The Biggest MHRA Failure Of Them All?
Rolling out a different "vaccine" to the public than the one tested in the clinical trials
Part 1 of my analysis of the Covid Inquiry Module 4 Hearings can be read here.
On January 22, it was MHRA Chief Executive, Dame June Raine’s turn to give oral evidence under oath at the Covid Inquiry.
The lead counsel to the Inquiry, Mr Keith KC, who has so far based his soft-style of questioning on assumptions rather than evidence- this time, in an indirect and muddled way, did bring up a scandal of epic proportions. One which I wrote about exactly a year ago and was republished by the Brownstone Institute. One that deserves wide-spread attention but has so far been ignored by the mainstream media.
Below is an extract of the transcript revealing Mr Keith’s key question to the MHRA’s Chief Executive, Dame June Raine.
Mr Keith: Some have suggested that the batches which were delivered to the United Kingdom for use amongst its population, which were then handed out, were not the same batches, or rather were batches that were produced by a different manufacturing process on the part of the manufacturer, as has been – as had been tested by the MHRA? So bluntly, the suggestion has been made, you tested and authorised and certified a certain number of vaccines made by process, manufacturing process A, and then the manufacturers actually delivered vaccines to British population produced as a result of a different manufacturing process, and one, by inference, which had not been tested. Is that right?
Dame Raine: Well, my understanding is that the manufacturing process would have been the same.
Well, the MHRA’s Chief Executive’s “understanding” is incorrect. There were two separate manufacturing processes involved with Pfizer/BioNTech’s Covid shot, BNT162b2. As head of the MHRA, how could she have not known this?
It was Debi Evans, healthcare commentator for UK Column, that first brought my attention to Dame Raine’s ignorance exposed at the Covid Inquiry Module 4 hearing.
Mr Keith could certainly be criticised in the way he presented the MHRA’s epic failure. It was not “a certain number of vaccines made by manufacturing process A.” More correctly, the product used in Pfizer’s clinical trials, tested on approximately 21,000 participants assigned BNT162b2, also referred to as the clinical batches, was made by Process 1, not Process A. It was also the product the MHRA “tested and authorised and certified.” However, the product that was made by a completely different manufacturing process, Process 2, was the one rolled out to the public.
Below is an extract from my original report published in January 2024.
Pfizer’s “Bait-and-Switch”
In late 2023, I interviewed Joshua Guetzkow PhD., senior lecturer at Hebrew University who succinctly explained how Pfizer/BioNTech conducted a “bait-and-switch” of their biological product that went on to be injected into the arms of billions.
A key takeaway from the interview was that the Pfizer/BioNTech mRNA product rolled out to the masses was not the same one tested in Pfizer’s pivotal clinical and non-clinical trials (animal studies).
This is because the commercially rolled out product was made using an entirely different method/process. Guetzkow, categorically stated, when it comes to biological products: “The process is the product.”
The product used in the clinical trial was made via Process 1.
Small-scale clinical batches made using the more expensive PCR process to amplify the DNA template used to the make the modified mRNA for the vaccines.
A highly efficient filtration mechanism was also employed using magnetic beads.
The product that was sold and distributed around the world was manufactured using Process 2.
Large-scale batches made using a much cheaper process- E. coli bacteria was selected to replicate the DNA used as a template for the mRNA.
This introduced contamination both from the residual (plasmid/bacterial) DNA and the E. coli membranes called endotoxins, which are also highly inflammatory.
The significant drop in RNA integrity (a measure of how intact the RNA molecule is) was a direct result from this switch from Process 1 to Process 2.
The leaked European Medicines Agency emails
In late 2022, I extensively wrote on the leaked EMA emails, which first exposed the fact that there was a significant drop in RNA integrity. The private internal email from Evdokia Korakianiti (an EMA scientific administrator) to his colleagues, shown below, highlights this significant drop in %RNA integrity in the proposed commercial batches (made by Process 2) compared to the clinical ones (made by Process 1).
Source: ‘What the Leaked EMA Emails & Docs Reveal’ article published in Trial Site News
The leaked 26 November 2020 PowerPoint presentation of a meeting between Pfizer-BioNTech and the EMA, shown below, reveals how this major objection was shockingly ‘resolved’- the RNA integrity specification was simply lowered down to 50%, meaning that up to half of all mRNA molecules in the commercial batches were allowed to be truncated (not intact). More importantly, the potential implications of the RNA integrity loss in terms of safety and efficacy were completely unknown.
Source: ‘What the Leaked EMA Emails & Docs Reveal’ article published in Trial Site News
The promised comparison study was never done
In response to the switch from Process 1 to Process 2 “to support an increased scale of manufacture,” Pfizer added an amendment to its original clinical trial protocol. It promised that it would conduct a comparison study to explore the safety and immunogenicity in individuals 16 to 55 years of age vaccinated with “Process 1” and “Process 2”.
This protocol amendment was made on 6 October 2020.
New evidence has come to light, which shows that no comparison study was ever done. On the social media platform X, an anonymous account posted a key section from Pfizer’s “Protocol Amendment 20, 15 September 2022.”
On 15 September 2022, Pfizer removed ‘the objective to describe the safety and immunogenicity of prophylactic BNT162b2 in individuals 16 to 55 years if age vaccinated with study intervention produced by manufacturing “Process 1” or “Process 2” because of the volume of BNT162b2 now distributed and administered globally using manufacturing “Process 2” making the comparison unwarranted.’
Pfizer’s excuse for the study being “unwarranted” because the “Process 2” product had already been rolled out and administered in large volumes globally, is deplorable.
Moreover, a plausible conclusion can be drawn: if the “Process 1” product was the one tested on animals (nonclinical trials) and used in the clinical trial on human subjects- then the “Process 2” product, which was rolled out globally, did not even undergo any animal testing, let alone a clinical trial.
This goes far beyond lack of informed consent- when the public unknowingly, have been used as lab rats.
Recently, Dr Clare Craig and Nick Hunt of the Perseus Group have written about this scandal exposed at the hearing. Perhaps, the Covid Inquiry hearings have proven to be more than just a white-wash after all, by indirectly blowing this scandal wide open.
Millions of people were coerced/forced to be jabbed with an experimental drug referred to as the Covid vaccine in order to keep their jobs. There needs to be an investigation against all government officials who mandated people to take this so-called vaccine and of anyone in government who profited financially since implementation of the Covid vaccine mandate . And there needs to be a full release of information to the public about the adverse reactions/deaths caused by this so-called vaccine.
I’ve been following Hedley Rees who is is 40 year veteran in pharmaceutical supply chain. I recommended going to his Substack. He explains that pharma no longer manufacturers their products, instead they outsource to CMOs or Contract Manufacturing Organizations. The leading companies involved in the manufacturing of the SARSCoV2 injections are Lonza, Catalent and Rentslauer. The first two are global multi billion dollar companies that manufacture the drugs for pharma. FDA has been inspecting these facilities and issued multiple 483s since 2021 regarding the manufacturing of these products. 483s translate to injuries and deaths on the market and FDA has the legal authority to shut down manufacturing. Hedley says that there are enough 483s that production of these jabs should be shut down.
It is not unusual as a drug is scaled up to go from one process to another. What Pfizer neglected to do was test process 2 for safety and efficacy before deploying the jabs on the market. The data they gave to the FDA for EUA approval was from process 1. The big question is - would FDA would have authorized Pfizer’s EUA if Pfizer had tested and submitted data on process number 2 ????.
FDA has the ability to legally withdraw the EUA.