Hearing # 37 of German Corona Extra-Parliamentary Inquiry Committee (1)
This is Hearing No. 37 of the German Corona Extra-Parliamentary Inquiry Committee with Dr. Vanessa Schmidt-Krueger, beginning at minute 3.56.38 of the hearing to the end. The transcript was first produced in German and then translated (by Gilian Crowther, member of the BDÜ, the Federal Association of Interpreters and Translators).
The 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.
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.
On 30th January 2021 the German Corona Extra-Parliamentary Inquiry Committee interviewed Dr. Vanessa Schmidt-Kruger, a cell biologist with over 20 years’ experience in molecular medicine working at the Max Delbrück Center for Molecular Medicine.
This is her evidence presented at the 37th Hearing of the German Corona Extra-Parliamentary Inquiry Committee on 30th January 2021.
RF = Dr. Reiner Fuellmich
VSK = Dr. Vanessa Schmidt-Krueger
VF = Viviane Fischer
MT = Marcel Templin
Dr. H. = Dr. Holzeisen (Italy)
RF: Dr. Schmidt-Krueger conducts research on cardiovascular disease and will explain the mechanism and risks of the vaccine.
VSK: I’m 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’s 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.
I would like to explain a little using the example of the BioNTech vaccine, focusing on a number of specific points. I’ve made a few notes.
The first point is that the BioNTech vaccine that is currently already being used is not highly purified, it contains contaminants of certain components. This is in the EMA’s Open Assessment Report, the Agency that has granted the authorisation to this vaccine. The EMA (European Medicines Agency) has written this report, and covers this point.
Secondly, I would like to go into the first clinical study of the BioNTech vaccine, and how the quantity of vaccine to be used was determined: this has not been correctly characterised from a scientific perspective in my opinion.
Point 3 relates to the effects or risks of the LNPs, 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].
And finally if we have time I would like to talk about the long-term consequences relating to immune disease, that is an aspect that has not yet been discussed in public at all.
RF: I don’t 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.
VSK: Ok, pleased to help. I have made notes and can submit them in writing later. Good. Why isn’t all this being discussed? One reason might be that this Open Assessment Report is in English, and half of Germany can’t speak English. Then there’s 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’s why I’m here, and would like to aim and throw some light on all of this.
Basically the EMA Committee’s 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.
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.
But their approach to the second section concerning side effects was in stark contrast to that. They didn’t conduct any critical scrutiny at all, there are lots of side effects that were not discussed at all in public, they also didn’t critically scrutinise what consequences it will have to inject this into people, particularly vulnerable groups who already have certain organ-related complaints, who are especially susceptible to these adverse effects. I’ll go into them in detail at the end.
We know that normally vaccine development takes a very long time. It’s not just the clinical phase: with this vaccine, it’s 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 ½ years in total. And then one shouldn’t forget that the production optimisation is also important, at least a year would surely be needed for that. That hasn’t taken place at all. The vaccine is already being sold and used, but the production optimisation isn’t yet by any means completed. And there are considerable deficiencies.
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.
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. 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. Now that they have entered mass production, that is no longer possible, they have had to switch to lower-cost processes, 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 this leads to new dangers or risks, particularly contamination. 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 – they probably mean E.coli bacteria for example. There don’t seem to be any processes to ensure or monitor for that.
They also need to ensure that all the buffers – those are the solvents that are used – are free of RNAses. 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’t have any effect anymore.
They also have to analyse how strong the activity of the enzymes is; 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 – I’ll 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. And that is not the case. BioNTech has admitted that there are DNA contaminants.
Requirements were also made relating to the fact that they have not conducted a transport verification study. This means they have no idea whether the vaccine is still viable after transportation. That is currently being performed.
Then there’s the sterility of the vaccine vial. They have good vials, they have tested them, but they have been asked to develop a new “Quick Test” 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.
And then they don’t have any proper standard for the various batches.
It was found that the integrity of the RNA always varies in the batches that had been made. I will come back to that again. There needs to be a standard that is always the same for each batch. 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’t been done yet, they are in the process of doing that now.
So – the integrity of the RNA means of course the RNA quality. They have found that this is not very high: it was higher for the processes during the clinical phase. In this report they don’t 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, i.e., half of it is basically unviable.
I’ll 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. 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 as a result: at the end of the RNA there is an adenine attachment, and the longer this “tail” 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’s 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.
