Anyone know what the placebo was? Pharma have a habit of using another vaccine as a placebo and not an inert substance because it obscures safety signals.
Yes, usually they use the vaccine with the antigen removed, which of course is not a true placebo because there's all kinds of garbage in a vaccine besides the antigen. If they did that for these trials, the "placebo" would have LNP's for example. Just no mRNA. We know that LNP's are toxic. There's probably other garbage in these "vaccines" that are toxic as well.
According to Pfizer's NEJM article: "The participants were randomly assigned in a 1:1 ratio to receive two 30-μg intramuscular injections, 21 days apart, of BNT162b2 (0.3 ml volume per dose) or SALINE placebo."
Yes, the placebo was said to be 0.9% normal saline. The strange part is that Pfizer shipped a specific "saline solution" produced by one of their subsidiaries. This was the only saline that was allowed to be used as placebo and diluent of the frozen shipped vaccine vials. If one were to read the 6-Month Report of Adverse Events, there was a significant number of AEs in placebo subjects. Normal saline is regularly given to dehydrated patients in volumes far larger than 0.3 ml with no significant adverse affects. Why did the placebo subjects have any AE at all? The "placebo effect" is just not that large!!
Saline is, however, NOT recommended by regulations, which require "the full product without the active substance" (= true placebo).
For efficacy saline or true placebo should be no issue.
For safety they should have used a split placebo: 50% with saline and 50% with true placebo. For efficacy at "no costs", but for safety allowing to answer questions on safety of the unusual and new excipients. Again, for sensitivity of the safety analyses they could have pooled placebo for the comparison with avtive.
This was another failure of the authorities, namely to not demand a split placebo.
Yes, a split placebo would have been the way to go. That was not done probably because that would have been a test of the toxicity of the LNP carrier itself, which has never been tested. In summary, there has never been a truly placebo-controlled trial of any aspect of the mRNA-LNP class of "vaccines".
I do not agree with your statement "never been a truly placebo-controlled trial", as it is too strong considering these aspects alone.
With respect to efficacy beforehand, the issue saline or true placebo or split placebo would have been "at no costs" for the sponsor.
THE core problem was the lack of true blinding, vulgo double-blind(ing)*. I could not find any convincing argument why they went on to "observer-blinding". THE advantage of double-blinding it that it is cheap and clear-cut. Observer-blinding is complex and expensive, and usually we trust less.
Here, we had many indicators that the "observer-blinding" was broken several times. Not only the article above.
* The term "double-blind" is purely traditional and, as such , wrong or misleading. Everybody involved with a given trial, except those responsible for the packaging, must be blind to the treatment. This covers also monitors, data managers, statisticians, and other people on the sponsor's payroll.
What is your exact interpretation of "observer blinding" in this case, and how it differs from proper double-blinding? Just curious as I think their use of "observer blinding" is very conveniently confusing.
I would agree with you EXCEPT for the key fact that that exact same publication I linked to DID provide the devastating mortality data admitting that the vaccine was equally or more likely to kill people as to save them, even at the height of the pandemic. So I think the claim that they used a non-saline placebo (even if true, it can't be proven) is merely a DISTRACTION from the devastating mortality results, which Pfizer/Moderna will love.
Thanks. I am not disagreeing at all. The data in there however show there is no significant difference in death rates between the vax and placebo ie vax is ‘safe’ which is why I questioned the placebo. The issue as I see it is that the data is based on the process 1 vaccine and that the roll out used a different one (process 2 which we now know is full of DNA contamination). I am absolutely not an expert here but it would seem to me that you can’t use safety data when the trial vaccine is different. The pharma ‘fix’ this time is not their usual fake placebo but a change in the vaccine between the trial group and the roll out.
In the EMA's PAR for Pfizer it says "Placebo: normal saline".
I think Moderna used the Meningitis ACWY vaccine. Edit - they used saline as well so it must have been either J+J or that UK one that used the meningitis ACWY vaccine.
This tactic of using 'expired' vax junk as PLACEBO, also raises the DEATHS closer, in percentage terms, to the Adverse reactions and DEATHS caused by the real crap they pretend is a VACCINE! Mick from Hooe (Unjabbed!)
I'd read somewhere that the AZ placebo group had in fact been given a meningitis jab, maybe it was on news, also. I also read that Pfizer's placebo was "empty" LNPs which on their own very toxic as explained by Italian chemist in this video vimeo.com/807279310 Of course it would be extremely difficult to know the truth but, as already mentioned, previous vaccines have always been testeed against a previous vaccine or use the adjuvants which then reduces any SAEs. Also, they changed definitions on pandemic, herd immunity, vaccine and got away with calling gene therapy injections vaccines, to allow dispensing with all the other safety checks demanded for all other drugs not classed as vaccines.
In fact, AZ initially sponsored 4 active-controlled trials (against the meningococcus vaccine, notorious as being risky and badly tolerated, and submitted these data to EMA for the first marketing authorization.
