Were Dose The Data Upload Go For Unison League

Where to even begin with the FDA'due south preposterous risk-do good analysis of Pfizer'south mRNA COVID-19 "vaccine" in children ages five to xi?

Permit'due south start with my bona fides. I have a year of undergraduate statistics at one of the best liberal arts colleges in America (Swarthmore). I take 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 ane of the top universities in the earth (University of Sydney). My inquiry focus is on corruption in the pharmaceutical manufacture and so I've read scientific studies in connectedness with vaccines about every twenty-four hour period for v years. Earlier in my career I worked professionally fierce 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 most risk-benefit analysis and I'one thousand amend equipped than about to read one of these documents.

The FDA's risk-benefit analysis in connexion with Pfizer's Emergency Utilize Authority (EUA) application to inject children ages 5 to 11 with their COVID-19 vaccine is one of the shoddiest documents I've always seen.

Allow's take information technology from the top:

🚩 COVID-xix rates in children ages 5 to xi are so low that in that location were Nix cases of severe COVID-19 and Nada cases of death from COVID in either the treatment (n= 1,518) or control grouping (n= 750). And then any claims you lot see in the press nearly the Pfizer vaccine being "xc% constructive" in children are meaningless because they are referring to mild cases from which children usually recover quickly (and and so have robust wide spectrum immunity). So there is literally no emergency in this population for which one could apply for Emergency Apply Authorization. Pfizer's application should be dead on arrival if the FDA really followed the science and their own rules. We volition return to this topic beneath.

🚩 Pfizer's clinical trial in kids was intentionally undersized to hide harms. This is a well known play tricks of the pharmaceutical industry. The FDA even chosen them out on it earlier this summer and asked Pfizer to expand the trial and Pfizer merely ignored them because they can. (Pfizer fudged information technology by importing data from a different report but this other study only monitored adverse outcomes for 17 days and then if anything the new data polluted rather than clarified outcomes). To put it but, 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 one,518 in the treatment group then i is unlikely to spot this particular damage in the clinical trial. Voilà "Safe & Effective(TM)".

🚩 Pfizer only enrolled "participants v-11 years of age without evidence of prior SARS-CoV-2 infection ." Does the Pfizer mRNA shot wipe out natural amnesty and leave ane worse-off than doing nothing every bit 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 past pattern. Toxic polluters take learned to not ask questions that they do not want the answers to, lest they air current up staring at their own smoking gun in a future court case.

Co-ordinate to an analysis by Alex Berenson:

"What the British are maxim is they are now finding the vaccine interferes with your torso's innate power afterward infection to produce antibodies against not just the fasten protein but other pieces of the virus. Specifically, vaccinated people don't seem to be producing antibodies to the nucleocapsid protein, the shell of the virus, which are a crucial part of the response in unvaccinated people. This means vaccinated people volition be far more vulnerable to mutations in the spike protein Fifty-fifty Subsequently THEY HAVE BEEN INFECTED AND RECOVERED ONCE (or more than once, probably). It also ways the virus is likely to select for mutations that become in exactly that direction because those will substantially give information technology an enormous vulnerable population to infect. And information technology probably is nevertheless more evidence the vaccines may interfere with the development of robust long-term immunity post-infection."

🚩 Did Pfizer LOSE CONTACT with 4.9% of their clinical trial participants? The FDA risk-do good document states: "Among Accomplice i participants, 95.1% had prophylactic follow-up ≥ii months after Dose ii at the time of the September six, 2021 data cutoff." So what happened with those four.9% who did non accept safe follow-upwardly 2 months afterward Dose 2? Were they in the treatment or control group? Nosotros have no idea because Pfizer isn't maxim. Given the small size of the trial, failing to follow upward with iv.9% of the participants potentially skews the results.

🚩 The follow up period was intentionally too short. This is another well-know fob of the pharmaceutical industry designed to hibernate harms. Cohort 1 appears to accept been followed for 2 months, cohort 2 was only monitored for adverse events for 17 days. Many harms from vaccines including cancer and autoimmune disorders take much longer to bear witness up. Every bit the old saying goes, "you tin can have it quick or you lot can have it done right, but you cannot have both." Pfizer chose quick.