RF: 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 – at least I have not read anything about what you have just discussed – is that 45% of the RNA that is produced from the DNA is non-viable.
VSK: It may be non-viable if the protein is not formed – 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 – whether they are other proteins – 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.
VF: The small proteins: could they simply have no function, or might they produce some other effect?
VSK: I assume that they would then be without function.
RF: At least they wouldn’t be doing any damage then?
VSK: Yes, these are not completely different proteins, this is just a small fraction of the spike protein. (15.11)
VF: And just one other question about the DNA – what kind of DNA is this that is sort of swimming around, what effects could it have?
VSK: The sequence of the DNA is complementary to the RNA, and this is needed so that the enzyme has a “template”, so that the RNA can be “read”. 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.
WW: If shorter pieces are produced, i.e., not the longer proteins but these short sections, I’m 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.
VSK: 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’t 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’t 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.
WW: Thank you.
VSK: To come back to Ms. Fischer’s 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’s 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 – 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’t 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 – it is an error to believe the latter.
RF: That is important, that’s what really counts.
VSK: So it is theoretically possible that this linearised DNA that is in there as a contaminant could integrate into the host’s 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. I didn’t 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 – there are a lot more possibilities. So this contamination definitely has to be reduced.
RF: 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?
VSK: Ok. This integration: where it occurs is the nuclear genome – we can’t control that, it can occur anywhere. 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.
It may land on a gene: then the gene will become dysfunctional, the protein will no longer be formed, and if it is an important protein, the cell may die, and if this continues to replicate, this can cause really massive damage.
If for example it lands in an important cell that divides frequently, then clones can arise that are modified, 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.
If it leaps into genes that have a regulatory effect on gene expression, then the genes may be switched on or downregulated, i.e., the output will differ. And this means the metabolism of the cell will alter. If this is passed on in replication, then many aspects may alter in the body.
WW: 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’t say put that in and this is what will occur, these are eventualities – 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.
WW: With some aspects perhaps after 3 or 4 years. But one needs some time to be able to detect such effects clinically.
VSK: That’s exactly right. One never finds a group that all have the same mutation, this varies in people – exactly.
RF: 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?
VSK: Yes, that is true. The vaccine itself, even if the DNA – that contamination – were not in it – is still a genetic intervention. I’ll be talking more about that, then you will be able to understand it really clearly. But I don’t know how high the contamination is, they have only stated the fact that it is contaminated.
VF: But against the backdrop of this DNA issue, especially in the case of dividing cells, the question that arises is that it is probably especially dangerous to vaccinate pregnant women or children, because in those cases the cells are dividing much more than in an adult or a very old person.
VSK: That’s absolutely the case.
WW: In the case of pregnant women one also has the problem that the immune system reacts differently than in those who are not pregnant. Because in pregnancy the immune system is switched so that the foetus is tolerated and not rejected. It reacts differently as a result. This may also have a bearing with this vaccination, it can lead to complications in pregnancy, and also in older people, where certain processes no longer take place – the immune system tolerates more than normal, and immunological complications arise as a result. This could occur in elderly people and in pregnancy.
VSK: But as I have said, we are all at risk because our cells are subject to ongoing dynamism: millions of cells in us are being degraded and renewed every day: one has to consider all the stem cells, all the immune cells, it is a constant flux: if these contaminants interfere, then …
That’s why the AstraZeneca vaccine is an entirely different caliber.
But to stick with BioNTech: there are further contaminants, there is double-stranded RNA for instance. The EMA Committee says it is slight, it is acceptable, but …
It is measuring it in the quantities that are in there: part of the 30 micrograms is double-stranded DNA….that is something else that cannot be used.
Ok, so the EMA tells the vaccine manufacturer that the acceptance criteria for the mRNA integrity, the double-stranded RNA and these shortened RNA pieces etc., that all has to be reassessed, and as soon as further data are available they will review it again.
Good. Then there are also contaminants relating to the lipids that are used for these lipid nanoparticles (LNPs). They have sometimes observed visible particles in the ready vials. They don’t know why that is. They don’t think this comes from storage. They have certain automatic monitoring systems at the manufacturers and also later in the process that check and monitor for this, but this needs to be improved, it’s not sufficient for the EMA. The doctor who handles this vial later is meant to look and see if these particles are there. If so, it is meant to be discarded. I don’t know whether that is being communicated. 26.18
RF: But just to go a step back for a moment: You have just said that the EMA has specified several requirements, and when they have fulfilled them they should come back again. So how come vaccinations are already taking place?
