The FDA knew that the product they were approving under EUA was a poison pill
The Bait and Switch: Hiding In Plain Sight Part 1 - The Set Up
(Previously published on the DailyClout)
It wasn’t good enough to just quickly produce a product that was needed urgently, but with abandon, the FDA allowed a ‘trial within a trial’ at the behest of the European Union EMA (European Medicines Agency) who were concerned about the new commercial process planned by Pfizer to inject the European population.
Illustrations by Dr Chris Flowers MD
Process 1 and Process 2
The terms ‘process one’ and ‘process two’ were mentioned by Pfizer in the different iterations of the clinical trial protocol for this novel drug platform that would be used worldwide. The ‘process’ refers to the way the ‘vaccine’ was manufactured.
This vernacular has been described by several groups, and so I will just give a quick overview, rather than repeating other people’s work.
Process 1 was the clean manufacturing process for the product used in the Pfizer Clinical Trial that would be the justification for the FDA granting an EUA in December 2020. The original manufacturing process of BNT162b2, Pfizer’s COVID ‘vaccine,’ for the clinical trial used a messenger RNA duplication (amplification) technique known as PCR (polymerase chain reaction) — essentially like a photocopier, multiplying/cloning the original mRNA. This is known as ‘Process 1’.
Commercially, this type of process is expensive and would have to be significantly ramped up to provide doses for the whole world. The commercial scaling of the product used a proven way of mass production using e-coli bacteria. This mass production technique is 'Process 2’. The thorny issue was that ‘Process 2’ used a completely different manufacturing process than that used for the product in the clinical trial (Process 1), and the Emergency Use Authorization (EUA) for the ‘vaccine’ was granted based on Process 1. Moreover, Process 2 was not compliant with Good Manufacturing Practice (GMP). Note the FOIA’ed national contracts with Pfizer from South Africa and Albania.
This contamination is attributed to the use of e-coli during manufacture. These bacteria are naturally found in human gut bacteria and are a regular means of mass-producing mRNA sequences. The required gene is inserted into a ring of DNA, and the bacteria continually replicates these plasmids.
The plasmids produced by this process are purified using enzymes (DNAase) and have a regulated UPPER LIMIT in the end product.
Authorities in Europe concerned over contamination with DNA fragments
The EMA was concerned about the contamination of the commercially made product with DNA material due to its manufacture using e-coli bacteria. Several groups have brought this information to light, calling it a Bait and Switch, but the initial reporting came from Josh Guetzkow PhD of the Hebrew University. Dr. Guetzkow gave expert testimony and this was used as part of a lawsuit by a Member of Parliament in the UK, Andrew Bridgen MP, who was alleging the CEO of the British regulatory body (MHRA - Medicines and Healthcare products Regulatory Agency), had misled successive Secretaries of State for Health and Ministers for Health about the vaccine they approved for use in their population.
“The MHRA’s public statements that the BioNTech vaccine was safe because it had been tested was untrue when it Authorized the Product on 2nd December 2020. It could not be said to be safe because it had not been tested before the authorization of batch EJ0553 This is because there were two distinct products, a clinical trial product “P1” and a commercial scale-up product “P2” and the authorized product was P2. Hence potential adverse effects were unknown.”
from Allegation_Of_Criminal_Conduct_By_Mhra_Agency.pdf
Further reporting by Josh Guetzkow and Retsef Levi in a BMJ Rapid Response letter showed that the amended Pfizer clinical protocol (C4591001) October 2020 included reference to Process 1 and 2 and to a trial subset (trial within a trial) of approx 250 subjects given Process 2 apparently supposed to be compared with 250 Process 1. Guetzkow and Levi state that of the date of their letter (May 2023), no publicly available report was made.
The Enigma of EJ0553Z
This Lot number was the object of the UK lawsuit as it proved to be a prompting alert of an irregular batch.
From the Guetzkow Expert report (dated 11 July 2023) EJ0553 was defined by Pfizer as an ‘emergency supply’ lot. and according to the TGA FOIA release was manufactured in Puurs, Belgium fill/finish operations on filling line WSL5. The fill/finish lines L8 and L18 would shortly be transferred to the USA production lines in Kalamazoo, Michigan.
Also from the Pfizer documents, we confirm that this lot was only used on 11 subjects at four sites (1001,1002, 1003, 1007), confirming reports by Geutzkow, but were the first people to receive the ‘new’ formulation of the ‘vaccine’. The Trial within a Trial was about to occur and on a much larger scale. (see part 2)
DNA Plasmid fragment contamination
Simultaneously, through the discoveries by Kevin McKernan who had gene-sequenced leftover product from the shot vials (see his interview with the Daily Clout for more) and later, testimony to a South Carolina Senate Hearing by Dr. Philip Buckhaults who also sequenced the product, the presence of the contamination by short fragments of DNA of multiple lengths arising from the use of DNA Plasmids in the commercial manufacturing process of the EUA vaccine, was confirmed.
Naked DNA in the circulation gets broken down by the body quickly, so it is not a theoretical concern, and rat studies show no adverse events. But when these DNA fragments are in a Lipid NanoParticle (LNP) The DNA gets given immediate access to the inside of a cell, where it could potentially get inside a nucleus and be incorporated into the genome. (see MaryAnne Demasi interview with Dr Buckhault for more information)
Why the concern over the DNA clean-up process?
The clean-up of a biologic end-product manufactured by this process uses various enzymes to literally break up the contamination from the process. However, in this case the mRNA has been MODIFIED into a hybrid using pseudouridine, and it is possible that the DNAases they were using were not able to handle the modified mRNA. (for more information, please watch Dr Jessica Rose PhD in discussion with Dr Brian Hooker PhD of the Children’s Health Defense on CHD.TV)
As the EU was aware of DNA contamination of the produce many times greater in magnitude than the upper limits for safety back in 2020 before the trial in October, you would have imagined that Pfizer would have worked hard to clean up the process in the interim. They only had to say “We messed up, and are working to clean the product up” and maybe we would have been happy, but according to the work of groups including Kevin McKernan, the marked contamination is still there, years later.
There are many groups talking about Process 2 and I will leave much of the discussion to them.
But in Part 2, I will discuss how we came across the Trial within a Trial within the Pfizer documents. Stay tuned ……….
I ran across this comment early in this craziness, and I am more sure than ever it’s true: "You have to understand, it's not like this because people are idiots. It’s like this because someone wants it this way."