Lone document released early
|NE – nakedemperor.substack.com Mar 29 2022|
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The next batch of Pfizer’s data release is due soon. These are documents that the FDA had requested to be released over 75 years but ordered by a federal judge to do so by the end of this year. However, for some reason a lone document was released on 24 March. This document was a request by Pfizer for priority review, i.e. they were seeking licensure of the vaccine in May 2021.
A number of things of interest popped out of this document. Firstly on page 8, looking at the Phase 1 Safety data, it says:
“Reactogenicity and AEs [adverse events] were generally milder and less frequent in participants in the older group compared with the younger group and overall tended to increase with increasing BNT162b2 dose.”
Surely then, with a vaccine that is producing more frequent and more severe reactions and adverse events in younger individuals, the vaccine should have been restricted to those who were actually at risk of severe COVID-19.
Just after that sentence, it says:
“Clinical laboratory evaluations showed a transient decrease in lymphocytes that was observed in all age and dose groups after Dose 1, which resolved within approximately 1 week, were not associated with any other clinical sequelae, and were not considered clinically relevant.
Ribonucleic acid (RNA) vaccines are known to induce type I interferon, and type I interferons regulate lymphocyte recirculation and are associated with transient migration and/or redistribution of lymphocytes.11 This rapid rebound of lymphocytes supports that the lymphocytes are not depleted, but temporarily migrated out of the peripheral blood, and subsequently re-entered the bloodstream by the time of the next assessment.”
Decreased lymphocytes for a week, which have migrated out of the blood stream, suggests that there is some immune dysregulation occurring. This could increase the risk of infection, including the risk of catching SARS-CoV-2.
Many countries have shown a large increase in infections in the first weeks after vaccination. This has been dismissed as a coincidence but is lymphopenia the reason for it? Pfizer’s own trials showed that there were more suspected COVID-19 cases within the first 7 days of vaccination.
“Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.”
You might have the best vaccine in the world, but if it increases your chance of getting the disease before you are protected from it then is it really the best vaccine in the world? It definitely shouldn’t be mandated.
As many of us have been saying throughout the pandemic, mass vaccination when cases are high is a recipe for disaster. Combine that with dysregulating people’s immune systems and you are pouring fuel on the fire and fanning the flames at the same time.
The next area of interest in the document concerns efficacy and in particular efficacy against severe disease.
Firstly, Pfizer looked at vaccine efficacy against FDA-defined severe COVID-19 occurring at least 7 days after Dose 2. They concluded this was 95.3%.
“Among participants without evidence of SARS-CoV-2 infection before and during the vaccination regimen (evaluable efficacy population), the estimated VE against FDA-defined severe COVID-19 (protocol definition) occurring at least 7 days after Dose 2 was 95.3% (2-sided 95% CI: 71.0%, 99.9%), with 1 and 21 cases in the BNT162b2 and placebo groups, respectively.
Similarly, the estimated VE was also 95.3% (2-sided 95% CI: 70.9%, 99.9%) among participants with or without evidence of SARS-CoV-2 infection, also with 1 and 21 cases in the BNT162b2 and placebo groups, respectively.”
However, notice that it divides the groups into those without evidence of SARS-CoV-2 infection before and during the vaccination regimen and those with or without evidence. So by taking away the numbers from the without group we can work our the numbers in the with group.
In this case it’s very easy because the numbers are identical (1 and 21 cases without evidence and 1 and 21 cases with and without evidence of infection). Therefore, there were 0 cases of severe disease in trial participants with evidence of SARS-CoV-2 infection before and during the vaccination regimen.
The same thing happens when they looked at the estimated vaccine efficacy against CDC-defined severe COVID-19 occurring at least 7 days after Dose 2.
“Among participants without evidence of SARS-CoV-2 infection before and during the vaccination regimen (evaluable efficacy population), the estimated VE against CDC-defined severe COVID-19 occurring at least 7 days after Dose 2 was 100.0% (2-sided 95% CI: 88.1%, 100.0%), with 0 and 32 cases in the BNT162b2 and placebo groups, respectively.
Similarly, the estimated VE was also 100.0% (2-sided 95% CI: 88.0%, 100.0%) among participants with or without evidence of SARS-CoV-2 infection before and during the vaccination regimen, also with 0 and 32 cases in the BNT162b2 and placebo groups, respectively.”
This time, in the without evidence of infection group there were 0 cases with severe disease in the vaccine group and 32 in the placebo group. In the with and without infection group it stayed the same, 0 and 32, meaning the with evidence of SARS-CoV-2 group had 0 cases in both the vaccine and placebo groups.
So, for individuals with evidence of SARS-CoV-2 infection before and during the vaccination regimen there were 0 cases of severe disease, whichever definition they used. Surely this shows that natural immunity did what it does best and protected those individuals from severe disease.
If Pfizer’s own trials showed natural immunity protecting people against severe disease then why was natural immunity such a taboo subject? And why weren’t people who had been previously infected advised that vaccination was unnecessary? The cynical answer is that the trials showed that those people would not get severe disease and so would make the statistics look better as to vaccine efficacy in the real world.
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