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Guttermouth's avatar

I am reliably told that it is in fact the unvaccinated, not the vaccines, that lead to increased rates of mutation and variability.

I am uncertain as to what mechanism causes these evolutionary pressures in a normal, unaltered host immune system, but I do know that the unvaccinated are bad, so it is logical that they would incubate bad things in the manner of a witch's third nipple nursing a homunculus.

This leads me to a complete loss to explain the above discussion, so I am choosing to ignore it, out of an abundance of caution.

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Katherine Watt's avatar

Another path to the same conclusion is that legally, none of the pharma companies was ever required by FDA or any other regulatory agency to conduct valid clinical trials or produce valid clinical data.

Instead, the statutory framework for medical countermeasures, security countermeasures, pandemic products, epidemic products and Emergency Use Authorization products, requires no valid safety data, and only an HHS secretary declaration that a product “may be effective.” That simple statement by HHS secretary is enough to authorize procurement contracts, bulk manufacturing, distribution and mass injection.

If Pfizer and Moderna and the other contractors were never required to do valid clinical trials, they didn't do valid clinical trials.

21 USC 360bbb-3(c)(2)(A), added to FDCA in 1997, amended in 2004, means that there are no federally-required safety or efficacy standards for EUA products. The only requirement for "efficacy" claims, is that the HHS Secretary make a declaration that a product "may be effective." That declaration is to be "based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available."

But if no such data is available because it's a declared emergency and there's no time, the declaration that it "may be effective" can be made anyway.

21 USC 355g, added to FDCA in 2016, authorizes use of 'real world evidence’ for FDA regulatory decisions. This means products can legally be manufactured and then mass administered to general public, and safety and efficacy data only collected afterward (privately, not publicly) from health insurance systems, government databases including Medicare, Medicaid, Defense Medical Epidemiology Database, Veterans Health Administration.

21 USC 360bbb-3a(c), added to FDCA in 2013, holds that there are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices. EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.”

21 USC 360bbb-3(e)(2)(B)(ii), added to FDCA in 2004, holds that there are no labeling requirements regarding the contents or ingredients in EUA products.

10 USC 2371b, adopted 2015. renumbered 10 USC 4022 (Jan. 1, 2021, effective Jan. 1, 2022)

authorized DOD to contract with pharmaceutical corporations to conduct ‘prototype’ experiments on the general public, and under such contracts, exempted them from legal obligation to comply with Good Clinical Practices or other FDA regulations.

42 USC 247d-6b (c)(5)(B)(iii), added to PHSA in 2004, holds that one of the factors to be considered by HHS secretary in making determinations about EUA products (qualified security countermeasures) and use of Special Reserve Fund/Strategic National Stockpile appropriations to procure them is "whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure."

I started to piece the statutory timeline together between February and April, while reading up on Brook Jackson's false claims act case, and then Arkmedic and Jessica Rose started talking about the missing CRFs (case report forms, clinical record forms) in early May, which corroborated the conclusion: there were never valid clinical trials.

It was all fabrication.

https://bailiwicknews.substack.com/p/faked-clinical-trials-and-real-world

And Pfizer confirmed it in their April 22, 2022 Motion to Dismiss Jackson's case:

“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.”

https://bailiwicknews.substack.com/p/pfizers-motion-to-dismiss-the-brook

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

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