Then, AZ in fact sponsored a placebo-controlled trial with 10k performed in the USA.
I obviously cannot confirm anything and I know how easy it is to spread misinfo, 40 babies beheaded, for example. I am almost sure I heard it from one of those scientist journalists as they primed us to believe these injections would set us free. Seems AZ has no market in many countries whether due to SAEs or predestined forces who want mRNA to be the future cash cow. Thanks for your input. We get so much conflicting info, by design, we are then left in a situation where we shrug our shoulders and do nothing until we are notified of the next crisis when the cycle starts again.
The placebo-controlled trial of AZ had the ID D8110C00001
start of randomisation 28 August 2020, end of randomisation 25 January 2021, cut-off 5 March 2021, The report was submitted to EMA not before end of December 2021.
A bit too late...
As to my opinion: Vaxzevria does not work*, the VE for ITT, first C19 after exposure was 54,5% with CI 46,5%-61.3%. The lower confidence limit is below the magic 50%.
That VE was even a bit lower for the pooled active controlled trials.
I do not trust any VE that is calculated based those articifial PP populations or delayed onset of counting.
* However, I think that none of the C19 vaccines really works, namely in the sense of clinically relevant benefit.
I’m not sure about the honesty of Pfizer but as stated elsewhere the placebo was reported as saline solution in their trial. AZ was definitely not saline solution. It was meningococcal vaccine MenACWY. Maybe this was not well known but it certainly wasn’t ‘secret’.
Only 1 of 4 trials using saline solution in control group, others using a different vaccine with its own side effects. Standard practice maunufacturers have gotten away with when making vaccines.
Yes, but the post is about the Pfizer trial, which if they (Pfizer) are to be believed used saline solution, so the there is nothing to be gotten away with in this case, so the active placebo argument is moot in this case.
However, it would be interesting to see how the supposed 'inert' Pfizer vaccine placebo compared to 'active' MenACWY placebo used in the AZ trial in regards to AE. If the saline solution had a similar AE profile to MenACWY i'd supect either MenACWY is safer than I think or Pfizer are cooking the books.
If speculating, I also wonder if investigators could tell the difference between products (vax/placebo) when frozen i.e. I'd expect the saline solution would be a frozen block of ice at -90 to -60 Deg C. I'm not sure what an emulsion/suspension of vaccine containing LNP would like like when frozen then thawed. ATAGI* say about the vaccine "Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles." Could this also be a source of un-blinding or did they put empty LNP (+ sucrose?) in the saline solution to mimic the 'anti-freeze' properties (if any) of the vax vials to make them look similar?
Extremely similar (and alarming) patterns as those discussed here for Pfizer are ALSO present in the Moderna clinical trial mortality results: early mortality appeared to favor the vaccine, but after a few months excess deaths started accumulating in the vaccine arm relative to the placebo arm (before the trials were quickly unblinded). Those CONSISTENT results between Pfizer and Moderna are key. Also, just like for Pfizer as discussed in this article, the OLDER age group is where the excess all-cause vaccine deaths relative to placebo occurred in the Moderna trial as well (contrary to popular belief).
Also, don't forget the breakdown of CAUSE OF DEATH between the vaccine and placebo arms, which is also very consistent between the Pfizer and Moderna trials. The fact that "total deaths are similar between vaccine and placebo arms" is dangerously misleading, because the CAUSE OF DEATH breakdown between vaccine and placebo arms is NOT similar. For Pfizer and Moderna combined:
COVID deaths: 2 vaccine vs. 5 placebo (-60%)
non-COVID deaths: 29 vaccine vs. 25 placebo (+16%)
cardiovascular deaths: 16 vaccine vs. 11 placebo (+45%)
Overall: 4 more non-COVID deaths, 3 less COVID deaths (bluntly put, 4 KILLED FOR EVERY 3 SAVED)
I do not think this is quite correct. The Cell paper from Professor Benn in Denmark, who has spent years studying the non-specific effects of vaccination. From her paper analysing the original NEMJ publications, all cause deaths after the mRNA vaccines Pfizer and Moderna taken together is 31/37110 for vaccine vs 30/37083 for placebo ie no difference. There was a fall in covid deaths after vaccination and a balancing rise in cardiovascular deaths, thus leading to no overall change. You pays your money and you takes your choice. These changes did not reach statistical significancel
Exactly what is not correct? Please read the post carefully and substantiate your claim that something is "not correct". My second paragraph essentially says the same thing that you said. Also, "statistical significance" is a deeply flawed and outdated concept that is abused by bad actors to dismiss unwanted and inconvenient results: see this piece from Dr. Sander Greenland, one of the most respectable voices in statistics and epidemiology, and one of the ONLY such voices to admit the serious safety concerns of mRNA vaccines. https://www.jvsmedicscorner.com/Statistics_files/Retire%20statistical%20significance.pdf
This statement in your post "Overall: 4 more non-COVID deaths, 3 less COVID deaths (bluntly put, 4 KILLED FOR EVERY 3 SAVED)" just does not square with the data from Professor Benn's article in Cell which is that the overall all cause mortality for combined mRNA vaccines is the same for the vaccinated and unvaccinated.There is no denominator in your statement which renders it useless. There is actually only a difference of 1 death in over 37000 in each placebo and unvaccinated (Benn). Perhaps you would like to discuss the "deeply flawed and outdated concept" of statistical significance with the authors of the post, who rely heavily and correctly on statistical significance for their arguments
"fraudulent or systematic data manipulation" is indeed a thought one can entertain after looking at this trial. See also this work by Josh Guetzkow & myself, re strangely missing increments.
