There is no legal limit to the amount of so-called contamination that can legally be included in vaccines or any other biological products.

Part 8 of series.

Katherine Watt

May 21

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Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law

On Kevin McKernan’s latest re contaminants found (by McKernan’s lab and other labs) in vaccines:

There is no legal limit to the amount of so-called contamination that can legally be included in Covid-19 vaccines or any other vaccines or biological products. The FDA has no regulatory obligation to enforce compliance with any safety, efficacy or purity standards, and there are no defined safety, efficacy or purity standards to which FDA could enforce compliance, even if FDA inspectors were legally obligated to enforce compliance, which FDA is not obligated to do.
The entire FDA regulatory system pertaining to biological products, including vaccines, is fake: it’s intended only to deceive the public into believing that unregulated poisons are regulated medicinal products.

Reply to a comment at one of Sage Hana’s recent posts, about mRNA technology having been around since the 1970s, but not used “because of the regulations.”

From my findings about the non-regulation/pretend-regulation and non-definition of all biological products including vaccines, going back to 1902 and earlier, but better documented since the 1944 Public Health Service Act, 42 USC 262, and even better documented since the transfer of fake-regulatory functions from NIH to FDA in 1972, I think the statement that they’ve had the tech for about 50 years is also a mischaracterization.
There is no “tech” in the sense of a predictable method to produce measurable, physically/chemically/pharmacologically identifiable, standardized, pure biological products.
All vaccines are heterogenous mixtures of immunotoxic nucleic acids, metals, lipids and other junk, and they’re all inherently unstable and inherently destructive to the recipient organism.
The innovation of the post-2020 vaccines, I think, is slightly more effective lipid packaging to get the encased unstable junk into cells better and faster, to better bypass the functional parts of the immune system that can flag and destroy non-self genetic material (xenogeneic/different species, allogeneic/same species, different individual).
Maybe they’ve known about the better lipid packaging since the 1970s, but also were playing the long con and then decided circa 2019 to put the pedal to the floor.
The statutes and regulations were never in the way of putting toxic junk into babies and children and adults. They were always written to make and keep clear the legal path for the junk to get injected, and to make it look to the public like there was a real regulatory process to monitor and control manufacturing and use for safety, efficacy and purity. Which there was not.

As I’ve written previously, I have a firehose of information and supporting evidence that I would like to share, because the information may be useful to one or more readers, but my available time, energy and ability to concentrate to digest the material and write it in more-accessible form comes nowhere near close to enough. Series on biological product non-regulation so far.¹

For readers interested in putting together more of the data points themselves, a key false concept and FDA term to study is “well-characterized therapeutic recombinant DNA-derived” biotechnology products.

Briefly, in the mid-1990s, analytical equipment, techniques and skilled labor capable of more fully characterizing nucleic acids, genetic material, chemicals, metals and other biologically-active compounds became more readily available.

By that time, people working in the US Government, especially in the Public Health Service (PHS), Department of Health and Human Services (HHS), National Institutes of Health (NIH), Food and Drug Administration (FDA), National Institute for Allergies and Infectious Diseases (NIAID), Centers for Disease Control and Prevention (CDC) and related military divisions, had already been working since 1955 (mass vaccination of children with polio-predicated immunotoxins) to systematically poison American babies and children using heterogenous slurries of bacteria-, animal-and human-derived genetic material, toxic chemicals and toxic metals.

They had been increasing the toxic loads deliberately put into American babies and children by leaps and bounds since the 1986 adoption of the aptly-named National Childhood Vaccine Injury Act (Pub.L. 99-660) through the childhood immunization schedule inflicted by pediatric vaccine nurses.

And the health of American children was clearly deteriorating, as chronic disease rates shot up for autism, asthma, diabetes, cancer, depression and many other disorders.

The NIH/FDA regulatory record for biological products is non-existent, because as stated, the object of the vaccination program was and still is to systematically poison people and induce chronic disease for two purposes.

Long-term, over several decades, the perpetrators want to lower vitality, fertility and life expectancy among the population and thereby bring down budget expenditures for education, health care and pensions.

Short-to-medium term, the perpetrators want to increase profits, kickbacks and money-laundering for pharmaceutical corporation shareholders and Congress members, by supplying additional poisons to sick people, to manage the symptoms of induced chronic diseases.

To meet those dual goals, the most important thing was to build and maintain unquestioning public trust in the product class of vaccines.

The best way to build and maintain that trust — to shield the intentional poisoning from public view — was to pretend to operate a regulatory system that sets standards for product safety, efficacy and purity; monitors vaccine production to assess compliance by testing samples; and removes unsafe, ineffective and contaminated vaccines from the supply chain.

NIH-FDA set up and operated the required fake regulatory system from 1944 to the mid-1990s. Without going into detail, it hinges on provisions including 21 CFR 610.2, promulgated by Federal Register notice Nov. 20, 1973:

21 CFR 610.2. Requests for samples and protocols; official release.
Samples of any lot of any licensed product, together with the protocols showing results of applicable tests, may at any time be required to be sent to the Director, [FDA] Bureau of Biologics [now CBER].
Upon notification by the Director, Bureau of Biologics, a manufacturer shall not distribute a lot of a product until the lot is released by the Director, Bureau of Biologics;
Provided, That the Director shall not issue such notification except when deemed necessary for the safety, purity or potency of the product. 38 FR 32048.

This is called “lot-release” or “lot-by-lot release.”

It was a non-regulatory regulation when published in 1973.

