Thank you for all of this! 🙏💕 The past trials of vaccines already on the childhood vaccination schedule were often not tested against a placebo, but tested against another vaccine. I wonder if Pfizer has defined "placebo" in this trial... And now I'm reading the other comments where you say they defined saline placebo. Barefoot healer might be onto something, what is the concentration of salts in their saline solution....?
There was a story last year that indicated that they were not using a saline solution, but had used another, different kind of vaccine in some of their trials.
Unfortunately, the trials were never completed and hardly lasted long enough. That is how big pharma is able to hide the nastiness of their drugs...fake trials which the FDA never questions.
Sadistic demons. Its not a clinical trial, its a human experimentation with a biopweapon by the evil murderers
"Mengeles From the FDA Mass Murder Advisory Committee Discuss Clinical Trials for Babies: A 17-Month-Old Baby Received a Second Dose Despite Multiple Seizures From the First"
Btw, one of the things I am noticing in the case reports is a number of cases where there is an SAE from Dose 1 & they go ahead with dose 2 anyway. Usually turns out as expected, although sometimes the patient is "successfully rechallenged"
I have noticed this, as well. There seem to be far too many adverse reactions in the placebo group considering all they're getting is salt water.
One aspect that never seems to be discussed, especially by the likes of Pfizer, is the potential cross-reaction these gene therapies have, or could have, with many of the other vaccines that are given to children. Who knows whether or not the placebo group is receiving something the has a negative cross-reaction with ingredients in other childhood vaccines these kids already received?
Did these babies stop their other vaccines during the trial? I doubt it. There is not a month that goes by without an injection it seems during that timeframe on the CDC Schedule, so how would they separate those adverse events from these?
I vaguely remember seeing somewhere an actual account of someone continuing with regular vaccines while in the Pfizer trial. Can't remember offhand though.
Must be true since CDC assures parents they use different arms so it's fine to add mRNA to whatever the other arm got. That certainty can only come from their rigorous trials & peace of mind for parents there's vigilent safety monitoring ongoing! $cience™
"Before recommending COVID-19 vaccination for children, scientists conducted clinical trials. Then, the U.S. Food and Drug Administration (FDA) determined the Pfizer-BioNTech COVID-19 vaccine is safe and effective, and authorized it for emergency use in children.
Ongoing safety monitoring shows that COVID-19 vaccination continues to be safe for children and that the benefits of COVID-19 vaccination outweigh the known and potential risks.
Learn more about the safety of COVID-19 vaccination for children."
6. Children can safely receive other vaccines the same day they receive their COVID-19 vaccine.
Routine vaccination is an important preventive care service that should not be delayed.
If multiple vaccines are given at a single visit, each injection will be given in a different injection site, according to recommendations by age.
Although I suspect there are many bad motives there is perhaps a problem with all these injections that it would be all too evident in a genuine trial against placebo which was the active arm: indeed you might even get “the placebo effect” in the active arm because participants would know that had got something. I doubt whether in most cases a double-blind placebo trial if such a thing were ever to occur would be effective, or that any properly scientific testing of this kind of product is at all possible.
Why haven't I trusted big pharma for the last 3 decades? For the reasons above and more. There is no reason to vaccinate a baby or a child when the drug makers cannot prove that vaccinations are better than not vaccinating. And since they will never tell us what exactly is in any of their drugs, vaccines and mRNA gene therapy injections, I will never use their products...not even baby aspirin which has aluminum listed as an ingredient. I hope I live to see the day when these murderers are hanging from the rafters.
For adults, intramuscular injection of saline solutions cause these same adverse events, see: https://doi.org/10.21203/rs.3.rs-1702797/v1. Figure 1 illustrates a reproducible pattern of adverse events for intramuscular injection of saline solutions in COVID-19 clinical trials for adults.
For infants and toddlers, if the saline solution volume is not proportionally adjusted for the child's body size, they are receiving a proportionally higher dose of saline solution. The model predicts correspondingly higher frequencies of adverse events (see: https://doi.org/10.21203/rs.3.rs-1502384/v1 for reference) in proportion to the higher dose.
