Wow! Thanks for a careful examination the Pfizer trials. You reveal irregularities that were ignored. Pfizer followed the money not the science. Thanks for honest, investigative writing.
That was a very well thought through presentation. I have a couple of points of information I'd like to add to the discussion. First is a distinction between SAE's and Symptom Reduction. The primary efficacy endpoints used in the trial measured symptoms. I was very surprised to learn that symptom reduction was used to measure the efficacy of these vaccines and I bet it is a surprise to most people reading this now. There was no measurement of severe adverse events. unless there is a data set Dr. Setty found after the initial release of the data. This is a show stopper because reducing one or two symptoms is not equivalent to a serious adverse event. Please comment on this, Dr. Setty as you may have found data that was not available in the initial trial results made available the night they were released . It was at the beginning of February, 2021.
I did a similar video analysis the night the trial results became available. It was taken down quickly by YouTube. I re-posted it and it slipped through. Everyone said I was wrong for about 4 or 5 months. Then a group from Oxford U did an analysis and got the same Absolute Risk Reduction's and Number Needed to Treat as I did from the Pfizer and the Moderna data to the hundredths digit. I was vindicated! Here is the video. I include it because I put the exact Primary Efficacy Endpoints used in the trials which, as I explained above, is the critical issue here. Here is the video (please take a look): https://www.youtube.com/watch?v=RG7n1ZbDTww&t=848s
The second point is that Dr. Setty very astutely raised the question as to what was in the placebo injection. If it was saline or any other completely inert liquid, no harm done as far as the number of people in the placebo group is concerned who got SAE's (Dr. Setty) or or a symptom reduction (the PEE, me). Well, this was not the case. The trial designers injected a different vaccine formulation as the "placebo" in many of the trials, a MENNINGITIS/SEPTICEMIA VACCINE. When they do something like this, all bets are off. We cannot use the number of SAE's (or symptoms) in the placebo group in any traditional comparitive way. This should have invalidated the trials! Here is the reference: https://theconversation.com/coronavirus-vaccine-why-its-important-to-know-whats-in-the-placebo-146365
This was very dishonest on the part of the trial designers. They were trying to increase the complications in the placebo group and they invalidated the trials. I discovered this after I made the video explaining the "95 % efficacious" claim. Dr. Setty, please comment and thank you for another excellent post.
Reid, thank you for the comments. In my reading of the published results, an "outcome" was a person who presented with a subset of specific symptoms AND a positive PCR test.
A secondary outcome was those two criteria + hospitalization. They calculated a vaccine efficacy of preventing symptomatic infection of 95% and a VE against hospitalization of 90%.
Speaking specifically symptomatic Covid-19 infection, Pfizer only told us, in the published trial results in NEJM of 170 cases, 162 appearing in the placebo group. However in the Briefing Document to the FDA's VRBPAC they let them know that there were 3410 people in the entire trial that met the criteria for clinical Covid but 95% were "unconfirmed". They never told us whether they tested these people. It is only logical that they didn't. Otherwise there would be no reason to bring these "suspected" cases to the FDA's attention.
Of those 3.410, there were more that occurred in the placebo wing, but not significantly. The ratio was 9:8 which would mean that the vaccine's efficacy in preventing symptoms was only about 11%.
The thrust of this article is to highlight that the investigators were, beyond any reasonable doubt, unblinded. Once we can establish this then it becomes clear how they could have used a true saline placebo to exaggerate SAEs in the placebo group, thereby hiding the significant rate of SAEs in the vaccine group (0.6%) as nothing but background rates (0.5% in the placebo arm).
I feel that this is a more powerful argument than stating unequivocally that the placebo was not a true placebo, because we cannot prove that it wasn't. The point is that it could have been, but all bets are off if the investigators knew who was getting what.
As you know, unblinded investigators invalidates the entire trial results and proves fraud. Moreover it gives us a way to explain the astonishingly high VE in preventing symptomatic infection while several months later postmarking data showed that the jab barely stopped infections if at all.
