Vaccine effectiveness: it's all about presentation !

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Vaccine effectiveness: it's all about presentation !

Publié le 12/05/2021 à 17:56 - Mise à jour à 17:58
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Auteur(s): FranceSoir
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Vaccine efficacy : Pfizer announces 95% and Moderna 94%... really?

What if the numbers were : Pfizer 0.71% and Moderna 1.1%... would you take the jab?

 

When Pfizer states that its vaccine is 95% effective, what does it exactly mean?

This "efficiency" is a mesure of the reduction of the Relative Risk of getting the severe form of Covid-19 disease.

This value is linked to:

  • conditions of the clinical trial
  • those selected for this trial
  • as well as the period during which the test was conducted

For example, if the selected individuals had been older, with more comorbidities, or if the trial had been conducted during a period of high circulation of the virus, as in India today, the relative effectiveness of the same vaccine would have been much lower.

 

The "Absolute Risk" reduction is what’s important for people who are offered a vaccine or treatment. Let's define relative and absolute risks:

  • Relative Risk: A number that tells you how something you do or don't do can change your risk of developing a disease. For example: if you don't smoke, you'll be told that you have a 30% less chance of developing cardiovascular disease than someone who smokes. The relative risk reduction in this case is 30%. It is always a matter of comparisons between two groups; and knowing which group you belong to allows you to assess how likely you are to develop the disease or not.

As this number is relative and it does not apply to your personal case but to the group to which you belong. This information on relative risk reduction is useful for researchers because it allows them to combine the results of different clinical trials to make meta-analyses. Under no circumstances does this information give you the benefit you would expect from treatment because it does not take into account your basic risk of developing the disease without treatment.

What matters to all of us is what treatment or vaccine can do for us in our personal capacity. To do this, we need to know the value of "Absolute Risk Reduction."

  • Absolute Risk: This is your own initial probability of developing a disease such as cancer, cardiovascular disease... or Covid-19 if you are infected with Sars-Cov-2.  It is therefore necessary to know one's personal risk (%) to develop the disease without treatment and to subtract the value of "absolute risk reduction" (%) clinical trials.

This is the value that needs be known in order to make an informed decision about the benefits of treatment versus the risks of personal side effects.

However this "absolute risk reduction" value is always much lower than the "relative risk reduction" value. Therefore, it is not sexy enough to sell products that are fast tracked developed. For this reason, labs prefer to use the Relative Risk Reduction value and not the Absolute Risk Reduction value.

A simple example of a clinical trial to illustrate (Ref.1):

(Ref.1) https://www.mdpi.com/1648-9144/57/3/199

 

So it's easy to see why labs are using the Relative Risk Reduction value and not Absolute!

  • Relative risk reduction data is used for marketing and propaganda as it amplifies the expected actual benefit
  • Absolute Risk Reduction value is used by the same labs to minimize the importance of side effects!

 

Informed consent

When giving information to patients who are in the process of deciding whether or not to take a treatment or vaccine, doctors must give them the value of Absolute Risk Reduction so that they can assess the REEL benefit they can expect.  

Let's now exercise with Pfizer and Moderna vaccines using clinical trial data. For this we need some mathematical formulas (Ref.2):

(Ref.2) https://bestpractice.bmj.com/info/toolkit/learn-ebm/how-to-calculate-risk/

Pfizer Vaccine (Ref.3):

(Ref.3)  https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

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So if you are young with a near 0% risk of making a severe form of Covid-19 disease, would you take the vaccine for a 0.71% reduction in risk with all serious or even fatal side effects? Even with a risk of making a serious form of 30% what will this 0.71% be able to change for you? Let's ask ourselves the question!

NNT is another very important parameter : the number of people who need to be vaccinated, so that one person can benefit from the vaccine.

In the case of Pfizer's vaccine: NNT =  1 / ARR  = 1 / 0.0071 = 141.

This means that out of 141 people vaccinated with Pfizer, 140 people are taking the risk of the side effects without any benefits!

 

Will you take that risk?

The icing on the cake:

  • the Israeli data confirm the reduction of the relative risk RRR = 94%
  • in real life (with social distance and facial masks on), in terms of the absolute risk reduction it is ARR = 0.46%, therefore a lot less than the estimated 0.71% !!!
  • In this case, it will be necessary to vaccinate NNT = 1 / 0.0046 = 217 people for only 1 to have the benefit of the vaccine or 1.5 times more than the data from the clinical trial.

The "experts" have been careful not to elaborate on this parameter.
 