I was wondering about saline placebos in general, how safe they are, etc.
I assumed that saline has a markedly less pronounced rate of S/AE's, otherwise they wouldn't have to use meningitis vax for placebo in other vaccine trials.
But even if it has a more significant profile, why would there be such an extreme disparity between the younger people & adults, even accounting for increased dose/body weight or the stronger innate immune system of children. And especially since this pattern doesn't hold true across the board. A few of the AE's were higher in terms of raw #'s in the older groups, just more evenly balanced between V/P in the younger ones.
To me, a big part of the mystery here is the conflicting patterns present. Could be multiple separate things going on. What you're proposing definitely sounds like a credible explanation at least in part for what happened. (Of course, we can't definitively say that Pfizer didn't summarily delete a bunch of vax S/AE's and maybe did a sloppy job of it causing the #'s to look too suspicious.)
For saline controls: pain at the injection site decreases for age 18+, redness and swelling for age 12+, other adverse events lower for age 65+. Otherwise, the saline controls appear to be consistent with some expected variability. The hypothesis that these are saline solutions cannot be rejected. In my opinion, a control that induces these levels of adverse events is not really a control but rather a comparison treatment.
Haven't had time yet to plow through this totally,
but am I getting this right... the new(??) trick is: use rat poison* as the "placebo" and magically, your product looks like the mildest stuff ever?
Well the trick seems not to be that new in principle. I have heard from someone who claimed to be an ex employee of the PEI (Paul Ehrlich Institut in Germany) that they have been giving "placebos" lacking only viral material, but still containing adjuvants, in trials where then e.g. the level of autoimmune problems were declared "not significantly above placebo level".
Using non-inert placebo is an old Pharma tactic. But Pfizer explicitly said here that they were going to use an inert saline placebo. And the proportions of V/P incidence rates for different specific side effects as well as compared between the different age groups does not add up. I was trying to highlight that the numbers seem to be too "all over the place" to be from either saline or a routine adjuvanted saline or empty LNP formulation by itself.
One would need to compare with the onset of the same symptoms against a group that has neither; vaccine or saline. Young kids are always sick from something, there is no need to do anything special for them to exert a multitude of symptoms. Also looking at the time from injection to onset, would yield some information if the two are related...IMHO
I would say that pretty much every injectable drug causes some degree of local & systemic reactions, something you can see in pretty much any trial.
The oddities here are not that there are reactions happening, it is the pattern of the incidence rates between vax/placebo & between different age cohorts.
If the placebo were merely typical childhood experience, then you would expect to see markedly higher rates in the vaccine arm vs the placebo, where you would have the reactions caused by the vaccine plus the background childhood stuff as opposed to the placebo that only gets typical childhood stuff.
As far as time from injection onset, in the FDA docs (linked a the top), it is clearly stated that these are all reactions were within 7 days with a median of 1-2 days post vaccination (page 43).
My understanding is that in vaccine type trials, the placebo is another vaccine - flu or something (a "safe" vaccine, which I've learned are not safe at all) rather than saline.
but Pfizer specifically said they're using a saline placebo
and you shouldn't have divergent rates or imbalance between P/V depending on the age group, even if you were using meningitis vaccine as placebo - why would meng vax be all over the place either?
The best I can offer is the other age groups, particularly the adults, this is why I did the full 6-age-cohort comparison. I started looking at Moderna's #'s, they might have a similar prob...
Yeah exactly right. My understanding is that they are supposed to actually include THEIR definition of "saline placebo" in the reg documents, so the reader knows what the relational context is. Apples to apples or apples to oranges+apples.
We knew about 2/3rds of participants withdrew at various stages, so that would skew the results. And checking the pretrial notes the dosing was indeed like Schrödingers Cat, there but not there at the same time with no way of knowing. Ie goal seeking. Garbage in, garbage out.
Did you find results of the troponin subgroup? I'm guessing they buried that, pun intended.
I raised this question months ago asking WTF, you already know you will be permanently destroying myocardia?