The issue if the data manager is compromised is that every guarantee we're supposed to have from GCP falls. We need an independent and transparent audit of ICON.
Glad it was worth the time reading it. A few other Trial anomalies listed in this Substack - as I'm sure you noted since. At your disposal if you want to go through that & cross notes.
"Another theoretically possible explanation – if one really wants to stretch the imagination and engage in conspiratorial ideation – would be fraudulent or systematic data manipulation. But let us leave speculations aside for a moment and have a closer look at what the data says about differences between the two arms."
Hat tip setting aside speculation to wade through the numbers so folks like me who assume criminal liars are always lying have your hard work to cite & back it up! Kudos & thanks <3
Tore, thank you for this analysis of these previously hidden data. I have three questions.
1) In your conclusions you state:
"Furthermore, we have seen that prior health status is different between the two arms..."
I believe you meant to say that prior health status is different between the two arms of those who suffered an adverse event. Am I correct? If so, the significant finding here is the increased incidence of adverse events among placebo recipients (15% more according to your calculations). That is indeed indicative of a non-inert placebo or a reassignment from the therapy group to the control (or both). With more adverse events occurring in placebo recipients, as inexplicable as it is, we would expect there to be more in each subgroup categorized by health status, right?
2) Can you please clarify and unpack this a bit more:
"If the healthy people were selected to the vaccine arm, then why are 81 of the cases in the placebo arm people with “No Medical History” while only 56 cases in the vaccine arm are people with no medical history? Surely it should be the other way around if the healthy people were selected to the vaccine arm? And if the placebo was not inert at all, then we would expect similar rates between the two arms, not elevated solely in the placebo arm."
Are you pointing out the paradoxically higher rate of adverse events in people who got the placebo, or are you suggesting that something else is going on here? Why would we expect similar rates if the placebo was "not inert at all"? Wouldn't depend on how toxic the placebo was compared to the vaccine?
3) Did you find anything peculiar about the distribution of SAEs in general (not just the cardiac related ones)?
I am interested in the general question as to why so many placebo recipients developed an SAE (Serious Adverse Event). These SAEs, by definition and description, are serious indeed. Pfizer claimed that 0.5% of placebo recipients, who were generally young and healthy like all participants, suffered a SAE in the initial observational period which lasted an average of only six weeks. This seems unimaginable to me. This finding allowed the investigators and regulators to excuse the 0.6% rate of SAEs in the treatment arm.
I would like to point to the fact that not less than 100 subjects were said to have been randomised but not exposed.
Even with 44k randomised, 100 appears to be a lot. 100 subjects could almost every variable turn into a misleading direction; think of the "only" 38 deaths. And these 100 do not occur in any table (except the disposition) and in almost no listing, at least not in any listing readable for us.
Hence, shifts could have occurred not only between the randomization groups, but, for me more likely, between the vax group and the pool of not exposed subjects.
I would encourage you to take a closer look to the "Randomised but exposed" people. There were in fact 100! As to my opinion far too much, even for 44k randomised.
The point here is: You hardly find these people. The CSR provides nearly no details. The listings are also empty. These cases appear as lost from the earth.
Please consider these 100 cases. They could move almost every variable in a bad direction - or vice versa to neutrality.
"The observed patterns cannot be the result of random occurrence. The only explanation compatible with all the non-random patterns is that the records of vaccine recipients suffering adverse events and death were changed, moving them to the placebo arm after the event."
This is incredible. We're talking CRIMINAL FRAUD here. All corporate officers of Pfizer need to be arrested an prosecuted.
Quote from the contract between Pfizer and the South African Government (p21):
“Purchaser further acknowledges that the long-term effects and efficacy of the Vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known.”
They have put it out there now that there are side effects. Acknowledging the heart damage especially in younger males. Doesn't matter where the contract is. No one should have approved it due to this. Anyone believes they didn't know it at the time isn't in reality. Their stock is rapidly falling, hopefully with ongoing lawsuits there will be accountability. They admit that Paxlovid basically does nothing as well.
