><\/p>\n VSK<\/strong>: I\u2019m a cell biologist and my specialist field is the functional characterisation and elucidation of proteins, i.e., I understand how proteins are produced, how they are transported in the cell, how they are taken up by cells, how they are metabolised, how intra- and intercellular communication takes place, including within tissue, and how organs interact. This is all very important if one wishes to conduct a risk assessment: how the vaccine functions for example, and the dangers\/risks of the lipid nanoparticles (LNPs). This technology is not really new: it\u2019s novel as a vaccine, but we have been using these LNPs in research for over 20 years, and we have always been struggling with the problem of toxicity of the lipids and balancing this against their efficacy.<\/p>\n I would like to explain a little using the example of the BioNTech vaccine, focusing on a number of specific points. I\u2019ve made a few notes.<\/p>\n The first point is that the BioNTech vaccine that is currently already being used is not highly purified, it contains contaminants of certain components<\/u>. This is in the EMA\u2019s Open Assessment Report<\/u>, the Agency that has granted the authorisation to this vaccine. The EMA (European Medicines Agency) has written this report, and covers this point.<\/p>\n Secondly, I would like to go into the first clinical study of the BioNTech vaccine, and how the quantity of vaccine to be used<\/u> was determined: this has not been correctly characterised from a scientific perspective<\/u> in my opinion.<\/p>\n Point 3 relates to the effects or risks of the LNPs<\/u>, and again I will be focusing on the BioNTech vaccine, the preclinical study they conducted, everything that came out in that, and what has not been discussed in public, and also what the publications say. This is basically not the only research study [on this].<\/p>\n And finally if we have time I would like to talk about the long-term consequences<\/u> relating to immune disease, that is an aspect that has not yet been discussed in public at all.<\/p>\n RF<\/strong>: I don\u2019t know if you are aware of this, but right next to you [on screen] is the colleague Dr. Holzeisen, who is key in constructing the plea for annulment of the vaccine authorisation: what you say today is likely to have a substantial impact on the lawsuit that we formulate and submit to the European Medicines Agency\/the EU Commission.<\/em><\/p>\n VSK<\/strong>: Ok, pleased to help. I have made notes and can submit them in writing later. Good. Why isn\u2019t all this being discussed? One reason might be that this Open Assessment Report is in English, and half of Germany can\u2019t speak English. Then there\u2019s the factor that one needs to be very familiar with the entire medical terminology in the report. And then there are all the technologies and cellular operations described: only specialists like myself can really understand them. That\u2019s why I\u2019m here, and would like to aim and throw some light on all of this.<\/p>\n Basically the EMA Committee\u2019s report has two main sections: one is about Good Manufacturing Practice, GMP, i.e. all the production processes, purification, how good the quality is and the monitoring mechanisms. And the second section is the preclinical study.<\/p>\n In the first section on the GMP they have done very good work I would say: they were very critical, asked for subsequent submission of a great deal of scientific evidence, and asked for numerous improvements. They were very critical and granular, and I was impressed with that.<\/p>\n But their approach to the second section concerning side effects was in stark contrast to that. They didn\u2019t conduct any critical scrutiny at all<\/u>, there are lots of side effects that were not discussed at all in public<\/u>, they also didn\u2019t critically scrutinise what consequences it will have to inject this into people<\/u>, particularly vulnerable groups who already have certain organ-related complaints<\/u>, who are especially susceptible to these adverse effects<\/u>. I\u2019ll go into them in detail at the end.<\/p>\n We know that normally vaccine development takes a very long time<\/u>. It\u2019s not just the clinical phase: with this vaccine, it\u2019s set at three times two and a half years, i.e., three phases of 2.5 years each plus the evaluation phase, which makes 7 \u00bd years in total<\/u>. And then one shouldn\u2019t forget that the production optimisation<\/u> is also important, at least a year<\/u> would surely be needed for that. That hasn\u2019t taken place at all<\/u>. The vaccine is already being sold and used, but the production optimisation isn\u2019t yet by any means completed. And there are considerable deficiencies.<\/p>\n One issue I would like to discuss are the deficiencies relating to the active substance: by that, I mean the modified RNA that they are synthesising. As a second issue there are deficiencies in the consistency of the various production batches: they need to always be consistent so that one always obtains the same vaccine volume and quality.<\/p>\n The problem that BioNTech had is that in the clinical phase the product, i.e. the RNA, was produced with completely different techniques to how it is being produced now<\/u>. During the clinical phase they only needed small volumes of vaccine, they were able to use very expensive techniques that delivered highly purified end products<\/u>. Now that they have entered mass production<\/u>, that is no longer possible, they have had to switch to lower-cost processes<\/u>, e.g. using huge quantities of DNA that functions as the substrate to be able to produce the RNA in an in-vitro transcription reaction. This is done via bacteria, via the fermentation of transformed bacteria that contain this DNA. The bacteria multiply the DNA in huge amounts, and<\/u> this leads to new dangers or risks, particularly contamination<\/u>. At the moment for instance the situation is that the DNA is transformed in the bacteria, it is multiplied, next the bacteria are opened and the DNA is extracted, then it is linearised via enzymes, and after that the linearised DNA undergoes in-vitro transcription to produce the RNA using various procedures. The EMA Committee made various requirements of the vaccine manufacturer, i.e. BioNTech. The applicant needs to now develop and introduce various analysis processes to ensure that the substrate is free of microbiological contaminants<\/u> \u2013 they probably mean E.coli<\/em> bacteria for example. There don\u2019t seem to be any processes to ensure or monitor for that.