How Pfizer Manipulated COVID Vaccine Trial Protocols To Obtain Emergency FDA Authorisation For Children

Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination also for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings, including violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children.

How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

Violation of protocol conditions – How did children with a psychiatric diagnosis get to be included in the study?

According to the review document submitted by Pfizer to the FDA, four of the 1,131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (“SAEs”) – that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or congenital anomaly/birth defect.

Of these four children, three had such severe depression that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).

How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.

To reassure us, Pfizer notes in its review document that in fact, all three children had a pre-existing diagnosis of anxiety and depression. Moreover, they explain – all three actually reported a selective serotonin reuptake inhibitor (SSRI) that began within 1-2 months prior to vaccination.

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“Worsening suicidal ideas with initial SSRI treatment in adolescents”, they explain, “is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients”.

So here you go – why blame the vaccine, when there is a perfectly reasonable and logical alternative explanation for the exacerbation of their depression?

What is the problem with this explanation?

Two problems:

  1. The claim that the SSRIs the children received is an alternative explanation for the deterioration of the children’s mental state is doubtful. According to the scientific literature, exacerbation of suicide and mental state occurs right at the beginning of treatment with antidepressants, usually in the first two weeks, and certainly not more than a month after starting treatment – which is the time when you start to see improvement. In fact, the opposite is true: if there is no improvement within four weeks, a medication is usually replaced.
  2. More importantly, according to the study protocol – participants with a previous psychiatric diagnosis should never have been included in the study in the first place (see page 41 in the protocol).
    It turns out that one of the exclusion criteria in the study is: “Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study“.
How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

This is therefore a blatant violation of the study protocol established by the company itself and approved by the FDA. The implication of such a violation is severe: if Pfizer were so negligent that they included subjects with a psychiatric background in the experiment – contrary to the protocol they themselves established – it means that the subjects’ well-being is not their main concern. As Pfizer itself notes in the protocol: such a background may increase the risk of study participation. And if they do not adhere to ethics in recruiting subjects, who can assure us that they adhere to ethics in other sections of the study – for example, analysis of results?

Designing the protocol in a way that will allow the company to present positive findings regarding the safety of the vaccine

In at least two criteria, the company appears to have manipulatively designed the protocol in a way that would allow it to present as positive findings as possible in terms of vaccine safety in children:

  1. Designing the protocol in a way that will reduce, as much as possible, the inclusion of severe adverse events in a report submitted to the FDA.

In the Pediatric Study Protocol (see table on page 12), Pfizer undertook that the duration of follow-up for serious adverse events (SAEs) would be “from Dose 1 to 6 months after the second dose”.

How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

A six-month follow-up period is considered to be very short compared to the usual follow-up time in Phase 3 studies for vaccines. According to the FDA, Phase 3 in vaccine studies should last between one and four years (4).

Yet it turns out from Pfizer’s review document that the company did not complete even this relatively short follow-up period, and in fact was content with only 30 days of follow-up of the severe adverse events. This fact emerges from the chapter dealing with the date of analysis (page 30, under the heading of the SAEs chapter): “12-15-year-olds: SAEs from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of BNT162b2 recipients and 0.1% of placebo recipients“.

How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

How has this been made possible?

On page 114 of the study protocol – in the chapter dealing with the timing at which the statistical analyzes will be performed, Pfizer set a number of time points for the purpose of performing these analyzes. While the maximum time period for monitoring severe adverse events in the general study population is six months (the seventh section), the fifth section set an additional cut-off point, of only 30 days after the second dose for the purpose of comparing data between two age groups – one of ages 12-15 and one  of ages 16-25.

How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

In other words, the protocol appears to be designed in such a way that the review submitted to the FDA will only include the serious adverse events that appeared during the first month after vaccination.

Indeed the follow-up of the serious adverse events continues for another five months, but any adverse event that will be discovered during these months, or an adverse event that was observed during the first month but was defined as non-serious and has been worsening during the following months (or the diagnosis will change) – will simply not appear in the review report.

The concerning implication of this practice is that serious adverse events may not appear in the report on the basis of which the FDA issues the emergency authorization for children, so continued follow-up, even if published a few months or years after the temporary authorization was issued, will not help children who will be harmed or die following the FDA’s green light.

Designing the protocol so that diagnoses of serious adverse events given in hospitals unrelated to the study site can be ignored.

Within the terms of the Outcome Measures in the study protocol, as it is presented in Clinicaltrials.gov Pfizer determined that the research team selected by Pfizer will be the ones defining the adverse events as such: “As elicited by investigative site staff”.

This way, the company has in effect given researchers selected by them the power to define for themselves what the diagnosis will be, regardless of the diagnosis given at the hospital/ward which is not defined as the research site.

How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

Why is this problematic?

Because such a determination means that if a particular participant suffers from serious adverse events and has been treated, for example, outside the hospital or ward that functions as the research site, then in fact, the diagnosis made by the attending physicians at the hospital/ward in which the participant is treated is irrelevant.

This way, Pfizer has actually allowed its team to define what the diagnosis will be, rather than letting the diagnosis given by the attending physicians confuse them.