I agree with you except for one major thing. While the gold-standard randomized clinical trial results showed that mRNA vaccines were equally or more likely to kill than save people even at the height of the pandemic, the Paxlovid clinical trial had 0 deaths in the Paxlovid group vs. 13 deaths in the placebo group. So the gold-standard clinical trial results show a night-and-day difference between Paxlovid and the worse-than-useless mRNA vaccines. https://www.nejm.org/doi/full/10.1056/nejmoa2118542. But personally, I would much rather use ivermectin and FLCCC protocols than Paxlovid.
When I read their news release it just showed you how ridiculous it was that any of it was EUA approved was really my take from it. There is a new study out showing the added contaminants in Pfizer and Moderna that will hopefully be able to used for criminal liability.
About 6 months ago I read that it is possible that the placebo could have things in it that could cause harm and not contain the control substance. is that true and if so, could that be the thing causing problems for the placebo group?
For all other traditional vaccine trials the placebo is the adjuvants etc not a true placebo but Pfizer trial docs released claim it is saline placebo. While anything is possible it is far easier to juggle the numbers than to rely on patient level placebo contamination adding another wild card to an event they hope to control.
I saw someone above noted Pfizer told a med journal the placebo was saline. They were not under oath. And it could be saline plus whatever was in the jab minus mRNA. Pseudouridine, LNP and whatever else that managed to make its way into the jab. Bacteria. Do they have to disclose that? I wouldn't be shocked if the placebo was everything but the thing they were seeking to test.
My source is Pfizer clinical trial documents released under FOIA lawsuit by ICAN and link to the relevant section as primary source verification. Anything else is possible but a hypothesis needs some better evidence than XYZ would make wonky outcome. Find a whistleblower or contaminated product to devote energy to chasing more than guessing.
Thanks so much for your revealing analysis! I have one little quibble and one question.
1. You write: "the initial death rate during the first 80 days might represent the background death rate". That's likely still too high: apparently there were one or more deaths from vaccination within three weeks.
OK, thanks now I see that. But I still don't understand the issue here. Indeed the totals N(P)+N(V) in that table are ordered from high to low. Apparently, in its final form that table was ordered from most important to least important. That's certainly not by chance, but abnormal or suspect? To me it looks rather common to do, and it takes a few seconds in a spreadsheet. Did I miss something?
Good Post! I was looking long and hard at the person time in this study too. As Tore says, there should be way less person years for the placebo than the vaxxed. But if you look at pfizers 6 month study in the NEJM, they record them as both the same. Is it possible for them to be so stupid? Then we have the report that 2 of the placebo deaths occurred after they had been unblinded and given the juice. But they were still counted as placebo. Does this explain the bump up in deaths occurring at 80-100 days? That's around the time the placebo were getting the juice. Did they share the deaths around to make it look balanced? Were there also deaths in the vax arm in the first few weeks after vax that were eliminated because they occurred before the vax had built up full strength (ie from 1 dose to 7 days after dose 2)?
With all these anomalies the only thing to do is throw your hands in the air and call them out for BS...And it's not like pfizzer hasn't got a history for that.
If I see it correctly then the "bump" around 100 days of the placebo group is only at 100 days after the first placebo shot and not in calendar time. That points more to " sharing the deaths around". Also, the initial deaths shortly after vaccination were not that high (but still too high), see my comment elsewhere.
There could be a simpler explanation. They say they used saline as a placebo but did not. As in so many vaccine trials, they could have used another vaccine, or the « carrier » (LNP’s without RNA)
Anyone know what the placebo was? Pharma have a habit of using another vaccine as a placebo and not an inert substance because it obscures safety signals.
Yes, usually they use the vaccine with the antigen removed, which of course is not a true placebo because there's all kinds of garbage in a vaccine besides the antigen. If they did that for these trials, the "placebo" would have LNP's for example. Just no mRNA. We know that LNP's are toxic. There's probably other garbage in these "vaccines" that are toxic as well.
According to Pfizer's NEJM article: "The participants were randomly assigned in a 1:1 ratio to receive two 30-μg intramuscular injections, 21 days apart, of BNT162b2 (0.3 ml volume per dose) or SALINE placebo."
https://www.nejm.org/doi/full/10.1056/nejmoa2110345
Yes, the placebo was said to be 0.9% normal saline. The strange part is that Pfizer shipped a specific "saline solution" produced by one of their subsidiaries. This was the only saline that was allowed to be used as placebo and diluent of the frozen shipped vaccine vials. If one were to read the 6-Month Report of Adverse Events, there was a significant number of AEs in placebo subjects. Normal saline is regularly given to dehydrated patients in volumes far larger than 0.3 ml with no significant adverse affects. Why did the placebo subjects have any AE at all? The "placebo effect" is just not that large!!
There is little wrong with "saline" as placebo.
Saline is, however, NOT recommended by regulations, which require "the full product without the active substance" (= true placebo).
For efficacy saline or true placebo should be no issue.