The 95% efficacy was calculated from only 5% of symptomatic people who were tested. Giving the FDA regulators the benefit of the doubt, we would surmise that they assumed that Pfizer tested only 5% of those with Covid symptoms randomly. I don't think that is what happened. I think they selectively tested placebo recipients with PCR to get their numbers up. This is only possible if they were unblinded from the start.
Note that Pfizer never reports how many of those with "suspected" Covid-19 tested negative.
May 4, 2023·edited May 4, 2023Liked by Madhava Setty
Dr. Setty, Did you get a chance to see the video I made/ The Primary Efficacy Endpoints are in there. In it ,I used the 162 positives in the placebo group and 8 in the treated group you cited in the above comment. The Oxford group must have used the same dataset because they got the exact same results as me.
I must conclude that Pfizer and Moderna were up to no good on many fronts. Their trials in all age groups were full of fraud! How could the FDA not discover this? The answer appears to be that the FDA has lost independence/has become completely beholden to the BiG Pharma co.'s
Yes. A nice summary. The point about cherry picking healthy participants is very important. This definitely reduced the incidence of SAEs and made the results less applicable to the real world population, especially those who were urged to take it early on (the old and sick).
I recorded a similar explanation last year. You might find it interesting. I used the Lottery to explain absolute and relative risk:
Excellent! I recommended your comments at Your Local Epidemiologist this past week to several people. I’m not a paid subscriber, so I couldn’t reply to you there. This is superb information, meticulously put together. I’m looking forward to learning more from you!
Kudos.👍🏻👍🏻 Even I—not a numbers gal— got this. I’m going to give this to my husband who is a numbers guy and see what he says. He thinks I’m basically a nut case. Unvaxxed and staying that way. Hubby did stop at one JNJ. No boosters. Thank you!
Wow this is exactly the type of sobering analysis the unhinged debate need.
And I just saw your take on the UK non covid mortality data on youtube - excellent!
I used to follow the UK data in 2021 bc whatever happened there seemed to arrive to us in Scandinavia shortly after, and this non covid mortality has bothered me for a year now. There was a study on the non covid mortality in UK during vaccine rollout, stratified by age and vaccine status, that seemed to indicate that the unvaccinated had a higher non covid death rate in the weeks after the vaccinated of the same age cohort received their vaccinations... That study is not retracted so I assume the results are still valid. I cannot understand why this is still not the medical fraud super scandal of the century...? https://www.researchgate.net/publication/356756711_Latest_statistics_on_England_mortality_data_suggest_systematic_mis-categorisation_of_vaccine_status_and_uncertain_effectiveness_of_Covid-19_vaccination
The UK data is a treasure trove of revelations. You have found the crux of the matter. Fenton et al throws down irrefutable proof that the data has been manipulated, in the sense that unvaccinated mortality included deaths from the once jabbed.
However, in order to be able to apprehend the implications of this maneuver one has to recognize that if you were to examine the dataset as given it proves that the vaccine is causing a dramatic rise in mortality after a few weeks to a few months.
In other words, the vaccine is causing harm or the data has been fudged. It's one or the other.
Thank you for your time in investigating and reporting these events. Informative and explained in a way that most laypeople can understand. I'll be sharing this info. I'll be checking back when I can. Thanks
I have just read the paper by Michels et al. (2023) (https://doi.org/10.56098/ijvtpr.v3i1.85) and they have not talked about this 'deviation thing' except in just one case where the participant took the Moderna vaccine. I have reviewed Thomas et al. (2021) (https://doi.org/10.1056/NEJMoa2110345) and its Figure 1 with supposedly the flow of all the participants. The last pair of bifurcations don't add up:
— There are 1258 participants not accounted for in the treatment arm who neither have discontinued the trial (167, including 11 who "Had protocol deviation") nor entered the follow-up (20334): 21759-20334-167 = 1258.
