All modern vaccine efficacy research is a sleight of hand.
The "effective" part of "safe and effective" does not mean what you think it does.
Read this. You will be as shocked as I was when I discovered this.
The "effective" part of "safe and effective" does not mean what you think it does.
Read this. You will be as shocked as I was when I discovered this.
Let's take the example of the live polio vaccine used against polio in the developing world.
How is its efficacy defined?
How is its efficacy defined?
You may think that the entire purpose of the vaccine is to reduce polio-type paralysis among children.
That would be common sense.
But that is not at all how efficacy is defined.
That would be common sense.
But that is not at all how efficacy is defined.
Efficacy is defined by causing *paralyzed children* with polio-type paralysis to get negative stool test for type 1 and type 3 wild poliovirus.
The reason it is specifically against type 1 and type 3, but not type 2, is that type 2 poliovirus is the type of polio contained in the vaccine, and it is not expected that the vaccine will give you a negative stool test for its own type of polio.
All modern vaccine efficacy studies of this vaccine exclusively recruit children with "acute flaccid paralysis."
As explained on uptodate.com, accute flaccid paralysis is what used to be known as polio, but was renamed when the vaccine was considered to have eradicated polio.
"While numerous different pathologies can cause damage to anterior horn cells, the classic cause of AFP throughout history was the poliovirus, presenting as poliomyelitis...
"...As polio has neared eradication via vaccination, there has been increasing recognition that other viruses may cause AFP, including enterovirus D68."
uptodate.com
uptodate.com
Let's look at the four efficacy studies of the modern live poliovirus vaccine.
Grassly, 2007: Children in India who developed acute flaccid paralysis between 1997 and 2006 were included.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov
Cases had a positive stool test for type 1 wild poliovirus. “Wild” means it wasn't the poliovirus included in the vaccine itself. Controls were equally paralyzed, but had a negative stool test and were matched to each case by district, age of onset, and date of onset.
Vaccine efficacy was calculated as the likelihood that the paralyzed child would get a negative stool test.
Jenkins, 2008: Children in Nigeria who developed acute flaccid paralysis between 2001 and 2007 were included.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov
From 27,379 cases of paralysis, 16.2% were excluded for insufficient data and 5.4% were excluded because the vaccine virus was found in their stool (raising the obvious question of whether the vaccine caused their paralysis).
From among the remaining cases of paralyzed children, cases were those with at least one positive stool test for type 1 or type 3 wild poliovirus.
Controls were those who tested negative for both wild polioviruses and matched to the cases by region, age of onset, and date of onset.
Vaccine efficacy was calculated as the likelihood that the paralyzed child would get a negative stool test, with separate estimates for the two types of wild poliovirus.
Mahamud, 2014: This study looked at cases of childhood acute flaccid paralysis in Somalia between May and December of 2013.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov
It used two approaches, one was the test-negative design and one was a more traditional type of case-control study. They first defined cases of acute flaccid paralysis, and then separated these into wild poliovirus type 1 cases and nonpolio cases.
For both parts of the study, the wild poliovirus type 1 cases served as cases. In the test-negative portion, the nonpolio cases served as controls. In a second comparison, neighborhood contacts with no symptoms served as the controls.
Vaccine efficacy was calculated in the first comparison as the likelihood the paralyzed child would test negative, and in the second comparison the likelihood the child would be asymptomatic.
Notably, the comparison to neighborhood controls seems at first glance far more reasonable than the comparison to nonpolio paralysis, but this comparison is still specifically with the wild type 1 cases.
Nowhere in the paper, even in the section on neighborhood controls, do they give us any sense whether vaccination is related to a reduced risk of acute flaccid paralysis.
O'Reilly, 2012: Just under 47,000 children in Pakistan and Afghanistan who developed acute flaccid paralysis between 2001 and 2011 were included.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov
Vaccine-derived poliovirus was only found in six children's stool and those children were excluded.
Cases were paralyzed children who tested positive for type 1 or type 3 wild poliovirus and controls were chosen from among the paralyzed children who tested negative, matched to the cases by district, age of onset, and date of onset.
Vaccine efficacy was calculated based on the likelihood of the paralyzed child testing negative.
