The FDA knew that the product they were approving under EUA was a poison pill Part 2

The Bait and Switch: Hiding In Plain Sight - where's Waldo?

In tribute to Where’s Waldo @drchrisflowersmd (illustrations using mid-journey and Photoshop)

(Previously published on the DailyClout)

The recently coined “Bait and Switch” used by Josh Guetzkow had its origins in a secret Trial within a Trial. This is the C4591001 Pfizer Clinical Trial that took over 44,000 volunteers to determine whether the product should be approved for an Emergency Use Authorization (EUA).

Hiding in Plain Sight

Almost, but not quite, hidden. @drchrisflowersmd (illustrations using mid-journey and Photoshop)

What have the War Room/DailyClout volunteers found?

We identified a distinct cohort of the clinical trial subjects 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.

The Age of Z

The Guetzkow analysis was of lot EJ0553, in part 1 of my report. In the released documents in the USA, it has the Z suffix designation. The EJ0553Z lot was only used in 11 patients and in different study sites than those used for the Trial within a Trial.

This product had a unique Vendor Lot No. ‘EE8493Z’, identified in the Pfizer Batch/Lot inventory document.

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’.

The Process 2 subjects are clearly separated here

This data was available BEFORE the EUA was granted by the FDA, so they must have known and seen the data before the approval on 11 December 2020.

Adverse Events in this NOVEL Process 2

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.

As this was over a short time span of a few weeks and because of the small number, the Severe Adverse Events (SAEs) demonstrated in their Post Marketing Experience 5.3.6 document we not evident. However, they were so different from the placebos as to raise a safety signal that should have attracted the FDA’s attention.

The Placebo Group -

Of the 250 subjects in the placebo group, 185 had no adverse events and 65 had adverse events. These were mainly minor with pain or swelling at the injection site.

The Process 2 Group -

Of the 252 subjects in the Process 2 product arm, 97 had no adverse events, and 155 had adverse events. These were mainly minor with pain or swelling at the injection site.

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.

2.4 times more adverse events in Process 2 product than Placebo (saline)

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 products 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 the product from Process 2 was different from the 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.

CONCLUSIONS

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.