I showed Steve Kirsch the lopsided exclusions from the original trial report. He returned the favor and sent me the observation on the children study on Saturday, so I'll pass through some credit.
thanks FDA is holding meeting Oct. 26 (Tuesday) to authorize jabs for kids 5-11, Biden has already ordered 28 million shots, CDC is all set with guidelines and more, I've read a few of the comments people are making to the FDA and they are ALL against this insanity, plus the FDA buried data on a 12 year old seriously injured child, https://aaronsiri.substack.com/p/fda-buries-data-on-seriously-injured?
There's been a few deaths of the young here in NZ that have been covered up as well. And the Government recently wrote legislation that allows 12yos to make their "own" decisions about being vaxxed or not. It's amazing that there are so many psychopaths around and that they're all in Government. I mean you can see by the work of Project Veritas that there are actually fewer psychopaths in the Pharmaceutical companies than there are in Government.
One hypothesis I have for “protocol deviation” can be found by listening to the audio file in this link. To be unblinded (properly), the parents have to agree that the child will take the vaccine if they happen to be in the placebo group.
Now: suppose you are a parent with a child who just had a lingering adverse reaction after the shot. Naturally, you would want to know whether the vaccine had anything to so with it in order to get proper treatment. (In other words, you would want to rule out a different problem.)
But the protocol says that for unblinding to occur, you have to agree that your child get the vaccine of they are in the placebo group. Many parents would object to this, I suspect. And I also suspect that would be a “protocol deviation.”
I was surprised you didn't link to this in the article. It was the 1st thing I though of to explain the lopsided exclusions. I don't know how I feel about how dependent my understanding of world events is becoming on this substack. I guess I would be more concerned about confirmation bias if the corporate media wasn't so verifiably full of shit.
Those numbers are horrifying and should scream at anyone with some basic reasoning skills. It's unacceptable that the unspecified exclusions in either group would outnumber the other by nearly tenfold, without a clear explanation. Even WITH a clear explanation, I feel like it should warrant another study. But I think we know that this will somehow be considered enough to call the vaccine for 5 to 11 year olds "safe and effective." And as much as it's interesting to speculate whether the folks ramming these approvals through are stupid or evil, the bottomline is clearly that it's simply wrong.
It is troubling that such high impact research should have data kept from the public, but at the point at which governments are making decisions on it is the point at which the governments are no longer "of the people" in any meaningful sense. This is ripping the world apart in a dangerous way. And one question is: is that the whole goal?
Trillions of dollars of debt and also trillions of dollars of promises in regards to what I guess you could call 'Big Climate' projects. I'm sure that's in the mix.
With reverse engineered “vaccine” development underway in populous developing nations history should be acutely unkind to those who have so enthusiastically foisted this engineered solution upon us.
Also, thought I should just like to highlight this passage from page 20 of the Pfizer document, for those who don't like being nauseated:
"Due to reactogenicity observed in the initial 4/16 participants assigned to the 30 µg dose leveled group after they received both doses of BNT162b2 (Section 3.4.1), an IRC decision was made for the remaining 12/16 participants assigned to the 30 µg dose level group to receive the second dose based upon selection of the dose-level for Phase 2/3 ie, 10 µg. These subjects will not be discussed further."
I bet they won't. But to be clear, these lifesavers of our civilization at Pfizer take guesses at dosages until they see that too many (in this case 25%... which if you say "only four" I feel like you're already hopelessly lost) little kids get sick from the "treatment" you're giving them.
Modern medicine is founded on "what doesn't kill you makes you stronger." Are the folks who keep their kids masked to limit their exposure comfortable with how the sausage is made?
Oh, and just to point out - way too small of a sample size to check for myocarditis, obviously. But I'm nearly certain everyone on this substack already knows that.
In my reading about the initial adult trial research coordinators were responsible for fielding calls from the participants and sending them for COVID testing if they had symptoms. The problem was they become unblinded to treatment group when they got calls immediately after injection about headaches, pain etc. Unfortunately these are often the Same symptoms as the disease. They decided to record those calls as adverse event reports and did not send them for Covid testing. We now know the highest risk for Covid is immediately after shot one.