— There are 583 participants not accounted for in the placebo arm who neither have discontinued the trial (273, including 24 who "Had protocol deviation") nor entered the follow-up (20794): 21650-20794-273 = 583.
Are these numbers just the same you have pointed out (311 and 60) after growing up for some months?
This was in an AZ trial, not mRNA. Is there reason to believe that something similar was done in mRNA trials? Maybe to enable deaths from vaccine reactions to try to show that the Covid vaccine was not more dangerous than the (dangerous) placebo?
It's very common that the placebo in vaccine trials is not a true, saline placebo. However here I am trying to dispense with speculation and go with what everyone can agree upon is valid, which, for the purposes of this discussion is the published Pfizer/BioNTech trial data and protocols.
The FDA and Pfizer both assure us that the placebo was, in fact, saline. I am not challenging this. We have to start some place where everyone can agree in order to move things forward.
Agreed! One of the commenters on Jetelina’s new posts said that she seemed to be stuck in 2021, when we needed a plan for 2023, with a much milder virus, and vaccines the extreme dangers of which are being newly recognized.
I read Moskowitz’ Vaccination and was surprised by the routine dishonesty of vaccine trials. But how could this be changed? The “experts” and scientists have a lot riding on not changing.
I have MS from a reaction to a tetanus booster which caused temporary paralysis of both arms from brachial plexus neuropathy. At three months old, screaming syndrome, vaccine encephalitis, for several days, which caused brachial plexus neuropathy. My newborn was given the hep-B vaccine at birth against my orders: she reacted with screaming syndrome for four days and nights. Brain-damaged, she was still saying two words at 18 months, but when she got the DTaP booster, it erased her only words and she was diagnosed with autism at 20 months old. My father reacted to a flu vaccine with paralysis for the last three years of his life. But what can be done to correct this situation? Vaccines always irritate the immune system into reacting with inflammation, often acute: encephalitis or myocarditis, or chronic: allergic or autoimmune disease. In what direction should we go? Away from vaccines for mild or rare diseases for healthy people? Nosodes?
I am truly very sorry to hear of your situation and that of your child.
How can we change this? Scientific institutions, legislatures and judges can be bought. But the highest court in the land is the court of public opinion. This is where we all have a part to play.
The biggest impediment to progress is not always the medical orthodoxy and their dogmatic position. Often it is extremists in the vaccine-hesitant sphere that unknowingly present straw-man arguments that are easily dismantled. It is important that we stick to what can be known, acknowledge the uncertainty in our position and express ourselves coherently and rationally to those who are ready to hear another perspective.
I just read the article on YLE about the meeting the other day and also read the comments. A woman called Sarah put up two repeated comments asking what the biological mechanism was for reactions like stroke or myocarditis. At the end she said it would benefit society if more research were done on this. Then there were two good comments by Baydog. As I was reading, these all disappeared. After a few minutes, the one by Sarah came back, but without the last sentence. At that time, the two by Baydog were still down. The comments were decorously expressed. It may be good to know that that site censors opposing viewpoints.
I first noticed comments by you last week, on the two most recent posts on sudden deaths and organizations promoting what she calls disinformation. Last night I looked at the comments again, and your long comments on both were not there. One on the Covid vaccine’s not being sterilizing was still there. I just looked again, and many of your excellent comments were there again.
Several of your comments at YLE seemvto have been taken down at least temporarily. I screenshotted several of them: I hope it was all of them. They were very interesting and intelligent; it would be a shame if they were taken down for good.
This document is without a doubt, the most coherent, concise and convincing single dose red pill I’ve ever had the pleasure to read.
Thank you for the excellent work. I look forward to all of your content, present and future.
Wow! Thanks for a careful examination the Pfizer trials. You reveal irregularities that were ignored. Pfizer followed the money not the science. Thanks for honest, investigative writing.
