#BlotgateBig Pharma Falsified Data By Chris Knight (Florida)
This post relates to what is being listed on the internet as #Blotgate. It is a bit difficult to summarise, but it is important. The nuts and bolts seem to be that researchers in #Blotgate have uncovered what they believe is “smoking gun” evidence of Pfizer falsifying key data, based upon the Western Blot tests, that separates blood proteins to isolate specific proteins. The expressed proteins showed up as highly unusual bands, which has raised doubts among some researchers. I do not know enough about this to analyse it, but for our purposes what is important, as noted by Trialsitenews.com, is that supposing a case for the fabrication of crucial data did occur, and I am only quoting the source here, the indemnity status (protection from any legal liability resulting from deaths or injuries caused by their product), which the Covid contracts contain, would be void, since there is in most, a clause that denies indemnity if fraud occurs.
Thus, the challenge will be to see if these claims can be fully substantiated, then tested in court.
“Evidence has emerged casting serious doubt over the authenticity of tests carried out by BioNTech (Marketing Authorisation Holder) and Pfizer to prove the fidelity of their product by demonstrating that only the spike protein of SARS-CoV-2 is expressed in cells by the nucleoside-modified mRNA Pfizer-BioNTech Covid-19 vaccine (BNT162b2).
Several Western Blot tests were conducted to evaluate the protein expression of the mRNA in HEK cells transfected with the vaccine taken from different lots. Using this technique, the expressed proteins showed up as highly unusual looking ‘bands.’
Certain independent scientific experts have described these Western blots as the “smoking gun” evidence (particularly the “duplication” of the results) which suggest that BioNTech and Pfizer falsified key data as part of their submissions to the European Medicines Agency and the US Food and Drug Administration for securing emergency use authorisation (conditional) and later marketing authorisation approval of their product.
The bombshell evidence was dropped without so much as a ripple in the sea of brewing scandals washing up on the shores of the behemoth pharmaceutical company and its partner, BioNTech. However, some in the scientific community have taken notice and written about this scandal, known on social media as #Blotgate.
The fact there could be actual evidence to prove that Pfizer and BioNTech engaged in fraud by fabricating critical data would have major ramifications. For instance, their indemnity status (protection from any legal liability resulting from deaths or injuries caused by their product) which was written into their purchasing contracts and signed by many countries, would cease to apply.
The fraudulent-looking data provided by BioNTech/Pfizer with regards to the quality of their novel mRNA vaccine also raises other salient questions:
- How did the “copy and paste” data sail through the radar of the regulators?
- How did the Journal of Pharmaceutical Sciencespublish the same fraudulent looking data presented in a Pfizer-funded paper, written by Pfizer and BioNTech’s employees (Patel et al.)?
- What proteins are being expressed in human cells from the vaccinal modified mRNA, other than the SARS-CoV-2 spike protein?
- Why has no genomic sequence of the expressed protein of the mRNA vaccine ever been published?
The leaked EMA emails & other confidential documents
Last June, Trial Site News broke the scandal of the leaked European Medicines Agency emails and confidential Pfizer/BioNTech related documents, with an in-depth analysis and a follow up report.
Damning details in both reports exposed how key regulators such as the EMA, FDA, Health Canada and the MHRA were fully aware of the significant drop in RNA integrity (which is a critical quality attribute) to ~55% in the commercial batches (Process 2: large scale production) of the Pfizer-BioNTech Covid-19 vaccine compared to ~78% in the clinical batches (Process 1: small scale production).
The RNA integrity level is a measure of how intact the modified mRNA molecules are in the vaccine. The explanation of what an intact mRNA molecule is comprised of, can be extracted from the following Patel et al paper, written by Pfizer and BioNTech researchers.
'The 5’-cap, 3’-poly-adenylation tract (poly(A) tail), and an integral mRNA transcript of the target antigen sequence are critical quality attributes for the mRNA component in the COVID-19 vaccines. These features ensure transcript stability and translational efficiency to produce the intended antigen protein.’
