Pfizer/BioNTech C4591001 Trial - A deeper look to exclusions

The clinical trial of all statistical wonders...

Feb 21, 2023

Exclusions are a particular topic of interest in the Pfizer/BioNTech C4591001 trial which allowed the Covid-19 “vaccines” of this manufacturer to get to the market.

Researchers, from RoundingTheEarth’s Mathew Crawford1 2 3 to anonymous whistle-blower Arkmedic4, have tried to warn the public very early post December 2020’s EUA, denouncing the obvious red-flag of 311 exclusions in the BNT arm against 60 exclusions in the Placebo arm for the motive “other important protocol deviations on or prior to 7 days after Dose 2”5.

By “obvious red-flag”, we mean that the probability of this event to have occurred by chance in a normal randomized clinical trial, with such a large population, is zero. Or more accurately, as documented by the Mouse, 3.8 e-39.

Jikky the mouse 🐭 @TheJikky

@chrismartenson @MaryanneDemasi @sonia_elijah PS you would normally do this as a chi-square and the probability of this occurring by chance is 3.8 e-39 Not enough space for the zeros...

If you think this is “no big deal” or that it could have happened by “chance”, you should in good logic start to dig a bunker, because that’s billions times less likely than some big asteroid’s chances of hitting the Earth within the year6. Or billion times less likely than the chances that your DNA gets confused with someone's else in a criminal trial7.

You also may miss the point that the EUA was granted on the basis of 170 subjects data (the 170 positive “Sars-Cov-2 cases with symptoms” acknowledged in the study) - as stressed by the DailyClout Team 3 paper8 which we extensively covered in this article9.

So far, these don’t appear to have been accurately documented at “subject level”; which would allow us to focus on the CRFs of these subjects - when they will finally be released - to materialize further this clear evidence of fraud.

We therefore went looking for them in the documents obtained by PHMPT10, with the precious assistance of the excellent DailyClout’s Abstractor11 team, and of the sharp eye of Josh Guetzkow12, who has documented extensively these trials’ anomalies on his Substack13.

Some exclusions are documented in the .XPT file pd-production-070122/FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.xpt - but these are only screening-level exclusions, not relevant to our efficacy subjects’ exclusions issue.

Some others are documented in the .PDF file 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf, page 1 to 644. Only one table’s date (roughly) fits the data cut-off of November 14, 2020 : the first table “16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Populations”, finalized on November 24, 2020.

The 3 375 subjects concerned in this table appear to be the same “Participants excluded from evaluable efficacy (14 days) population” as those documented in the FDA memorandum’s page 18.

This PDF file contains details on the Subjects:

age group
product group (BNT162b2 or Placebo)
subject unique id (which is formed of 3 concatenated variables, the {trial id}, the {trial site id} and the {subject id} itself)
population
reason for exclusion

Each “unique subject id” - “population” pair is unique, which means that a subject has only one “categorized reason” to be excluded from a given population.

Focusing on subjects excluded from the “Evaluable efficacy (14 days)”, and on the motives corresponding to these “Other important protocol deviation”, we were able to isolate the 311 BNT162 subjects - and the 61 subjects of the Placebo arm.

Focusing on the “Evaluable efficacy (7 days)”, we find the 311 BNT162 subjects - and the 60 subjects of the Placebo arm.

You can download the list of these 372 subjects in the Google spreadsheet accessible here.