7 Pfizer COVID-19 Trade Secrets in 3.2.P.1?

There appear to be up to 7 fully redacted ingredients in Pfizer’s experimental genetic vaccine BNT162b2. In this video, I discuss a heavily redacted excerpt of Section 3.2.P.1 from a confidential Pfizer document, released by the MHRA in response to my Freedom of Information request. For further details, please visit alltherisks.com/trade-secret. I have already extensively documented #AllTheRisks across toxicology, molecular biology, virology, immunology and epidemiology in a fully independent biosecurity risk assessment at http://www.alltherisks.com.

Summary Basis for Regulatory Action – Comiranty

Source: https://www.fda.gov/media/151733/download

https://drive.google.com/file/d/1sgZYqm7vJhxEk4Zc0nbFsv69ClCZqniX/view

CRITICAL UPDATE! In response to my Freedom of Information (FOI) request, on 11 November 2021, the MHRA provided the below heavily redacted excerpt from a confidential Pfizer document. Table 3.2.P.1-1 appears to list 7 fully redacted ingredients.

Background: COMIRNATY is a trade name of Pfizer’s experimental SARS-CoV-2 genetic vaccine BNT162b2, the same experimental product deployed in the UK under Regulation 174 from the MHRA, the UK’s Medicines and Healthcare Regulatory Agency. According to the CDC, “There has been no change in the formulation of the vaccine since the name change.” The FDA’s document Summary Basis for Regulatory Action – COMIRNATY, dated 23 August 2021, outlined the full approval of COMIRNATY. As below, Table 2 protected a 0.450ml excipient from public disclosure, according to U.S.C. § 552(b)(4), in lieu of “[t]rade secrets and commercial or financial information obtained from a person and privileged or confidential”.

Without reversioning their document, as below, the FDA later spontaneously updated Table 2 to supposedly reveal this previously undisclosed excipient to simply be water for injection (UNII: 059QF0KO0R).

However, this new disclosure cannot be reconciled with Table 3 in the same FDA document.

Therefore, on 20 October 2021, I raised a Freedom of Information (FOI) request to the MHRA entitled: Exact quantity of Water for Injection pre and post dilution in BNT162b2.

On 28 October 2021, the MHRA responded with the following:

The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm whereby the information can be used by competitors to inform their own product development and overcome regulatory hurdles.

Critical questions that must immediately be addressed by the MHRA therefore include:

  1. What could possibly warrant the MHRA’s decision to not disclose the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 by invoking an absolute exemption (Section 41) and a qualified exemption (Section 43)?
  2. Why would the disclosure of the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 inflict any “commercial harm” on Pfizer, as the MHRA claim?
  3. If the only solution present in BNT162b2 in liquid or frozen state is water for injection (UNII: 059QF0KO0R) then how could confirmation that it comprises the entire solution of BNT162b2 in its pre-dilution and post-dilution state “be used by competitors to inform their own product development and overcome regulatory hurdles”?

A diagram of mine illustrating dilution and post-dilution dosing of BNT162b2 is shown below.

NAC’s Crucial Role in Preventing and Treating COVID-19

Analysis by Dr. Joseph Mercola

Source: https://media.mercola.com/ImageServer/Public/2021/November/PDF/coronavirus-n-acetylcysteine-pdf.pdf

STORY AT-A-GLANCE

  • N-acetylcysteine (NAC) is a precursor to reduced glutathione, which appears to play a crucial role in COVID-19. There’s evidence glutathione deficiency may worsen COVID-19 severity
  • Patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency are more prone to COVID-19 as it depletes glutathione. Some of these patients are also at increased risk of hemolytic anemia when given the COVID-19 drug hydroxychloroquine
  • High-dose intravenous NAC may address the chain of events leading to red blood cell hemolysis in these patients, allowing them to recover from severe COVID-19
  • NAC also inhibits expression of proinflammatory cytokines, improves T cell response, benefits a variety of lung problems, and inhibits the hypercoagulation that can result in stroke and/or blood clots that impair the ability to exchange oxygen in the lungs
  • As the benefits of NAC against COVID-19 are starting to become known, the U.S. Food and Drug Administration is suddenly cracking down on NAC, claiming it is excluded from the definition of a dietary supplement

Dr. John Campbell – Neuro disease after vaccine with Nikk

Nikk describes her experiences after vaccination and her struggles to be heard, thank you Nikk. This is the link referred to in the discussion, https://www.c19vaxreactions.com (C19 vax reactions) On a separate note, John would like to talk to Eric Clapton, if anyone knows Mr Clapton please pass on this request, campbellteaching@hotmail.com

THE BMJ – Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Source: https://www.bmj.com/content/375/bmj.n2635

PDF: https://www.bmj.com/content/bmj/375/bmj.n2635.full.pdf

Feature BMJ Investigation

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.