For safety they should have used a split placebo: 50% with saline and 50% with true placebo. For efficacy at "no costs", but for safety allowing to answer questions on safety of the unusual and new excipients. Again, for sensitivity of the safety analyses they could have pooled placebo for the comparison with avtive.
This was another failure of the authorities, namely to not demand a split placebo.
Yes, a split placebo would have been the way to go. That was not done probably because that would have been a test of the toxicity of the LNP carrier itself, which has never been tested. In summary, there has never been a truly placebo-controlled trial of any aspect of the mRNA-LNP class of "vaccines".
Makes sense as a strategy to not use LNP placebo. Did they distribute the placebo at the same super cold temperature as the so called Vax?
Do you really think they kept the vax super cold? Even in the remote reaches of Turkey and South Africa?
I do not agree with your statement "never been a truly placebo-controlled trial", as it is too strong considering these aspects alone.
With respect to efficacy beforehand, the issue saline or true placebo or split placebo would have been "at no costs" for the sponsor.
THE core problem was the lack of true blinding, vulgo double-blind(ing)*. I could not find any convincing argument why they went on to "observer-blinding". THE advantage of double-blinding it that it is cheap and clear-cut. Observer-blinding is complex and expensive, and usually we trust less.
Here, we had many indicators that the "observer-blinding" was broken several times. Not only the article above.
* The term "double-blind" is purely traditional and, as such , wrong or misleading. Everybody involved with a given trial, except those responsible for the packaging, must be blind to the treatment. This covers also monitors, data managers, statisticians, and other people on the sponsor's payroll.
What is your exact interpretation of "observer blinding" in this case, and how it differs from proper double-blinding? Just curious as I think their use of "observer blinding" is very conveniently confusing.
I disbelieve anything that comes out of Pfizer. There is 100% conflict of interest.
I would agree with you EXCEPT for the key fact that that exact same publication I linked to DID provide the devastating mortality data admitting that the vaccine was equally or more likely to kill people as to save them, even at the height of the pandemic. So I think the claim that they used a non-saline placebo (even if true, it can't be proven) is merely a DISTRACTION from the devastating mortality results, which Pfizer/Moderna will love.
I am confused. In the link the report states “a favourable safety profile”. What am I missing?
Of course that is their "conclusion", but look at the mortality data which is hidden in the Supplementary Appendix, Table S4: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf
Thanks. I am not disagreeing at all. The data in there however show there is no significant difference in death rates between the vax and placebo ie vax is ‘safe’ which is why I questioned the placebo. The issue as I see it is that the data is based on the process 1 vaccine and that the roll out used a different one (process 2 which we now know is full of DNA contamination). I am absolutely not an expert here but it would seem to me that you can’t use safety data when the trial vaccine is different. The pharma ‘fix’ this time is not their usual fake placebo but a change in the vaccine between the trial group and the roll out.
In the EMA's PAR for Pfizer it says "Placebo: normal saline".
I think Moderna used the Meningitis ACWY vaccine. Edit - they used saline as well so it must have been either J+J or that UK one that used the meningitis ACWY vaccine.
This tactic of using 'expired' vax junk as PLACEBO, also raises the DEATHS closer, in percentage terms, to the Adverse reactions and DEATHS caused by the real crap they pretend is a VACCINE! Mick from Hooe (Unjabbed!)
We have the batch numbers of the 0.9% NaCl Placebo shipped to each Pfizer Clinical Trial site.
Wow, that is quite the allegation.
Thank you!
I'd read somewhere that the AZ placebo group had in fact been given a meningitis jab, maybe it was on news, also. I also read that Pfizer's placebo was "empty" LNPs which on their own very toxic as explained by Italian chemist in this video vimeo.com/807279310 Of course it would be extremely difficult to know the truth but, as already mentioned, previous vaccines have always been testeed against a previous vaccine or use the adjuvants which then reduces any SAEs. Also, they changed definitions on pandemic, herd immunity, vaccine and got away with calling gene therapy injections vaccines, to allow dispensing with all the other safety checks demanded for all other drugs not classed as vaccines.
That is not true.
In fact, AZ initially sponsored 4 active-controlled trials (against the meningococcus vaccine, notorious as being risky and badly tolerated, and submitted these data to EMA for the first marketing authorization.
Then, AZ in fact sponsored a placebo-controlled trial with 10k performed in the USA.
I obviously cannot confirm anything and I know how easy it is to spread misinfo, 40 babies beheaded, for example. I am almost sure I heard it from one of those scientist journalists as they primed us to believe these injections would set us free. Seems AZ has no market in many countries whether due to SAEs or predestined forces who want mRNA to be the future cash cow. Thanks for your input. We get so much conflicting info, by design, we are then left in a situation where we shrug our shoulders and do nothing until we are notified of the next crisis when the cycle starts again.
The placebo-controlled trial of AZ had the ID D8110C00001
start of randomisation 28 August 2020, end of randomisation 25 January 2021, cut-off 5 March 2021, The report was submitted to EMA not before end of December 2021.
