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In Nov. 2020, Pfizer told FDA reviewers, led by Marion Gruber, that safety studies were neither needed nor conducted.
In making that argument, Pfizer cited WHO guidance written in 2002 by a team led by Marion Gruber.
Marion Gruber should be among the first men and women to enter the dock during the trials to hold the government scientists who orchestrated the biotechnological genocide accountable for their crimes against humanity.
As part of my work developing self-help legal tools for injured and bereaved victims of the Covid-19 genocide, I did a keyword search on my hard-drive last night for “Wistar,” referring to the Wistar rat biodistribution study: SARS-COV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Overview of Pharmacokinetic Test. (Japanese version; English translation.)
A longer version of the Wistar rat study — A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats — dated 11/09/2020, was released under the Freedom of Information Act, by the FDA, to the Public Health and Medical Professionals for Transparency group, as part of the court-ordered document batch releases that began in late 2021 and have been studied by the DailyClout researchers organized by Naomi Wolf.
Pfizer cited the Wistar rat study results in their 11/20/2020 application to the FDA for Emergency Use Authorization.
The FDA cited the Wistar rat study in the Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum, signed by Marion Gruber on 12/11/2020 in her capacity as director of the US-Health and Human Services Department Food and Drug Administration Center for Biologics Evaluation and Research, Office of Vaccines Research and Review (HHS-FDA-CBER-OVRR).
Gruber resigned from that position Nov. 1, 2021, and now works as Vice President for Public Health and Regulatory Science at IAVI, the International AIDS Vaccine Initiative, launched by the Rockefeller Foundation in 1994.
Hers was the signature that launched the mass lethal injection program ongoing to this day: Marion Gruber signed the death warrant used to kill millions of people around the world.
The Pfizer Wistar rat study data was not provided to the people of the United States or the world alongside the rollout of the lethal injections.
It was provided to Japanese regulatory agencies probably around February 2021.
A copy was forwarded to Canadian vaccine researcher Byram Bridle a few months later, translated into English, and then discussed by Bridle in an interview with LifeSite news published May 31, 2021.
Ten days later, it was discussed during a Darkhorse podcast with Bret Weinstein, Steve Kirsch and Robert Malone on June 10, 2021.
At this point in early Summer 2021, four facts became more widely understood among the community of people trying to understand the biotechnology, risks and benefits of the products marketed as ‘Covid-19 vaccines.’
The inflammatory lipid nanoparticles and their payloads collect in the ovaries and other key organs, are not rapidly cleared from the human body and are toxic.
Pfizer scientists knew this before seeking EUA approval from the FDA through the 11/20/2020 EUA application.
FDA scientists led by Marion Gruber knew this when authorizing the product for emergency use on 12/11/2020.
Pfizer, FDA and Gruber withheld this information from the public and knowingly lied each time they described the products as “safe and effective.”
Throughout the process, Pfizer also submitted COMIRNATY (COVID-19 mRNA Vaccine) Risk Management Plans to FDA regulators and regulatory agencies in other countries.
I don’t have all of the Risk Management Plans. I have Version 4.0, dated 11/25/2021, which was submitted to regulators concurrent with the push to lethally inject American children ages 5-11.
At p. 35/178, referring to the Wistar rat studies:
…Two [good laboratory practice]-compliant repeat-dose toxicity studies were performed in Wistar Han rats; one with each variant. Both studies were 17 days in duration with a 3-week recovery period. A DART [Developmental and Reproductive Toxicology] study in Wistar Han rats has been completed.
Safety pharmacology, genotoxicity and carcinogenicity studies have not been conducted, in accordance with the 2005 WHO vaccine guideline. Footnote 88.
Footnote 88 at p. 165/178 refers to WHO guidelines on nonclinical evaluation of vaccines, Annex 1 of the 2005 WHO Expert Committee on Biological Standardization Technical Report Series 927 (160 pages).
WHO Technical Report Series 927 of 2005 refers to the 2004 WHO Expert Committee on Biological Standardization Technical Report Series 924 (242 pages).
Both reports emerged from meetings held in 2002 and 2003, at which Marion Gruber played a central role.
UPDATE - WHO issued revised guidelines on non-clinical evaluation of vaccines, Annex 9 at p. 503-573 of the 2017 WHO Expert Committee on Biological Standardization Technical Report Series 1004 (616 pages). Gruber was a member the 2017 drafting committee, listed on p. 569.
However, Pfizer didn’t cite the 2017 guidelines in its 2021 Risk Management Plan; Pfizer cited the 2005 guidelines.
I skimmed the WHO guidelines on nonclinical evaluation of vaccines this morning, enough to confirm that it provides plenty of room for ‘vaccine’-bioweapon manufacturers to skip safety testing in animal models and proceed directly to human injections.
For example, General Remarks, TRS-927 at 32-33:
Nonclinical studies are aimed at defining the in vitro and in vivo characteristics of candidate vaccines including those relating to safety and immunogenicity. Nonclinical studies in animals are valuable tools for identifying possible risks to the vaccinees and helping to plan protocols for subsequent clinical studies in human subjects.
However, in all cases, when safety testing in animals is performed, there should be a clear rationale for doing so and the study should be performed in compliance with the national and international laws for the protection of laboratory animals (4), biosafety requirements (5) and with good laboratory practice (GLP) (6).
However, there may be situations where full compliance with GLP is not possible…
The need for and extent of nonclinical testing will depend on the product under consideration. For example, for a product for which there is no prior nonclinical and clinical experience, nonclinical testing would be expected to be more extensive than for those vaccines previously licensed and used in humans.
In some cases, it may not be necessary to perform preclinical safety studies prior to the initiation of phase 1 clinical trials. For example, in the case of transfer of technology, where access to the database of the originally developed vaccine is available, data from nonclinical bridging studies (e.g. physico-chemical characterization and abbreviated in vivo studies) may be an acceptable basis for further development of the product…
Section 4 - Toxicity assessment, TRS-927 at 44:
The nonclinical safety assessment of vaccines needs to be viewed in the context of the evolving field of vaccine development. Thus, judgement based on the best science available should always form the basis for any decisions regarding the need for nonclinical safety studies, types of study and study designs.
Similarly, scientific judgement should be applied to the interpretation of data from preclinical studies, regarding the risk–benefit ratio, animal model, dosing etc. For example, the observation of hypersensitivity reactions in an animal model may not necessarily preclude proceeding to clinical trials, but may indicate the necessity for careful monitoring of a particular clinical parameter.
Marion Gruber was at the scientific-legal center of the global criminal conspiracy to conduct lethal biological attacks on the global human population under the experimental ‘vaccine’ rubric, confirmed by her repeated citations in the Authors and Acknowledgements sections of WHO reports produced between 2002 and 2005.
And then she was at the scientific-legal center of the American EUA approvals for the bioweapons falsely labelled ‘vaccines’ in 2020 and 2021.