This matches my understanding as well. The vast majority of suspected COVID cases from the original trial (something like 20 to 1) were NEVER TESTED to be recorded as virus-caused COVID cases, and certainly not assessed per symptom diagnostic for matching with COVID (as in Type II COVID). The entire result is pure illusion.
311 Important Protocol Deviation. IPD is defined in the original Pfizer protocol (2.7 from memory) and is a Determination by an investigator that the dose or storage was wrong.
This determination must have been made AFTER the administration of the dose. But why would the investigator have cause to want to go back and check? Had the dose in some way failed? I strongly suspect they used this loophole to retrospectively sift the results and exclude certain participants.
Certainly the numbers so excluded were more than those who met the efficacy endpoint and could well nullify the trial results (if there are IPDs in the trial then wouldn't that happen in real life?).
Ironically Pfizer excluded for IPDs on temperature storage, but have since relaxed this anyway.
Pfizer is making 10s of billions, ultimately from taxpayers. I think a little transparency is deserved.
Trial fraud is not unknown and fraud will void any indemnity pharma have been given by Gov.
I understand when Pfizer were fined 2.3Bill 6 whistle-blower received some 100mill in payment. That ought to prove some incentive.
You are correct about one possible protocol deviation.
Regarding the temperature issue...we would think the IPDs would go down after such allowance, not up.
It's hard to know what the story is precisely given Pfizer's refusal to release their raw data, but they should not be taken as good actors at face value without releasing it.
See Pfizer doc 2.7.3, summary of clinical efficacy at 2.7.3.2.1.2.1:
311 IPDsq in the BNT162B2 arm
263 related to improper administration of investigational product
Most we are told, were dosing or administration errors (105), or administration of investigational product "deemed not suitable" (144 participants).
Pfizer clinical review document at page 40 separately confirms these are due to dosing (dilution) errors or the temperature "excursion in shipment or storage" meant the product was deemed "not suitable". The wording confirms the product had been "administered". So although the IPD arose on or before 7 days after dose 2, the participants would have met the evaluable efficacy endpoint, but were deemed not to be valid and so excluded.
It is rather important to have the data disclosed on IPDs.
Can you link to the doc you're referring to? I have the 2017 Efficacy Guidance for Industry, and it does not contain a 2.7.3.2.1.2.1, and is there a version specific to Pfizer?
TBH even if they just caught Covid, they can go back scrutinise the administration data and say, Aha! Here is the issue, wrong dose etc etc we must exclude for IPD.
The thing is, and as you note, in the far far smaller scale trial in kids the IPD rate is 220% higher. This has to be a signal that they are gaming it, how can the IPD be higher:
* Did they learn nothing from the IPD experience in the main trial?
* How can they make way more errors second time around in a smaller trial?
* The storage protocols were relaxed in June 2021 for the product.
This is an old case from an era when a handful in Congress and DoJ still had teeth and an appetite for public service over corporate clients but the roots of scientific fraud run deep. Many Monsanto chemicals were involved in IBT Labs fraud. Monsanto and Pfizer did M&A merge & divest dance in 2002ish to dump PCB liabilities and "share biotech tech knowledge" Nice folks at J&J were selling asbestos laced baby powder. Can't forget Ecohealth was originally BioPort Labs mired in covert investors and anthrax vaccines. Suspecting scientific fraud in the reporting is as likely as artificial ingredients in Cheez Whiz.
Yes to the first, no to the second (unless I'm missing something in this 81 page document). And the second is a damning no, because as Mathew showed, if even a percentage were excluded for an adverse reaction or COVID-like symptoms/positive test, then this entire study is garbage. 3 kids got COVID from the vaxxed group, 16 from the placebo. 47 were excluded from the vaxxed group, 4 from the placebo. I know I'm just restating the article here now, but it's important that it's completely clear that this is very much in the realm of potential for "fudging the numbers" and to whistle past this in this report should be unacceptable for anyone that's actually being held accountable.
Many people in various industries would be at the very least lectured (up to possibly terminated) for submitting a report like this.
Dr McCullough says that there were no women of child bearing potential in the original Pfizer study. Can someone confirm that? I’d be curious to know what the make up of that group was.
