War Room/DailyClout Research Team Finds Serious Protocol Deviations Among the 170 Patients Upon Whom the Covid Vaccine EUA is Based

Pfizer reached an efficacy rate of 95% for their COVID vaccine. That conclusion was reached based on 170 patients.

Note: I apologize for my unusually long absence from Substack. Thankfully, it was for happy reasons, as I took off to travel with my family to a close relative’s wedding. I’m back, I’m thrilled to be continuing my work with the DailyClout team, and I have tons of information coming through the pipeline.

As originally published on DailyClout:

95% Vaccine Efficacy

When Operation Warp Speed commenced in 2020, it effectively gave the leaders of Pfizer the green light to do what they needed to do to get the data that would justify authorizing, approving, and ultimately mandating a vaccine for COVID-19. A team of researchers has begun to uncover just how far Pfizer went to ensure they achieved their data goals, allowing them to quickly boast an efficacy rate of 95%.

While Pfizer assumed that their protocols and data would remain under their tight control for most of our lifetimes, a judge decided otherwise. When the Pfizer documents were released under a court order earlier this year, Dr. Naomi Wolf and Mr. Steve Bannon embarked on a huge undertaking to gather professional volunteers to analyze the data released by the FDA. Within a span of a few short weeks, the War Room/DailyClout Pfizer Documents Analysis team, led by Amy Kelly, was born.

In the last year, there have been dozens of reports published by DailyClout of egregious examples of Pfizer possessing documented data that should have been shared with the public yet was actively covered up or ignored.

Jeyanthi Kunadhasan, MD, FANZCA; Ed Clark, MSE; and Chris Flowers, MD of Team 3 have spent months poring over the details of the trial participants, in an attempt to understand how Pfizer reached its conclusion that the COVID-19 mRNA vaccine has a 95% efficacy rate.

Timeline

The clinical trial timeline unrolled as follows:

July 27- Nov 14, 2020: The clinical trial run by Pfizer to determine efficacy enrolled approximately 44,000 participants.

Nov 20: Pfizer submitted their data with a request for an Emergency Use Authorization (EUA) for its COVID vaccine

Dec 10, 2020: FDA held a meeting to discuss Pfizer’s EUA request

Dec 11, 2020: EUA was APPROVED

Dec 14, 2020: First dose administered to the public

DailyClout Digs into the Data

On December 10, 2020, one day before the EUA was approved, an article was published in the New England Journal of Medicine (NEJM) titled “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine”. It is a detailed layout of the process of the clinical trial, authored by 12 scientists for the “C4591001 Clinical Trial Group” and “supported by BioNTech and Pfizer”. In the article, the authors explain the breakdown of their conclusion that the vaccine had an efficacy rate of 95%.

Out of the tens of thousands of trial participants, the efficacy rate was determined by just 170 participants who contracted COVID-19 in the time frame set after Dose 2, IF they remained eligible and in the trial.

An endpoint is the main outcome that is being measured by a clinical trial. In the case of the Pfizer trial, the endpoint was efficacy. Once the DailyClout research team had that efficacy endpoint number of 170 participants, plus the court-ordered release of the Pfizer documents, the team was able to comb through the summaries, notes, and code numbers of the approximately 44,000 participants and managed to find the 170 participants who changed the world.

Protocol Deviations

Unsurprisingly, the DailyClout team found a number of serious issues upon which the patient population conclusion was 95% efficacy based on the way the trial was conducted:

• Five of the 170 did not get Dose 2 in the originally scheduled time frame, which was 19-23 days from Dose 1.

• The 14 amendments to the protocol never formally stated a widening of the dosing interval. Instead, this change was only found in the Statistical Analysis Plan, a document not normally publicly available. The formal protocol allowed ambiguity by using the words “predefined window” for the dosing interval.

• One of the 170 patients had an investigational product dosing/administration error.

• Another of the 170 had a significant protocol deviation, as they had received a blood product within 60 days of enrollment through the conclusion of the study. 16 other patients had this protocol deviation.

• Two of the 170 were withdrawn from the trial prior to the issuance of the EUA. One of them withdrew because he/she disagreed with the medical management of the trial.

• Approximately 2,305 participants did not move on to Dose 2 after receiving Dose 1.

• The participants were handpicked by Pfizer, and then randomized into placebo and vaccinated groups on a 1:1 ratio. The issue with this is that the trial managers overwhelmingly chose young, healthy people to be participants, yet the initial vaccine campaign targeted the elderly and the sick.

In the protocol, it was clearly stated that a major protocol deviation would exclude the patient from being part of the endpoint analysis, from the date it occurred until the participant’s remaining follow-up. In order to declare a drug effective, the trial must be done on a population that had followed the protocol correctly.

Original Reports and Videos

The DailyClout team has spent months doing a meticulous job detailing and providing evidence for their concerns.

• The full report can be found on DailyClout.

• A short video explanation of the 170 can be found here.

  

  Link to Video

• A long video explanation by the author, Jeyanthi Kunadhasan, MD, FANZCA can be found here.