Part 2 of Does 95% Efficacy Seem too Good to be True?

Sadly the answer is yes — the reported results of this deeply flawed study are more untrue than I perceived in Part 1 and are incontrovertibly too good to be true.

Let me be clear from the outset, I do not believe that Pfizer mined data or worse. The data does not fit those actions. The data is explained by well-intentioned yet misguided desires to get rich and famous for helping humanity; and in the rush to market of innovative and exciting technology, a deeply flawed study was allowed to proceed.

I am both sad and excited about writing this article. I am excited about seeing through the BS. I am sad because so many people are ready for the somewhere-over-the-rainbow that the vaccine promises. The vaccine may in fact be the tremendous scientific achievement that we all hope for — if so, it’s too bad, no, it’s an archetypical crying shame, that its and the scientists’ reputations require resuscitation.

Math does not lie

The positivity rate in the study is impossibly low. It’s not dissimilar to the pre-election polling results. We should have known from 2016 that polling is not designed to accurately reflect an election involving Donald Trump. In many ways, the Pfizer study is similarly flawed.

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo.

Presently, the lowest positivity rate in the United States is 2.2% (VT and HI) and the overall rate is about 12.5%. The U.S.-resident share of the study exceeded 80% (I infer this from 130 of 154 randomization sites being in the U.S.)

In the study, the placebo positivity rate is 0.7% — .0007 as decimal number. It is impossible for the placebo group to have 95% fewer infections than the general population.

The flawed design.

The study should be put in the shredder, but let’s examine the flaws in the hope they are not repeated. First, no protocol was put in place for uniformity of diligence by the participants not to be exposed to the virus. It’s likely that participants wanting to be part of a successful trial were hyper-vigilant. On the other hand, it’s possible that some assuming they had the vaccine were less than vigilant. The lack of any consideration whatsoever for a study-design-solution for these matters is an obvious flaw.

Efficacy was based completely on self-reporting of symptoms. Only those reporting symptoms were tested. So, as it is generally accepted that approximately 20% of those testing positive remain asymptomatic, one can infer that over 540 completely asymptomatic infections were missed in the placebo group alone. Moreover, as no one in the study wants to admit that they are sick unless they feel that their life is threatened, it’s likely that very few with mild symptoms self-reported and that another approximate 2,000 cases were missed in the placebo group.

There is no way of knowing how many cases were missed for the same reasons in the vaccinated group.

2,000,000 tests per day are being administered in the United States. It’s beyond irresponsible that study participants were not tested at least weekly, symptoms or no symptoms.

I’m sorry but this study of a never before used modality for conferring immunity to a virus that is from a class of virus for which no vaccination-induced-immunity has previously been induced, is garbage.

It seems Pfizer and the government know they have a boondoggle on its hands that make the Edsel and New Coke amazing successes by comparison and are scrambling to do damage control. The assertion of 95% efficacy is being repurposed to 95% efficacious at preventing disease if it does not prevent infection. In The Atlantic, Ed Yong now reports:

The print version of this article stated that the Moderna and Pfizer/BioNTech vaccines were reported to be 95 percent effective at preventing COVID-19 infections. In fact, the vaccines prevent disease, not infection.

That may turn out to be true if and when a properly designed study is implemented. As I have shown, this study cannot be relied upon for proof of symptom prevention.

Pfizer, come clean, admit your mistake, apologize and start a new study ASAP. Spinning this will never get the public on board. A much younger woman with whom I am dear friends, who has no scientific training, and had not yet read any of my drafts, intuited yesterday in from-the-mouth-of-babes fashion:

It’s retarded and Ill never trust it until they actually do proper research

As I noted in Part 1, James Hamblin’s article states: “trust must consistently be earned through transparency.”

Transparency. Transparency. Transparency.

As long as I am correct that motives were pure, the public will forgive a sincere apology. Do not pull another Ellen Disengenuous. See Kelli María Korducki’s A Real Apology Isn’t 7 Minutes Long.

My theory of why and how

Pfizer and its scientists believe deeply in the mRNA technology design. In their hearts and minds they are sure it will work and will work safely. Two problems: they didn’t try hard enough to come up with a study-design that eliminates or otherwise solves for the vigilance issue; and the fame of solving a pandemic combined with the pressure of not solving it overwhelmed them. The results that I shed light on cannot have been missed by them. So, confident that they are doing no harm they construct the 95% efficacy story which is so great that people want to believe it and its such a simple statement that when repeated enough, it is believed. (The psychological basis for such successful propaganda campaigns is described very well by Tessa Schlesinger last week in Why Freedom of Speech No Longer Works). Now they close the logic gap with the story that at least it treats the symptoms, presumably by reducing the viral load, which is testable, but no one asks for that proof because they so want it to be true, and as the study deems it safe, they see no harm. Of course as I pointed out in Part 1, it will be years before we know if that is true.

Personal note — How and why me?

I can see the expressions on some former friends’ faces, and I can even hear my own mother saying, ‘who does he think he is? He’s not a scientist.’ No, I am not.

I am a HS-INTP, who is awake to the fact that my soul has emerged to share much of my conscious mindspace, and I do not fear one iota leaving myself vulnerable to criticism or scorn. My willingness to expose myself in this manner, is more than a strength — my willingness to be vulnerable is my superpower for which there is no kryptonite.

Namaste

YG