That was a very well thought through presentation. I have a couple of points of information I'd like to add to the discussion. First is a distinction between SAE's and Symptom Reduction. The primary efficacy endpoints used in the trial measured symptoms. I was very surprised to learn that symptom reduction was used to measure the efficacy of these vaccines and I bet it is a surprise to most people reading this now. There was no measurement of severe adverse events. unless there is a data set Dr. Setty found after the initial release of the data. This is a show stopper because reducing one or two symptoms is not equivalent to a serious adverse event. Please comment on this, Dr. Setty as you may have found data that was not available in the initial trial results made available the night they were released . It was at the beginning of February, 2021.
I did a similar video analysis the night the trial results became available. It was taken down quickly by YouTube. I re-posted it and it slipped through. Everyone said I was wrong for about 4 or 5 months. Then a group from Oxford U did an analysis and got the same Absolute Risk Reduction's and Number Needed to Treat as I did from the Pfizer and the Moderna data to the hundredths digit. I was vindicated! Here is the video. I include it because I put the exact Primary Efficacy Endpoints used in the trials which, as I explained above, is the critical issue here. Here is the video (please take a look): https://www.youtube.com/watch?v=RG7n1ZbDTww&t=848s
The second point is that Dr. Setty very astutely raised the question as to what was in the placebo injection. If it was saline or any other completely inert liquid, no harm done as far as the number of people in the placebo group is concerned who got SAE's (Dr. Setty) or or a symptom reduction (the PEE, me). Well, this was not the case. The trial designers injected a different vaccine formulation as the "placebo" in many of the trials, a MENNINGITIS/SEPTICEMIA VACCINE. When they do something like this, all bets are off. We cannot use the number of SAE's (or symptoms) in the placebo group in any traditional comparitive way. This should have invalidated the trials! Here is the reference: https://theconversation.com/coronavirus-vaccine-why-its-important-to-know-whats-in-the-placebo-146365
This was very dishonest on the part of the trial designers. They were trying to increase the complications in the placebo group and they invalidated the trials. I discovered this after I made the video explaining the "95 % efficacious" claim. Dr. Setty, please comment and thank you for another excellent post.
Reid, thank you for the comments. In my reading of the published results, an "outcome" was a person who presented with a subset of specific symptoms AND a positive PCR test.
A secondary outcome was those two criteria + hospitalization. They calculated a vaccine efficacy of preventing symptomatic infection of 95% and a VE against hospitalization of 90%.
Speaking specifically symptomatic Covid-19 infection, Pfizer only told us, in the published trial results in NEJM of 170 cases, 162 appearing in the placebo group. However in the Briefing Document to the FDA's VRBPAC they let them know that there were 3410 people in the entire trial that met the criteria for clinical Covid but 95% were "unconfirmed". They never told us whether they tested these people. It is only logical that they didn't. Otherwise there would be no reason to bring these "suspected" cases to the FDA's attention.
Of those 3.410, there were more that occurred in the placebo wing, but not significantly. The ratio was 9:8 which would mean that the vaccine's efficacy in preventing symptoms was only about 11%.
The thrust of this article is to highlight that the investigators were, beyond any reasonable doubt, unblinded. Once we can establish this then it becomes clear how they could have used a true saline placebo to exaggerate SAEs in the placebo group, thereby hiding the significant rate of SAEs in the vaccine group (0.6%) as nothing but background rates (0.5% in the placebo arm).
I feel that this is a more powerful argument than stating unequivocally that the placebo was not a true placebo, because we cannot prove that it wasn't. The point is that it could have been, but all bets are off if the investigators knew who was getting what.
As you know, unblinded investigators invalidates the entire trial results and proves fraud. Moreover it gives us a way to explain the astonishingly high VE in preventing symptomatic infection while several months later postmarking data showed that the jab barely stopped infections if at all.
The 95% efficacy was calculated from only 5% of symptomatic people who were tested. Giving the FDA regulators the benefit of the doubt, we would surmise that they assumed that Pfizer tested only 5% of those with Covid symptoms randomly. I don't think that is what happened. I think they selectively tested placebo recipients with PCR to get their numbers up. This is only possible if they were unblinded from the start.