All four studies considered a vaccine effective in proportion to how well it made a paralyzed child likely to test negative for wild poliovirus.
Only Mahamud, 2014 also included neighborhood asymptomatic controls.
However, even in this comparison, only the likelihood the vaccine protected against type 1 wild poliovirus was calculated. No comparison was made to see if the vaccine made children in the neighborhood any less likely to get paralyzed.
The most bizarre statement found in any methods section of these four papers is found in O'Reilly, 2012:
To calculate vaccine-induced population immunity, children with non-polio acute flaccid paralysis (control children) were assumed to represent a random sample of children in the population of the corresponding age.
Really? A random sample of children from the population has a 100% rate of acute flaccid paralysis???
While it is certainly an important scientific question to see if a vaccine protects against a positive test for the specific pathogen or strain of pathogen it is designed to protect against...
...it is scientific malfeasance to only look at this without looking at whether the intervention causes a reduction in the clinical presentation being targeted.
While there are many other causes of acute flaccid paralysis than type 1 or type 3 wild poliovirus, for example, and while it is interesting to know if the vaccine is effective at reducing those specific causes...
...the design of these four studies allows for the possibility that the vaccine causes paralysis through one of three means:
1) viral competition (making children less likely to get wild poliovirus but more likely to get a different virus that causes paralysis)
2) vaccine side effects (for example, causing Guillain-Barre syndrome)
or 3) antibody-dependent enhancement (perhaps causing a worse infection of nervous tissue, while also causing more effective clearance of the virus from stool).
This is over and above the small percentage of children whose paralysis appears to be directly caused by type 2 vaccine-type poliovirus.
Now, is polio unique?
No. This is HOW IT ALL IS DONE.
No. This is HOW IT ALL IS DONE.
I spent the first year of the COVID vaccines being out saying that COVID is nothing like polio.
I was wrong.
COVID is EXACTLY like polio.
I was wrong.
COVID is EXACTLY like polio.
The model we are looking at here is called a "test-negative case control study."
Mark Lipitsch and others have reviewed this design here:
ncbi.nlm.nih.gov
Mark Lipitsch and others have reviewed this design here:
ncbi.nlm.nih.gov
This design was first used in in 1980 for the pneumococcal vaccine. Its use rapidly increased in the last decade, and since 2011 it has been the design of 90% of vaccine efficacy studies.
The definition of the test-negative design is a design in which “the same clinical case definition is used for enrollment of both cases and controls, and laboratory testing is subsequently used to distinguish which patients were cases and which were controls.”
Notice in this definition that the same clinical case is used to enroll the cases and the controls. In other words, the cases and controls are all cases.
At first glance this may not seem to make sense. How can the cases and controls all be cases?
The key word is clinical.
For enrollment, everyone is equally sick. But for analysis of vaccine efficacy, the clinical picture becomes irrelevant and suddenly we switch to defining a case as someone who tests positive for the pathogen of interest and a control as someone who tests negative.
Hence the design is called the “test negative” design.
Hold up!
Everyone is what?
Everyone is equally sick.
Everyone is what?
Everyone is equally sick.
This is, in fact, how the CDC models *ALL* of the COVID data.
In "The Pandemic of PCR-Negative COVID-Like Illness" I covered an example of this.
chrismasterjohnphd.substack.com
In "The Pandemic of PCR-Negative COVID-Like Illness" I covered an example of this.
chrismasterjohnphd.substack.com
87,904 hospitalizations for COVID-like illness were 57% among the vaccinated and wherein 79% of them tested negative for COVID.
They all met the same clinical case definition — hospitalization for COVID-like illness —
but, in the words of the test-negative definition “laboratory testing [the PCR test] is subsequently used to distinguish which patients were cases [PCR positive] and which were controls [PCR negative].”
Because those who had received an mRNA booster shot were, assuming correlation is causation, 94% effective at causing someone to test negative during the delta-dominant period and 90% effective during the omicron-dominant period...
the authors concluded that they were 90-94% effective against “COVID-19–associated hospitalizations.”
