How Pfizer carried out the biggest pharma trial heist ever
Headlines around the world repeated “Pfizer’s vaccine is more than 90 percent effective” and more importantly by the regulators FDA, TGA, EMA and MHRA
The “real” statistic was actually 95 percent.
Yep, Pfizer and the FDA concluded – after one of the quickest and largest randomised controlled trials in pharma history – that receiving a Pfizer COVID vaccine would give you only five percent of the risk of “catching COVID” than someone who didn’t receive their product1.
Just to reiterate – this was about COVID infection.
No claims on severity, hospitalisation or death were made by Pfizer.
The FDA agreed that Pfizer’s trial showed that for every 100 people who were not vaccinated and “got COVID” only five vaccinated people would “get COVID”. And remember this is COVID infection (testing positive), not anything else.
FDA’s analysis of the available efficacy data from 36,523 participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirmed the vaccine was 95 percent effective (95 percent credible interval 90.3, 97.6) in preventing COVID-19 occurring at least 7 days after the second dose (with eight COVID-19 cases in the vaccine group compared to 162 COVID-19 cases in the placebo group).
Putting this another way, for every vaccinated person you met who had COVID you should have met at least 24 vaccinated people that didn’t ever have COVID.
Given that most of the vaccinated population actually “got COVID” – many of them multiple times, that sounds impossible, right?
That’s because it was.
Yet the trial itself showed 95 percent reduction in the risk of infection and was published in the infamous New England Journal of Medicine (the same journal that published the fraudulent Surgisphere study) on the 10th December 2020.
Dates Matter
As a background to the first red flag concerning this trial and subsequent “emergency approval” of the Pfizer COVID-19 vaccine it is worth noting some dates.
- The first patient recruited to the study was July 27th 2020.
- By 31st August 2020 half of the participants had been recruited, meaning that less than half the participants had follow-up of at least 75 days from the first injection. Given that you were supposed to need two weeks after the second injection (35 days) for it to “work” this means that half the participants had follow up of less than 47 days for the “effective dose”2.
- The original submission from Pfizer to the FDA happened on November 20th 2020. The “data cut-off” for the trial – the last day that COVID infections could be registered – was November 14th 2020.
- The VRBPAC meeting (Vaccines and Related Biological Products Advisory Committee) at the FDA met on the 10th December 2020, the same day the trial was published.
- The VRBPAC assessment document3 for the Pfizer submission was written on the 7th December 2020, just two weeks after the submission was made – and having had to assess a trial with 44,000 participants.
This median of 47 days was the basis on which the approval was given, but it gets worse – much worse.
In fact we are going to show that the whole study was a sham and that there never was a benefit – at all, never mind “95 percent reduction in infection”.
Here is the chart provided by Pfizer that they used to show that there was a 95 percent reduction in infection. It’s impressive. The red line is the “placebo” group and the blue line is the “vaccinated” group.
And although they initially start off getting infected at the same rate – after about 10 days after the first jab, the vaccinated pretty much stop getting infected at all.
A true miracle vaccine.
Note that his chart is by “day after dose 1” and not “day of the year” or “day of the trial”.
The point of mentioning the dates is not only to show that the approval was made on the basis of 47 days of follow-up for most patients but was also made in 1 day, because the VRBPAC meeting was the 10th December 2020 and the EUA approval was declared on the 11th December 2020.
It is of course not possible that such a decision could have been made overnight and so the implication is that this was a pre-agreed approval and all that needed to happen was that Pfizer provide data that shows that, in the group that were followed up for more than 35 days, there were less infections in the vaccination group.
And we are going to see that this was all planned to happen by around the 20th of October, around four weeks before the data cut-off date.
What’s “COVID” according to Pfizer?
Here comes the next important part of the hustle.
For most of us, “COVID” is a clinical syndrome signified by a viral infection that causes symptoms. Those symptoms invariably involve a fever and lethargy. For some people it involves a cough or runny nose.