Note that Pfizer never reports how many of those with "suspected" Covid-19 tested negative.
Dr. Setty, Did you get a chance to see the video I made/ The Primary Efficacy Endpoints are in there. In it ,I used the 162 positives in the placebo group and 8 in the treated group you cited in the above comment. The Oxford group must have used the same dataset because they got the exact same results as me.
I must conclude that Pfizer and Moderna were up to no good on many fronts. Their trials in all age groups were full of fraud! How could the FDA not discover this? The answer appears to be that the FDA has lost independence/has become completely beholden to the BiG Pharma co.'s
Yes. A nice summary. The point about cherry picking healthy participants is very important. This definitely reduced the incidence of SAEs and made the results less applicable to the real world population, especially those who were urged to take it early on (the old and sick).
I recorded a similar explanation last year. You might find it interesting. I used the Lottery to explain absolute and relative risk:
https://www.youtube.com/watch?v=4kf5VK0djBY&t=2495s
Excellent! I recommended your comments at Your Local Epidemiologist this past week to several people. I’m not a paid subscriber, so I couldn’t reply to you there. This is superb information, meticulously put together. I’m looking forward to learning more from you!
Thank you for your curiosity and support. I do hope we can all come together in our understanding of this complicated topic.
Kudos.👍🏻👍🏻 Even I—not a numbers gal— got this. I’m going to give this to my husband who is a numbers guy and see what he says. He thinks I’m basically a nut case. Unvaxxed and staying that way. Hubby did stop at one JNJ. No boosters. Thank you!
Wow this is exactly the type of sobering analysis the unhinged debate need.
And I just saw your take on the UK non covid mortality data on youtube - excellent!
I used to follow the UK data in 2021 bc whatever happened there seemed to arrive to us in Scandinavia shortly after, and this non covid mortality has bothered me for a year now. There was a study on the non covid mortality in UK during vaccine rollout, stratified by age and vaccine status, that seemed to indicate that the unvaccinated had a higher non covid death rate in the weeks after the vaccinated of the same age cohort received their vaccinations... That study is not retracted so I assume the results are still valid. I cannot understand why this is still not the medical fraud super scandal of the century...? https://www.researchgate.net/publication/356756711_Latest_statistics_on_England_mortality_data_suggest_systematic_mis-categorisation_of_vaccine_status_and_uncertain_effectiveness_of_Covid-19_vaccination
The UK data is a treasure trove of revelations. You have found the crux of the matter. Fenton et al throws down irrefutable proof that the data has been manipulated, in the sense that unvaccinated mortality included deaths from the once jabbed.
However, in order to be able to apprehend the implications of this maneuver one has to recognize that if you were to examine the dataset as given it proves that the vaccine is causing a dramatic rise in mortality after a few weeks to a few months.
In other words, the vaccine is causing harm or the data has been fudged. It's one or the other.
Thank you for your time in investigating and reporting these events. Informative and explained in a way that most laypeople can understand. I'll be sharing this info. I'll be checking back when I can. Thanks
I have just read the paper by Michels et al. (2023) (https://doi.org/10.56098/ijvtpr.v3i1.85) and they have not talked about this 'deviation thing' except in just one case where the participant took the Moderna vaccine. I have reviewed Thomas et al. (2021) (https://doi.org/10.1056/NEJMoa2110345) and its Figure 1 with supposedly the flow of all the participants. The last pair of bifurcations don't add up:
— There are 1258 participants not accounted for in the treatment arm who neither have discontinued the trial (167, including 11 who "Had protocol deviation") nor entered the follow-up (20334): 21759-20334-167 = 1258.
— There are 583 participants not accounted for in the placebo arm who neither have discontinued the trial (273, including 24 who "Had protocol deviation") nor entered the follow-up (20794): 21650-20794-273 = 583.
