Report 30: Inconsistencies in Pfizer Clinical Trials Are Surfacing

Inconsistencies in Pfizer Clinical Trials Are Surfacing – Report

This Report was written exclusively for DailyClout by the Members of the Pfizer Analysis team. 

It should not be copied or republished without permission from DailyClout or a full credit and link to DailyClout.io

Summary:

This report is based on the currently released Pfizer documents. There is evidence to support that, at the start of the clinical trials, there were two groups. One group was given the vaccine, the other was given a placebo. However, contrary to the usual practice of spacing out the timing to account for side effects, only four months after the second group was given a placebo, the vaccine was administered to them. Because of this, there would have been no way to tell if the vaccinated group was experiencing side effects if the placebo group was given the vaccine as well, thus eliminating the control group. Analysis on this will continue as new documents are released.

I would like to share my findings based on three FDA-released Pfizer documents: 125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf (Demographic File), 125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf (Two Shots File), and 125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf (Four Shots File).

Please refer to the end of this document for a full description of these three files.

I have also discovered numerous files (greater than a dozen) that have repetitive information to the three files that I have converted to a database. It’s unclear if these files were documents used internally or simply documents exported from their database and presented in a slightly different form.

The Demographic File [125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf] was the first discovery. Presented from Pfizer as a nearly 3,000-page document, it seemed far too daunting a task to make any discoveries in that document form. The flat file was converted to a fully searchable database. I created the database using the Filemaker Pro application. This is a well-known and respected database application with a 37-year history.

I initially believed that there was a unique identifier (an ID number) to be found within each record presented in the Demographic File. This proved to be true. I further believed that there would be additional documents revealed in the future that would be related to the Demographic File allowing us to track the subjects introduced in the Demographic File. This also proved to be true.

Next, I found a similar file called, Two Shots File for short.[125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf] This PDF followed a similar format to the Demographic File [125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf] and, most importantly, it included the unique ID number. After converting the Two Shots File to database form, I was able to create a relationship between the Demographic File[125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf] and the Two Shots File [125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf] based on the ID number. This provided a subject’s demographic information, as well as information regarding their first two test shots. Subjects were placed in “Randomization Vaccine Groups” that included a “Placebo” group. The dose of each shot given to the test subjects was also recorded.

Next, I discovered a similar file called, Four Shots File for short.[ 125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf] This PDF followed a similar format to the Demographic File [125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf] and Two Shots File [125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf] and again it importantly included the unique ID number. After converting the Four Shots File [125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf] to database form I was able to create a relationship between the three files based on the ID number. Further, the second two files also include a “Randomization Number” that is also unique to each subject. This provided a subject’s demographic information, as well as information regarding their first four test shots.

However, not all subjects were given a third and fourth shot. Shockingly, only the Placebo group were given third and fourth shots — with actual vaccine, not a placebo. These third and fourth shots were identified with a vaccine group value (consistent with the previously vaccinate subjects) and a designated dose. In this case, all the doses were 30 micrograms.

Just four months after entering the trial and being given a placebo, the Placebo Group was given the vaccine, thus eliminating a control group. I am not a doctor, but this seems to make the entire trial null and void.

I consider this an ongoing investigation, and I will be examining current and future document releases to find more related data.

Other Related Findings

I found 625 subjects included in the Four Shots File [125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf] that were not in the Two Shots File [125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf]. 428 (77%) of these 625 subjects are under the age of 18. I’m not sure if this is significant or if it has any significance that these subjects were not included in the Two Shots File.[ 125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf] Based on the data, they should have been included as they received either a vaccine or a placebo.

The Two Shots File [125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf] reveals that 2,449 subjects were given the first shot but not a second shot. No explanation is given.

Among the 19,645 subjects in the Placebo Group who received a third shot of 30 micrograms of vaccine, 3,626 did not receive a fourth. No explanation is given.

In all three files the “Subject” field offers one of 154 unique values for a respective test subject. The second of three numbers expressed here appears to be a physical/geographic test location. I have a breakdown of the number of subjects that hail from each site.

About the three Pfizer files I have used:

125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf (Demographic File) [125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf]

Downloaded from the DailyClout site on April 11, 2022

This file is 2,951 pages in length and contains 44,257 unique records. Within the document the data is described in the header as: “16.2.4 Listing of Demographic Characteristics – All Subjects ≥16 Years of Age.”

