Looking for the positive PCR & Symptomatic subjects through Pfizer/BioNTech's data obfuscations - and uncovering some more major anomalies on the way...
The trials were completely faked and incomplete. That is because this substance is not a vaccine or even a fake vaccine. It is a prototype countermeasure that was contracted by the DOD to be manufactured and distributed by big pharma and green-lighted by the FDA without questions.
Since it was an undefined (as far as exact purpose goes) countermeasure instigated under the EUA, no trials or testing was necessary before it hit the public. According to the DOD/big pharma contracts, this mRNA substance IS NOT a pharmaceutical. Therefore, it did not require ANY RCT trials.
It was promoted as a safe and effective vaccine but big pharma was acting under contractual orders of the DOD and HHS. It was a lie from day one.
I don't have the techie skills to plod through the stats, and I greatly appreciate that you all are able and willing. But I can contribute something else here.
What caught my attention in the article was this, shown in the screen capture of Pfizer's memo to the FDA asking for EUA (online date 11/dec/2020):
“It is possible that the imbalance in suspected COVID-19 cases [409 pfizered vs. 287 placebo] occurring in the 7 days post vaccination **represents vaccine reactogenicity** with **symptoms that overlap with those of COVID-19.** Overall though, these data do not raise a concern that protocol-specified reporting of suspected but unconfirmed COVID-19 cases could have masked clinically significant adverse events **that would not have otherwise been detected.**” (star highlights added)
First highlight:
Looking up "reactogenicity" revealed a lot of studies over the past 2 years were trying to verify the universal public reassurance that if you have serious AEs from the jab, "it means you're getting a good immune response."
I random-checked some peer-reviewed articles... from Germany, South Korea, Saudi Arabia, and China.
None of them could find a correlation between reactogenicity and immunogenicity. Not even the Chinese, who lied in their abstract but admitted the truth in their results.
In fact, the Germans described this idea as "a common belief" with "limited data" [read: none] to support it. And the Koreans flatly said that "reactogenicity… cannot be assumed to correlate with immunogenicity.”
So it's a myth. Yet the CDC website, updated just this month, repeats that AE reactions from the mRNA jab "are normal signs the body is building immunity."
Second/third highlights:
Remember the alarmingly long duration of the "clinically significant" AEs which we now know among the jabbed, and put it together with this neat identification of the AEs with what came to be called "long Covid" symptoms. We see that Pfizer knew about it from the start. And so did the FDA.
Presumably that includes the AEs causing "sudden death syndrome" - which we now know clustered within 14 days of the jab and were thus written off as "unvaxxed" deaths, or even "Covid" deaths. These too had "otherwise been detected" already by Pfizer and were expected to occur during the global roll-out.
The question is: Does knowing any of this, after the fact, help the cause of justice?
If I understand Jikky correctly, he's suggesting that a persons' vaccine status (real vaccine or placebo) could be found out via simple PCR test from an oral swab? Is that really possible without blood draw?
This is an excellent body of work. Thank you for putting in the effort. I am disappointed that I have only found this substack recently.
What strikes me is the large number of participants that suffered Covid like symptoms. NEJM reports that the median time of observation was 2 months. However we can easily calculate through person-years and number of participants in each wing that the mean observation period was only six weeks.
Does it make sense that about 1 in 10 relatively healthy participants would come down with Covid symptoms in such a short time? Is it reasonable that only 1 in 20 symptomatic people actually had Covid in the middle of a Covid pandemic?
When it comes right down to the utility of this product, it barely did anything with regard to preventing Covid-like symptoms.
The "FDA Briefing Document" of December 2020 stated:
"Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group".
I would highlight that the 1st sentence tells "suspected but unconfirmed", while the 2nd sentence only tells "Suspected COVID-19 cases"; maybe a nasty issue .. or not?
My question is: Are the 409 / 287 cases from 2nd sentence a subset of the 1594 / 1816 in the 1st sentence or to be understood as in addition to those?
My understanding of the "suspected but unconfirmid" is that the subjects actually had symptoms which triggered a "COVID-19 Illness Visit", but the subsequent RT-PCR-Test was negative (i.e. not confirmed).
If the meaning of the second sentence is identical, you would have to build the difference, yielding 1594-409 = 1185 in Active and 1816-289 = 1529 in Placebo.
This is a significant difference and would speak for a protective effect of Active against symptomatic disease after 8 days (we meanwhile know as far as the RT-PCR-test is concerned: after 11 days). I am not in favor of this interpretation.
However, if the meaning of the second sentence would be: Yes, there was this suspcicion (then: where was this suspicion documented) but because of the 7-days-rule this suspicion did not trigger a "COVID-19 Illness Visit", then confirmation was not an issue (= empty), then you should add both figures, yielding 2003 Active and 2103 Placebo, i.e. no difference. Although such outcome is still not the one that I would expect, "better" than anything else.