Are these numbers just the same you have pointed out (311 and 60) after growing up for some months?
Excellent article. I will share it widely.
When you said that it may not be correct that volunteers in the placebo group in the vaccine trials received saline solution, I remembered that the Brazilian Joao Pedro Feitosa in the AZ trials died. It was said that he was in the placebo group, but also that he received a meningitis vaccine as a “placebo,” because it was already “known” to be safe. In reality, the meningitis vaccines have never veen safe and have caused many deaths. https://www.washingtonpost.com/world/the_americas/coronavirus-oxford-astrazeneca-vaccine-trial-death/2020/10/21/3f5bedac-13c0-11eb-ad6f-36c93e6e94fb_story.html?outputType=amp
This was in an AZ trial, not mRNA. Is there reason to believe that something similar was done in mRNA trials? Maybe to enable deaths from vaccine reactions to try to show that the Covid vaccine was not more dangerous than the (dangerous) placebo?
It's very common that the placebo in vaccine trials is not a true, saline placebo. However here I am trying to dispense with speculation and go with what everyone can agree upon is valid, which, for the purposes of this discussion is the published Pfizer/BioNTech trial data and protocols.
The FDA and Pfizer both assure us that the placebo was, in fact, saline. I am not challenging this. We have to start some place where everyone can agree in order to move things forward.
Agreed! One of the commenters on Jetelina’s new posts said that she seemed to be stuck in 2021, when we needed a plan for 2023, with a much milder virus, and vaccines the extreme dangers of which are being newly recognized.
I read Moskowitz’ Vaccination and was surprised by the routine dishonesty of vaccine trials. But how could this be changed? The “experts” and scientists have a lot riding on not changing.
I have MS from a reaction to a tetanus booster which caused temporary paralysis of both arms from brachial plexus neuropathy. At three months old, screaming syndrome, vaccine encephalitis, for several days, which caused brachial plexus neuropathy. My newborn was given the hep-B vaccine at birth against my orders: she reacted with screaming syndrome for four days and nights. Brain-damaged, she was still saying two words at 18 months, but when she got the DTaP booster, it erased her only words and she was diagnosed with autism at 20 months old. My father reacted to a flu vaccine with paralysis for the last three years of his life. But what can be done to correct this situation? Vaccines always irritate the immune system into reacting with inflammation, often acute: encephalitis or myocarditis, or chronic: allergic or autoimmune disease. In what direction should we go? Away from vaccines for mild or rare diseases for healthy people? Nosodes?
I am truly very sorry to hear of your situation and that of your child.
How can we change this? Scientific institutions, legislatures and judges can be bought. But the highest court in the land is the court of public opinion. This is where we all have a part to play.
The biggest impediment to progress is not always the medical orthodoxy and their dogmatic position. Often it is extremists in the vaccine-hesitant sphere that unknowingly present straw-man arguments that are easily dismantled. It is important that we stick to what can be known, acknowledge the uncertainty in our position and express ourselves coherently and rationally to those who are ready to hear another perspective.
I just read the article on YLE about the meeting the other day and also read the comments. A woman called Sarah put up two repeated comments asking what the biological mechanism was for reactions like stroke or myocarditis. At the end she said it would benefit society if more research were done on this. Then there were two good comments by Baydog. As I was reading, these all disappeared. After a few minutes, the one by Sarah came back, but without the last sentence. At that time, the two by Baydog were still down. The comments were decorously expressed. It may be good to know that that site censors opposing viewpoints.
I first noticed comments by you last week, on the two most recent posts on sudden deaths and organizations promoting what she calls disinformation. Last night I looked at the comments again, and your long comments on both were not there. One on the Covid vaccine’s not being sterilizing was still there. I just looked again, and many of your excellent comments were there again.
Several of your comments at YLE seemvto have been taken down at least temporarily. I screenshotted several of them: I hope it was all of them. They were very interesting and intelligent; it would be a shame if they were taken down for good.
Really? Do you remember on which posts?