And when “severe COVID” happens, if it does, that almost always involves a post-viral pneumonia – just like the 1918 “Spanish flu” and basically every other respiratory virus ever – as I wrote about extensively here.
If you don’t have any symptoms you can’t really have “COVID” or any similar illness of any significance.
Testing positive on a PCR test is irrelevant if you don’t have symptoms (why are you even testing?) but if you do have symptoms it’s highly predictive of a viral infection with SARS-Cov-2.
So you would think that the definition of “COVID” in the Pfizer trial was something like “symptoms of respiratory viral infection with fever cough and a positive PCR or lateral flow test conducted at the local health authority” wouldn’t you?
Oh no. This is the case definition in the Pfizer protocol4.
Efficacy will be assessed .. If, at any time, a participant develops acute respiratory illness (see Section 8.13), for the purposes of the study he or she will be considered to potentially have COVID-19 illness.. the participant should contact the site, an in-person or telehealth visit should occur, and assessments should be conducted… will include a nasal (midturbinate) swab, which will be tested at a central laboratory using a reverse transcription–polymerase chain reaction (RT-PCR) test… The central laboratory NAAT result will be used for the case definition
There is one phrase hidden in there that not many people noticed but prompted this tweet over three years ago…
And the phrase of interest is “The central laboratory NAAT result will be used for the case definition”.
The tweet is basically asking why – when a large proportion of the trial participants were recruited in Argentina – you would send your “suspected COVID” swab all the way to New York.
Well the answer becomes obvious when you realise what the “central laboratory” is – it’s Pfizer’s lab in Pearl River, New York. How do we know that? Because it’s in the documents that Pfizer and the FDA tried to withhold for 75 years – until Aaron Siri took the FDA to court to provide those very same documents.
It’s worth noting at this point that those documents in total work out at over two million pages, so I hope readers will forgive me for taking a long time (arguably three years) to produce this article which is based on analysing and verifying the data in them. It’s a lot of work, and anybody who’s looked at these files will know that it’s not possible to review them properly in two weeks]
And here is the confirmation5 that the “central laboratory” was at Pfizer’s vaccine HQ…
… Which means that the people that decided whether a swab would be marked as PCR positive or negative – which was the only test that mattered – were Pfizer.
Nothing to see there, obviously. But it gets better.
VRBPAC SHMERPAC
The FDA’s VRBPAC meeting was held on the 10th December 2020 and comprised a bunch of people who appeared completely incompetent – and in some cases didn’t appear to know what time of day it was, or how to use zoom.
Except Doran Fink, who gave a polished presentation, that almost looks like it was written for him, explaining how the FDA had been investigating this trial data “for months”.
That was despite (supposedly) having no clinical data in that time – so that was not possible. To clarify, unblinding in the trial was not allowed to have happened until after November 14th, 2020, so it seems that Doran is throwing Pfizer under the bus by telling us that there was some way that Pfizer knew who was in which arm before the 14th November6.
Neither was it possible for Doran Fink himself to have analysed such a quantity of data because he had no experience in handling large clinical data sets, so it certainly wasn’t him that did that analysis.
Doran was rewarded with a plum job at Moderna for his efforts to put lipstick on the Pfizer trial data… and if that wasn’t good enough he’s now rocking it at the home of the pharma vaccine cartel – GSK.
Absolutely nothing to see there then, because the “revolving door” corruption at the FDA is just part of the furniture.
And here he is at the VRBPAC meeting itself telling us how the FDA (i.e. Fink and friends) did a “thorough and extensive” review of the 44,000 participant study in no time at all but that actually he (and his elves) had been doing it for months.
As well as working over thanksgiving – you know, just to really hammer it home that they’d been working on it.
Except that they didn’t need to work on anything because there is nothing at all to stop Pfizer ghost writing the whole “analysis” for them. It is certainly improbable that Doran Fink produced the 60-page document.