A bit too late...
As to my opinion: Vaxzevria does not work*, the VE for ITT, first C19 after exposure was 54,5% with CI 46,5%-61.3%. The lower confidence limit is below the magic 50%.
That VE was even a bit lower for the pooled active controlled trials.
I do not trust any VE that is calculated based those articifial PP populations or delayed onset of counting.
* However, I think that none of the C19 vaccines really works, namely in the sense of clinically relevant benefit.
I’m not sure about the honesty of Pfizer but as stated elsewhere the placebo was reported as saline solution in their trial. AZ was definitely not saline solution. It was meningococcal vaccine MenACWY. Maybe this was not well known but it certainly wasn’t ‘secret’.
https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222-oxford-phase-iii-trials-interim-analysis-results-published-in-the-lancet.html#
Only 1 of 4 trials using saline solution in control group, others using a different vaccine with its own side effects. Standard practice maunufacturers have gotten away with when making vaccines.
Yes, but the post is about the Pfizer trial, which if they (Pfizer) are to be believed used saline solution, so the there is nothing to be gotten away with in this case, so the active placebo argument is moot in this case.
However, it would be interesting to see how the supposed 'inert' Pfizer vaccine placebo compared to 'active' MenACWY placebo used in the AZ trial in regards to AE. If the saline solution had a similar AE profile to MenACWY i'd supect either MenACWY is safer than I think or Pfizer are cooking the books.
If speculating, I also wonder if investigators could tell the difference between products (vax/placebo) when frozen i.e. I'd expect the saline solution would be a frozen block of ice at -90 to -60 Deg C. I'm not sure what an emulsion/suspension of vaccine containing LNP would like like when frozen then thawed. ATAGI* say about the vaccine "Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles." Could this also be a source of un-blinding or did they put empty LNP (+ sucrose?) in the saline solution to mimic the 'anti-freeze' properties (if any) of the vax vials to make them look similar?
* https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125-pi.pdf
A bombshell of an allegation yet carefully researched and presented. Eager to hear the repercussions.
There won't be any.
Extremely similar (and alarming) patterns as those discussed here for Pfizer are ALSO present in the Moderna clinical trial mortality results: early mortality appeared to favor the vaccine, but after a few months excess deaths started accumulating in the vaccine arm relative to the placebo arm (before the trials were quickly unblinded). Those CONSISTENT results between Pfizer and Moderna are key. Also, just like for Pfizer as discussed in this article, the OLDER age group is where the excess all-cause vaccine deaths relative to placebo occurred in the Moderna trial as well (contrary to popular belief).
Also, don't forget the breakdown of CAUSE OF DEATH between the vaccine and placebo arms, which is also very consistent between the Pfizer and Moderna trials. The fact that "total deaths are similar between vaccine and placebo arms" is dangerously misleading, because the CAUSE OF DEATH breakdown between vaccine and placebo arms is NOT similar. For Pfizer and Moderna combined:
COVID deaths: 2 vaccine vs. 5 placebo (-60%)
non-COVID deaths: 29 vaccine vs. 25 placebo (+16%)
cardiovascular deaths: 16 vaccine vs. 11 placebo (+45%)
Overall: 4 more non-COVID deaths, 3 less COVID deaths (bluntly put, 4 KILLED FOR EVERY 3 SAVED)
Pfizer: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf – Table S4
Moderna: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113017/suppl_file/nejmoa2113017_appendix.pdf – Table S26
Summary paper: https://www.cell.com/iscience/fulltext/S2589-0042(23)00810-6
I do not think this is quite correct. The Cell paper from Professor Benn in Denmark, who has spent years studying the non-specific effects of vaccination. From her paper analysing the original NEMJ publications, all cause deaths after the mRNA vaccines Pfizer and Moderna taken together is 31/37110 for vaccine vs 30/37083 for placebo ie no difference. There was a fall in covid deaths after vaccination and a balancing rise in cardiovascular deaths, thus leading to no overall change. You pays your money and you takes your choice. These changes did not reach statistical significancel
Exactly what is not correct? Please read the post carefully and substantiate your claim that something is "not correct". My second paragraph essentially says the same thing that you said. Also, "statistical significance" is a deeply flawed and outdated concept that is abused by bad actors to dismiss unwanted and inconvenient results: see this piece from Dr. Sander Greenland, one of the most respectable voices in statistics and epidemiology, and one of the ONLY such voices to admit the serious safety concerns of mRNA vaccines. https://www.jvsmedicscorner.com/Statistics_files/Retire%20statistical%20significance.pdf
This statement in your post "Overall: 4 more non-COVID deaths, 3 less COVID deaths (bluntly put, 4 KILLED FOR EVERY 3 SAVED)" just does not square with the data from Professor Benn's article in Cell which is that the overall all cause mortality for combined mRNA vaccines is the same for the vaccinated and unvaccinated.There is no denominator in your statement which renders it useless. There is actually only a difference of 1 death in over 37000 in each placebo and unvaccinated (Benn). Perhaps you would like to discuss the "deeply flawed and outdated concept" of statistical significance with the authors of the post, who rely heavily and correctly on statistical significance for their arguments
I read the Pfizer is paying for legal help for FDA. They also share same marketing agency as CDC, plus staff revolving door.
