Buried within the FDA’s briefing document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10, 2020, for the Pfizer-BioNTech COVID-19 Vaccine- there is alarming data and a concerning issue which should be addressed.
Firstly, it’s worth pointing out that Pfizer used a ‘central laboratory’ (see page 13 of the document) of its choice, to confirm COVID-19 cases using a PCR test. ‘If, at any time, a participant develops acute respiratory illness, an illness visit occurs. Assessments for illness visits include a nasal (mid-turbinate) swab, which is tested at a central laboratory using a reverse transcription-polymerase chain reaction (RT-PCR) test.’
I’ve previously written an in-depth investigative report on the PCR test. The cycle threshold (CT) value used, greatly impacts the outcome of a test.
According to a study by Jaafar et al., the authors found that when running PCR tests with 35 cycles or more – the accuracy dropped to 3%, meaning up to 97 % of positive results could be false positives.
There is no information given on the CT value used at this ‘central laboratory.’
Given what we know, that Pfizer’s pivotal clinical trial was a de facto, unblinded one – their unblinding guidelines are clearly stated within their own study protocol and for potential COVID-19 cases, the trial site staff were immediately unblinded. This means, trial staff knew whether a particular symptomatic participant had the placebo or the vaccine.
Pfizer’s widely touted vaccine efficacy rate of 95%, arose from PCR test results generated from this central lab. The unblinding of clinical trials leads to strong bias and a severe loss of data integrity, so potentially the CTs could have been ramped up for the unvaccinated (placebo) participants suspected of having COVID-19, leading to almost guaranteed Covid positive results. For those who had the vaccine, the CT value used could have been much less, making it more likely to generate a negative result.
On page 24 of the document, the results showing 95% VE (vaccine efficacy) for the vaccine can be found below.
![](https://brownstone.org/wp-content/uploads/2022/05/pfizer2-800x415.png)
The 95% VE (vaccine efficacy) arises from the 8 confirmed Covid cases from the vaccinated group (from at least 7 days after Dose 2) compared to 162 from the placebo group. These two data points are essentially what Pfizer hang their hat on to prove their vaccine was a success.
This is the data that the FDA and other regulatory bodies around the world relied upon to grant EUA (Emergency Use Authorisation) for the Pfizer-BioNTech COVID-19 vaccine and for billions of doses to be shipped around the world with some countries enforcing highly controversial draconian vaccine mandates.
A key section buried within this document, which alludes to possibly the real VE at that time, is the following damning data below (found on page 42).
![](https://brownstone.org/wp-content/uploads/2022/05/https-bucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com-public-images-d6ab220b-634b-4932-a060-453381e25bc8_1538x162-800x84.png)
These were people showing actual symptoms. If you calculate the VE from these numbers, it’s a staggeringly low 12%. VE is calculated by dividing the difference between the case numbers in the placebo and vaccine groups, by the case number in the placebo group x 100 = VE of 12 %
This is a vast climb down from the 95% VE generated by easily manipulated PCR tests, conducted in a central lab chosen by Pfizer. What’s even more alarming, is that this data was known almost a year and a half ago, by the FDA themselves.
Republished from Substack
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