Statistical Fraud in the FDA Vaccine Approval Process

The Pfizer vaccine is on a fast track for FDA approval, hearings possible today according to the NYTimes. I suspect the political pressures are enormous. Still, how can approval be possible when the safety record of this vaccine is far worse than any vaccine in the past, including many that were pulled from the market?

Efficacy

Part of the answer is that CDC is not reporting the statistic most relevant to measuring efficacy. That is: Vaccination status of COVID patients. How many of the new infections and new deaths are in vaccinated individuals, and how many in unvaccinated? Of course, this information is known in CDC databases; it is scandalous that the numbers are not being made public. I do not know if they are being provided to FDA. Israel is more honest, and numbers from there are not encouraging.

Likewise, data about transmissibility, comparing vaccinated and unvaccinated populations, are not being reported, and were not part of the clinical trials last fall.

Safety

There are several systems for reporting vaccine reactions, including deaths, but the only one available to the public is VAERS. It is incomplete, because it relies on voluntary reporting, there is no incentive to report to VAERS, and it is a cumbersome process.

We may compare reports of the COVID vaccines to past years, when there were also hundreds of millions of vaccinations, including annual flu shots and childhood vaccine schedules. The comparison is dramatic.

There were more than twice as many deaths related to the COVID vaccines this year as the sum total of all vaccine deaths in the 30-year history of VAERS.

Given this safety record, how is there any possibility of approval? Here is where the statistical fraud comes in. [I am grateful to have been alerted to this situation by Matthew Crawford]

The safety criterion they have chosen is an obscure computation called PRR for Proportional Reporting Ratio. As the name implies,  it is based on RATIOS of different event types and is utterly blind to the ABSOLUTE RATE of such events.

PRR measures the distribution of different kinds of adverse events, e.g. blood clots, heart attacks, and deaths. If those ratios are severely out of line with the great variety of vaccine reactions in the past, PRR would detect that. For example, if the new vaccines caused an extraordinary risk of myocarditis, but everything else was low, then PRR would flag that. But if myocarditis was just one risk among many that have been reported from past vaccines, then PRR would not pick that up.

The real scandal is that PRR is blind to the absolute risk numbers. PRR is defined in such a way as to look for unusual PATTERNS of adverse events, but it is completely insensitive to unusual RATES of adverse events. Of course, it is the rates and not the patterns that are of primary concern, and the PRR is designed NOT to reflect that.

For example, suppose we have 2 vaccines:  

Vaccine A has 1 reported death per million vaccinations, 3 reported heart attacks per million, and 20 reported headaches per million.

Vaccine B has 1 reported death per hundred vaccinations, 3 reported heart attacks per hundred, and 20 reported headaches per hundred.

Vaccine A is quite safe, and vaccine B is extremely dangerous. And yet the formula for PRR will produce the same result for vaccine A and B!

Clearly, PRR is not an appropriate criterion for evaluating safety of any particular vaccine. Someone has arranged to cook the books.

36 thoughts on “Statistical Fraud in the FDA Vaccine Approval Process

  1. Hi Josh

    What would you consider to be the safest vaccine at the moment? My family is about to get it for the first time and we age from 15 to 55.

    Thanks!

    Cheers

    Toby

  2. I don’t know if you are trolling or just misguided, but you linked to Matthew Crawford whose blog contains obviously false statements like “over 100,000 Americans have been killed by the experimental vaccines”, so probably the latter.

      • Classic lack of critical thinking that is so sad to see over and over again. Good response Josh. The only idea that matters, “logan” is the idea we are considering and challenging, or supporting – ON ITS MERITS.

        Stop the distracting side issues and emotional attacks. What is going on currently is outright medical fraud. I can support that in 10 more ways beyond Josh’s article here.

  3. I don’t know enough of this topic to understand or to reconcile with
    https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
    Initial points of note to me are
    1. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.
    2. ALL deaths on VAERs is above 12000 of which 6,789 are labeled as covid., Therefore the NON covid reporting seems like a huge increase compared to previous years. Isn’t the NON covid reporting also more than twice as much as the sum total of all vaccine deaths in the 30-year history of VAERS? If approximately so, then the simplist explanation may be that with reporting rates have changed due to environment of increased scrutiny.