🚩 The chance-benefit model created past the FDA only looks at one known harm from the Pfizer mRNA shot — myocarditis. But we know that the existent world harms from the Pfizer mRNA shot go well beyond myocarditis and include anaphylaxis, Bell'due south Palsy, middle attack, thrombocytopenia/ low platelet, permanent disability, shingles, and Guillain-Barré Syndrome (GBS) to name a few. Cancer, diabetes, endocrine disruption, and autoimmune disorders may show up later on. Merely the FDA does not care virtually whatsoever of that because they accept a vaccine to sell so they just ignore all of those factors in their model.

🚩 Pfizer intentionally wipes out the command grouping as soon as they tin can by vaccinating all of the kids who initially got the placebo. They claim that they are doing this for "ethical reasons". But anybody knows that Pfizer's true aim is to wipe out whatsoever comparing group so that there tin can be no long term safety studies. Wiping out the control grouping is a criminal act and yet Pfizer, Moderna, J&J, and AZ do this every bit standard exercise with the blessing of the FDA/CDC.

🚩 Given all of the above, how on world did the FDA claim any benefits at all from this shot? You lot should probably sit down downward for this part because it'south a doozy! Here's the key judgement:

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

Expect, what!? I'll explicate. There were ZERO cases of astringent COVID-xix in the clinical trial of children ages 5 to xi. So Pfizer and the FDA just ignored all of the bodily health outcomes (they had to, in that location is no emergency, and so the awarding is moot). INSTEAD Pfizer switched to looking at antibodies in the blood. In general, antibodies are a poor predictor of amnesty. And the antibodies in the blood of these five to 11 year old children tell us zippo because again, at that place were nothing cases of astringent COVID-19 in this study (none in the handling group, none in the control group). So Pfizer had to get artistic! What they came upward with is "immuno-bridging". Pfizer looked at the level of antibodies in the bloodwork of another report, this ane 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 eleven 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 eleven population in the future, based on the antibiotic levels and wellness outcomes from the sixteen to 25 twelvemonth 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 stalk from this volition be flat out wrong. Not just wrong but preposterous and criminally wrong.

The whole ballgame comes downwards to Table fourteen on page 34 of the FDA's risk-do good document. And there the red flags come fast and furious.

🚩 The FDA model only assesses the benefits of vaccine protection in a 6-month period after completion of two doses. Furthermore it assumes abiding vaccine efficacy during that time catamenia. This is problematic on several counts.

Showtime, reducing balmy cases in children is not a desired clinical outcome. As Dr. Geert Vanden Bossche points out, mass vaccination turns kids into shedders of more infectious variants.

"Under no circumstances should immature and healthy people be vaccinated equally information technology will just erode their protective innate amnesty towards Coronaviruses (CoV) and other respiratory viruses. Their innate immunity ordinarily/ naturally largely protects them and provides a kind of herd immunity in that it dilutes infectious CoV pressure at the level of the population, whereas mass vaccination turns them into shedders of more than infectious variants. Children/ youngsters who go the disease more often than not develop mild to moderate disease and as a upshot keep to contribute to herd amnesty by developing broad and long-lived immunity. If you lot are vaccinated and get the affliction, y'all may develop life-long immunity too just why would you take the adventure of getting vaccinated, especially when you're young and healthy? Firstly, there is the hazard of potential side effects; secondarily, there is the ever increasing take a chance that your vaccinal antibodies volition no longer be functional while still bounden to the virus, thereby increasing the likelihood of ADE or even astringent disease...."

Second, nosotros know that vaccine efficacy in the month later the first dose is negative considering it suppresses the immune arrangement and information technology begins to wane after 4 months so all of the FDA's estimates of vaccine efficacy are inflated.

Third, the harms of myocarditis from these shots will likely unfold over the course of years. Robert Malone, the inventor of mRNA applied science notes that the FDA is albeit that children will be injected twice a year forever (hence the 6 month fourth dimension frame in the FDA risk-do good model). But the risks of "agin events such equally cardiomyopathy will be cumulative." Then any model that only looks at a six month time frame is hiding the true adverse event rate.

