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?
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.”
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.
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.
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.
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.
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.
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.
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?
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
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.
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.
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.
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?
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.
I really don't believe in viruses anymore.
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?
How is there no fever with the first 30 ug dose?