  4. Say, a painter 100 old houses a year, and 10 of those houses develop plumbing issues within 1 year of the job. If the norm is 10 year per non painted houses, then you can’t blame the painter. It is paranoia to blame the painter for the 10 plumbing leaks, mainly because you do not have a mechanism (in my eyes), but also need a relative ratio out of proportion to the norm.

    As far as blood clotting goes, I have revisited the proposed mechanism. One study proved and described the exact amino acid mutation on the platelets that allow the antibodies to attach to the platelets-fortunately very rare, and there is a test. The other paper and experiment proved that non optimized batched of the dna technology, impossible for the mrna technology, could be mis-cut in the nuclease at the wrong places around the intron by spliceosomes, resulting in an untethered spike protein presented on the mhc1 complex, soluble spike proteins, that attach to the endothelial. To be affected, you would need to get the batch, have a genetic susceptibility to this phenomena, have a really good hair trigger immune system like a young fertile female, have a certain sleeping position for the type of blood clots we are seeing, and not be on baby aspirin or any other blood thinners (so goes their hypothesis). This would explain why more blots in dna vaccines than mRNA , and why AstraZeneca is 10x worse than the Jansen jab.

    Old technology vaccines are more danger for two reasons: 1. Because they don’t train the innate arm, they risk antibody dependent enhancement. 2. They lack adjuvants, because when you get into the cell, the cell sends out interferon distress calls to wake up all parts of the immune system.

    This extra training is why the mrna vaccine is 95 percent effective, when the typical flu vaccine is only 45 percent effective. The media is misreporting and skewing the events in their blogs that they pass off as news. According to the world o meter numbers, deaths from the coronavirus was 20 less in the vaccinated population v. the unvaccinated population from May to August, during the delta variant. This is exactly 95 percent. the several months leading up to may 1, vaccination deaths were a whooping 1500 times greater in the unvacinated than the vaccinated, according to the worldometer numbers.

    If you go to vaers, they talk about a 10 percent death rate, for example. This means 10 percent of the reports, not 10 percent of the number of shots or people fully vaccinated. Political leaning and scare peddlers are lifting these sentences out of context to purposely, or unwittingly, scare others.

    There are valid reasons to not get vaccinated, so consult with your doctor. What I have found is that the people with a 20 percent chance of hospitalization and a tube down their throat, are the first no want the shot. I think the valid political reasons not to get the shot are outweighed by altruistic reasons for getting the shot. This is also true for younger healthier people.

    Yes, during the first 2 days, the viral load in the upper sinus should not differ between the vaccinated. But after 2 days, the chance of spreading is far less.

    This is why sinus sprays and eye dropper administed nasal antivirals/antibactera could be added to the nih recommendations. Look into how effected every nasal spray study have turned out. The results are startling. Unfortunately, bigger companies are not interested because there are a ton of viral inactivators that are cheap: chloraseptic and 1:20 thinned betadine, just to name 2, among possibly 100s.

    I awoke on Thanksgiving 2020 with no smell or ability to taste (no mint or capsaicin sensitivity, I drank a half a bottle of hotsauce to prove to wife), which has never happed before. I also had a sore throat. I unloaded my armory of science credible oral antiviral pills (including quercetin, massive amount of zinc, ivermectin at 4x dose), however it was soaking my olfactory bulb with a viral inactivation and anti-inflammatory solution (while upsidedown on bed) for 10 minutes, every 3 hours. That partly gave me some taste from the evening, and knocked out the sore throat. I got 90 percent of my taste back by the next morning. I didn’t have any sinus congestion at any point. I knocked it back, but I didn’t let it go more than a few hour before boiling it out of the upper respiratory track. I also hold the medicine on each tonsil, nasal administerated with eye dropper 1/5 ml, which knocks out the sore throats in a matter of hours. My solution works on strep too, as it is a very, very broad spectrum solution that took me 2006 to 2008 to get the essentials, and to 2013 before I feel it was perfected after a suggestion by a geologist.