But the important bit is that Pfizer already knew by the 9th of November that the vaccine had “worked”. So did all those “mainstream” media outlets and the World Economic Forum.
Which was all a bit naughty because, if the data cut off was the 14th November Pfizer couldn’t have known before that date that they had achieved anything at all, unless the “unblinded team” that they conveniently had as part of their protocol had told them.
And although they had an “unblinded team” who knew which patients were in which groups they didn’t need that information, because they had another way of finding out, which we’ll come back to soon.
What Did Doran Do?
Well, apart from earning himself a cushy job with pharma (twice), after selling the COVID vaccine efficacy line to the world in order to get the EUA (emergency use authorization) approval done and dusted in less than 24 hours, the answer is likely not very much at all.
It is also worth an honourable mention to Moderna here, who managed to achieve a similar EUA approval only 7 days later (having played the same “central laboratory” trick).
Yes, that’s right, while Fink and crew were giving up their thanksgiving Turkey to sift through the 44,000 clinical trial participants data for Pfizer they were also apparently “thoroughly assessing” the 30,000 participant Moderna trial.
Either that, or any analysis they pretended to do was ghost written for them by pharma (again).
But getting back to the Doran Fink analysis of the Pfizer trial… At the VRBPAC meeting itself it was actually Susan K Wollersheim who gave the statistical presentation.
Her ability to analyse a 44,000 participant clinical trial in record time is legendary as she has never published a clinical research study7. Therefore the probability of Wollersheim having analysed this 44,000 participant data is close to zero.
Here she is with her blue light filter glasses8 on noting that the FDA also had the inside information on the fabulous “95 percent efficacy” figure in October.
Of course only a cynic would suggest that this “miraculous” result could have been revealed to the US population before the 2020 election so that they didn’t have to set up special ballot drops but that’s a story for another day.
If you actually watch the VRBPAC monologue from the blue-tinted Wollersheim you can see that she is just reading a script. It’s no surprise because there is no way that these people were doing this analysis.
They don’t have the skill set and the amount of work required is incredible – particularly for someone who is a practising doctor and therefore doesn’t have the time.
For context, what you will see below in my analysis is just a part of what we have been working on for over 3 years. When I say “we” I mean a handful of people with the skillset to look through the Pfizer data that was eventually released over 2 years by the FDA.
That was the expedited release after the court quashed the FDA’s attempt to take 75 years to release that data. It is literally millions of pages and there is not a chance in hell that the Susan Wollersheims of the world could have provided a full re-analysis of the data in two weeks.
Just working on this one aspect of the Pfizer data fraud (the subject of this article) has taken me three years on and off. Similarly,
In comparison, one of the data reviewers from the FDA, Ye Yang, the lead statistician at the FDA, concluded9 in just a few weeks:
No major statistical issues were identified for the safety data during review. A higher percentage of subjects in the BNT162b2 group reported solicited local and systemic reactions than placebo recipients in both the younger (16 to 55 years) and older (>55 years) adult age groups after each dose.
There were no major imbalances in reported SAEs, AEs leading to withdrawal, or deaths between the treatment groups at one month and up to six months after the second dose or unblinding/data cut-off. (b) (6)
There is evidence of reactogenicity associated with BNT162b2; the overwhelming majority of events were of mild or moderate severity and short duration. There was no evidence of increased risk of unsolicited SAE or death associated with BNT162b2 in Study C4591001.
I defer to Drs. Susan Wollersheim and Ann Schwartz’s clinical review memo on the overall safety conclusion for BNT162b2.
Nice job, Ye Yang. Not a single mention of Brook Jackson’s fraud complaint registered with the FDA in September 2020. Everything rosy in the garden.
So I think we can safely say that the FDA have no interest in looking for fraud in these kind of trials.
In fact it’s very likely that the FDA didn’t analyse anything at all other than rehashing what Pfizer gave them.
This is taken from a long document. Read the rest here arkmedic.info
Header image: World Trademark Review
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