In this blog I will discuss what the Pfizer’s own clinical trial data actually shows. I will not discuss or speculate on the contents of the vaccine here, I will leave this to others and perhaps return to this aspect myself in a future blog. I want to concentrate on what Pfizer’s own data actually demonstrates, and crucially what is does not demonstrate.
I will refer to two of Pfizer’s own clinical trial publications:
– Their interim clinical trial results published in the New England Journal of Medicine (NEJM), 31st December 2020 (ref 1)
– Their subsequent analysis of adverse events released by the US Food and Drug Administration (FDA), 17th November 2021 (ref 2)
Developing new pharmaceuticals is a risky business. Pharmaceutical companies have to invest vast sums of cash and then hope to demonstrate that new products have benefits in order to be accepted and used in health services. In normal times, the return on investment may follow after 5-10 years. Sometimes the product fails to demonstrate effectiveness or is shown to be unsafe and there is no return on investment.
We are not living in normal times. As discussed in my first blog, the Emergency Use Authorization of the Covid vaccines has resulted in products being used after merely 12 months of development. The return on investment has been unprecedented. The Pfizer vaccine generated $37Bn of sales in 2021, almost doubling the company’s sales for the year. (ref 3)
Expectations for 2022 sales include $$22Bn for their new Covid antiviral drug and a further $32Bn in Covid vaccine sales. If you want to understand why World events are happening, simply follow the money!
But I am not at all interested in the financial risk to pharmaceutical companies in developing new products. The topic for discussion here is the risks we take when deciding to take a Covid vaccine, or let our own immune system deal with Covid, as nature intended.
The risky business I want to explore here is the balance of effectiveness and safety, or put another way the balance of benefits and harms that everyone contemplating taking the Covid vaccine should understand. This is a key part of informed consent, which is an essential pillar of all medicine. How patients have been informed about the Covid vaccines and with what information is potentially a topic for a future blog.
In order to understand the real benefit of any intervention you must understand the difference between the relative risk reduction and the absolute risk reduction of an event happening to you. You might be surprised to know that few clinicians understand the difference. But you should not be surprised to know that all pharmaceutical companies are experts in statistics and presenting data in ways that will ensure their products are supported by clinicians and accepted by patients. What appears to be very effective in the promoted headline can be shown to be not effective at all within the hidden detail.
It is also very important to understand what event is being referred to and over what timescale when someone says your risk of the event happening to you is reduced by the intervention. Does the intervention reduce your risk of dying from the ‘infection’ this year, or over the next 10 years? Does the intervention reduce your risk of becoming ‘infected’, or does it reduce your risk of testing positive for the ‘infection’?
By now everyone must have heard that the Pfizer vaccine is “95% effective”. The “95% effective” statistic has been widely publicized in the media and has been used by the regulators as sufficient proof that the vaccine can be approved for use widely across the world. This statistic has also been used by clinicians to ‘inform’ patients in order to obtain ‘consent’ before giving Covid vaccines.
The abstract in the New England Journal of Medicine gave the following conclusion (BNT162b2 is the product code for the Pfizer Covid vaccine):
“A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.”
We will return to the safety data later. But what does “95% protection against Covid 19” actually mean?
A. 95% receiving the vaccine will survive if they catch Covid.
B. 95% receiving the vaccine will not catch Covid.
C. 95% receiving the vaccine will not go to hospital if they catch Covid.
D. 95% receiving the vaccine will not have Covid symptoms.
E. 95% receiving the vaccine will not test positive for Covid.
Most members of the public and perhaps most clinicians will believe that the 95% figure relates to one of the above statements. But which one? Read on to find out!
The interim clinical data published in the NEJM includes the following information:
– 37,706 trial participants with a minimum of 2 months follow up data were included in the results. 18,860 received the Pfizer vaccine and 18,846 received the saline placebo.
– The primary outcome being measured in the trial was “laboratory-confirmed Covid-19”, meaning a positive Covid test to you and me.
– 8 participants who received the Pfizer vaccine tested positive.
– 162 participants who received the saline placebo tested positive.
This is where the 95% effective comes from:
8 is 95% smaller than 162 (or 1 – (8/162) * 100 = 95.06%)
This is known as the relative risk reduction; being the relative difference between 8 and 162.
But what really matters to you is the reduction in your absolute risk. This can be calculated as follows:
– 8 of the 18,860 Pfizer participants tested positive: (8/18,860 = 0.04%)
– 162 of the 18,846 saline participants tested positive: (162/18,846 = 0.86%)
So the absolute risk reduction is 0.82% (0.86% – 0.04%).
0.82% effective doesn’t sound quite as good as 95% does it?
Remember, the primary outcome being measured is merely a positive Covid test. The trial did not seek to measure a reduction in significant illness, a reduction is hospitalization, a reduction in ventilation or a reduction in death.
In plain language, the Pfizer trial showed a 0.82% absolute risk reduction of testing positive for Covid-19. Compare this with the NEJM paper conclusion that the Pfizer vaccine conferred 95% protection against Covid-19.
So I have a proposal for you and the other 99 people sat waiting in my Covid clinic:
I want to inject all 100 of you with my new experimental treatment so that ONE of you (but nobody knows which one) will have a lower chance of testing positive for Covid-19. The other 99 of you will not benefit at all (but all 100 of you risk having “side effects”). Do all 100 of you want to accept my offer?
Here are some other facts about the Pfizer Covid trial:
– The Phase I trial animal testing was not done. If you want to know why, look into effects of antibody dependent enhancement (ADE) on the animals in the SARS-Cov-1 mRNA vaccine clinical trials.
