COMIRNATY Summary Basis for Approval Document - The Difference in Deaths of Vaccine Versus Placebo Increases

24% more deaths in vaccine group - 21 vs 17; Massive redactions in document as to composition and manufacturing

The COMIRNATY Summary Basis for Approval document has been released, and it only raises more concerns. I can now see why the number of deaths was conspicuously absent from the product label.

In the preprint 6-month data released just a few weeks ago, there were 15 deaths in the vaccine arm versus 14 in the placebo arm. However, in the Summary Basis for Approval document that increased to 21 deaths in the COMIRNATY group versus 17 in the control group. Even more interesting is the fact it says, “From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY group and 17 in the placebo group.”

Source: COMIRNATY Summary Basis for Regulatory Action, page 23

Update (11/22/2021): I have noticed that the FDA has replaced the original document the above links to after a commenter asked me for the link (the information should not be substantially different other than the date, but I have not gone through it line by line). I have the original dated August 23, which used to be at the above link, you can find here uploaded by someone else.

So this means they have known this since March 13! How on earth did Pfizer report only 15 versus 14 in their 6 month report preprint only weeks ago? That study report actually represented a broader patient population than the final label (included patients less than 16 years of age), so there is no reason that they should not have included deaths that were known from March 13th in a study preprint that went out in August.

Unlike the preprint we have no details on the manner of deaths. Only the statement “None of the deaths were considered related to the vaccine.” A point I have made before, no one considered stroke related to Vioxx, until the data showed over more nad more patients a significant difference. The only way you know is by observing the difference.

I would be quite interested to know if the extra 6 deaths in the report had cardiac arrests, because there were 4 in the vaccine arm and 1 in the control. A few more deaths in the differential and that might start to look very concerning. It would have also been interesting to see the number of COVID-19 related deaths to see if that had gone up.

By my calculations, this is nowhere near statistical significance and you had on average 0.2 more months on treatment in the vaccine arm. There is still a really good chance this is random noise. But the argument that this vaccine is some big “life safer” is starting to look more and more ridiculous.

Also interesting is the fact the document admits that the vaccine efficacy has declined to 70% with the Delta variant. Unfortunately, the data they based this number is based on does not appear to be in the document. There is an argument that this should have been included on the label in terms of full disclosure, but generally the label only represents the results of randomized studies. Data collected outside of randomized studies is never as reliable. That is one of the reason the study should have never been crossed over and unblinded. That is how you get real data.

Source: COMIRNATY Summary Basis for Regulatory Action, page 24

Also very disturbing is the fact they are relying on models where the assumptions are not given to assess the myocarditis risk.

Source: COMIRNATY Summary Basis for Regulatory Action, page 24

So how many of these 13,000 cases of “non-hospitalized COVID-19 per million vaccinated males” would actually be hospitalized? I want to see the numbers.

They use as an estimate 200 cases of myocarditis/pericarditis per million:

Source: COMIRNATY Summary Basis for Regulatory Action, page 24

So let’s see if we can work out what their estimates likely were. Just to equal the risk of myocarditis you are talking 200/(13,000+200) = 1.5% rate of hospitalization in younger people as a lower bound of what the FDA must have assumed. Any less than that and myocarditis cases would be greater than hospitalizations and it would be hard to say that the risk outweighs the benefit, especially since there are also other adverse events other than COVID-19. Let’s not forget that there is a 41.6% increased risk of a severe adverse outcome with the vaccine versus control.

In the Pfizer trial, 30 out of 1,034 patients (using preprint number because that gives real world dose 1 numbers unlike the label) had severe COVID-19. Even though that includes non-hospitalized pulse oximeter criteria, lets assume that approximates hospitalization. The CDC endpoint in the label suggests it might not be a bad approximation. That represents a 2.9% rate of severe COVID-19 in the randomized controlled trial, the best estimate we have since there is actually a control group you are prospectively following the entire time.

But the myocarditis calculation was specifically focused on 16-17 year olds and the 2.9% number is for the entire 16 and up cohort, and a lot of those severe cases is going to be concentrated in the older people. We know younger patients are at a much lower risk of hospitalization. According to the CDC’s data adolescent hospitalization rates are roughly 12.5 times lower than those aged 18 and higher!

Source: Hospitalization of Adolescents Aged 12–17 Years with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, March 1, 2020–April 24, 2021

The 2.9% includes some 16 year olds, but the vast majority are over 18. So let’s call it a 3% rate of severe hospitalization. If we divide that by 12.5, we get a 0.24% severe COVID-19 rate as a proxy for hospitalization. So let’s multiply that times 13,000 and we get 31 patients per million with severe COVID-19 might be hospitalized.

That is nearly an order of magnitude below the FDA’s own estimate for myocarditis!

Did they literally use the adult morbidity number for the 16-17 year olds? No wonder they are hiding their assumptions.

Source: COMIRNATY Summary Basis for Regulatory Action, page 24

It is freaking Orwellian. An order of magnitude times more myocarditis compared to hospitalization and “the benefits of vaccination sufficiently outweigh risks to support approval of the vaccine in males 16-17 years of age.” I bet you anything, they either (1) used their original severity estimates proven to be too high by Pfizer’s controlled trial or (2) they used the adult numbers, not accounting for the fact younger people do not go down as hard with COVID-19.

So now in addition to the COVID-19 death disclosed in the pre-print not properly counted as a severe COVID-19 on the label, we have more evidence that no one from the FDA seriously reviewed this filing. The FDA is literally a joke! A tool of big pharmaceutical companies.

I just also want to highlight that this is quite important for our young men and women in service. The data was not stratified by 18 to 22 year old, but I would imagine if it was the general risk/reward would be similar to 16-17 year olds. I just watched a video of a tenured navy surgeon stating that myocarditis has a 66% 5-year mortality rate and that 80 members of the military have come down with myocarditis since the vaccinations started versus only 20 deaths from COVID-19 in 2020. This again confirms that this risk is real, and makes a further mockery of the FDA’s “risk calculus.”

Even the FDA admits “information is not yet available about potential long-term sequelae and outcomes in affected individuals,” yet they are rushing to jab every young person in the military using what appears to be phony math to say the risks outweigh the rewards. And i will remind you, the myocarditis problem has been suspected as being an issue for awhile, and was even included as a warning on the original UK label in late 2020.

Source: COMIRNATY Summary Basis for Regulatory Action, page 23

I call on the FDA to make their assumptions in the risk calculus referred to above public. Heads should roll over what is going on here!

Redactions Everywhere in the Document

There is a lot of information redacted from the document with regards to the formulation and manufacturing. Here are some examples:

Source: COMIRNATY Summary Basis for Regulatory Action, page 7

Source: COMIRNATY Summary Basis for Regulatory Action, page 6

Source: COMIRNATY Summary Basis for Regulatory Action, page 10

What are they hiding? Don’t people have a right to know what they are being asked to inject in their bodies?

So we basically have here four takeaways. (1) It appears that both Pfizer and the FDA chose to suppress the fact that there were 4 more deaths in the treatment arm by burying the data far away from the label and their recent preprint ahead of approval, (2) the FDA admits in the document the efficacy of the vaccine is probably closer to 70% now and chose not to put that on the label, (3) FDA appears to also hidden their assumptions on the myocarditis benefit because it appears they had to be rediculous given the rates of morbidity in Pfizer’s own trial, and (4) the FDA seems to be going out of its way to hide what some of the components of this drug are.