And tomorrow the FDA will not broadly approve the 5-11 group but it will be rolled out anyway. But we all know this. The world must be under a spell. We have completely lost our minds.
Pregnant women are almost always excluded unless they are the target audience. Only a few old people too. When studies are designed the inclusion and exclusion criteria are written to eliminate folks who have a high likelihood of treatment failure or adverse events if possible.
To me, it goes beyond a "belief" in viruses. It is entirely possible that there are microbes that exist that correlate with disease... but conclusively proving causation is near impossible (especially if you have any ethics). Typhoid Mary and the acceptance of asymptomatic carriers turned viral theory from a potential hard science to a statistical shellgame, which articles like this show how easily you can gild the lily in that department.
I suggest looking up Harold Hillman's work. Deceased neurbiologist and expert with electron microscopy. All those visualized bits could be artefacts of the sample preparation process - because (he claimed) no study done to determine effect of chemicals in the process on the various tissues and cell bits.
Note that it is acknowledged now that vaccine efficacy against infections declines over time such that after about 6 months, some reports put it as soon as 4 months, protectiveness against infection is no better than the unvaccinated.
It had been assumed that it would just stop there after the 6 months. But the recent data from the UK suggest the protection gets WORSE than the unvaccinated after this time. However, this has only been intimated at by the way this is being measured, looking at infection rates for vaxxed and unvaxxed since January.
But clearly what needs to be done is to instead count the NUMBER OF INFECTIONS SINCE VACCINATED. This would show clearly that once you get past 6 months or so, you are worse off being vaxxed for protection against infection then being unvaxxed.
This is being judged by infection rates. But is there an actual immunity system measurement that suggests also this is the case? There may indeed be one, and it may have just missed seeing this signal because it did the cut off at 6 months, *assuming* again the drop would not be below the standard baseline of the unvaxxed.
See the image and link to a CDC video here:
Robert Clark
@RGregoryClark
Replying to
@noorchashm
@amobeirne
and 2 others
In this CDC video Fauci acknowledges antibody titers even for vaccine tells us the degree of protection. So why not have everyone get their antibody levels tested? And why can’t they acknowledge prior infection also results in high antibody levels?
This data is what led the CDC saying booster shots would be needed but notice it is looking at actual antibody levels, not mere numbers of infections rates.
What needs to be done then is go beyond 6 months in this data to see if antibody levels drop *below* the standard baseline of the unvaccinated.
Then we would have two separate pieces of evidence to suggest the vaccine over sufficient time is actually damaging to our immune system.
Note this very strongly suggests the much feared “antibody dependent enhancement”(ADE) is occurring now. It is extremely important to find out if this is happening since all prior attempts to come up with a corona vaccine in animals failed with the animals all dying due to ADE.
Apropos of very little in this particular post: The Venn diagram type 1/type 2 covid has reminded me to ask a question which has been on my mind for a while... I'm assuming that a lot of vax injuries are ending up in hospital and being classified as covid. Therefore +ve PCR tests must be evident or somehow produced to enable the cover-up. Can someone explain to me how that might be done?
Eagle eye, Mathew. Well done.
I showed Steve Kirsch the lopsided exclusions from the original trial report. He returned the favor and sent me the observation on the children study on Saturday, so I'll pass through some credit.
Electronic comments must be submitted on or before October 25, 2021. Here is the link to use your voice: www.regulations.gov/document/FDA-2021-N-1088-0001
thanks FDA is holding meeting Oct. 26 (Tuesday) to authorize jabs for kids 5-11, Biden has already ordered 28 million shots, CDC is all set with guidelines and more, I've read a few of the comments people are making to the FDA and they are ALL against this insanity, plus the FDA buried data on a 12 year old seriously injured child, https://aaronsiri.substack.com/p/fda-buries-data-on-seriously-injured?
There's been a few deaths of the young here in NZ that have been covered up as well. And the Government recently wrote legislation that allows 12yos to make their "own" decisions about being vaxxed or not. It's amazing that there are so many psychopaths around and that they're all in Government. I mean you can see by the work of Project Veritas that there are actually fewer psychopaths in the Pharmaceutical companies than there are in Government.
