Ten red flags in the FDA's risk-benefit analysis of Pfizer's EUA application to inject American children 5 to 11 with its mRNA product
The FDA briefing document is preposterous junk science and it must be withdrawn immediately

Toby Rogers, Oct 25 2021

https://tobyrogers.substack.com/p/ten-red-flags-in-the-fdas-risk-benefit

Where to even begin with the FDA’s preposterous risk-benefit analysis of Pfizer’s mRNA COVID-19 “vaccine” in children ages 5 to 11?

Let’s start with my bona fides. I have a year of undergraduate statistics at one of the best liberal arts colleges in America (Swarthmore). I have a year of graduate statistics at the masters program rated #1 for policy analysis (UC Berkeley). And I have a Ph.D. in political economy from one of the top universities in the world (University of Sydney). My research focus is on corruption in the pharmaceutical industry so I’ve read scientific studies in connection with vaccines nearly every day for 5 years. Earlier in my career I worked professionally tearing apart shoddy cost-benefit analyses prepared by corporations that were trying to get tax breaks, contracts, and other concessions from local government. Suffice it to say I’ve thought a lot about risk-benefit analysis and I’m better equipped than most to read one of these documents.

The FDA’s risk-benefit analysis in connection with Pfizer’s Emergency Use Authorization (EUA) application to inject children ages 5 to 11 with their COVID-19 vaccine is one of the shoddiest documents I’ve ever seen.

Let’s take it from the top:

🚩 COVID-19 rates in children ages 5 to 11 are so low that there were ZERO cases of severe COVID-19 and ZERO cases of death from COVID in either the treatment (n= 1,518) or control group (n= 750). So any claims you see in the press about the Pfizer vaccine being “90% effective” in children are meaningless because they are referring to mild cases from which children usually recover quickly (and then have robust broad spectrum immunity). So there is literally no emergency in this population for which one could apply for Emergency Use Authorization. Pfizer’s application should be dead on arrival if the FDA actually followed the science and their own rules. We will return to this topic below.

🚩 Pfizer’s clinical trial in kids was intentionally undersized to hide harms. This is a well known trick of the pharmaceutical industry. The FDA even called them out on it earlier this summer and asked Pfizer to expand the trial and Pfizer just ignored them because they can. (Pfizer fudged it by importing data from a different study but this other study only monitored adverse outcomes for 17 days so if anything the new data polluted rather than clarified outcomes). To put it simply, if the rate of particular adverse outcome in kids as a result of this shot is 1 in 5,000 and the trial only enrolls 1,518 in the treatment group then one is unlikely to spot this particular harm in the clinical trial. Voilà “Safe & Effective(TM)”.

🚩 Pfizer only enrolled “participants 5-11 years of age without evidence of prior SARS-CoV-2 infection.” Does the Pfizer mRNA shot wipe out natural immunity and leave one worse-off than doing nothing as shown in this data from the British government? Pfizer has no idea because children with prior SARS-CoV-2 infection were excluded from this trial. This was by design. Toxic polluters have learned to not ask questions that they do not want the answers to, lest they wind up staring at their own smoking gun in a future court case.


-- excerpt, rest (many other important points and information) at link above --

A couple of more from the link above:



🚩 Pfizer intentionally wipes out the control group as soon as they can by vaccinating all of the kids who initially got the placebo. They claim that they are doing this for “ethical reasons”. But everyone knows that Pfizer’s true aim is to wipe out any comparison group so that there can be no long term safety studies. Wiping out the control group is a criminal act and yet Pfizer, Moderna, J&J, and AZ do this as standard practice with the blessing of the FDA/CDC.

🚩 Given all of the above, how on earth did the FDA claim any benefits at all from this shot? You should probably sit down for this part because it’s a doozy! Here’s the key sentence:

Vaccine effectiveness was inferred by immunobridging SARS-CoV-2 50% neutralizing antibody titers (NT50, SARS-CoV-2 mNG microneutralization assay).

Wait, what!? I’ll explain. There were ZERO cases of severe COVID-19 in the clinical trial of children ages 5 to 11. So Pfizer and the FDA just ignored all of the actual health outcomes (they had to, there is no emergency, so the application is moot). INSTEAD Pfizer switched to looking at antibodies in the blood. In general, antibodies are a poor predictor of immunity. And the antibodies in the blood of these 5 to 11 year old children tell us nothing because again, there were zero cases of severe COVID-19 in this study (none in the treatment group, none in the control group). So Pfizer had to get creative! What they came up with is “immuno-bridging”. Pfizer looked at the level of antibodies in the bloodwork of another study, this one involving people 16 to 25 years old, figured out the level of antibodies that seems to be protective in that population, then figured out how many kids ages 5 to 11 had similar levels of antibodies in their blood, and then came up with a number for how many cases, hospitalizations, ICU admissions, and deaths would be prevented by this shot in the 5 to 11 population in the future, based on the antibody levels and health outcomes from the 16 to 25 year old population. If your head hurts from that tortured logic, it should, because such chicanery is unprecedented in a risk-benefit analysis.

So when the FDA uses this tortured logic at the beginning of their briefing document, all of the calculations that stem from this will be flat out wrong. Not just wrong but preposterous and criminally wrong.

The whole ballgame comes down to Table 14 on page 34 of the FDA’s risk-benefit document. And there the red flags come fast and furious.


-- excerpt, rest at link above --

Some amazing abuse and torture of science and scientific methods to arrive at these conclusions. And, the fact that the FDA accepted this crap is unforgivable.