by Sonia Elijah
Part 1 of my investigative report published in Trial Site News, centered on the unusual-looking Pfizer-BioNTech ‘Western Blots’- the scandal known as Blotgate. Western Blots were conducted by BioNTech to prove the fidelity of their product (to the regulators) that only the expected spike protein was being expressed in vitro by the modified vaccinal mRNA and was consistent across different batches.
The problem with them not looking like authentic/conventional Western blots but rather computer-generated versions (automated Western blots, despite not being labeled as such in any of the reports), is a distraction from the real scandal at hand: the evidence, which shows prima facie, BioNTech/Pfizer ‘copied and pasted’ these bands, in other words, falsified their key data. These seemingly fabricated Westerns (shown below) were exhibited in Pfizer’s response to the U.S. Food and Drugs Administration’s queries around November 2020, in the run-up to Emergency Use Authorization.
Only when these bands were quantified using image software analysis (thanks to an anonymous expert), the ‘copy and paste’ job, conducted across 4 separate batches of their product, transfected at 6 different concentrations, become strikingly visible.
The odds of these exact same bands showing up naturally across four separate batches of the vaccine, transfected at 6 different concentrations, can been seen in the table below.
Source: anonymous expert
On the heels of Part 1 of my investigative report, Epoch Times conducted their own investigation into Blotgate; the mRNA quality issues of the Pfizer-BioNTech vaccine and referenced the Trial Site News investigation into the leaked European Medicines Agency (EMA) emails and documents.
‘Hiding the dirty bands’- a further look at Blotgate
On January 13, shortly after the Blotgate scandal broke, the Pfizer and BioNTech sponsored, Patel et al. paper ‘Characterization of BNT162b2 mRNA to Evaluate Risk of Off-Target Antigen Translation’ was published in the Journal of Pharmaceutical Sciences. Many anomalies can be found with the paper and it’s worth noting that computational and molecular biologist, Dr Jessica Rose has written a comprehensive critical analysis of this study.
Firstly, it’s worth noting the competing interests of the authors which can be seen below.
On speaking with Dr Jessica Rose, who’s extensively carried out conventional Western Blots, she explained: “In my expert opinion, [a traditional Western] it’s one of the bench assays that is a procedure, like the safety testing for biological (that is meant to take 10 years). A western blot requires a sequence of specific steps, these steps cannot be rushed and cannot be overlapped…the experiments done using Robo Jess [automated Western Blot machine] and the blots submitted by Pfizer need to be reproduced by human hands, reproducibility is a requirement especially when the conflict of interest list is so long by the submitting authors [Patel et al.]’
The image below, taken from the Patel et al. paper shows their ‘Western Blot.’ Notice the very thick (homogenous) black regular bands with no smearing whatsoever.
The same ‘Western Blot,’ (seen below) just a much cruder, scanned in copy version can be found in the European Medicines Agency’s CHMP (Committee for Medicinal Products for Human Use) August 2021 redacted report, approximately 18 months prior to the Patel et al. paper.
Since the Patel et al. authors reference ProteinSimple’s technology in their study (extract below), a comparison can be made with a sample of an automated Western Blot, using the same company’s software.
‘The cell lysates were analyzed with the specific antibodies to detect the SARS-CoV-2 spike proteins using ProteinSimple technology. 12-230 kDa Wes Separation Module and 25 capillary cartridges were used. SARS-CoV-2 Spike S1 subunit mouse antibody (R&D systems, Catalog No. MAB105403) and SARS-CoV-2 Spike S2 subunit mouse antibody (R&D systems, Catalog No. MAB10557) were used. mRNA sample results are reported as ProteinSimple Wes assay run lane images.’
Source: Patel et al. paper
The image below is of an automated Western using ProteinSimple’s technology.
Source: Product brochure for ProteinSimple’s Simple Western automated machine, page 4
What’s striking is that a gradient (smeared effect) can be observed in each of the varied bands. They look quite different to BioNTech/Pfizer’s thick black homogenous bands.
To gain further insight, I interviewed R&D lead of the Human Genome Project and genomics scientist, Kevin McKernan, who explained that BioNTech/Pfizer’s “data is unusable” and his reasoning for the Western Blot bands’ unusual appearance (seen in the EMA report and Patel paper) is because “they [BioNTech] jacked the gain up so much and most people do that to hide ‘dirty bands.’ They’re probably 5 bands in there [in a single-looking thick band].” I refer to that informative interview, later in this report.
This then begs the question: did BioNTech/Pfizer conduct a wilful cover-up of their ‘Western blot’ results by presenting manipulated versions (of automated Westerns) to the regulators? Perhaps, a copy and paste job for the FDA and manipulation of the saturation levels for the EMA? And more importantly: how did the regulators accept these ‘Western blots’ as the primary evidence for proving the fidelity and consistency of BioNTech and Pfizer’s product?
I reached out to the EMA for a response regarding concerns raised in this investigation. Their press officer responded with the following statement: ‘These figures [Western Blot images] were extracted from the submitted dossier and inserted into the assessment report, resulting in a loss of image quality. Furthermore, the redaction software used by EMA to prepare documents for release following an ATD request has an impact on the resolution of the documents.
With regards to method validation, the Western Blot analytical methods used in characterization studies were previously assessed during the initial conditional marketing authorization application as part of the ‘development history and comparability assessment’ and were considered appropriate for that purpose.’
The FDA, Pfizer, and BioNTech failed to respond for comment.
Quality parameters set months after CMA granted
The reason the Marketing Authorization Holder (BioNTech) conducted a further series of tests was because Conditional Marketing Authorisation (CMA) was granted on the basis that the MA Holder meet specific obligations (such as, additional data to further characterise the truncated and modified mRNA species) made upon them by the EMA. Running up to the time CMA was granted, multiple CMC (Chemistry, Manufacturing and Controls) issues were flagged as major concerns by the EMA, in particular the drop in mRNA integrity (presence of truncated/fragmented mRNA- lacking a critical attribute, a 5’cap and/or poly (A tail) of the commercial batches compared to those used in the clinical trials. The ‘solution’ to this major problem was a lowering of the acceptance criteria of the fragmented/truncated mRNA species down to 50%, which the regulators simply waived through.
Canadian pharmacist, Maria Gutschi, PharmD, who has over 30 years of experience in hospital, community, and government, independently analyzed the quality issues of Pfizer/BioNTech vaccine identified by the European Medicines Agency, in an informative presentation video. On speaking with Gutschi, she raised other important concerns: ‘It wasn’t until May 2021 [5 months after authorization was given] that OCABR had established the quality parameters and more importantly the standardization of the assays used. One issue I found was that at launch, many of the assays used to determine quality and identity were ‘in house’ assays by BioNTech. Well, a regulator can’t just accept that. They need to be validated so that they are consistent, reproducible, and reliable.’
OCABR stands for Official Control Authority for Batch Release, which sets out guidelines for human vaccines authorized in the EU. Notice the highlighted May 2021 date of OCABR’s document, seen below.
The fact that OCABR established the first-ever quality parameters of a human vaccine, a staggering 5 months after CMA was granted- is unprecedented. Secondly, the fact that these assays (tests) needed to be validated is noteworthy.
The questionable “in house” assays
It’s worth noting that Gutschi’s concern with BioNTech’s ‘in-house’ assays was also shared by an EMA assessor in the leaked Rapporteur’s Rolling Review Report from November 2020, shortly before CMA was granted.