Why non-regulatory or performative only?

Because of the conditional terms. Director “may” require samples and protocols, but “shall not except when deemed necessary.”
Because the regulatory definitions of safety and potency were relative, not objective (all medical interventions involve personalized calculations about the starting condition of the patient, the risks of causing harm, and the potential benefits of the intervention);
Because the regulatory definition of purity was also given in relative, not objective terms (biological products are intrinsically impure, unstable, heterogeneous and non-standardizable, and FDA regulators and vaccine manufacturers knew this, have known this since the early 1900s and still know it.)
Because the patient, in the case of vaccines, is a healthy baby or child, and the probability that introducing mixtures foreign genetic material, chemicals and metals into a healthy child’s body will cause more harm than good, by inducing chronic disease, approaches 100% as more toxins are introduced (sooner during pregnancy or after birth, additively, and cumulatively.)

That’s the nutshell version of the non-regulation regulation “lot-release” system that was in play between 1973 and 1996.

In 1996, under the deregulation framework launched by President Ronald Reagan and continued by President Bill Clinton, the FDA eliminated lot-release for “well-characterized therapeutic recombinant DNA-derived” biotechnology products, stripping itself of the manufacturing quality control lot-release tool it had pretended to have and had pretended to use since 1973.

Lot-release was only one of many regulations eliminated or rendered more inapplicable to and unenforced for biological products since the mid-1990s.

If you work for an organization (Public Health Service-HHS-FDA-CDC-NIH-NIAID) that’s systematically poisoning people with intrinsically heterogeneous, unstable, immunotoxic products, and you understand that parents will eventually start to notice the sickliness of their children and themselves, the last thing you want is a regulatory process — supported by analytical equipment and techniques — through which toxins might be identified and disclosed to the public, justifying removal of those toxic products from the supply chain.

But you also don’t want to reduce public trust in the poison-products known as vaccines.

That’s the point the systematic poisoners had reached by the mid-1990s.

The solution, to buy themselves what turned out to be another 30 years, was to further eliminate the pretend-regulatory functions they had pretend-fulfilled, by simply claiming that the manufacturers would self-regulate using the analytical equipment, methods and skilled labor that became available by the mid-1990s.

Throughout the process, FDA would make true statements such as:

Biologics have traditionally been complex mixtures of substances produced primarily from living organisms, and have been difficult to characterize by precise tests. They include vaccines, products made from human or animal blood, and other products made from a variety of materials. 60 FR 63048

And then establish non-regulatory policy based on the false, opposite premise:

…technical advances over the last 15 years have greatly increased the ability of manufacturers to control and analyze the manufacture of many biotechnology- derived biological products. 61 FR 24227

In other words, FDA offers the public a series of lies — that biological products are homogeneous, stable and non-toxic; that biological products can be “well-characterized” as such; and that biological products are produced and distributed in safe and pure form by manufacturers, who police their own compliance with regulatory standards so thoroughly that FDA need not test samples or enforce compliance.

The lies are offered as a substitute for the truth: biological products are heterogeneous, unstable and toxic; every vial tested provides evidence of those truths; and FDA and manufacturers coordinate with each other to ensure that vials are not properly tested and that information about the intrinsic heterogeneity, instability and toxicity of vaccines doesn’t reach the public in credible, actionable form.

There is no legal limit to the amount of so-called contamination that can legally be included in Covid-19 vaccines or any other vaccines or biological products.

Some relevant documents below for readers who want to track this a bit more around the mid-1990s, and also bring it up to date with Antonia Gatti and Stefano Montanari’s 2017 study identifying contaminants “not declared among the components,” in 43 of 44 vaccine samples tested; HHS’ 2018 stipulation that HHS has conducted no valid, public vaccine manufacturing or vaccine safety monitoring since 1986 adoption of the National Childhood Vaccine Injury Act; Joy Garner’s 2019-2020 study comparing chronic disease burdens of vaccinated and unvaccinated cohorts, cited in her 2021-2022 federal litigation; Mike Yeadon and Wolfgang Wodarg’s December 2020 petition to European Medicines Agency; Sasha Latypova and Craig Paardekooper’s initial study from October 2021 on Covid vaccine batch variability, foundation for HowBadIsMyBatch website; Max Schmeling, Vibeke Manniche and Peter Riis Hansen’s March 2023 study of batch variability; and Kevin McKernan’s April 2023 study of DNA contamination.

Note:

Readers who read very closely will notice that in some documents, FDA states that vaccines are in the class of “well-characterized” biological products exempt from manufacturing regulation, and in other documents, FDA states that vaccines are excluded from the class of “well-characterized” biological products.

World Health Organization does the same thing.

Following the paper trail long enough, and looking at the documents alongside what you can see happening and not happening in your own body, your own family and friends, in the regulatory agencies and in the courts, supports the conclusion that vaccines are not subject to valid regulation.

FDA and WHO use a wide variety of ill-defined terms, which cannot be clearly defined because biological products are inherently heterogeneous, unstable and toxic, and an intricate web of cross-references, exemptions, exclusions, suspensions, conditionals and waivers, because those linguistic and legal tools are very effective for deceiving the public.

FDA and WHO have forged those linguistic and legal tools for themselves, to obscure the criminal nature of the systematic, deliberate worldwide poisoning campaign they have conducted for about 100 years in collaboration with pharmaceutical companies and non-governmental organizations such as Bill and Melinda Gates Foundation and GAVI.