Orientation for new readers; American Domestic Bioterrorism Program; Tools for dismantling kill box anti-law
In
recent months, as I’ve learned more about the non-regulatory,
fraudulent character of FDA’s purported oversight of biological product
manufacturing, I’ve tried to convey a few key points.
Vaccine manufacturers, FDA and the FDA’s regulatory partner — the US Pharmacopeia-National Formulary — have never established
any objective, measurable, verifiable physical, chemical or biological
standards for gene-containing, cell-based products including but not
limited to products labeled as vaccines.
Pharmaceutical
manufacturers, FDA and USP-NF have never identified or developed
techniques or equipment that can validly measure physical, chemical and
biological characteristics of vaccines and related biological products.
And FDA has never enforced,
on vaccine manufacturers, compliance with any objective, measurable,
verifiable physical, chemical or biological standards for vaccines and
related biological products, because such standards have never been
established and do not exist.
I have argued that these failures are attributable to the inherent heterogeneity, instability and toxicity of biological material contained in vaccine packages.
In each vial and each dose, there is a wide variety of genetic material, along with other, non-biological substances such as metals.
At
every step along the path, from the raw materials and cell lines
propagated in the factories, to the moment of injection and after the
contents enter the living human or animal body, genetic material is
prone to decay, fragmentation, sedimentation, protein-folding, and other
transformations.
It is not in stasis; it is dynamic; it is unstable.
And
the genetic material, because it is foreign to the person receiving it
and living creatures are designed to respond defensively to invasions of
foreign matter, is harmful to the recipients.
It
is toxic — to a greater or lesser degree depending on infinite
variables — to every person who receives any vaccine, each time such
invasion occurs.
There
is no way for anyone to know even the identity of the biological
material in the vials, and thus also no way for anyone to know the
purity, potency, safety or efficacy of genetic material whose identity
is unknown.
All
vaccines, up to and now including mRNA/LNP vaccines, have always
contained genetic, cell-based material foreign to the recipient.
All vaccines, up to and now including mRNA/LNP vaccines, have always caused harm to the recipients.
In the last couple of days, I’ve come across reinforcement of these points from several sources.
Without
providing in-depth analysis, I’m offering some quotes and links for
readers who want to study and think about these things more, to further develop confidence in decisions to stop taking all vaccines and stop all vaccination of babies and children.
The
sources cited below support the conclusion that the inherent
heterogeneity, instability and toxicity of vaccines has been known to
manufacturers, fake-regulators and vaccination proponents for a very
long time.
For
more than 100 years, and still today, US and international government
and non-governmental agents have advocated and coerced public submission
to vaccination as an intentional program to deceive, harm and kill people.
Critical Quality Attributes
An important phrase to learn is “critical quality attributes.”
I
first heard it in June 2024 during a conversation with a pharmacist
about the relationship between FDA and the US Pharmacopeia-National
Formulary, and about USP-NF employees’ efforts, in recent years, to
grapple with mRNA/LNP vaccines and other novel genetic, cell-based
products.
FDA has defined CQAs as
“a
physical, chemical, biological, or microbiological property or
characteristic that should be within an appropriate limit, range, or
distribution to ensure the desired product quality.” (November 2009, FDA Guidance for Industry Q8 (R2) Pharmaceutical Development)
CQAs
are related to all the things that Sasha Latypova has investigated and
written about, concerning Chemistry, Manufacturing and Controls (CMCs),
the complete non-applicability and non-enforcement of CMCs to Covid
vaccines, including her December 2022 memo to Senator Ron Johnson.
Again,
without trying to contextualize the information, apart from a few brief
comments, below are the sources I’ve come across in the last few days.
1910 - Vaccine Virus, paper by Milton J. Rosenau, [second Director of Public Health and Marine Hospital Service Laboratory of Hygiene, 1899-1909], published by JAMA
Vaccine
virus is the specific principle in the material obtained from the skin
eruption of calves having a disease known as vaccinia [cowpox]…
Both the pulp and the lymph are mixtures
containing epithelial cells, serum, blood, leucocytes, products of
inflammation, debris, bacteria, etc., in varying proportions.
The specific principle of vaccinia [cowpox] is unknown…
It is impossible to obtain vaccine virus free from the bacteria of the skin…
The
fact that a serum or vaccine is granted a license does not mean that it
is a valuable curative or prophylactic; in fact, it may have little or
no therapeutic value…
Why vaccine virus should be in the Pharmacopeia…
The objection, that vaccine virus is an indefinite substance, the ‘active principle’ of which is not known,
is no longer valid, for the Pharmacopeia contains many such substances,
including the ferments, against which similar objection holds.
The objection that vaccine virus cannot be “assayed” [quantitatively and qualitatively analyzed
to determine the presence, amount or functional activity of a
substance] by the average druggist also lacks force when we recall that
the potency and purity of vaccine virus in interstate traffic is cared
for by the federal government under the law of July 1, 1902, which relieves the pharmacist of this responsibility…
KW
comment: Rosenau asserted that the presence of other undefined
substances in the Pharmacopeia, meant that pharmacists should have no
problem handling and dispensing the undefined substances contained in
vaccine packages.
Rosenau
further asserted that, although the unknown and unknowable contents of
vaccine packages couldn’t be objectively analyzed by anyone, including
dispensing pharmacists, pharmacists should not be concerned about it:
the federal government had legally relieved them of responsibility for
the contents of vaccines.