    However, I am horrified that people are choosing early treatment over the vaccine, proving democrats correct. False dichotomy. In my book you are either working toward a solution, or against solutions to the problem.

    Yeah, the early treatments will work against future invaders, while the vax is a temporary fix. No virus has been eradicated in history that has animals for a reserve specie. … BTW Vincent Racaniello, ferrets are people too! I made a tee shirt saying so before the pandemic and genocide in Holland.

    • The analogy to painting a house and the expected background rate of plumbing problems is completely off-target. (1) The rate of adverse effects after vaccination is much higher than background. (2) There is a plausible mechanism connecting blood clots to the spike protein, unlike house painting and house plumbing.

      The statistics on vaccine injury have been doctored this last year for the mRNA vaccines. CDC has cooked the books to make the vaccines look safe and effective, when in fact they are neither. Vaccine-related hospitalizations and deaths have been re-classified as “covid-related”, and the status of vaccinated people who die or are hospitalized has been changed to “unvaccinated”.

      But even taking VAERS data at face value, the mRNA vaccines have been a public health disaster.

  5. I just read the Isreal article, which focuses on ifr. No immunologist or immunology 101 student would expect any vaccine to prevent infection, because it takes 2 days to recognize and ramp up antibodies for a typical vaccinated person. Shorter for young people, longer for the old.

    I never expected old people with dead thymuses to every have much vaccine response. I was wrong.

    Death rate of the vaccinated v. unvaxed is all that really matters. And we would expect the gap to close as the spike mutates more. A recoded booster shot will be needed at some point.
    Also, don’t forget that after months, the bcells with the antibodies go to sleep and the numbers pair down, (else your blood would be thick with antibody protiens from every infection since birth) which should make the time to recognize and respond longer than if you were vaccinated 3 months ago. This should be especially true with not so bright T cells, senile old guys, because of a dead thymus (the training center boot camp for Tcell selection), due to being over age 70. We should expect a higher death rate with them, even vaccinated, as time passes after the shot. Fortunately, not as bad as I predicted for older people.

    This is why early treatment is still important even after you get the shot.

  6. Josh describes Israel’s results as discouraging. Israel’s results seem to be encouraging with respect to the vaccinated compared to the unvaccinated. The unvaccinated appear to face a much greater chance of death or hospitalization.

    “The rate of serious cases among unvaccinated people over age 60 (178.7 per 100,000) was nine times more than the rate among fully vaccinated people of the same age category, and the rate of serious cases among unvaccinated people in the under-60 crowd (3.2 per 100,000) was a little more than double the rate among vaccinated people in that age bracket.”

    “The bad news, doctors say, is that half of Israel’s seriously ill patients who are currently hospitalized were fully vaccinated at least five months ago. Most of them are over 60 years old and have comorbidities. The seriously ill patients who are unvaccinated are mostly young, healthy people whose condition deteriorated quickly.”

    https://www.npr.org/sections/goatsandsoda/2021/08/20/1029628471/highly-vaccinated-israel-is-seeing-a-dramatic-surge-in-new-covid-cases-heres-why

  7. From Josh’s article: “Clearly, PRR is not an appropriate criterion for evaluating safety of any particular vaccine. Someone has arranged to cook the books”
    ———————

    Yes. That is a frightening thought, but sadly all too true.

    Josh:

    I am glad to see you feel well enough to continue with your writing.

    I am looking forward to that book you are considering writing someday regarding your present healing journey.

  8. Thank you so much for the fantastic update. Please stay off your bike. You may have another “accident” because of your work.

  9. I have read that the Chinese have several vaccines they use and distribute world wide however none are mRNA based. I’m not sure I would be too trustful of their vaccine and I doubt that it would be available here anyway. I’m just saying I don’t want a mRNA vaccine.

    • John is right to maintain reasonable doubt and to seek the truth. To learn from the molecular about the real and potential risks of adverse and unexpected effects – about mixing vaccines of different technology, etc. lecture of the virologist, pharmacist, biochemist, etc. listen to the slow voice of Dr. Goldschmidt.