One hypothesis I have for “protocol deviation” can be found by listening to the audio file in this link. To be unblinded (properly), the parents have to agree that the child will take the vaccine if they happen to be in the placebo group.
Now: suppose you are a parent with a child who just had a lingering adverse reaction after the shot. Naturally, you would want to know whether the vaccine had anything to so with it in order to get proper treatment. (In other words, you would want to rule out a different problem.)
But the protocol says that for unblinding to occur, you have to agree that your child get the vaccine of they are in the placebo group. Many parents would object to this, I suspect. And I also suspect that would be a “protocol deviation.”
(This is discussed only in the audio.)
https://aaronsiri.substack.com/p/fda-buries-data-on-seriously-injured?justPublished=true
Very interesting. The trial designers have been working their way toward such manipulations over the years:
https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html
I think I’m starting to
Understand. Trials are designed for approval and not to establish safety and efficacy.
I was surprised you didn't link to this in the article. It was the 1st thing I though of to explain the lopsided exclusions. I don't know how I feel about how dependent my understanding of world events is becoming on this substack. I guess I would be more concerned about confirmation bias if the corporate media wasn't so verifiably full of shit.
Actually, I meant to link it originally. I've dropped that link before, and I'll probably do so again.
fascinating. thank you for sharing this.
Those numbers are horrifying and should scream at anyone with some basic reasoning skills. It's unacceptable that the unspecified exclusions in either group would outnumber the other by nearly tenfold, without a clear explanation. Even WITH a clear explanation, I feel like it should warrant another study. But I think we know that this will somehow be considered enough to call the vaccine for 5 to 11 year olds "safe and effective." And as much as it's interesting to speculate whether the folks ramming these approvals through are stupid or evil, the bottomline is clearly that it's simply wrong.
It is troubling that such high impact research should have data kept from the public, but at the point at which governments are making decisions on it is the point at which the governments are no longer "of the people" in any meaningful sense. This is ripping the world apart in a dangerous way. And one question is: is that the whole goal?
Trillions of dollars of debt and also trillions of dollars of promises in regards to what I guess you could call 'Big Climate' projects. I'm sure that's in the mix.
With reverse engineered “vaccine” development underway in populous developing nations history should be acutely unkind to those who have so enthusiastically foisted this engineered solution upon us.
Also, thought I should just like to highlight this passage from page 20 of the Pfizer document, for those who don't like being nauseated:
"Due to reactogenicity observed in the initial 4/16 participants assigned to the 30 µg dose leveled group after they received both doses of BNT162b2 (Section 3.4.1), an IRC decision was made for the remaining 12/16 participants assigned to the 30 µg dose level group to receive the second dose based upon selection of the dose-level for Phase 2/3 ie, 10 µg. These subjects will not be discussed further."
I bet they won't. But to be clear, these lifesavers of our civilization at Pfizer take guesses at dosages until they see that too many (in this case 25%... which if you say "only four" I feel like you're already hopelessly lost) little kids get sick from the "treatment" you're giving them.
Modern medicine is founded on "what doesn't kill you makes you stronger." Are the folks who keep their kids masked to limit their exposure comfortable with how the sausage is made?
I have screenshot and posted above on twitter hope that's ok
Of course!
Oh, and just to point out - way too small of a sample size to check for myocarditis, obviously. But I'm nearly certain everyone on this substack already knows that.
In my reading about the initial adult trial research coordinators were responsible for fielding calls from the participants and sending them for COVID testing if they had symptoms. The problem was they become unblinded to treatment group when they got calls immediately after injection about headaches, pain etc. Unfortunately these are often the Same symptoms as the disease. They decided to record those calls as adverse event reports and did not send them for Covid testing. We now know the highest risk for Covid is immediately after shot one.
This matches my understanding as well. The vast majority of suspected COVID cases from the original trial (something like 20 to 1) were NEVER TESTED to be recorded as virus-caused COVID cases, and certainly not assessed per symptom diagnostic for matching with COVID (as in Type II COVID). The entire result is pure illusion.
311 Important Protocol Deviation. IPD is defined in the original Pfizer protocol (2.7 from memory) and is a Determination by an investigator that the dose or storage was wrong.