Beyond the severe criticism towards Pfizer, the analysis and comparison raise serious questions for the FDA itself:

  • How is it possible that the FDA has even approved a protocol that allows such manipulations?
  • Why did the FDA allow the company to perform the data analysis and submit the application for the emergency permit in children after such a short follow-up time of only 30 days?
  • What made the FDA so eager to approve the emergency permit for children? Why is this approval given based on a safety report that is not even “cooked” half way? After all, there is no emergency situation for children.
  • Why did the FDA not address these manipulations and violations of the protocol after the company submitted its review?

Yaffa Shir-Raz, PhD, is a risk-communication researcher and a teaching fellow in the University of Haifa and the Interdisciplinary Center Herzliya in Israel. This article was published on American Frontline Doctors.

References:

  1. Pfizer-BioNTech. (2021). Emergency Use Authorization (EUA) Amendment for an Unapproved Product Review Memorandum. https://www.fda.gov/media/148542/download
  2. (2021). A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALShttps://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
  3. (2021). Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. https://clinicaltrials.gov/ct2/show/NCT04368728
  4. (2018). Step 3: Clinical Researchhttps://www.fda.gov/patients/drug-development-process/step-3-clinical-research
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9 COMMENTS

  1. What Parents in their right minds would put their children in for a Experimental Gene therapy Bioweapon Trial they have just killed their Children or at least those Children will never have kids of there own when they ready to have kids or get to live that long.

    Even with Pfizer Children Clinical trials they obtained an 86% Failure rate however FDA still approves these deadly injections. Australia’s Therapeutic Goods Administration is also considering to all Pfizer to kill Children in Australia as well. It is due to the Delta variant that actually does not exist because there is no Covid 19 Virus however there is 5G Virus and there is your smoking gun. Why do you think it’s highly censored because these 1%ers do not want you to know their real playbook. Those who open their eyes can see it clear as day.

    Look here plenty of reading with the Truth not Governments Health Propaganda that dribbles plenty of Fear Porn. https://ambassadorlove.wordpress.com/2021/04/07/masks-and-covid-tests-contain-nanotech-vaccines-without-informed-consent

  2. Suicidal ideation is reasonably attributed to the SSRI’s, it can take 1.5 months to adjust to the medicine.. I’ve heard of no complaints about mental health issues from the vaccine so far, so it’s odd to suspect that it’s responsible. That removed confidence in the competency of the article. It seems like it was written from a mindset that was wanting to find wrongdoing and judgment was skewed by confirmation bias.

  3. Once you look down the rabbit hold of Pfizer BoNtech there are breadcrumbs leading to the place you started from.

    First of all remember the Indian scientists who had to retract their paper because it wasn’t peer reviewed ( via Fauci), well BNT162 report isn’t peer reviewed but stayed published on site and gets permission from FDA for EUA.

    Then under the article on BNT163 we find Faucis NIH again.
    “Pharmaceutical companies are not the only claimants of key technology. The U.S. government claims a patent on a key technology
    which may be relevant for BioNTech and Pfizer to stabilize the spike protein. See Public Citizen, Leading COVID-19 Vaccine
    Candidates Depend on NIH Technology (Nov. 10, 2020), ”

    https: / /www. citizen . org/article/leading-covid-19-vaccines-depend-on-nih-
    technology/.

    6 “Certain of our technologies, including in particular certain proprietary manufacturing processes or technologies and/or
    neoantigen prediction technologies, are protected as trade secrets”,.BioNTech SE, SEC Filing (July 21 2020),

    https: //www. sec. gov/Archives/edgar/data/1776985/000119312520195911/d939702df1.htm.

    Noteworthy:
    1-Candidates Depend on NIH Technology (Nov. 10, 2020), ” clear tie from Fauci NIH connection to approval of a non peer reviewed candidate for EUA .

    2-6 “Certain of our technologies, including in particular certain proprietary manufacturing processes or technologies and/or
    neoantigen prediction technologies, are protected as trade secrets”,.BioNTech SE, SEC Filing (July 21 2020),
    ****These lipid nanoparticles technologies that deliver mRNA to our cells are trade secrets and not for public disclosure.

    On biotech site: ”
    Do you need support in protecting your inventions?

    Our attorneys have many years of expertise in patent law as well as in the entire field of intellectual property and are entitled to represent you before any court – in Germany and internationally.
    Please contact us if you are interested.

    -*** interesting that a cluster of attorneys are ready and able to protect pharma and patents but not citizens ….they aren’t liable to citizens for injuries.

    Nice cabal they got going there….

  4. 60 year old female developed psychosis first time in her life with no family history whatsoever post vaccination

  5. I have 4 men acquaintances that I know in my small circle that have developed heart conditions after taking this Vax.
    The vax is loaded with graphene. Graphene attaches to your neural synapses among other things when injected. It is an excellent conductor of electricity and reacts well to microwaves at the 5g frequency. You can read about graphene and microwaves. What is next?
    Governments, media, big pharma are all untrustworthy and it looks like a major population changing event is ready to take place.