🚩 The FDA/Pfizer play fast and loose with their estimates of myocarditis. Starting time they estimate "backlog" (read: caused past the shot) myocarditis using information from the private "Optum health merits database" instead of the public VAERS system (p. 32). And then information technology'due south impossible for the public to verify their claims. Then, when information technology comes to estimating how many children with vaccine-induced myocarditis will be hospitalized and admitted to the ICU they use the Vaccine Safe Datalink (see page 33). Why switch to a different database for those estimates? Finally, there is no explanation for how they calculated "backlog" myocarditis deaths, so they just put 0. Carmine flag, red flag, red flag.

The FDA estimates that there will be 106 extra myocarditis cases per 1 million double-jabbed children 5-11. At that place are 28,384,878 children ages 5 to 11 in the U.S. The Biden assistants wants to inject Pfizer mRNA shots into all of them and has already purchased enough doses to exercise only that (even though just 1/3rd of parents want to jab their kids with this shot). So (if the Biden administration has its way) 106 backlog myocarditis cases per 1 meg 10 28.38 million people would be 3,009 excess myocarditis cases postal service-vaccination if the Pfizer vaccine is approved.

And over the course of several years many of those children volition die. Dr. Anthony Hinton ("Consultant Surgeon with 30 years experience in the NHS") points out that myocarditis has a 20% fatality rate after 2 years and a fifty% fatality rate afterwards 5 years.

And then the FDA has it exactly backwards — they want to forbid mild COVID in children which reduces herd amnesty and they just apartment out lie nearly the harms from myocarditis.

I've taken the liberty to correct the FDA'southward Table 14 with actual real world data and extended it over 5 years. It looks like this:

A study by Harvard Pilgrim Healthcare for the U.S. Department of Health and Homo Services estimated that VAERS only captured 1% of bodily vaccine injuries. Steve Kirsch has done elaborate modeling that puts the Under-Reporting Factor of COVID-19 vaccine deaths at 41 (and then multiply the above numbers by 41). And myocarditis is merely i of a multitude of possible harms from COVID-19 vaccines. Dr. Jessica Rose recently calculated an Nether-Reporting Cistron of 31 for all astringent adverse events post-obit vaccination.

Decision

The Pfizer vaccine fails any honest risk-do good cess in connection with its use in children ages five to 11. The FDA'south chance-benefit analysis of Pfizer's mRNA vaccine in children ages 5 to 11 is shoddy. It used tortured logic (that would be rejected past whatever proper academic journal) in order to accomplish a predetermined result that is not based in scientific discipline. The FDA briefing document is a work of fiction and information technology must exist withdrawn immediately. If the FDA continues with this grotesque charade it will crusade irreparable harms to children and the FDA leadership volition one day exist prosecuted for crimes against humanity.

Want to share your concerns with the members of the VRBPAC? Hither'south a link to an article with additional context and all of their contact data:

[Updated to add:]

🚩 An acute reader pointed out that on page fourteen, the FDA explains that Pfizer has changed the ingredients in their mRNA vaccine. They write:

To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphate-buffered saline (PBS) every bit used in the previous formulation and excludes sodium chloride and potassium chloride.

I'm deeply skeptical of this account (I incertitude this has anything to do with an "improved stability profile") and invite others to weigh in on this. I also think that tromethamine has a long and troubled history and invite readers to dig into this further (I'm happy to post additional links as they become bachelor).

The FBA'south flawed take a chance-benefit analysis was written by:

Hong Yang
Biologist
DHHS/FDA/CBER/OBE
Building, WO71, Room 5338
Mail stop: HFM-210
Argent Spring MD 20993-0002
phone: (240) 402-8836
fax: (301) 595-1240
Hong.Yang@fda.hhs.gov

and

Richard Forshee
Associate Director
DHHS/FDA/CBER/OBE
Building, WO71, Room 5342
Argent Spring MD 20993-0002
phone: (240) 402-8631
fax: (301) 595-1240
Richard.Forshee@fda.hhs.gov

This is a live commodity. The FDA only gives the public 2 days to review coming together materials so I had to publish this article immediately. If y'all spot any errors please let me know and I will right them. If yous find boosted flaws in the FDA's gamble-benefit analysis please post them in the comments so that I may add them.

A revolution is coming. ✊

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