Absolutely no non-scientist in the public will hear this and intuitively grasp that this means the vaccines would give them a roughly equal chance of winding up in the hospital with COVID-like illness but would be highly effective at preventing them from testing positive.
Almost anyone would think that this means if they are exposed to COVID, they are 90-94% likely to stay out of the hospital.
The sleight of hand is this:
When they say the vaccine protects you against "COVID-19-associated hospitalization," you think the operative word is "hospitalization," but the operative phrase is "COVID-19-associated."
You may die of respiratory failure, but you tested negative!
When they say the vaccine protects you against "COVID-19-associated hospitalization," you think the operative word is "hospitalization," but the operative phrase is "COVID-19-associated."
You may die of respiratory failure, but you tested negative!
Now, it is not simply the case-control studies that use the test-negative design.
All of the randomized controlled trials used this design as well.
All of the randomized controlled trials used this design as well.
Every single COVID vaccine trial had you first report that you thought you had COVID, and had a doctor agree, before you got tested.
That is, by design, every person who counted as a positive or negative test was equally sick.
That is, by design, every person who counted as a positive or negative test was equally sick.
In all of the trials, the people with PCR-negative COVID-like illness were purged from the trial reports.
Their coughs, fevers, and other symptoms were completely purged from history. They did not show up in "adverse effects" because they were COVID symptoms, but they did not count as COVID because the PCR test was negative.
Only from the FDA's VBRPAC briefing document from the December 2020 approval of the EUA for the Pfizer vaccine do we have the data on the PCR-negative COVID-like illness, which was never published in the peer-reviewed literature.
As originally pointed out by Peter Doshi, in the 2-month data from the Pfizer trial, there were 3,580 cases of COVID-like illness, 95.3% of which tested negative for COVID.
blogs.bmj.com
blogs.bmj.com
The vaccine only reduced the incidence of COVID-like illness by a relative 9.4% from an absolute 18% to an absolute 16.3%, yet it reduced the likelihood of getting a positive test after one became ill by a relative 95% from an absolute 1.6% to an absolute 0.08%.
This 95% efficacy means the vaccine is 95% effective at giving you a negative test after you become ill.
This COVID-like illness, whether testing positive or negative, was overwhelmingly mild. According to the FDA report, there were only six serious cases of COVID-like illness, only four of which led to hospitalization.
#page=42" target="_blank" rel="noopener" onclick="event.stopPropagation()">fda.gov
#page=42" target="_blank" rel="noopener" onclick="event.stopPropagation()">fda.gov
The six serious cases were spread evenly across the two groups, with three cases in each.
The hospitalizations were spread evenly as well, with two cases in each group.
However, two of the three serious cases in the vaccine group tested negative, while all three in the placebo group tested positive.
Both of the hospitalizations in the vaccine group tested negative, while both of the hospitalizations in the placebo group tested positive.
These numbers are too small for stats, but this is consistent with the vaccine having no effect whatsoever on seriousness or hospitalization, while decreasing the likelihood of a positive test among those seriously ill by 67% and decreasing it among those hospitalized by 100%.
You may wonder what is actually causing PCR-negative COVID.
The only study to look at that was done before the vaccine rollouts, at Rutgers University Hospital in New Jersey, from April to October, 2020.
pubmed.ncbi.nlm.nih.gov
The only study to look at that was done before the vaccine rollouts, at Rutgers University Hospital in New Jersey, from April to October, 2020.
pubmed.ncbi.nlm.nih.gov
It suggests that 44% of PCR-negative patients hospitalized for COVID-like illness have a compelling alternative diagnosis, and in 69% of the remaining 56%, or 39% of the total, it is genuine COVID that has been missed by the PCR test.
In other words, much but not all of it is actually COVID.
The vaccine can create a systemic inflammatory response that gives you a negative viral count in your nose earlier than an unvaccinated person but doesn't reduce the risk of symptoms.
The vaccine can create a systemic inflammatory response that gives you a negative viral count in your nose earlier than an unvaccinated person but doesn't reduce the risk of symptoms.
However, this really misses the point.
Isn't the reason you don't want COVID because you don't want respiratory failure?
Don't you want to not be in the ICU at all?