Shameful blatent unblinding to blur any inevitable life changing damage. Expect skeletal defects too as well as cancers, personality disorders and so on. I don't expect some to live very long and many will be quite sickly. Shame on the parents.
"Dependent upon safety and/or immunogenicity data generated during the course of this study, it is possible that dose levels may not be started, may be terminated early, and/or may be added with dose levels below the lowest stated dose."
"Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing
If testing of troponin I levels in individuals who did not receive BNT162b2 indicates that troponin I level could be a reliable indicator of potential subclinical myocarditis, obtaining serum samples for potential troponin I testing during the period of increased risk of clinical myocarditis may help characterize the absence/presence and frequency of subclinical myocarditis. To assess, an additional group of participants will be included: 5 to <12 years: 750 participants randomized 2:1 to receive BNT162b2 10 µg or placebo, and 500 participants 12 to <16 years of age: open-label receipt of BNT162b2 30 µg"
"At the 6-month follow-up visit, all participants will be unblinded. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 as part of the study. Participants who originally received placebo and become eligible for receipt of BNT162b2 or another COVID-19 vaccine according to local or national recommendations prior to the 6 month follow-up visit (Visit 5 or 405) (detailed separately and available in the electronic study reference portal) will have the opportunity to receive BNT162b2 (10 µg or 3 µg) based on age at the time of vaccination."
Response to criticism of recently peer-reviewed paper by Fraiman, Doshi, Wheelan, re: imbalance of harms from Pfizer & Moderna's own vaccine trial data:
A team in the United Kingdom is conducting a trial of a new COVID-19 vaccine (charmingly called ChAdOx1 nCOV-19) and they are comparing it not to a saline injection but to a vaccine against meningitis...
I reached out to the team conducting the UK trial and was told the reason they changed their mind from using a saline injection to using the meningitis vaccine was that saline injections don’t cause a sore arm, which might unwittingly reveal to the volunteers what group they are in. No soreness after the injection? You may have received a placebo, which could alter your behaviour and thus add a nasty variable to explain away the results of the trial.
This official explanation, however, is questionable. Injecting a saline solution into a muscle can be associated with side effects, as many vaccine trials have demonstrated.
Thank you for all of this! 🙏💕 The past trials of vaccines already on the childhood vaccination schedule were often not tested against a placebo, but tested against another vaccine. I wonder if Pfizer has defined "placebo" in this trial... And now I'm reading the other comments where you say they defined saline placebo. Barefoot healer might be onto something, what is the concentration of salts in their saline solution....?
I did not attempt to look into the salinity of their saline lol
😄 right, who would ever think they'd need to!
:))
There was a story last year that indicated that they were not using a saline solution, but had used another, different kind of vaccine in some of their trials.
Unfortunately, the trials were never completed and hardly lasted long enough. That is how big pharma is able to hide the nastiness of their drugs...fake trials which the FDA never questions.
Sadistic demons. Its not a clinical trial, its a human experimentation with a biopweapon by the evil murderers
"Mengeles From the FDA Mass Murder Advisory Committee Discuss Clinical Trials for Babies: A 17-Month-Old Baby Received a Second Dose Despite Multiple Seizures From the First"
https://lionessofjudah.substack.com/p/mengeles-from-the-fda-mass-murder?s=w
yup, now we've reached human placebo experimentation lol :)
Btw, one of the things I am noticing in the case reports is a number of cases where there is an SAE from Dose 1 & they go ahead with dose 2 anyway. Usually turns out as expected, although sometimes the patient is "successfully rechallenged"
I have noticed this, as well. There seem to be far too many adverse reactions in the placebo group considering all they're getting is salt water.
One aspect that never seems to be discussed, especially by the likes of Pfizer, is the potential cross-reaction these gene therapies have, or could have, with many of the other vaccines that are given to children. Who knows whether or not the placebo group is receiving something the has a negative cross-reaction with ingredients in other childhood vaccines these kids already received?
Jessica Rose wrote a response discussing this:
https://jessicar.substack.com/p/on-placebos-either-way-its-evidence
Thank you.