<\/p>\n They also need to ensure that all the buffers \u2013 those are the solvents that are used \u2013 are free of RNAses<\/u>. RNAses are enzymes that degrade RNA. If there are any contaminants of these RNAse solvents, then RNA in the vaccine will be degraded and the vaccine won\u2019t have any effect anymore.<\/p>\n They also have to analyse how strong the activity of the enzymes is<\/u>; that is very important because I explained that after that the RNA is transcribed from the DNA and then the DNA has to be eliminated, it is digested by enzymes: by DNAses. And if this DNA is not digested well enough, if residues are left, this harbours risks \u2013 I\u2019ll come back to the risks from DNA residues, but the activity of the enzymes has to be monitored well and at the end you need to have a pure RNA without any more DNA<\/u>. And that is not the case<\/u>. BioNTech has admitted that there are DNA contaminants<\/u>.<\/p>\n Requirements were also made relating to the fact that they have not conducted a transport verification study<\/u>. This means they have no idea whether the vaccine is still viable after transportation<\/u>. That is currently being performed.<\/p>\n Then there\u2019s the sterility of the vaccine vial<\/u>. They have good vials, they have tested them, but they have been asked to develop a new \u201cQuick Test<\/em>\u201d so that the doctor or whoever administers the vaccine can conduct this test to check whether the batch that they have just purchased is really sterile. This is simply an additional step that should be taken.<\/p>\n And then they don\u2019t have any proper standard for the various batches<\/u>.<\/p>\n It was found that the integrity of the RNA always varies in the batches that had been made<\/u>. I will come back to that again. There needs to be a standard that is always the same for each batch<\/u>. This should be used as the reference to measure the standard. And they only have this of course for the processes of the clinical phase. Now we have to generate a new standard for the new manufacturing processes, i.e., for the commercial sales. That hasn\u2019t been done yet, they are in the process of doing that now.<\/p>\n So \u2013 the integrity of the RNA means of course the RNA quality<\/u>. They have found that this is not very high: it was higher for the processes during the clinical phase. In this report they don\u2019t say how high it is, but I have other information that says 78% of the RNA was good [translator: this refers to the integrity], the remainder was not, but they have found new batches with only 55% RNA integrity<\/u>, i.e., half of it is basically unviable.<\/p>\n I\u2019ll explain that again: during the synthesis of this RNA, the DNA serves as a template, and then the RNA is produced. It is possible that the entire RNA is not produced, the process is broken off prematurely, this is necessary to be checked<\/u>. There are analysis methods for checking what percentage of the product that has been produced has the full RNA length (100%), and what percentage is only 80% or whatever. These truncated pieces of RNA are more unstable<\/u> as a result: at the end of the RNA there is an adenine attachment, and the longer this \u201ctail\u201d is, the more stable the RNA is in the cell. If this is truncated, the RNA is degraded in the cell relatively fast, and then no protein can be formed at all: in the worst case so little protein is formed that no immune response can take place. But that\u2019s the worst case. If you have RNA integrity of only 55% and the remaining 45% is just truncated pieces because you have found shortened pieces of RNA, then the EMA Committee wanted to know whether truncated protein pieces would be produced, and how much of the proper protein [translator: i.e., spike protein] is produced. This all needs to be analysed.<\/p>\n RF<\/strong>: You are just explaining to us everything that is going wrong with production, and a risk that does not appear to have been discussed at all \u2013 at least I have not read anything about what you have just discussed \u2013 is that 45% of the RNA that is produced from the DNA is non-viable.<\/em><\/p>\n VSK<\/strong>: It may be non-viable if the protein is not formed \u2013 BioNTech has to check that now because one can make the proteins visible using a specific technique, and then one can see how large the proteins are. They are divided up according to their size, and if truncated proteins are made due to shortened pieces of RNA, then one sees that because new shorter proteins are formed. In their analysis they have seen various bands, i.e. various protein sizes, and the EMA Committee would like to know from BioNTech whether these various sizes all belong to the same protein or not \u2013 whether they are other proteins \u2013 shortened proteins that perhaps have no effects at all, and what percentage of the correct protein that we want to have is actually in the vaccine dose. How much is being made.<\/p>\n VF<\/strong>: The small proteins: could they simply have no function, or might they produce some other effect?<\/em><\/p>\n VSK<\/strong>: I assume that they would then be without function.<\/p>\n RF<\/strong>: At least they wouldn\u2019t be doing any damage then?