The information provided is organized in 11 fields as follows:

1. “Age Group (Years)” — This field is blank with the exception of:

Page 1 – record 1 of 15, value = “16-55”

Page 1745 – record 12 of 15, value = “18-55”

Page 1752 – record 12 of 15, value = “65-85”

Page 1758 – record 12 of 15, value = “>55”

2. “Subject” — This field contains three set of values. The first is an eight-character, alphanumeric value = “C4591001” that is constant in all records. Next is a four-digit number that is not unique to each record. There are 154 unique four-digit numbers in this second value. It is now understood that this number represents a test location. Third is an eight-digit number that is unique to each record. Among the 44,257 records this number does not repeat. Once this was discovered, I considered this number to be the subject’s unique ID number hoping that it would appear in future files giving a basis to track individual subjects.
3. “Age (Years)” — the subject’s age expressed in two digits ranging from 15 to 91.
4. “Sex” — expressed as Male or Female
5. “Height (cm)” — height expressed in centimeters
6. “Weight (kg)” — weight expressed in kilograms
7. “Body Mass Index (BMI)” — expressed numerically rounded to one decimal
8. “Race”
9. “Racial Designation” — most often left blank
10. “Ethnicity”
11. “Informed Consent Date (Screening)” — date expressed, example, 26AUG2020

125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf (Two Shots File) [125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf]

Downloaded from the DailyClout site on April 18, 2022

This file is 4,412 pages in length and contains 43,746 unique records. This document is two documents in one file. The first 37 pages are described in the header as: “16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2.”

Pages 38 through 4,412 are described in the header as: “16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects.”

It’s unclear why this document is in two parts especially when considering that the first 37 pages contain data that is exactly duplicated in the following pages.

The information provided is organized in 10 fields as follows:

1. “Subject Study Identifier” — This field is the third eight-digit number that I had previously identified as a unique ID number.
2. “Subject” — same as “Subject” in previous file.
3. “Age Group (Years)” — expressed as an age range, example, 18-55.
4. “Randomization Date” — date expressed, example, 26AUG2020.
5. “Randomization Number” — a second unique ID number expressed as four-to-six-digit number.
6. “Randomization Vaccine Group” — expressed as eight-character, alphanumeric value, as well as a dose expressed in micrograms EXCEPT if the group value = “Placebo.”
7. “Date” — date of first dose expressed as previous dates.
8. “Dose 1” — expressed as eight-character, alphanumeric value, as well as a dose expressed in micrograms EXCEPT if the group value = “Placebo.”
9. “Date” — date of second dose expressed as previous dates.
10. “Dose 2” — expressed as eight-character, alphanumeric value, as well as a dose expressed in micrograms EXCEPT if the group value = “Placebo.”

125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf (Four Shots File) [125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf]

Downloaded from the DailyClout site on May 4, 2022

This file is 4,376 pages in length and contains 44,360 unique records. Within the document the data is described in the header as: “16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Age.”

The information provided is organized in 10 fields as follows:

1. “Subject Study Identifier” — This field is the third eight-digit number that I had previously identified as a unique ID number.
2. “Subject” — same as “Subject” in previous files.
3. “Age Group (Years)” — expressed as an age range, example, 18-5.
4. “Randomization Date” — date expressed, example, 26AUG2020.
5. “Randomization Number” — a second unique ID number expressed as four-to-six-digit number.
6. “Randomization Vaccine Group” — expressed as eight-character, alphanumeric value, as well as a dose expressed in micrograms EXCEPT if the group value = “Placebo.”
7. “Date/Dose 1” — date of first dose expressed as previous dates with an eight-character, alphanumeric value, as well as a dose expressed in micrograms EXCEPT if the group value = “Placebo.”
8. “Date/Dose 2” — date of second dose expressed as previous dates with an eight-character, alphanumeric value, as well as a dose expressed in micrograms EXCEPT if the group value = “Placebo.”
9. “Date/Dose 3” — date of third dose expressed as previous dates with an eight-character, alphanumeric value, as well as a dose expressed in micrograms.
10. “Date/Dose 4” — date of fourth dose expressed as previous dates with an eight-character, alphanumeric value, as well as a dose expressed in micrograms.

All data presented to the best of my understanding.