Did these babies stop their other vaccines during the trial? I doubt it. There is not a month that goes by without an injection it seems during that timeframe on the CDC Schedule, so how would they separate those adverse events from these?
I vaguely remember seeing somewhere an actual account of someone continuing with regular vaccines while in the Pfizer trial. Can't remember offhand though.
Must be true since CDC assures parents they use different arms so it's fine to add mRNA to whatever the other arm got. That certainty can only come from their rigorous trials & peace of mind for parents there's vigilent safety monitoring ongoing! $cience™
"Before recommending COVID-19 vaccination for children, scientists conducted clinical trials. Then, the U.S. Food and Drug Administration (FDA) determined the Pfizer-BioNTech COVID-19 vaccine is safe and effective, and authorized it for emergency use in children.
Ongoing safety monitoring shows that COVID-19 vaccination continues to be safe for children and that the benefits of COVID-19 vaccination outweigh the known and potential risks.
Learn more about the safety of COVID-19 vaccination for children."
6. Children can safely receive other vaccines the same day they receive their COVID-19 vaccine.
Routine vaccination is an important preventive care service that should not be delayed.
If multiple vaccines are given at a single visit, each injection will be given in a different injection site, according to recommendations by age.
https://web.archive.org/web/20220415170429/https://www.cdc.gov/vaccines/covid-19/planning/children/6-things-to-know.html
I’m beginning to suspect these aren’t “experimental” vaccines at all. I suspect these dark forces know exactly what they’re doing.
It is perhaps of relevance that prior to Covid there was zero history of vaccines ever having been trialled against placebo:
https://www.icandecide.org/wp-content/uploads/2019/09/ICAN-Reply-1.pdf
https://www.bmj.com/content/365/bmj.l4291/rr-37
Although I suspect there are many bad motives there is perhaps a problem with all these injections that it would be all too evident in a genuine trial against placebo which was the active arm: indeed you might even get “the placebo effect” in the active arm because participants would know that had got something. I doubt whether in most cases a double-blind placebo trial if such a thing were ever to occur would be effective, or that any properly scientific testing of this kind of product is at all possible.
https://www.bmj.com/content/371/bmj.m4924/rr-3
Thanks, good resources!
Why haven't I trusted big pharma for the last 3 decades? For the reasons above and more. There is no reason to vaccinate a baby or a child when the drug makers cannot prove that vaccinations are better than not vaccinating. And since they will never tell us what exactly is in any of their drugs, vaccines and mRNA gene therapy injections, I will never use their products...not even baby aspirin which has aluminum listed as an ingredient. I hope I live to see the day when these murderers are hanging from the rafters.
For adults, intramuscular injection of saline solutions cause these same adverse events, see: https://doi.org/10.21203/rs.3.rs-1702797/v1. Figure 1 illustrates a reproducible pattern of adverse events for intramuscular injection of saline solutions in COVID-19 clinical trials for adults.
For infants and toddlers, if the saline solution volume is not proportionally adjusted for the child's body size, they are receiving a proportionally higher dose of saline solution. The model predicts correspondingly higher frequencies of adverse events (see: https://doi.org/10.21203/rs.3.rs-1502384/v1 for reference) in proportion to the higher dose.
Thanks!!
I was wondering about saline placebos in general, how safe they are, etc.
I assumed that saline has a markedly less pronounced rate of S/AE's, otherwise they wouldn't have to use meningitis vax for placebo in other vaccine trials.
But even if it has a more significant profile, why would there be such an extreme disparity between the younger people & adults, even accounting for increased dose/body weight or the stronger innate immune system of children. And especially since this pattern doesn't hold true across the board. A few of the AE's were higher in terms of raw #'s in the older groups, just more evenly balanced between V/P in the younger ones.
To me, a big part of the mystery here is the conflicting patterns present. Could be multiple separate things going on. What you're proposing definitely sounds like a credible explanation at least in part for what happened. (Of course, we can't definitively say that Pfizer didn't summarily delete a bunch of vax S/AE's and maybe did a sloppy job of it causing the #'s to look too suspicious.)
These studies you linked to are fascinating.