VSK: That’s a question I’d ask you! 26.41
Such political pressure.
Dr. H: That’s criminal. Terrifying.
WW: Another point is that in the USA and elsewhere it is now being permitted to combine different vaccines for the first and second vaccine … Mixing the different vaccines so that one can’t even draw clear conclusions, and this while studies are still ongoing – well, they are supposed to be studies – that the vaccine doses are being mixed so that you can scarcely determine which vaccine is having which effect and which side effect – that seems to be intentional, it’s like that in the USA, that the Moderna, BioNTech and AstraZeneca vaccines can be mixed – if one isn’t available, another can be used. This makes it impossible to have an overview and it means it can’t be evaluated in the observational study either – which means we’re flying blind.
VSK: Yes, that’s exactly how I see it. They have a deadline of the end of July of this year for these investigations, and then the decision will be made as to whether the vaccine receives final authorisation or not; it only has a temporary authorisation at the moment from what I understand. The problem is that all these analysis techniques, protocols, all these commitments which are necessary that they make, it’s all running parallel to the vaccines actually being administered – that’s what’s so disastrous.
RF: If we wait until end of July we won’t have any Israelis left as far as I can tell. Holy Shit.
Dr. H: At the same time the EU Commission in the person of its President has given clear instructions to have most adults vaccinated by July, especially those who are already have underlying conditions, and our health professionals, etc. There’s huge pressure towards mandatory vaccination. This is criminal. We will definitely file a criminal complaint next week: this information was the final evidence that we needed. The plea for annulment, if we don’t file it with the European Court of Justice – we will pursue to next week. I’d request that you submit your written notes quickly to me please, it is essential, we really need to expedite the proceedings, this is costing lives every day across the world. We can aim to block it on an EU level. This is dreadful.
RF: We will do the same in the USA, we’ve already discussed this, but it’s ready Renate, it’s on the way to you.
Dr. H: This information, if you could send to me in writing what you have said here afterwards, that would be really superb.
VSK: I will send you everything. The information is public, it’s in the Assessment Report.
Dr. H: That’s clear, we’ve seen it too, but it’s always important to have a coherent commentary, too.
VSK: That’s fine. So I’ll continue. There are also contaminants with regard to the lipids (30.32). […] And they have found that the end product – that there are contaminants in the end product in some batches. They don’t know where this is coming from, probably from the cationic lipid. They now need to find out where the contaminants are coming from, and the EMA has therefore asked them to write a report on how the chemical synthesis functions, where they obtain it from, i.e., the manufacturer, which means conducting a quality control for the feedstock and the solvents. They need to list which steps are critical in the synthesis. And they have to do all this by the end of July 2021. So they don’t know the source of the contaminants, and the EMA Committee didn’t go into what consequences the contamination might have.
There is no evidence of contamination for the PEG, but they also need to document their strategy for the quality control, purity, etc. on this in writing, too.
The EMA Committee issued complaints about 20 points in total regarding Good Manufacturing Practice. These are very extensive points, it will be quite a challenge to manage this in half a year I’d say, and they have issued 23 recommendations for further development of the quality of the of the product. And then there are another six pages at the end: I’ll quote from that: “The assessment of the safety risk is considered acceptable; there are theoretical calculations of worst-case concentrations from residues from the manufacturing process, but these have been found to be below established safety limits”. What this means is that our health depends on theoretical calculations, and not on actual tests in practice.
I just wanted to have said that.
RF: What do these lipids do? We have heard from all over the place – not from the mainstream media of course, you don’t hear a word of criticism from there – but we are hearing reports from the Internet that can be substantiated that in Gibraltar for example, 53 people died after vaccination. In Germany we are hearing that the same is occurring in old people’s homes. People who have just been vaccinated are either dying immediately afterwards or getting very ill, while those who have not been vaccinated are in the same condition as previously. And we have heard from top scientists that this could have something to do with the lipids or liposomes that in some people are immediately leading to very poor oxygen saturation in the lungs, or are somehow docking in the brain and causing neurological issues – tremors and all kinds of dysfunctions. Does this have something to do with the lipids?
VSK: I can confirm that. This is the large topic that I would like to cover at the end. Could we come back to that later? I will explain that in detail, that really is the case.
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July 29, 2021