Isn't the reason you don't want COVID because you don't want respiratory failure?
Don't you want to not be in the ICU at all?
The CDC test-negative case-control study I referenced earlier defined COVID-like illness as COVID-like lung damange on ct scan, respiratory failure, pneumonia, trouble breathing, fever, vomiting, or diarrhea.
If the vaccine doesn't save you from THAT, what good is it?
If the vaccine doesn't save you from THAT, what good is it?
Now recall that this has become the NORMAL and NEARLY UNIVERSAL model for testing vaccine efficacy.
What does this tell you about the vaccine efficacy research community?
What does this tell you about the vaccine efficacy research community?
If you expected your product to protect against the clinical disease, why would you *control for* the clinical disease and define efficacy as a *negative test*?
If you thought you could reduce the severity of the disease, you would control for a positive test and define efficacy as a reduction in the clinical manifestation.
If you thought you could reduce the clinical manifestation *via* reducing the incidence of the disease, you would not control for either, you would look for efficacy against both points in a randomly selected population.
But they don't do any of this.
They have nearly universally converged on a model that *controls for the clinical expression of the disease* and defines efficacy as a *negative test.*
They have nearly universally converged on a model that *controls for the clinical expression of the disease* and defines efficacy as a *negative test.*
The implication is clear and incontrovertible:
None of them think their vaccines work against clinical expression of disease, and they all believe they do work against positive PCR tests!
None of them think their vaccines work against clinical expression of disease, and they all believe they do work against positive PCR tests!
The question is, what is the path to health?
Is it a series of negative tests?
Or does it start with not having paralysis or respiratory failure?
Is it a series of negative tests?
Or does it start with not having paralysis or respiratory failure?
I would argue that "health" is more than the absence of disease. It is preparation for resilience and effectiveness in the face of an evolving landscape of stressors you can expect to face by living an active life as a genuine human.
Yet I think it is also extremely clear that you are not healthy if you are paralyzed as a child or if you are in the ICU with respiratory failure, and it doesn't make you any more healthy to test negative for polio and COVID.
So why has the vaccine efficacy research community lost sight of what seems like basic common sense?
One possibility is the "ivory tower effect."
"an impractical often escapist attitude marked by aloof lack of concern with or interest in practical matters or urgent problems"
merriam-webster.com
"an impractical often escapist attitude marked by aloof lack of concern with or interest in practical matters or urgent problems"
merriam-webster.com
However, this brings to mind the quote from Upton Sinclair,
"It is difficult to get a man to understand something when his salary depends upon his not understanding it."
"It is difficult to get a man to understand something when his salary depends upon his not understanding it."
Most people need to feel authentic and good, and are likely to play as dumb to themselves as they do to others.
So it may simply be that the Upton Sinclair phenomenon reinforces the ivory tower effect, and they are genuinely blind to common sense.
So it may simply be that the Upton Sinclair phenomenon reinforces the ivory tower effect, and they are genuinely blind to common sense.
On the other hand, perhaps some do realize that they are tricking everyone into thinking the vaccines prevent paralysis or respiratory failure using sly language when they really mean they prevent positive PCR tests.
Regardless, this system can clearly be gamed by the pharmaceutical companies, and it clearly has.
In short, the modern model of vaccine efficacy research does not even try to look at whether vaccines prevent diseases.
It assumes that they cannot, and defines efficacy based on tests that have no clear relevance to net health and disease.
It assumes that they cannot, and defines efficacy based on tests that have no clear relevance to net health and disease.
If you want to read more about this, here are some of my articles.
A Brand New Study on PCR-Negative COVID-Like Illness Suggests It is Often... COVID!
chrismasterjohnphd.substack.com
chrismasterjohnphd.substack.com
Explaining the "Hospitalization Paradox"
How a negative PCR test can serve as a marker for systemic inflammation and spike protein toxicity, creating a widely exploited statistical anomaly to make misleading claims about hospitalization.
chrismasterjohnphd.substack.com
How a negative PCR test can serve as a marker for systemic inflammation and spike protein toxicity, creating a widely exploited statistical anomaly to make misleading claims about hospitalization.
chrismasterjohnphd.substack.com
End thread.
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