For saline controls: pain at the injection site decreases for age 18+, redness and swelling for age 12+, other adverse events lower for age 65+. Otherwise, the saline controls appear to be consistent with some expected variability. The hypothesis that these are saline solutions cannot be rejected. In my opinion, a control that induces these levels of adverse events is not really a control but rather a comparison treatment.
Haven't had time yet to plow through this totally,
but am I getting this right... the new(??) trick is: use rat poison* as the "placebo" and magically, your product looks like the mildest stuff ever?
Well the trick seems not to be that new in principle. I have heard from someone who claimed to be an ex employee of the PEI (Paul Ehrlich Institut in Germany) that they have been giving "placebos" lacking only viral material, but still containing adjuvants, in trials where then e.g. the level of autoimmune problems were declared "not significantly above placebo level".
* (slight exaggeration)
Using non-inert placebo is an old Pharma tactic. But Pfizer explicitly said here that they were going to use an inert saline placebo. And the proportions of V/P incidence rates for different specific side effects as well as compared between the different age groups does not add up. I was trying to highlight that the numbers seem to be too "all over the place" to be from either saline or a routine adjuvanted saline or empty LNP formulation by itself.
One would need to compare with the onset of the same symptoms against a group that has neither; vaccine or saline. Young kids are always sick from something, there is no need to do anything special for them to exert a multitude of symptoms. Also looking at the time from injection to onset, would yield some information if the two are related...IMHO
Cheers
L.
Thanks :)
I would say that pretty much every injectable drug causes some degree of local & systemic reactions, something you can see in pretty much any trial.
The oddities here are not that there are reactions happening, it is the pattern of the incidence rates between vax/placebo & between different age cohorts.
If the placebo were merely typical childhood experience, then you would expect to see markedly higher rates in the vaccine arm vs the placebo, where you would have the reactions caused by the vaccine plus the background childhood stuff as opposed to the placebo that only gets typical childhood stuff.
As far as time from injection onset, in the FDA docs (linked a the top), it is clearly stated that these are all reactions were within 7 days with a median of 1-2 days post vaccination (page 43).
My understanding is that in vaccine type trials, the placebo is another vaccine - flu or something (a "safe" vaccine, which I've learned are not safe at all) rather than saline.
usually meningitis vax
but Pfizer specifically said they're using a saline placebo
and you shouldn't have divergent rates or imbalance between P/V depending on the age group, even if you were using meningitis vaccine as placebo - why would meng vax be all over the place either?
Wow, I missed that they said saline - ! Thanks.
Meningitis, well. That's the "baseline" for writing off much of the non-placebo symptoms then in other trials?
The best I can offer is the other age groups, particularly the adults, this is why I did the full 6-age-cohort comparison. I started looking at Moderna's #'s, they might have a similar prob...
By definition "saline placebo" just means of or containing salts. That can be lots of things.
Frankly if they did use salted water, then judging by those results it's was prepared at an extremely high solution.
My impression is that there is a specific meaning of the term "saline placebo" in regulatory filings (doesn't mean that there is no wiggle room)
Yeah exactly right. My understanding is that they are supposed to actually include THEIR definition of "saline placebo" in the reg documents, so the reader knows what the relational context is. Apples to apples or apples to oranges+apples.
We knew about 2/3rds of participants withdrew at various stages, so that would skew the results. And checking the pretrial notes the dosing was indeed like Schrödingers Cat, there but not there at the same time with no way of knowing. Ie goal seeking. Garbage in, garbage out.
Did you find results of the troponin subgroup? I'm guessing they buried that, pun intended.
I raised this question months ago asking WTF, you already know you will be permanently destroying myocardia?
Shameful blatent unblinding to blur any inevitable life changing damage. Expect skeletal defects too as well as cancers, personality disorders and so on. I don't expect some to live very long and many will be quite sickly. Shame on the parents.
"Dependent upon safety and/or immunogenicity data generated during the course of this study, it is possible that dose levels may not be started, may be terminated early, and/or may be added with dose levels below the lowest stated dose."
"Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing
If testing of troponin I levels in individuals who did not receive BNT162b2 indicates that troponin I level could be a reliable indicator of potential subclinical myocarditis, obtaining serum samples for potential troponin I testing during the period of increased risk of clinical myocarditis may help characterize the absence/presence and frequency of subclinical myocarditis. To assess, an additional group of participants will be included: 5 to <12 years: 750 participants randomized 2:1 to receive BNT162b2 10 µg or placebo, and 500 participants 12 to <16 years of age: open-label receipt of BNT162b2 30 µg"
"At the 6-month follow-up visit, all participants will be unblinded. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 as part of the study. Participants who originally received placebo and become eligible for receipt of BNT162b2 or another COVID-19 vaccine according to local or national recommendations prior to the 6 month follow-up visit (Visit 5 or 405) (detailed separately and available in the electronic study reference portal) will have the opportunity to receive BNT162b2 (10 µg or 3 µg) based on age at the time of vaccination."
https://clinicaltrials.gov/ct2/show/NCT04816643
Thank you...I will probably spend much of my day wondering what a DoorlessCarp is...lol
yeah, what is a doorless carp exactly?
it is possible that the phenomena is caused by vaccine shedding.
unvaccinated babies could be kept in the same room as vaccinated babies. in a confine environment, shedding is possible.
also as well, shedding from vaccinated nurses could very well skew the result.
SEPT 2022 UPDATE
Thread about unusual placebo SAE trends over time..
https://twitter.com/ClareCraigPath/status/1569958383704313856
**********
Referencing this excellent substack post:
https://philharper.substack.com/p/pfizers-own-data-showed-vaccine-creates
**********
RANDOM LINKS WORTH SHARING
Response to criticism of recently peer-reviewed paper by Fraiman, Doshi, Wheelan, re: imbalance of harms from Pfizer & Moderna's own vaccine trial data:
https://sensiblemed.substack.com/p/why-we-question-the-safety-of-covid
**********
Letter from Doctor: Reasons for Concern About mRNA Vaccines:
https://nakedemperor.substack.com/p/bmj-investigation-are-drug-regulators
**********
Response to Dr. Norman Doidge's 4-part series on understanding vaccine hesitancy. (Don't skip the Comments!)
https://charleseisenstein.substack.com/p/elements-of-refusal
**********
Doctors & Scientists Petition for Public Health Reform (Sept 2022)
https://dc.hillsdale.edu/Academy-for-Science-and-Freedom/The-Ethical-Principles-of-Public-Health/
**********
[FDA VRBPAC & CDC ACIP Advisory Committees]
Vaccine Regulators & Pharma Ties
The Vaccine Conflict - July 2003
By MARK BENJAMIN, UPI Investigations Editor
https://www.upi.com/Odd_News/2003/07/21/UPI-Investigates-The-vaccine-conflict/44221058841736/
**********
Hearing Transcript | June 15, 2000
House of Representatives | Government Reform
CDC & FDA Advisory Committees Approved Rotavirus Vaccine, Despite Conflicts of Interest w Pharma Companies;
Rotavirus Vaccine Eventually Pulled From Market After Multiple Injuries & Deaths in Infants
https://www.govinfo.gov/content/pkg/CHRG-106hhrg73042/html/CHRG-106hhrg73042.htm
https://www.mcgill.ca/oss/article/covid-19-health/placebos-used-vaccine-trials-do-not-please-everyone
A team in the United Kingdom is conducting a trial of a new COVID-19 vaccine (charmingly called ChAdOx1 nCOV-19) and they are comparing it not to a saline injection but to a vaccine against meningitis...
I reached out to the team conducting the UK trial and was told the reason they changed their mind from using a saline injection to using the meningitis vaccine was that saline injections don’t cause a sore arm, which might unwittingly reveal to the volunteers what group they are in. No soreness after the injection? You may have received a placebo, which could alter your behaviour and thus add a nasty variable to explain away the results of the trial.
This official explanation, however, is questionable. Injecting a saline solution into a muscle can be associated with side effects, as many vaccine trials have demonstrated.