This determination must have been made AFTER the administration of the dose. But why would the investigator have cause to want to go back and check? Had the dose in some way failed? I strongly suspect they used this loophole to retrospectively sift the results and exclude certain participants.
Certainly the numbers so excluded were more than those who met the efficacy endpoint and could well nullify the trial results (if there are IPDs in the trial then wouldn't that happen in real life?).
Ironically Pfizer excluded for IPDs on temperature storage, but have since relaxed this anyway.
Pfizer is making 10s of billions, ultimately from taxpayers. I think a little transparency is deserved.
Trial fraud is not unknown and fraud will void any indemnity pharma have been given by Gov.
I understand when Pfizer were fined 2.3Bill 6 whistle-blower received some 100mill in payment. That ought to prove some incentive.
You are correct about one possible protocol deviation.
Regarding the temperature issue...we would think the IPDs would go down after such allowance, not up.
It's hard to know what the story is precisely given Pfizer's refusal to release their raw data, but they should not be taken as good actors at face value without releasing it.
See Pfizer doc 2.7.3, summary of clinical efficacy at 2.7.3.2.1.2.1:
311 IPDsq in the BNT162B2 arm
263 related to improper administration of investigational product
Most we are told, were dosing or administration errors (105), or administration of investigational product "deemed not suitable" (144 participants).
Pfizer clinical review document at page 40 separately confirms these are due to dosing (dilution) errors or the temperature "excursion in shipment or storage" meant the product was deemed "not suitable". The wording confirms the product had been "administered". So although the IPD arose on or before 7 days after dose 2, the participants would have met the evaluable efficacy endpoint, but were deemed not to be valid and so excluded.
It is rather important to have the data disclosed on IPDs.
Can you link to the doc you're referring to? I have the 2017 Efficacy Guidance for Industry, and it does not contain a 2.7.3.2.1.2.1, and is there a version specific to Pfizer?
Hi, These are the links to the docs. See PDF pages 27 and 41 respectively.
Any issues let me know.
https://www.yumpu.com/en/document/read/65941972/red-summary-of-clinical-efficacy
https://www.yumpu.com/en/document/read/65941945/clinical-review-memo-august-23-2021-comirnaty
I'm grateful for these documents. I am making copies now.
"OMG, she died. Must have been the temperature."
It's curious how often this happens in such a lopsided way in their trials and nobody is around to check and confirm.
TBH even if they just caught Covid, they can go back scrutinise the administration data and say, Aha! Here is the issue, wrong dose etc etc we must exclude for IPD.
The thing is, and as you note, in the far far smaller scale trial in kids the IPD rate is 220% higher. This has to be a signal that they are gaming it, how can the IPD be higher:
* Did they learn nothing from the IPD experience in the main trial?
* How can they make way more errors second time around in a smaller trial?
* The storage protocols were relaxed in June 2021 for the product.
It is amiss.
This is an old case from an era when a handful in Congress and DoJ still had teeth and an appetite for public service over corporate clients but the roots of scientific fraud run deep. Many Monsanto chemicals were involved in IBT Labs fraud. Monsanto and Pfizer did M&A merge & divest dance in 2002ish to dump PCB liabilities and "share biotech tech knowledge" Nice folks at J&J were selling asbestos laced baby powder. Can't forget Ecohealth was originally BioPort Labs mired in covert investors and anthrax vaccines. Suspecting scientific fraud in the reporting is as likely as artificial ingredients in Cheez Whiz.
IBT Labs - https://planetwaves.net/contents/faking_it.html
part two. - https://planetwaves.net/contents/ibt_guity.html
2001. BioPort - https://www.salon.com/2001/10/15/anthrax_vaccine/
Current reporting - Whitney Webb https://www.organicconsumers.org/newsletter/stop-madness/whitney-webb-sam-husseini-first-journalists-cover-possible-lab-origins-covid
Did they report the side effects/safety signals in their data? It'd be interesting to see more specifics on exclusions. Is that reported anywhere?
