By Aaron Siri

Clinical trials are supposed to be statistical comparisons. They are designed to compare the outcomes in the group receiving a novel product with the outcomes in the group receiving a placebo. The resulting statistics are then used to decide if the product is safe and effective.

This statistical approach also makes sense for new products. This is because, with a novel product, we don’t know how it affects the human body. So, to avoid bias or speculation, a cold, hard statistical comparison is deployed.

This is why, if more people died in the vaccinated group than in the placebo group in Pfizer’s clinical trial, the FDA should have pulled the plug on this product.

Yet, when more people died in the trial after vaccination than after placebo, did the FDA pull the trial? Nope. Instead, it let Pfizer explain away the deaths.

More Deaths in Vaccinated Group Compared to Placebo Group

In July of 2021, a study published by Pfizer explained that “during the blinded, placebo-controlled period, 15 participants in the [Pfizer vaccine] BNT162b2 group and 14 in the placebo group died.” Using FDA-style math, that is a 7% increased chance of death.

But it gets worse. After the placebo group was unblinded, an additional 5 participants who received the vaccine died. As Pfizer explains, “3 participants in the [Pfizer vaccine] BNT162b2 group and 2 in the original placebo group who received [Pfizer vaccine] BNT162b2 after unblinding died.”

Adding this up, in the clinical trial from July 2020 to March 2021, 20 deaths occurred among those who received the vaccine as compared to 14 who received the placebo. Here is a nice chart summarizing this from the Canadian Covid Care Alliance (CCAA):

Oddly, in a separate FDA report, it said there were 38 total deaths—21 in the vaccinated group and 17 in the placebo, reflecting a 24% increased risk of mortality—and there has been, despite demand (discussed below), no accounting by the FDA for the discrepancy between its data and Pfizer’s data.

Either way, this data should have ended the analysis for the FDA. The statistical comparison of this novel product showed more deaths among those getting it; hence, it should have been “game over.”

Instead, FDA let Pfizer explain away these deaths and guess what Pfizer concluded: “None of these deaths were considered related to [Pfizer vaccine] BNT162b2 by [Pfizer’s] investigators.” And the FDA simply parroted Pfizer’s conclusion in its report: “None of the deaths were considered related to vaccination.”

Double the Cardiovascular Deaths in Vaccinated Group Compared to Placebo Group

A closer look at the reason Pfizer gave for each of these deaths should have raised alarm bells. This is because there was double the number of deaths from cardiovascular issues in the group that got the vaccine. 

This is another great table from the CCCA of just the initial 15 deaths in the vaccinated and 14 deaths in the placebo group showing the cause of death as disclosed by Pfizer: 

(See original data here and CCCA document here.)

As the above table reflects, cardiovascular conditions were reported as the cause of death for 9 people receiving the vaccine and only 5 people receiving the placebo.

And after unblinding, among the 5 additional deaths after vaccine, at least 2 of these were cardiovascular-related, as seen from a document obtained from our lawsuit against the FDA to obtain the Pfizer documents.

Meaning there were 11 cardiovascular-related deaths among those getting Pfizer’s vaccine compared to 5 cardiovascular deaths among those getting a placebo. But guess what Pfizer concluded? You won’t be surprised. Pfizer concluded that “BNT162b2 had a favorable safety profile.”

Death is the most important measure in the clinical trial. When the statistical comparison worked against Pfizer and FDA’s desired outcome, they just ignored it.

They also ignored that in 2021 after the roll-out of the vaccine there were 3,469,627 total deaths in the United States, whereas in 2020 when there was effectively no vaccine there were fewer deaths at 3,347,128.

Data from various countries also reflects that the vaccinated have a higher rate of mortality. For example, see Dr. Josh Geutzkow’s analysis here, which may also explain why various countries or provinces/regions have stopped reporting death data between the vaccinated and unvaccinated.

FDA’s Incredible Response

On behalf of the Informed Consent Action Network (ICAN), my firm has been sending letters to the FDA demanding explanation for the foregoing discrepancy, and the FDA’s incredible response was as follows:

We are unable to respond substantively at this time due to resource constraints and the ongoing pandemic response.  It is thus necessary for the Agency to prioritize its responses to individual inquiries.  We note that the Agency is providing to your law firm, in response to a FOIA request, an unprecedented volume of records that comprise the license application for this product.  Additionally, there are more than 50 pending FOIA requests submitted by your firm for data and information about COVID‐19 vaccines.

Truly incredible. The FDA really doesn’t have the resources to figure out why more people are dying in the vaccinated versus placebo group in Pfizer’s clinical trial?! Obviously, it has the resources. It just doesn’t have a good answer.

This again brings into focus why we must never yield to the tyranny of permitting others to dictate what can or must be placed, administered, or injected on or into our bodies. For once that right is ceded, none truly remain.  

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Source: Originally published on Substack.