– The Phase II and III trials were combined, thereby removing another 2 years of safety testing requirements.
– There were 5,241 adverse events in the Pfizer vaccine participants and 1,311 in the saline placebo participants. This represents a 300% greater risk of adverse events amongst the Pfizer participants.
– There were 262 serious adverse events in the Pfizer vaccine participants and 150 in the saline placebo participants. This represents a 75% greater risk of serious adverse events amongst the Pfizer participants.
– Only 4.4% of the trial participants were in the over 75 age group; the group most at risk from Covid. 77% of the participants were in the 16 to 74 age group. This helps the trial as younger participants have less side effects.
– 84% of the NEJM article authors were employed by Pfizer or Biotech or had other conflicts of interest.
– The saline placebo group was “unblinded” in early 2021, meaning that all the participants who received saline were informed and then offered the Pfizer vaccine. There is no longer a control group in the trial!
– There were 15 deaths in the Pfizer vaccine participants and 14 in the saline placebo participants. After unblinding 3 more of the original Pfizer participants died and two more of the original placebo participants died.
In addition, the clinical trial protocol allowed clinicians running the trial to decide which participants were tested for Covid. You might be surprised to learn that not all symptomatic participants were sent for testing.
So what does the detail buried in the interim report say about how many participants had Covid symptoms?
– You already know that 8 of the 18,860 Pfizer vaccine participants tested positive.
– And you know that 162 of the 18,846 saline placebo participants tested positive.
– There were another 1,594 Pfizer vaccine participants who had symptoms but were NOT TESTED!
– There were another 1,816 saline placebo participants who had symptoms but were NOT TESTED!
I will not speculate here on why only some participants with symptoms were sent for testing. There has already been plenty of coverage of the conduct of the clinical trial from whistleblowers. But we can now recalculate those effectiveness figures using data from all the trial participants who had Covid symptoms.
So I now have an improved proposal for you and the other 99 people sat waiting in my Covid clinic. I still want to inject all 100 of you with the same new experimental treatment, but now TWO of you (but nobody knows which two) will have a lower chance of testing positive for Covid-19. The other 98 of you will not benefit at all (but all 100 of you will risk having “side effects”).
Do all 100 of you now accept my improved offer?
If you are wondering which answer about the 95% effective statement was correct, you should now realize that none of the statements (A, B, C, D or E) were correct!
I will now move to the second Pfizer publication. This one was only released by the FDA after a legal challenge forced the publication of Pfizer documents that were intended to be kept secret for 55 years! The 38 page report was written in April 2021 and contains details of adverse events recorded by Pfizer up to the end of February 2021. I could write a whole blog just about this report, but will conclude this blog with some of the more alarming details.
You will recall that Pfizer’s interim report at the end of December 2020 confirmed that there had been a total of 34 deaths in the clinical trial participants. By the end of February 2021, the number of deaths had increased to 136. A further 102 trial participants had died in the subsequent 2 months and this section of the report concludes with the following recommendation to the FDA:
The cumulative case review does not raise new safety issues. Surveillance will continue.
The report contains details on the numbers of adverse events affecting different organs within the human body. These include events affecting skin, blood, liver, nervous system, immune system, lungs, kidneys and heart. The effects on the heart and cardiovascular system have been well publicized, so I will highlight here that the report confirms that up to the end of February 2021 there were 449 cases of facial paralysis. Once again, this section of the report concludes with the same “nothing to see here” recommendation for the FDA.
As a pharmacist, I am always concerned about medication errors. These are events where patients are given the wrong dose or even the wrong drug. I was amazed to read that there had been 2,792 medication errors affecting 2,056 trial participants. That is an astonishingly high number of errors in a trail of around 43,000 participants where the only medication given is two injections under supervised conditions. More alarmingly, the report confirms that these errors resulted in the deaths of 7 trial participants and 124 have been left with “serious consequences”.
I will conclude with the most alarming section of the report; the section on what happened to the 270 pregnant women in the Pfizer trial. This section contains the following information:
– 23 had spontaneous abortions
– 5 women had an “outcome pending”
– 2 had a premature birth with neonatal death
– 2 had spontaneous abortions with intrauterine deaths
– 1 had a spontaneous abortion with neonatal death
– 1 had a “normal outcome”
– There was “no outcome data reported” on the remaining 238 women
Once again, the section concludes with the following recommendation for the FDA:
There were no safety signals that emerged from the review of these cases of use in pregnancy and whilst breast feeding.
So, Pfizer have found that 10% of pregnant women given their vaccine lost their babies. Did you see this reported in the media? Neither did I, but we have all been informed by our regulators and Governments that the Pfizer vaccine is safe in pregnancy!
In my time in the UK National Health Service, I became very familiar with the statistical manipulation that pharmaceutical companies use in order to present their products in the very best possible light. They do this to influence the decision makers that decide which products can be used in our health services. I have been on the receiving end of this manipulation as a public servant and I have also been employed as a specialist consultant by pharmaceutical companies to advise them how best to present their products to health services. I thought I was fully aware of the tactics and methods used by the pharmaceutical industry. I was wrong!
The misrepresentation of the Pfizer trial data represents a new low for the allopathic healthcare system. What is more concerning is that our Governments have fully adopted the methods used by pharmaceutical companies to corrupt our public health policies and implement medical tyranny. We have all been deceived and denied the truth.
I believe we are nearing the end of the collapsing allopathic healthcare system. The globalists have become even more greedy and have made a fatal mistake. Their deception is now obvious to ever greater numbers of previously trusting patients. We need a new healthcare system that is founded on truth. A system of the people, for the people.
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