Two major problems in the FDA statement were: No reference to any tabulation and no reference to a denominator (analysis set). As long as the numerators were as tiny as the 50 / 275 (ITT-Set) this is a marginal issue. However, as soon as the numerator is in the 4-digit range, it is a problem.
Do you have ideas that help answering my questions?
B. Pfizer are always as ambiguous as they can on formulations, nothing unusual, the terms not defined or improperly used in the protocol are legion.
C. "suspected but unconfirmed actually had symptoms which triggered a "COVID-19 Illness Visit" : Correct ; physically or via the e-diary for the 6000 recipients of it.
D. The Pfizer data can't be used to infer any positive aspect on the product given the heavy degree of frauds characterized.
Overall, Pfizer recipients reported far more symptoms, but the mix between AEs & Symptoms operated by the sponsors obfuscated that.
The trials were completely faked and incomplete. That is because this substance is not a vaccine or even a fake vaccine. It is a prototype countermeasure that was contracted by the DOD to be manufactured and distributed by big pharma and green-lighted by the FDA without questions.
Since it was an undefined (as far as exact purpose goes) countermeasure instigated under the EUA, no trials or testing was necessary before it hit the public. According to the DOD/big pharma contracts, this mRNA substance IS NOT a pharmaceutical. Therefore, it did not require ANY RCT trials.
It was promoted as a safe and effective vaccine but big pharma was acting under contractual orders of the DOD and HHS. It was a lie from day one.
The whole clip is good, but skip to around 24:00 for the good part.
https://rumble.com/v289h2g-sasha-latypova-covid-19-countermeasures-evidence-of-the-intent-to-harm.html
"We didn't defraud the government. We delivered the fraud the government ordered."
I don't have the techie skills to plod through the stats, and I greatly appreciate that you all are able and willing. But I can contribute something else here.
What caught my attention in the article was this, shown in the screen capture of Pfizer's memo to the FDA asking for EUA (online date 11/dec/2020):
“It is possible that the imbalance in suspected COVID-19 cases [409 pfizered vs. 287 placebo] occurring in the 7 days post vaccination **represents vaccine reactogenicity** with **symptoms that overlap with those of COVID-19.** Overall though, these data do not raise a concern that protocol-specified reporting of suspected but unconfirmed COVID-19 cases could have masked clinically significant adverse events **that would not have otherwise been detected.**” (star highlights added)
First highlight:
Looking up "reactogenicity" revealed a lot of studies over the past 2 years were trying to verify the universal public reassurance that if you have serious AEs from the jab, "it means you're getting a good immune response."
I random-checked some peer-reviewed articles... from Germany, South Korea, Saudi Arabia, and China.
None of them could find a correlation between reactogenicity and immunogenicity. Not even the Chinese, who lied in their abstract but admitted the truth in their results.
In fact, the Germans described this idea as "a common belief" with "limited data" [read: none] to support it. And the Koreans flatly said that "reactogenicity… cannot be assumed to correlate with immunogenicity.”
So it's a myth. Yet the CDC website, updated just this month, repeats that AE reactions from the mRNA jab "are normal signs the body is building immunity."
Second/third highlights:
Remember the alarmingly long duration of the "clinically significant" AEs which we now know among the jabbed, and put it together with this neat identification of the AEs with what came to be called "long Covid" symptoms. We see that Pfizer knew about it from the start. And so did the FDA.
Presumably that includes the AEs causing "sudden death syndrome" - which we now know clustered within 14 days of the jab and were thus written off as "unvaxxed" deaths, or even "Covid" deaths. These too had "otherwise been detected" already by Pfizer and were expected to occur during the global roll-out.
The question is: Does knowing any of this, after the fact, help the cause of justice?
This is a very concerning and important analysis. Can you put an abstract?
There is a summary of results - but I'll try to format a more formal abstract asap; thanks for your feedback.
Great work thus far.
If I understand Jikky correctly, he's suggesting that a persons' vaccine status (real vaccine or placebo) could be found out via simple PCR test from an oral swab? Is that really possible without blood draw?
Jab status via blood draw, you say?
https://www.hopkinsmedicine.org/news/newsroom/news-releases/covid-19-story-tip-rapid-at-home-blood-test-could-confirm-covid-19-vaccination-in-minutes
https://www.youtube.com/watch?v=Uu4oawH4Hho
This has been documented by Jikkyleaks in the tweet I pinned in the article introduction :
https://twitter.com/Jikkyleaks/status/1618470299082850304
Interdasting, thanks.
So they're just testing for jab mRNA and calling it good. LOL
Makes me think of another issue. Has anybody OUTSIDE a lab NOT using Illumina sequencing equipment isolated "le virus?"
https://files.catbox.moe/6lzx4s.PNG
yes, i think via blood its possible, but is is possible just by saliva pcr?