      You will not regret it. Everything is said there. Which doesn’t mean that the truth makes us happy, but at least we know what it’s all about.
      Angelhttps://www.youtube.com/watch?v=z5I5mgGQLqs

  10. Hi Josh, and readers, let’s forget about the small stuff. If you want to be depressed just read the latest UN climate report. There is much to smile about for the lucky few. I just published a book called (sadly, not the only one with that title), but it is so apt) ‘The illusion of knowledge’ (I think I’ll call it “the illusion of truth”). ‘Just so you know if it’s worth you time, here’s the first published review (the book comes out Sept 4 but it’s already the number 1 and 2 downloads for ‘biotechnology’ on Amazon, (there are two formats). So a review and short description can be found here: https://www.longevity.technology/katcher-on-the-nigh-why-longevity-is-almost-here/ .

    • Hello Dr. Katcher.

      I purchased your book early, and its a wonderful read!

      I am very much looking forward to the result of the various E5 trials!!

      I’ll keep watching this blog for more updates.

      Many thanks

      Toby

    • I’m very happy you finished your book, I’ll read it as soon as it is it.

      But to call the current global coup “small stuff”?

      • Yes, compared to the millions if not billions of displaced and starving people as the Earth heats up, ocean levels rise and warm, releasing billions of tons of methane hydrate – methane, a much more powerful greenhouse gas than CO2, the arctic permafrost releasing its methane the world’s boreal forest, the taiga burning up, emitting carbon dioxide instead of capturing it. Life or death for humanity is much bigger.

        • There is no question that the growth paradigm that has characterized the world economies since the beginning of the industrial revolution is facing an abrupt shift.

          Question is when and how dramatic it will become?

          Currently, the initiatives are marginal and without any real effect.

          Relying on politicians, who are more concerned about their re-election and keeping the steam going on the growth engine is clearly not an option.

          Can 700 top scientist all be dead wrong? I think not.

          Get ready for the big ride.

        • The same “machine”* that is devouring the earth as you describe is devouring humanity as Josh’s write about. Talking about one is taking about the other. Both are crucial.

          *Call it wetiko, left brain dominance, the Old story of Separation, capitalism,…

        • My goodness such a dim view of the future. So it’s a foregone conclusion that the world has a fever? Seems ridiculous given our past history of warm times…how else to explain:
          https://www.sciencedaily.com/releases/2007/07/070705153019.htm
          Fossil DNA Proves Greenland Once Had Lush Forests; Ice Sheet Is Surprisingly
          July 5, 2007
          Source: University of Copenhagen
          Summary: Ancient Greenland was green. New Danish research has shown that it was covered in conifer forest and had a relatively mild climate. The research is painting a picture which is overturning all previous assumptions about biological life and the climate in Greenland. The findings also show evidence of ice in Greenland during the Eemian interglacial period 125,000 years ago, which indicates that although we are now confronted with global warming, the whole ice sheet will probably not melt and bring about the tremendous sea-level rises which have been the subject of so much discussion

          • Yes, it is preposterous. The only issue humanity has currently is yet another coordinated move towards communism. Not seeing this makes you the stooge that they are quite happy to inject with anything and create surveillance and slave states with. Wake up people.

          • Agreed Pierre:

            It is amazing how all the global warming scientists that are allowed to be heard totally ignore the earth’s past evidential geological history of climate patterns.

            In the distant past, when it is documented by geological investigations that rapid climate changes occurred, there were far fewer people, no industrialization, and no rampant industrial use of Fossil fuels.

            Yet, some scientists insist on blaming humans and claiming humans can control climate completely.

            Most likely global climate change….warmer or ice cold, is spurred by global and universal forces that are presently, and maybe always, far beyond our control.

            Sadly climate change is controversial. Still, only one louder side is being heard and the other side is being crushed.

            Not very scientific.

            There must be some other reason for why some so named scientists choose to shun intelligent discussion and observations regarding the issue.

          • Pierre, Heather:

            I wrote a lengthy reply, but it never posted for some reason. Maybe it is still being reviewed by the moderator? In any event, I will try again with a shorter post.