<\/em><\/p>\n VSK<\/strong>: Yes, these are not completely different proteins, this is just a small fraction of the spike protein. (15.11)<\/p>\n VF<\/strong>: And just one other question about the DNA \u2013 what kind of DNA is this that is sort of swimming around, what effects could it have?<\/em><\/p>\n VSK<\/strong>: The sequence of the DNA is complementary to the RNA, and this is needed so that the enzyme has a \u201ctemplate\u201d, so that the RNA can be \u201cread\u201d. The RNA is transcribed by the DNA, that is basically the gene of the spike protein. The gene codes for the protein; the RNA is the interim product.<\/p>\n WW<\/strong>: If shorter pieces are produced, i.e., not the longer proteins but these short sections, I\u2019m thinking about the immune system. There are many homologies in biology, the immune system reacts differently to what is produced in the cell. Is it possible that something is recognised there by the immune system that leads to cross-reactions, leading to aberrant immunity or aberrant immune reactions? I would be interested in the immunological aspect of these contaminants.<\/em><\/p>\n VSK<\/strong>: The protein has a specific sequence length and a specific number of amino acids, this results in specific folding of the protein. If one has truncated RNA, it is possible that the folding looks different, and this can of course have an effect on the antibody formation. I wouldn\u2019t say that it would have a negative effect because the protein has to reach the cell surface for the cell to recognise it at all. If it is very truncated, then it doesn\u2019t find its way there, it would not be anchored in the membrane, it would be secreted from the cell and enter the [blood] flow. So this is theoretically possible, but I think the likelihood is very slight that another protein or a differently folded protein would arise, causing other types of side effect.<\/p>\n WW:<\/strong> Thank you.<\/em><\/p>\n VSK<\/strong>: To come back to Ms. Fischer\u2019s question about the DNA. The problem is that when it contains DNA contaminants, then the situation is: well, with RNA it is relatively unlikely that it can integrate into the host\u2019s cell nucleus. The situation is different with DNA, and especially in this case because you have contaminants of linearised DNA. The integration of DNA into the nuclear genome is relatively rare really \u2013 many different factors have to come together for this to function. First of all the cell has to divide; if it divides properly it can\u2019t be integrated because the cell genome is in the nucleus of the cell and this cell nucleus first has to dissolve. But it only does this when the cell is dividing. I will come back to this, because the lipid nanoparticles get into all cells, not just the muscle cells \u2013 it is an error to believe the latter.<\/p>\n RF<\/strong>: That is important, that\u2019s what really counts<\/em>.<\/p>\n 18.42<\/p>\n VSK<\/strong>: So it is theoretically possible that this linearised DNA that is in there as a contaminant could integrate into the host\u2019s cell nucleus in a dividing cell, linearised DNA is optimal for integration. Circular DNA is not. DNA from bacteria is circular and is not as easy to integrate. It occurs, but not so often. But as soon as you have a situation like we do here, it will occur more often. That is the risk<\/u>. I didn\u2019t really want to get into what can occur if this is the case: genes can be switched on and off, upregulated and downregulated, cancer can develop<\/u> \u2013 there are a lot more possibilities. So this contamination definitely has to be reduced.<\/p>\n RF<\/strong>: Can you explain that to us again because that is particularly important for us as lawyers, especially for Dr. Holzeisen. What can occur in that case?<\/em><\/p>\n VSK<\/strong>: Ok. This integration: where it occurs is the nuclear genome \u2013 we can\u2019t control that, it can occur anywhere<\/u>. There are sections in the DNA that are vulnerable to it, and others that are not so vulnerable. And it is important where the DNA lands.<\/p>\n It may land on a gene: then the gene will become dysfunctional<\/u>, the protein will no longer be formed<\/u>, and if it is an important protein, the cell may die, and if this continues to replicate, this can cause really massive damage<\/u>.<\/p>\n If for example it lands in an important cell that divides frequently<\/u>, then clones can arise<\/u> that are modified<\/u>, they are gene modified, and in that case in these cloned cells these proteins are no longer produced and then, in the worst case, there is a loss of function<\/u>.<\/p>\n If it leaps into genes that have a regulatory effect on gene expression<\/u>, then the genes may be switched on or downregulated<\/u>, i.e., the output will differ. And this means the metabolism of the cell will alter<\/u>. If this is passed on in replication, then many aspects may alter in the body<\/u>.<\/p>\n WW<\/strong>: But these are processes that are probably not the same in all patients. Whether this occurs at all is stochastic at the most, and if it does occur, the results are probably also dependent on each individual and what else is going on in their cells. So one can\u2019t say put that in and this is what will occur, these are eventualities \u2013 if a million or so and so many thousands of people are vaccinated, then one can perhaps say with a certain degree of probability after 10 or 20 years whether something will occur or not.<\/em><\/p>\n VSK<\/strong>: Yes.<\/p>\n WW<\/strong>: With some aspects perhaps after 3 or 4 years. But one needs some time to be able to detect such effects clinically.<\/em><\/p>\n VSK<\/strong>: That\u2019s exactly right. One never finds a group that all have the same mutation, this varies in people \u2013 exactly.<\/p>\n RF<\/strong>: This description is not the normal way a vaccine works, from what we have known up to now, the possibilities that you describe seem reminiscent to more of a genetic intervention or perhaps one should say a genetic experiment<\/u>?<\/em><\/p>\n<\/a><\/p>\n<\/a>