Excellent and important piece, thanks.
"fraudulent or systematic data manipulation" is indeed a thought one can entertain after looking at this trial. See also this work by Josh Guetzkow & myself, re strangely missing increments.
https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-the
The issue if the data manager is compromised is that every guarantee we're supposed to have from GCP falls. We need an independent and transparent audit of ICON.
Excellent analysis, very interesting and damning data! The bigger picture just looks worse and worse...
Glad it was worth the time reading it. A few other Trial anomalies listed in this Substack - as I'm sure you noted since. At your disposal if you want to go through that & cross notes.
In the "related mysteries" category :
https://twitter.com/a_nineties/status/1718198399931924782
R code reproducing the figures provided :
https://twitter.com/canceledmouse/status/1718316230887584067
"Another theoretically possible explanation – if one really wants to stretch the imagination and engage in conspiratorial ideation – would be fraudulent or systematic data manipulation. But let us leave speculations aside for a moment and have a closer look at what the data says about differences between the two arms."
Hat tip setting aside speculation to wade through the numbers so folks like me who assume criminal liars are always lying have your hard work to cite & back it up! Kudos & thanks <3
Agreed. Respectful yet forensic. The very best approach.
Tore, thank you for this analysis of these previously hidden data. I have three questions.
1) In your conclusions you state:
"Furthermore, we have seen that prior health status is different between the two arms..."
I believe you meant to say that prior health status is different between the two arms of those who suffered an adverse event. Am I correct? If so, the significant finding here is the increased incidence of adverse events among placebo recipients (15% more according to your calculations). That is indeed indicative of a non-inert placebo or a reassignment from the therapy group to the control (or both). With more adverse events occurring in placebo recipients, as inexplicable as it is, we would expect there to be more in each subgroup categorized by health status, right?
2) Can you please clarify and unpack this a bit more:
"If the healthy people were selected to the vaccine arm, then why are 81 of the cases in the placebo arm people with “No Medical History” while only 56 cases in the vaccine arm are people with no medical history? Surely it should be the other way around if the healthy people were selected to the vaccine arm? And if the placebo was not inert at all, then we would expect similar rates between the two arms, not elevated solely in the placebo arm."
Are you pointing out the paradoxically higher rate of adverse events in people who got the placebo, or are you suggesting that something else is going on here? Why would we expect similar rates if the placebo was "not inert at all"? Wouldn't depend on how toxic the placebo was compared to the vaccine?
3) Did you find anything peculiar about the distribution of SAEs in general (not just the cardiac related ones)?
I am interested in the general question as to why so many placebo recipients developed an SAE (Serious Adverse Event). These SAEs, by definition and description, are serious indeed. Pfizer claimed that 0.5% of placebo recipients, who were generally young and healthy like all participants, suffered a SAE in the initial observational period which lasted an average of only six weeks. This seems unimaginable to me. This finding allowed the investigators and regulators to excuse the 0.6% rate of SAEs in the treatment arm.
Thank you.
Excellent analysis!
I would like to point to the fact that not less than 100 subjects were said to have been randomised but not exposed.
Even with 44k randomised, 100 appears to be a lot. 100 subjects could almost every variable turn into a misleading direction; think of the "only" 38 deaths. And these 100 do not occur in any table (except the disposition) and in almost no listing, at least not in any listing readable for us.
Hence, shifts could have occurred not only between the randomization groups, but, for me more likely, between the vax group and the pool of not exposed subjects.
Excellent!
I would encourage you to take a closer look to the "Randomised but exposed" people. There were in fact 100! As to my opinion far too much, even for 44k randomised.
The point here is: You hardly find these people. The CSR provides nearly no details. The listings are also empty. These cases appear as lost from the earth.
Please consider these 100 cases. They could move almost every variable in a bad direction - or vice versa to neutrality.
"The observed patterns cannot be the result of random occurrence. The only explanation compatible with all the non-random patterns is that the records of vaccine recipients suffering adverse events and death were changed, moving them to the placebo arm after the event."
This is incredible. We're talking CRIMINAL FRAUD here. All corporate officers of Pfizer need to be arrested an prosecuted.
I don't know if you saw the press release of Pfizer. They admit finally of the serious side affects in this document.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-amends-us-government-paxlovid-supply-agreement-and?utm_source=substack&utm_medium=email
Quote from the contract between Pfizer and the South African Government (p21):
“Purchaser further acknowledges that the long-term effects and efficacy of the Vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known.”
https://s3.documentcloud.org/documents/23941524/south-africa-pfizer-contract.pdf?utm_source=substack&utm_medium=email
They have put it out there now that there are side effects. Acknowledging the heart damage especially in younger males. Doesn't matter where the contract is. No one should have approved it due to this. Anyone believes they didn't know it at the time isn't in reality. Their stock is rapidly falling, hopefully with ongoing lawsuits there will be accountability. They admit that Paxlovid basically does nothing as well.