            I think it’s likely that climate change is caused by both humans and natural earth changes. There is reasonable evidence that both are contributing factors.

            However, even if one does not believe that humans are a contributing factor to climate change, why not reduce human emissions to the maximum extent possible for the sake of human health? There is no reasonable doubt that pollution increases mortality and disease.

            Some examples:

            “Air pollution doubled the risk for obesity, hypertension, chronic pulmonary disease, and cardiovascular disease in older people ”
            Lee BJ, Kim B, Lee K. Air pollution exposure and cardiovascular disease. Toxicol Res. 2014;30(2):71-75. doi:10.5487/TR.2014.30.2.071

            “Ambient air pollution is one of the main global health risks, causing significant excess mortality and LLE, especially through cardiovascular diseases. It causes an LLE that rivals that of tobacco smoking. The global mean LLE from air pollution strongly exceeds that by violence (all forms together), i.e. by an order of magnitude (LLE being 2.9 and 0.3 years, respectively).”
            Loss of life expectancy from air pollution compared to other risk factors: a worldwide perspective,
            Cardiovascular Research, Volume 116, Issue 11, 1 September 2020, Pages 1910–1917,

            Science Direct indicated that the above study found that:
            “Air pollution is responsible for shortening people’s lives worldwide on a scale far greater than wars and other forms of violence, parasitic and vector-born diseases such as malaria, HIV/AIDS and smoking;” and

            “People’s lives are shortened by an average of nearly three years from different sources of air pollution”

            See: The world faces an air pollution ‘pandemic’
            People’s lives are shortened by an average of nearly three years from different sources of air pollution, Science Direct Website,March 2, 2020

            I included many more references that demonstrate some of the harmful health effects of pollution in my original post. I limited the number of refences this time around.

  11. Katcher, stick to your longevity research, not political and NGO propaganda to try to get people to enter the slave surveillance state. It’s embarrassing for an intelligent person to pull alarmism like this, and signifies extreme foolishness and all lack of wisdom regarding what really is going on in the world recently and right now.

    • *sigh* I never thought I’d find a conspiracy nutter here on this blog. Josh – any way you can block him? If you don’t, it’s obvious he’s going to spam your blog with endless nonsense.

      • Yes, somehow all of this is just a big conspiracy between powerful interests you can do nothing about, based on evidence few of us believe. You can do nothing about it, so why bother? – Your reasoning is exactly why I wrote in: Josh’s interest is in life extension, not crackpot theories about China in collusion with the rich and powerful (and maybe Russia too or is Russia our ‘friend’?) to force us to take expensive vaccines (free to us maybe – but we still pay for them through our government). If that is your function in life – then I guess you are fulfilling – so what’s your point – people should wear masks, nor take vaccines? The fact that 97% of those hospitalized with COVID were unvaccinated is enough to tell rational human beings to get vaccinated.

        • Harold you are obviously a very smart person. Be more skeptical. It is true that under the current glaciers in Greenland are the remains of forests. There is a lot more evidence along the same lines in regards to this not being the warmest it’s been on earth. The entire theory of man made global warming rests on the idea that this is the warmest it’s been. That should be easy for you to see though.

          Now about conspiracies…whenever discussion is not encouraged, when scientific skepticism is set aside, when people are punished for the wrong viewpoint science is not happening. Whenever governments start to agree you should be scared of what they believe not swallow it whole. Throughout history it has always been governments who were the greatest threats to the lives of their own citizens. That’s not a conspiracy…that is simple fact.

          https://iceagenow.info/wp-content/uploads/2014/04/Harris-Mann_Historic_Temp_Chart.jpg

          • Of course it’s not the warmest it’s been on Earth. At one time, before photosynthesis, the air was nitrogen and carbon dioxide, so the temperatures were higher (it’s entirely predictable from a formula.) I don’t waste my time on man-made controversies that are ultimately unimportant and about which I can do nothing. Nature presents its own questions, the correct answers to which can change our lives. That’s what this column was about, not conspiracy theories – popular as they might be.

        • Harold:

          “Absence of evidence is not evidence of absence”

          When data s incomplete…the lack of evidence should not result in firm conclusions.

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