The Moderna vaccine (Ref.4):

https://www.nejm.org/doi/full/10.1056/nejmoa2035389

In the case of Moderna's vaccine: NNT = 1 / ARR = 1 / 0.011 = 91.

91 people are required to be vaccinated for only one to reap the benefits. The other 90 will have taken the risk of side effects, or even die without any benefit!

So here's the complete data for Pfizer and Moderna vaccines that are supposed to save the world!

 

In the FDA's marketing regulations (Ref.5), it is notified that labs must make all this data available to the public so that everyone can assess the risks and benefits based on evidence and inform consent.

"Provide absolute risks, not just relative risks. Patients are unduly influenced when risk information is presented using a relative risk assessment approach; this can lead to suboptimal decisions. So an absolute risk format must be used"

(Ref.5) : P60. https://www.fda.gov/media/81597/download + https://www.fda.gov/about-fda/reports/communicating-risks-and-benefits-evidence-based-users-guide

2.          Provide absolute risks, not just relative risks. Patients are unduly influenced when risk information is presented using a relative risk approach; this can result in suboptimal decisions. Thus, an absolute risk format should be used. Strangely neither the FDA nor the EMA have required it for these vaccines... On the contrary they insist only on the benefit based on the evaluation of the Reduction of the Relative Risk!

Failing to give all information to the public to allow informed consent is not only dishonest but dangerous.

An example of an advertisement "presenting," without saying it, the relative and absolute risk reduction data on the poster (Ref.6): the Pfizer Atorvastatin blockbuster "Lipitor in the US or Tahor in France" which is a statin to lower cholesterol and triglycerides in the blood.

The poster basically shows the reduction in the risk of having a heart attack by taking this medication: - 36%. But this is the Reduction of Relative Risk and not Absolute Gisk. To find the Absolute Risk Reduction, follow the asterisk or small prints:

 

This drug has made Pfizer record profits for over a decade: US$130 billion! (Ref.6) : https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/number-needed-to-treat/

Therefore how on earth is it possible that, based on such data, our health authorities, ministers and other tv-show doctors advocates that these “special Covid-19 vaccines” work, that their benefit outweighs their risks, that they will get us out of the crisis?

How can they consider vaccinating individuals who are not at risk or children, when these vaccines will be of no benefit to them but the side effects, sometimes fatal, are very real and accumulate day after day... and of course without knowing the long-term side effects!

However, some will argue that vaccination works by using the Israeli or English examples, where there no more deaths are accounted for.

Let's take a look at the mortality curves of these two countries (Ref.7, 8). Israel and England started vaccinating the older and more fragile individuals leading to an explosion in mortality concomitant with the onset of vaccination. This phenomenon is also observed in all countries that vaccinate “en masse”. This is what some epidemiologists call the "harvest" effect. The start of the vaccination campaign precipitated the death of the most vulnerable.

 

(Ref.7) : https://www.worldometers.info/coronavirus/country/uk/

(Ref.8) : https://www.worldometers.info/coronavirus/country/israel/

Taking this into consideration, it is rather normal for mortality curves to decline. Nothing miraculous!

Cases of infection of fully vaccinated people (2 jabs) are increasing the world over, people vaccinated in Care Home continue to die and no one wants to face the truth. But where do the 300-400 France deaths come from if vulnerable people are almost all vaccinated? What's the difference between now and before the vaccination campaign? Why is no one really concerned with the right questions and, we drive on this morbid track .

There will most likely be a fourth wave in the fall that will take away vulnerable people, vaccinated or not. Instead of recognizing the futility and toxicity of these gene therapies, the narrative is already well prowled: minds are prepared for new variants, vaccines that will not be effective and booster required in 6 months! Then there will be the annual subscription at Pfizer – recuring income model. And the most cynical thing is that it is the CEO of Pfizer himself who announces the next season (Ref.9)! https://www.latribune.fr/economie/international/une-troisieme-dose-du-vaccin-pfizer-probablement-necessaire-selon-son-pdg-882539.html

How did it come to this? It is difficult to rationalize this furious madness that will leave people sick, crippled or dead when this disease would not have hurt them in anyway. What society are we in to accept and encourage this? What society that has already done so much harm to its youngest is now considering putting them in even greater danger with gene therapies whose long-term side effects we know nothing about?

With goals in sight, European leaders are moving forward with the health passport and the vaccine passport. Population is kept in fear to prevent them from thinking.

Many of us will remember this.... and they will be held accountable

 

Auteur(s): FranceSoir

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Vaccine effectiveness: it's all about presentation !

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