  6. Heard of other mental health effects post deathjab,which is what it is,Not avaccine-look up the definition.Even Moderna calls it an Operating system!How many people get trained in driving forklifts,semis,cars,variousproduction processes involving robots or automation?How many people make their kids take swim lessons and firstaid classes?Labels,proper testing/data recording,verifying,training and certificates,safetybelts,drunkdriving laws/punishments,why?Safety,reasonable risk control,reduction in injuries/deaths to others,not just the trained.Most people have a working knowledge of basic car maintenance and common malfunctions,yet is it too much to expect reasonable people to take an interest in how their own bodies work or do not work well? Why would someone take an unproven mystery deathjab? Pharmaco.s are proven deceivers,liars,poisoners,and criminals,check the Many courtcases. Unfortunately,the afore mention unprofessional,corrupted method of skewing so-called studies/research is Very common especially in research off-shored to Africa or poorer countries. Theres also a widespread problem of not being able to duplicate many results of various studies.

  7. This very good analysis that exposes the dishonesty in a corporate led drug safety “research” overlooks the fact that asking the same laboratory that is pursuing the approval of the drug to make the safety assessment is like asking a thief to safeguard your valuables, and expecting him to be honest. A profit driven company will always stretch its dishonesty to the extent that law and possibility of getting caught allows, bribes included. Murder is never off the table in these cases, if it comes to it.

  8. It gets even worse than that – your politicians have sold your rights (if you ever had any) to Pfizer and now Pfizer tells the respective governments what they must do to manage us, bearing in mind we elected the governments to look after us and not Pfizer, ever, at all – which begs the question, what has Pfizer got on everyone at the top of the tree, that they had to sign off on Pfizer’s mRNA contract, without a second thought for those of us who elected them to the positions they hold now – to look after us, not only in America, but everywhere? Read and weep!!

    Pfizer vaccine contracts with governments strangle people’s rights with no recourse for obvious malfeasance
    Aug 4
    Cybersecurity Expert Ehden Biber has legally obtained copies of the Pfizer contracts with Albania, Brazil, Israel and the EU.
    He discovered the first one on an Albanian website, where it was published on January 2021. Its veracity was confirmed when he was able to see Brazil’s Pfizer contract, which is virtually identical on that country’s health ministry website, with a signature that was verified by DocuSign. He has since seen virtually same contract with the EU and heard the details of Israel’s Pfizer contract.
    The contract, which exposes Pfizer to zero liability for anything and places the liability for everything on the government, which is called the “Purchaser” in the contract.
    The deal is a criminal shakedown of epic proportions, the likes of which it is hard to even fathom. Why would anybody sign it?
    Reading the contract’s language sheds some light on the inexplicable behavior of the government authorities of the world and on the true nature of this whole COVID operation.
    It also may shed light on the untimely deaths of two African presidents and the Haitian president, who all very understandably refused to sign this contract!
    In his blog, Biber wrote, “If you were wondering why #Ivermectin was suppressed, well, it is because the agreement that countries had with Pfizer does not allow them to escape their contract, which states that even if a drug will be found to treat COVID19, the contract cannot be voided.”
    And here’s a shocking clause about supplying the product:
    “Pfizer shall have no liability for any failure to deliver doses in accordance with any estimated delivery dates… nor shall any such failure give Purchaser any right to cancel orders for any quantities of Product.
    “Pfizer shall decide on necessary adjustments to the number of Contracted Doses and Delivery Schedule due to the Purchaser … based on principles to be determined by Pfizer … Purchaser shall be deemed to agree to any revision.”
    So Pfizer can breach its own contract but their hitmen will kill you if you refuse to sign it!
    You can really see how this Globalist entity that is Pfizer hates nation states and will not recognize their laws but it acts like a “government that dictates to other governments around the world,” as Biber says. If we look around at the complete lawlessness and the meltdown of once-solid institutions all over the world, you can see that Big Pharma is being used like a massive battering ram against the national laws and national sovereignty of all nations.
    The contract forces the “Purchaser”, which is how they refer to the nation that is contracting with them to defend Pfizer’s interests and not those of the citizens they’re supposed to be representing and defending – and whose taxpayer money they’re using to pay Pfizer these billions of dollars.
    As Biber tweeted, Israel has turned into a pharmaceutical #BananaRepublic, where the priorities of a multinational supercedes the priorities of its citizens.
    Not only is Pfizer held completely harmless from all claims, the “Purchaser”, ie, the national government is responsible for Pfizer’s legal defense against any and all claims!
    However, “Pfizer shall have the right to assume control of such defense… and Purchaser shall pay all Losses, including, without limitation, the reasonable attorneys’ fees and other expenses incurred.” Pfizer makes sure the country will pay for everything.
    I really don’t get why governments across the world have signed this. What’s in it for them? Did they sign this voluntarily? It really seems like a colossal shakedown and a complete abdication on the part of these governments to protect their people. It’s malfeasance on a scale that beggars belief.
    THE ONLY WAY to get a product recall on these shots is if you can prove fault in Current Good Manufacturing Practice (CGMP), which is regulated by the FDA.
    However, CGMP will tell you NOTHING about mRNA, because we don’t have CGMP for an mRNA vaccine, so you cannot prove CGMP malpractice.
    CairnsNews

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