Yes to the first, no to the second (unless I'm missing something in this 81 page document). And the second is a damning no, because as Mathew showed, if even a percentage were excluded for an adverse reaction or COVID-like symptoms/positive test, then this entire study is garbage. 3 kids got COVID from the vaxxed group, 16 from the placebo. 47 were excluded from the vaxxed group, 4 from the placebo. I know I'm just restating the article here now, but it's important that it's completely clear that this is very much in the realm of potential for "fudging the numbers" and to whistle past this in this report should be unacceptable for anyone that's actually being held accountable.
Many people in various industries would be at the very least lectured (up to possibly terminated) for submitting a report like this.
Dr McCullough says that there were no women of child bearing potential in the original Pfizer study. Can someone confirm that? I’d be curious to know what the make up of that group was.
And tomorrow the FDA will not broadly approve the 5-11 group but it will be rolled out anyway. But we all know this. The world must be under a spell. We have completely lost our minds.
Pregnant women are almost always excluded unless they are the target audience. Only a few old people too. When studies are designed the inclusion and exclusion criteria are written to eliminate folks who have a high likelihood of treatment failure or adverse events if possible.
I really don't believe in viruses anymore.
To me, it goes beyond a "belief" in viruses. It is entirely possible that there are microbes that exist that correlate with disease... but conclusively proving causation is near impossible (especially if you have any ethics). Typhoid Mary and the acceptance of asymptomatic carriers turned viral theory from a potential hard science to a statistical shellgame, which articles like this show how easily you can gild the lily in that department.
I suggest looking up Harold Hillman's work. Deceased neurbiologist and expert with electron microscopy. All those visualized bits could be artefacts of the sample preparation process - because (he claimed) no study done to determine effect of chemicals in the process on the various tissues and cell bits.
Sounds like the same thing that Stefan Lanka says.
Thanks.
Note that it is acknowledged now that vaccine efficacy against infections declines over time such that after about 6 months, some reports put it as soon as 4 months, protectiveness against infection is no better than the unvaccinated.
It had been assumed that it would just stop there after the 6 months. But the recent data from the UK suggest the protection gets WORSE than the unvaccinated after this time. However, this has only been intimated at by the way this is being measured, looking at infection rates for vaxxed and unvaxxed since January.
But clearly what needs to be done is to instead count the NUMBER OF INFECTIONS SINCE VACCINATED. This would show clearly that once you get past 6 months or so, you are worse off being vaxxed for protection against infection then being unvaxxed.
This is being judged by infection rates. But is there an actual immunity system measurement that suggests also this is the case? There may indeed be one, and it may have just missed seeing this signal because it did the cut off at 6 months, *assuming* again the drop would not be below the standard baseline of the unvaxxed.
See the image and link to a CDC video here:
Robert Clark
@RGregoryClark
Replying to
@noorchashm
@amobeirne
and 2 others
In this CDC video Fauci acknowledges antibody titers even for vaccine tells us the degree of protection. So why not have everyone get their antibody levels tested? And why can’t they acknowledge prior infection also results in high antibody levels?
https://youtu.be/X2CESL6Ej1M
2:13 PM · Aug 20, 2021·Twitter for iPad
https://twitter.com/RGregoryClark/status/1428782183938920455?s=20
This data is what led the CDC saying booster shots would be needed but notice it is looking at actual antibody levels, not mere numbers of infections rates.
What needs to be done then is go beyond 6 months in this data to see if antibody levels drop *below* the standard baseline of the unvaccinated.
Then we would have two separate pieces of evidence to suggest the vaccine over sufficient time is actually damaging to our immune system.
Note this very strongly suggests the much feared “antibody dependent enhancement”(ADE) is occurring now. It is extremely important to find out if this is happening since all prior attempts to come up with a corona vaccine in animals failed with the animals all dying due to ADE.
Robert Clark
Apropos of very little in this particular post: The Venn diagram type 1/type 2 covid has reminded me to ask a question which has been on my mind for a while... I'm assuming that a lot of vax injuries are ending up in hospital and being classified as covid. Therefore +ve PCR tests must be evident or somehow produced to enable the cover-up. Can someone explain to me how that might be done?
Obviously cranking up CT would work but that metric is not determined on a test-by-test basis
How is there no fever with the first 30 ug dose?