90% effective? What does Pfizer’s preliminary report mean?

Media outlets are enthusiastic, saying that Pfizer announced their COVID-19 vaccine candidate is 90% effective. The tone of the media has been mostly joy and relief, absent any scrutiny or analysis. A simple, almost childlike acceptance of the press release content.

Fierce Pharma reported that if authorized, the shot could earn Pfizer/BioNTech $258 million this year, $4.6 billion in 2021, and could still be “pulling in $1.2 billion to $1.6 billion in annual sales from 2026 through 2029.”

Fierce Pharma also said that “Questions about the durability of protection, safety, and more remain.”

What exactly did Pfizer say in their press release about effectiveness? There were 43,538 participants in the trial. Half of them received the vaccine, and the other half purportedly received a saline placebo. The trial began on July 27. After 94 people in the entire trial were confirmed to be positive for COVID-19 (through uncontrolled and unknown random exposure in their daily routines) an interim analysis was done and less than 10% of the cases were found to be in the vaccine group. So they say this means the vaccine is 90% effective.

“. . . the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

Does it? Pfizer did not yet release any actual data. It’s not known which subjects were exposed to COVID-19, if the cases were clustered or randomly dispersed, or any other details about the subjects who tested positive. People enrolled in the trial live all around the world, in varying conditions. Positive tests in 94 out of 43,538 volunteers? Is that statistically meaningful? For Phase 2 & 3 trials, subjects were chosen who “in the judgment of the investigator, are at higher risk for acquiring COVID-19 (including, but not limited to, use of mass transportation, relevant demographics, and frontline essential workers).” It’s not known what symptoms anyone had. We don’t know if the vaccine prevented any serious cases or any deaths — the trial will never tell us that, even when completed, because it was not designed to, none of the vaccine candidate trials are.

With billions of dollars of profit at stake, not just with this vaccine but future mRNA technology vaccines, the world would be foolish to ignore the history of the pharmaceutical industry and their repeated criminal convictions for behaviors that put our lives at risk. Manipulating various aspects of a clinical trial to skew results would be very easy to do, especially considering that those who stand to profit are in full charge of every detail. Any and all results should be examined very closely once the data is released, and any possibility of manipulation or fraud investigated.

Journalists and federal agencies should be scrutinizing every step of vaccine development and clinical trials in order to stand between the public–the targeted consumers–and the pharmaceutical industry. Instead, they are acting as marketing arms, heralding interim results without question. Much is being said about ensuring safety, but actions speak louder than words. The public needs more than verbal assurances of effectiveness and safety. The public deserves actual evidence. Our current regulatory agencies run on the “honor system.” All data is produced and submitted by the companies that stand to profit. The drug industry has not earned our trust; using the honor-system may very well usher in products that only belatedly are found to cause far more harm than good.

There are several concerning red flags:

  1. Pfizer didn’t provide anything new about safety in their press release, other than to say vaguely “no serious safety concerns have been observed”. And yet their Phase 1 trials said something far different. Fierce Pharma reported on September 16, 2020: “Most side effects after the second dose were mild to moderate, but some participants did experience severe or grade 4 side effects that could be life-threatening or disabling, according to the presentation. There were more severe side effects after the second dose as compared with the first dose, even though a smaller number of participants—1,682—were in that group.” How could it be that in 1,682 subjects there were grade 4 and life-threatening or disabling side effects, but in 43,538 subjects, there “were no safety concerns”?
  2. Participants were not given adequate information for valid informed consent. A new study explains that it is well-established that vaccination against a coronavirus “may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.”
  3. Pfizer’s CEO sold $5.6 Million in stock on the same day of the press release about interim results. Does this show confidence? Officers of Moderna, the company with a competing mRNA vaccine, also began selling their stock as soon as the price soared.

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