I agree with you except for one major thing. While the gold-standard randomized clinical trial results showed that mRNA vaccines were equally or more likely to kill than save people even at the height of the pandemic, the Paxlovid clinical trial had 0 deaths in the Paxlovid group vs. 13 deaths in the placebo group. So the gold-standard clinical trial results show a night-and-day difference between Paxlovid and the worse-than-useless mRNA vaccines. https://www.nejm.org/doi/full/10.1056/nejmoa2118542. But personally, I would much rather use ivermectin and FLCCC protocols than Paxlovid.
When I read their news release it just showed you how ridiculous it was that any of it was EUA approved was really my take from it. There is a new study out showing the added contaminants in Pfizer and Moderna that will hopefully be able to used for criminal liability.
https://kirschsubstack.com/p/ok-you-were-right-we-admit-vaccine?r=1qdxoh&utm_campaign=post&utm_medium=web
About 6 months ago I read that it is possible that the placebo could have things in it that could cause harm and not contain the control substance. is that true and if so, could that be the thing causing problems for the placebo group?
For all other traditional vaccine trials the placebo is the adjuvants etc not a true placebo but Pfizer trial docs released claim it is saline placebo. While anything is possible it is far easier to juggle the numbers than to rely on patient level placebo contamination adding another wild card to an event they hope to control.
If they used empty lipid nanoparticles instead of placebo, that could explain a lot. Who knows?
I saw someone above noted Pfizer told a med journal the placebo was saline. They were not under oath. And it could be saline plus whatever was in the jab minus mRNA. Pseudouridine, LNP and whatever else that managed to make its way into the jab. Bacteria. Do they have to disclose that? I wouldn't be shocked if the placebo was everything but the thing they were seeking to test.
My source is Pfizer clinical trial documents released under FOIA lawsuit by ICAN and link to the relevant section as primary source verification. Anything else is possible but a hypothesis needs some better evidence than XYZ would make wonky outcome. Find a whistleblower or contaminated product to devote energy to chasing more than guessing.
https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf
Thanks so much for your revealing analysis! I have one little quibble and one question.
1. You write: "the initial death rate during the first 80 days might represent the background death rate". That's likely still too high: apparently there were one or more deaths from vaccination within three weeks.
In Pfizer's original report, one death in the vaccination group was misreported as withdrawn and thus not counted (unclear if it was counted here). See https://infocheckers.org/wiki/Blog:Pfizer_omitted_at_least_one_vaccine_trial_death
And as also mentioned there, it looks as if one vaccinated who died shortly after (probably due to vaccination) was moved to placebo.
2. "This data represents an ordered sequence (ordered by frequency)" ? What sequence, what frequency? Please clarify.
Frequency is the number of participants, N(P) and N(V). See Figure 6 - this is the data being refered to.
OK, thanks now I see that. But I still don't understand the issue here. Indeed the totals N(P)+N(V) in that table are ordered from high to low. Apparently, in its final form that table was ordered from most important to least important. That's certainly not by chance, but abnormal or suspect? To me it looks rather common to do, and it takes a few seconds in a spreadsheet. Did I miss something?
Good Post! I was looking long and hard at the person time in this study too. As Tore says, there should be way less person years for the placebo than the vaxxed. But if you look at pfizers 6 month study in the NEJM, they record them as both the same. Is it possible for them to be so stupid? Then we have the report that 2 of the placebo deaths occurred after they had been unblinded and given the juice. But they were still counted as placebo. Does this explain the bump up in deaths occurring at 80-100 days? That's around the time the placebo were getting the juice. Did they share the deaths around to make it look balanced? Were there also deaths in the vax arm in the first few weeks after vax that were eliminated because they occurred before the vax had built up full strength (ie from 1 dose to 7 days after dose 2)?
With all these anomalies the only thing to do is throw your hands in the air and call them out for BS...And it's not like pfizzer hasn't got a history for that.
If I see it correctly then the "bump" around 100 days of the placebo group is only at 100 days after the first placebo shot and not in calendar time. That points more to " sharing the deaths around". Also, the initial deaths shortly after vaccination were not that high (but still too high), see my comment elsewhere.
Statistical analysis of official data from Israel: All-cause mortality, stroke, cardiac arrest, PE, GBS, cancer, infant mortality, sarcoidosis.
https://israelab.substack.com/p/index
There could be a simpler explanation. They say they used saline as a placebo but did not. As in so many vaccine trials, they could have used another vaccine, or the « carrier » (LNP’s without RNA)
Another stellar contribution to finding the truth. Thanks so much !