No, PCR picks up infection. Pfizer also used blood tests in trials.
This is an excellent body of work. Thank you for putting in the effort. I am disappointed that I have only found this substack recently.
What strikes me is the large number of participants that suffered Covid like symptoms. NEJM reports that the median time of observation was 2 months. However we can easily calculate through person-years and number of participants in each wing that the mean observation period was only six weeks.
Does it make sense that about 1 in 10 relatively healthy participants would come down with Covid symptoms in such a short time? Is it reasonable that only 1 in 20 symptomatic people actually had Covid in the middle of a Covid pandemic?
When it comes right down to the utility of this product, it barely did anything with regard to preventing Covid-like symptoms.
Wow! Great work. I posted on Reddit
Thanks mate; said work is nothing without the mouse army to spread the word !
Thank you, great job!
The "FDA Briefing Document" of December 2020 stated:
"Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group".
I would highlight that the 1st sentence tells "suspected but unconfirmed", while the 2nd sentence only tells "Suspected COVID-19 cases"; maybe a nasty issue .. or not?
My question is: Are the 409 / 287 cases from 2nd sentence a subset of the 1594 / 1816 in the 1st sentence or to be understood as in addition to those?
My understanding of the "suspected but unconfirmid" is that the subjects actually had symptoms which triggered a "COVID-19 Illness Visit", but the subsequent RT-PCR-Test was negative (i.e. not confirmed).
If the meaning of the second sentence is identical, you would have to build the difference, yielding 1594-409 = 1185 in Active and 1816-289 = 1529 in Placebo.
This is a significant difference and would speak for a protective effect of Active against symptomatic disease after 8 days (we meanwhile know as far as the RT-PCR-test is concerned: after 11 days). I am not in favor of this interpretation.
However, if the meaning of the second sentence would be: Yes, there was this suspcicion (then: where was this suspicion documented) but because of the 7-days-rule this suspicion did not trigger a "COVID-19 Illness Visit", then confirmation was not an issue (= empty), then you should add both figures, yielding 2003 Active and 2103 Placebo, i.e. no difference. Although such outcome is still not the one that I would expect, "better" than anything else.
Two major problems in the FDA statement were: No reference to any tabulation and no reference to a denominator (analysis set). As long as the numerators were as tiny as the 50 / 275 (ITT-Set) this is a marginal issue. However, as soon as the numerator is in the 4-digit range, it is a problem.
Do you have ideas that help answering my questions?
Thanks for your comment.
A. 409 vs. 287 is indeed a subset of 3410 - 1594
B. Pfizer are always as ambiguous as they can on formulations, nothing unusual, the terms not defined or improperly used in the protocol are legion.
C. "suspected but unconfirmed actually had symptoms which triggered a "COVID-19 Illness Visit" : Correct ; physically or via the e-diary for the 6000 recipients of it.
D. The Pfizer data can't be used to infer any positive aspect on the product given the heavy degree of frauds characterized.
Overall, Pfizer recipients reported far more symptoms, but the mix between AEs & Symptoms operated by the sponsors obfuscated that.
See for example : https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-the
And : https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-local
Further to the 3410 (1594 and 1816):
Is it thinkable that these figures refer to the PP-Set? (Rather than the ITT-Set)
Note that they (who ever) did not specify the set or denominator in the FDA Briefing Document.
Thank you very much for this rapid response!
Are you aware of this problem:
ITT Set (Dose 1 all available efficacy populatio) form CSR 14.258:
21718 BNT / 21731 PLA
Actually named denominator in Table 31 of the CSR:
21669 BNT / 21686 PLA
MIssing 49 / 45
Obviously analysed as denominator, i.e. subjects with "Surveillance time":(Table 31)
21314 BNT / 21258 PLA
MIssing 404 / 473*
* p = 0.019
Why so few subjects actually analysed?
I did not identify a rational for the missing counts. And I currently cannot imagine a good reason.
By the way: I do not care about the PP-Set. Ridiculous for a superiority trial.
I'm very aware ; I spent a long time attempting to reproduce their various figures in every way possible.
The 301 subjects disappeared I linked you are a good part of the problem in my opinion - probably constituent of a larger one : https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-would
I'm finishing a new (and likely final) report with a few colleagues ; expect more details in a few days.
Don't forget they were/are counting TESTS as CASES no matter the final result.
Not like the any of the tests can tell you anything anyway since they don't provide differentiation.
"The SAS .XPT file “S1_M5_c4591001-S-D-mb” contains, among other Hepatitis or HIV tests, the raw results of the PCR tests performed on the subjects."
Does this file contain CT values?
Nop, these "details" haven't been provided.
Ah, ok. thanks. So that remains suspicious then... if a PCR swab could unblind, then this is a possible route... thanks