colinnew
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.
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).
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.
