INSIDE PHARMA

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The first big lie in the mRNA story—and there are thousands more
hedleyrees.substack.com

The first big lie in the mRNA story—and there are thousands more

Lying by omission is rife!

Hedley Rees
May 24
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The first big lie in the mRNA story—and there are thousands more
hedleyrees.substack.com

The first big lie

This article: The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race was published Nov. 10, 2020. The headline picture is of giant ultra-low temperature freezers, ready to store finished vials containing mRNA vaccines for injection.

The article begins:

ANDOVER, Mass. — The liquid that many hope could help end the Covid-19 pandemic is stored in a nondescript metal tank in a manufacturing complex owned by Pfizer.

Most working in the industry will know that Pfizer owns none of the physical assets required to develop, manufacture, transport and store the mRNA vaccines—it is all carried out by third-party organisations.

The next big lie

As it turned out, the ‘finished vials’ were not finished—they contained 5 patient doses, frozen down to -70°C, requiring the addition of a measured quantity of saline diluent (supplied separately) to each vial, with a subsequent mixing operation to be carried out.

Adding to the complexity, the vials containing the 5 doses were packed in trays, each tray housing 195 vials. They had to be thawed from -70°C to room temperature, in a refrigerator (+2 to +8°C). This is a tricky business, as molecular structure could alter during thawing. Studies have to be run to prove the thawing can take place safely.

The full details can be found towards the bottom of this document on the MHRA website: Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech (Regulation 174), updated 5 May 2022.

Pharmaceutical law requires a licensed facility to carry out the conversion

Under pharmaceutical law (in any country) the conversion of the -70°C vials must be carried out in a facility licensed to manufacture pharmaceutical products. To achieve a license, the facility owner needs to prove every operation is carried out to Current Good Manufacturing Practice (CGMP). The definition of manufacturing below should help with understanding the scope of what comes under that umbrella:

Pharmaceutical manufacturer means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs.

Is that clear enough for you?!

The hurriedly constructed vaccination centres had no such licenses and given none of the people working in them had any kind of skills or experience in manufacture, they would not be capable of getting one.

These licenses are not ‘nice to haves’, they are essential to ensure the proper checks and balances are in place to avoid potentially dangerous errors.

This lie led to gross non-compliances with pharmaceutical law, under the responsibility of FDA/EMA/MHRA etc.

Normally, this would call for a halt to all activities carried out in the vaccination centres, period. Why is it not happening?

Lying by omission is still lying!

If you refer to the earlier article The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race you will be able to decide for yourself what is likely to be fact, and what is fiction.

Note, much of it is lying by omission. There is no mention of the issues in manufacture above. Neither is there mention of these ‘scientists’ merely playing with genetic code as a theory, when they have never been part of bringing a drug to market ever before!

My plea to you

Now you are aware, if you weren’t already, of the scale of the lying by omission throughout this dreadful COVID nightmare, you must keep asking questions. You probably are anyway if you are subscribed here!

More on this topic soon :O)

Hedley

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SomeDude
May 27·edited May 27Liked by Hedley Rees

article about the "why," or at least the how, the standard safety regulations aren't applied.

plenty of links to government documents.

last month's news

As reported yesterday, on April 22, 2022, Pfizer filed a motion to dismiss whistleblower Brook Jackson’s False Claims Act case.

In its motion for dismissal, Pfizer doesn’t argue that the clinical trials for the products marketed by the US government were not fraudulent.

Instead, Pfizer argues that the corporation never had an obligation to conduct sound, non-fraudulent trials under the terms of its Base Agreement with the US government (Exhibit A to Pfizer’s Motion to Dismiss filed 04/22/2022) and the Statement of Work (Exhibit 10 to Jackson’s Complaint filed 01/08/2021 and her Amended Complaint filed 02/22/2022).

“Because of pandemic-related exigencies, the agreement was not a standard federal procurement contract, but rather a ‘prototype’ agreement executed pursuant to 10 U.S.C. § 2371b[.]…

The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations.”

Pfizer further argued:

“The Government’s ‘actual behavior’ here says it all. Both the complaint itself and the public record show the Government has been fully aware of [whistleblower Jackson’s] Relator’s allegations for nearly two years without withdrawing authorization or stopping payment for Pfizer’s vaccine.”

This is true. Jackson told the FDA the trials were being conducted in corrupt and illegal ways in September 2020, and the FDA moved ahead anyway.

Jackson told the Department of Justice in January 2021 when filing her original False Claims Act complaint. The DOJ gagged her from speaking publicly, and declined to prosecute Pfizer or its subcontractors.

10 USC 2371b has been renumbered. It’s now 10 USC 4022 - Authority of the Department of Defense to carry out certain prototype projects.

Here’s where 10 USC 4022 sits under Title 10, Military Law:

Title 10 - Military Law

→ Subtitle A - General Military Law

→ →Part V - Aquisitions

→ → →Subpart E - Research and Engineering

→ → → → Chapter 301 - Research and Engineering Generally

→ → → → → Subchapter II - Agreements

→ → → → → → Section 4022 - Authority of DOD to carry out certain prototype projects

Subchapter II - Agreements, includes:

§ 4021. Research projects: transactions other than contracts and grants

§ 4022. Authority of the Department of Defense to carry out certain prototype projects

§ 4023. Procurement for experimental purposes

§ 4024. Merit-based award of grants for research and development

§ 4025. Prizes for advanced technology achievements

§ 4026. Cooperative research and development agreements under Stevenson-Wydler Technology Innovation Act of 1980

[§ 4027. Disclosure requirements for recipients of research and development funds]

The first part of 10 USC 4022 explains:

“[T]he Director of the Defense Advanced Research Projects Agency (DARPA), the Secretary of a military department, or any other official designated by the Secretary of Defense may, under the authority of section 4021 of this title, carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces.

That’s what the SARS-CoV-2 epidemic and the Covid-19 injection program are: a military prototype project.

Related: The US Congress in 1997 pretended stop to unethical US government experimentation on military personnel, while actually expanding the pool of human subjects for DOD experiments to include the military and the rest of the American population, by moving the experimental programs from the Department of Defense to the Department of Health and Human Services Food and Drug Administration, and then merging HHS with DOD through subsequent legislation.

https://bailiwicknews.substack.com/p/implications-of-10-usc-2371b-the/

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Jonathan Gilthorpe
May 24Liked by Hedley Rees

Thanks Hedley - this is useful information. As a case in point, please have a look at the picture in this Swedish news article from a vaccine distributor talking about a digital site visit from the PM and minister for health...how many times will these vials have stood out in room temperature before reaching their destination? Nobody will have any idea.

https://www.apoex.se/nyhet-2021-06-03-statsministern-lovordar-apoex/

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