Report 86: Pfizer’s Clinical Trial ‘Process 2’ COVID Vaccine Recipients Suffered 2.4X the Adverse Events of Placebo Recipients; ‘Process 2’ Vials Were Contaminated with DNA Plasmids.
Process 2 was hidden all along in Pfizer’s COVID ‘vaccine’ clinical trial, and the War Room/DailyClout investigators’ findings about it are mind-blowing. The Food and Drug Administration (FDA) knew that the Process 2 subjects had very high levels of adverse events, but there is no evidence that the agency acted on those alarming findings.
This Process 2 ‘trial within a trial’ was discovered earlier this year in the tens of thousands of the Pfizer documents released by the FDA. The DailyClout teams were reviewing the expert testimony of Josh Guetzkow, Ph.D. of Hebrew University, Jerusalem, used in a lawsuit in the United Kingdom, and started looking for evidence of the approximate 250 subjects who may have taken part in an experiment on behalf of the European Medicines Agency (EMA). Further reporting by Dr. Guetzkow and Retsef Levi, in a British Medical Journal (BMJ) Rapid Response letter to the Editor, highlighted that the amended Pfizer clinical protocol (C4591001) in October 2020 included references to Processes 1 and 2 as well as to a trial subset (a trial within a trial) and that no public reporting of results was available: “The protocol amendment states that ‘each lot of ‘Process 2′-manufactured BNT162b2 would be administered to approximately 250 participants 16 to 55 years of age’ with comparative immunogenicity and safety analyses conducted with 250 randomly selected ‘Process 1’ batch recipients. To the best of our knowledge, there is no publicly available report on this comparison of ‘Process 1’ versus ‘Process 2’ doses.”
Eagle-eyed War Room/DailyClout volunteer, pharmacist Erika Delph, noted an anomaly in randomization numbers that matched the number and dates of this appended ‘trial within a trial.’ Our data team and medical experts analyzed the data. What they found is shocking: 502 subjects were in a Pfizer COVID-19 vaccine sub-trial and received a drug contaminated with unacceptably high levels of DNA plasmids. It may be tempting to write this off as an accident; however, the documentation notes show that Pfizer knew that it was giving 252 unfortunate trial subjects a completely different injection than that for which they had signed up. This fact alone violates the Nuremberg Code (1947), which states that it is unlawful to run human experiments without full informed consent.
What is Process 2, and why all the fuss?
The terms ‘Process 1’ and ‘Process 2’ 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.
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 FOIAed national contracts with Pfizer from South Africa and Albania.
Revelations from gene sequencing of the residual product in the vials produced using Process 2 by Kevin McKernan, confirm other groups’ reporting of the determination that there is marked contamination of the modified mRNA with high levels of DNA plasmid fragments.
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 due to the theoretical concerns about the incorporation of this DNA into the human host genome.
Despite the active ingredient being identical in Process 2 compared with Process 1, the European Medicines Agency (EMA) had noted the level of contamination by DNA plasmids and were concerned because it was well above previously published safety levels. EMA was sufficiently concerned to ask Pfizer and the FDA to incorporate the new process to the end of the clinical trial using around 250 subjects.
What have the War Room/DailyClout volunteers found that was hiding in plain sight?
We have identified a distinct cohort, due to anomalous randomization numbers that otherwise made no sense, compared with the sequences used during the main part of the clinical trial. We have also identified the anomalous batch numbers that contain Process 2 developed products. These 502 subjects were tested at four sites in the United States, 250 of whom acted as placebo subjects and the other 252 who received the Process 2 product. (Thank you to OpenVAET for providing data for the War Room/DailyClout volunteers to validate their findings about the 252 Process 2 subjects.)
The product had a unique Vendor Lot No. ‘EE8493Z’, identified in Pfizer Batch/Lot inventory document (https://www.phmpt.org/wp-content/uploads/2022/06/125742_S1_M5_5351_c4591001-interim-mth6-patient-batches.pdf).
The cohort also was separated from the subjects receiving Process 1, as well as from the unblinded segment of the trial after the EUA was granted and where virtually all the placebo group from the main trial received the ‘vaccine’.
Zooming into the Process 2 data, the separation of subjects is easier to see.
There was a significant difference in the number of adverse events in the Process 2 group of test subjects, which should have rung alarm bells in the regulator’s heads as it was so much worse than the significant adverse events (AEs) found in the majority of the clinical trials.
Although the adverse events were minor, there is such a big difference between the placebo and treatment arms, 65 versus 155 or 2.4 times more, that further scrutiny would be expected to determine the cause, since the NEW PROCESS was about to be used for the worldwide roll-out.
How do these findings compare to those already found and reported on by Josh Guetzkow?
Reporting out of Europe was based on testimony about an ‘emergency batch,’ EJ0553, that was used in 11 subjects at four different sites than those in the mini clinical trial (sites 1001, 1002, 1003 and 1007). In the Pfizer lot number document, Process 2 product also has a ‘Z’ designation that may have been used to identify product made with the new process. For the U.S., no product manufactured outside of the country was supposed to be used, but evidence from the Australian regulatory agency, the Therapeutic Goods Administration (TGA) FOI 3659 document 4, titled, “BNT162b2 (PF-07302048) Comparability Report for PPQ Drug Product Lots”, the Lot EJ0553Z was manufactured in Puurs, Belgium, and released as an “emergency supply”.
Our novel findings are based on empirical evidence found in the Pfizer documents, already released.
As a result, the different adverse events profiles demonstrated that product from Process 2 was different from product from Process 1. With that safety signal, the FDA should have taken note and determined that the clinical trial would need repeating, as it is a different product with a different safety profile.
Process 2 should have been the subject of a separate clinical trial due to the safety signals from the small number of subjects tested at the end of the clinical trial before the EUA was approved. The DNA plasmid fragment contamination found was multiple times more than the maximum allowed by the EMA.
Data found in the Pfizer documents show the 502 subjects who made up the additional trial within a trial all having a marked safety signal due to higher adverse events.
The process tested and approved was never publicly rolled out and given to the population of the world. Instead, the public only received the DNA plasmid tainted Process 2 product.