The lower the integrity level, indicates a higher amount of fragmented or truncated (not intact by missing either a 5’-cap or a poly A tail) mRNA species present in the batches. From the leaked documents, we know that fragmented species were classified as “product-related impurities” by the regulators.
A document from a pivotal meeting of November 26, 2020, between the regulator (EMA) and Pfizer/BioNTech revealed the alarming fact that this “major objection” was “solved” by simply lowering the standard down to 50% even when Pfizer claimed, “The efficacy of the drug product is dependent on the expression of the delivered RNA, which requires a sufficiently intact RNA molecule.” Furthermore, the level set was significantly lower than the minimum threshold of 70% that Acuitas Therapeutics had stipulated.
This lowering of the standard to allow up to half of the modified mRNA in the vaccines to be fragmented or truncated was done against the backdrop of another alarming concern arising from these impurities: ‘the possibility of translated proteins other than intended spike protein (S1S2) resulted from truncated and/or modified mRNA species should be addressed.’
The impact on safety and efficacy of the vaccine resulting from the ‘possibility of translated proteins other than the intended spike protein’ was completely unknown to the regulators and the manufacturers.
Furthermore, the leaked EMA rolling review report from November 2020, disclosed how the applicant [BioNTech] had failed to adequately characterise the protein expressed by the vaccinal modified mRNA.
'A severe deficiency of the characterisation section is that no biological characterisation is presented and that the mode of action is not described. This is not found acceptable and the dossier should be updated with relevant information. Even though full biological characterisation is not possible to perform on DS (drug substance i.e. the modRNA), the strategy to determine potency and relevant functional assay(s) should be described in section 3.2.S.3…..Furthermore, it is observed that in the Development History and Comparability section (3.2.S.2.6), the expressed protein size is evaluated by in vitro expression followed by Western blot. Results obtained by this method could be regarded as biological characterisation and should be included in section 3.2.S.3. The method needs further description and the results should be sufficiently characterized.’
Source: Rappaport Rolling Review Report Overview LoQ-COVID-19 mRNA Vaccine BioNTech.
The Western Blot data, submitted by the Marketing Authorization Holder [BioNTech] was in response to the regulator’s request which became a specific obligation that needed to be met to secure marketing authorization approval.
'It is likely that the fragmented species will not result in expressed proteins, due to their expected poor stability and poor translational efficiency (see below).
However, the lack of experimental data on the truncated RNA and expressed proteins does not permit a definitive conclusion and needs further characterisation. Therefore, additional characterisation data remain to be provided as a specific obligation (SO1).’
Source: Extract from the European Medicines Agency (EMA) European Public Assessment Report (EPAR) for the BioNTech/Pfizer vaccine
The data provided by the MAH to meet this specific obligation is at the centre of this investigative report.
A western blot is a technique used to identify and separate specific proteins from a mixture of proteins extracted from cells, based on their molecular weights (measured in kDa= kilo Daltons), through gel electrophoresis.
It can be said that a limitation of this technique is that it only tests for the proteins of interest which are specific to the type of antibodies used in the experiment. In this case, only the SI and S2 antibodies (specific to the S1S2 spike protein) were used in the experiments. Therefore, only S1S2 spike protein would have been found, since it was the only protein they (Pfizer/BioNTech) were looking for. So, even if other novel proteins were present (perhaps expressed aberrant proteins from the truncated mRNA species), they would have gone undetected by using this type of test.
The problem with Pfizer/BioNTech’s ‘Western Blots’
They do not appear to be Western blots at all, even though they were claimed as such by Pfizer/BioNTech and readily accepted by the regulators and published- no questions asked, by the Journal of Pharmaceutical Sciences.
A PhD chemist from Hong Kong with mRNA research experience (who wishes to remain anonymous) provided me with the following material which strongly suggest Pfizer/BioNTech’s Western blots were fabricated (copy and pasted). Similar evidence by the same chemist was also presented in a blog by another anonymous expert known as ‘A Midwestern Doctor.’”
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