2010 - Sequence-Based
Classification of Select Agents, A Brighter Line: Committee on
Scientific Milestones for the Development of a Gene Sequence-Based
Classification System for the Oversight of Select Agents (NASEM)
“…Natural variation and intentional genetic modification blur the boundaries around any discrete list based on taxonomic names…
The committee was specifically charged with identifying: the scientific advances that would be necessary to permit serious consideration of developing and implementing an oversight system for Select Agents that is based on predicted features and properties encoded by nucleic acids rather than a relatively static list of specific agents and taxonomic definitions.
It is implicit in the charge that a “predictive oversight” system is not now feasible.
It is also implicit that “gene sequence-based classification,” is
synonymous with “predict[ing] features and properties encoded by nucleic
acids.”
However,
it soon became clear that the committee was confronted by two quite
different tasks, one of which is feasible and one is not. It is possible
to classify a new sequence as belonging within a group of known sequences; it is not feasible to predict the function(s) that sequence encodes. Thus, it is essential to distinguish sequence-based classification from sequence-based prediction of biological function.
A sequence-based prediction system for oversight of Select Agents is not possible now and will not be possible in the usefully near future.
Select
Agent is not a biological term; rather it is a regulatory designation.
Some properties historically considered in assigning an organism to the
Select Agent list are not biological properties, and therefore, can
never be determined from the organism’s genome sequence.
High-level biological phenotypes—such as pathogenicity, transmissibility, and environmental stability—cannot plausibly be predicted with the degree of certainty required for regulatory purposes, either now or in the foreseeable future.
Reliable
prediction of the hazardous properties of pathogens from their genome
sequence alone will require an extraordinarily detailed understanding of
host, pathogen, and environment interactions integrated at the systems,
organism, population, and ecosystem levels. It is a prediction problem
of the greatest complexity.
Biology is not binary. Microorganisms are not either “potential weapons of mass destruction” or “of no concern.”
No single characteristic makes a microorganism a pathogen, and no
clear-cut boundaries that separate a pathogen from a non-pathogen.
Pathogenic microorganisms are not defined by taxonomy; it is common for a
given microbial species to have both pathogenic and non-pathogenic
representatives. An agent has multiple biological attributes, and the
degree to which these are expressed fall along a spectrum for each
biological characteristic; (1) consequently, agents present varying
degrees of risk.
For
the foreseeable future, the only reliable predictor of the hazard posed
by a biological agent will be actual experience with that agent…
…The
scientific community does not have sufficient knowledge to create a
novel, viable life form, even a virus, from the bottom up. Designing an infectious viral genome de novo by
sequence requires the accurate prediction of protein structure and
function, the design of protein-protein interactions and protein
machines, all of which must produce progeny virions efficiently in an
order of magnitude more complex host cell.
If
we cannot predict protein structure and function on the basis of
sequences with any accuracy, how can we design and synthesize novel
viruses that will replicate, regardless of their disease potential?
KW comments:
There is no ‘bright line’
or even the possibility of a bright line, distinguishing cell-based
biological weapons — ‘select agents and toxins,’ in HHS regulatory
language’ (42 USC 262a; 42 CFR 73) from vaccines and other biological, genetic, cell-based products.
And
because it is not feasible to predict biological functions of encoded
sequences, for the purposes of classifying a sequence as a select agent
or biological weapon, it is also not feasible to predict biological
functions of encoded sequences in terms of their therapeutic value as
treatments or prophylactics.
In
other words, there is no scientifically-feasible foundation upon which
vaccine manufacturers, regulators, advocates or users can make any
valid, verifiable, credible, trustworthy claims about the identity,
purity, potency, safety or efficacy of vaccines and other genetic
products.
2017 - Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop (National Academies of Sciences, Engineering and Medicine)
…Although
regenerative medicine has great potential for producing both health and
economic benefits, this relatively new field faces unique regulatory
and manufacturing challenges. The reliance of regenerative medicine
products on living cells and tissues, which are inherently dynamic,
adds a fundamental complexity to the manufacturing and scale-up process
that is not present in the manufacture of most non-biologic therapies.
Since
the variety of cells and tissues used in regenerative medicine is vast
and the characteristics of cells can differ between in vitro and in vivo
environments, defining and assessing the quality of products is
challenging.
In
addition, it can be difficult to accurately measure or test for
critical quality attributes (CQAs) (i.e., physical, chemical,
biological, or microbiological characteristics that should be within an
appropriate limit, range, or distribution in order to ensure the desired
product quality (2) of cells because these attributes can change over time as they are affected by the cell maturation process and exposure to environmental stimuli.
…[O]n
June 26, 2017, the Forum on Regenerative Medicine hosted a public
workshop in Washington, DC…to examine and discuss the challenges,
opportunities, and best practices associated with defining and measuring
the quality of cell and tissue products and raw materials in the
research and manufac turing of regenerative medicine therapies. (4)
The
goal of the workshop was to learn from existing examples of the
manufacturing of early-generation regenerative medicine products and to
address how progress could be made in identifying and measuring CQAs.
While there are increasingly more regenerative medicine products in the clinical pipeline and on the market, there
is not yet consistency in the approaches to cell sourcing, product
characterization, manufacturing processes, or logistics and delivery
models…
Inherent Challenges to Preparing and Regulating Biologics
Many
of the approaches and practices that the day’s presentations and
discussions would highlight are rooted deeply in the history of
biologics development, said Jay Siegel, a forum co-chair and the chief
biotechnology officer and head of scientific strategy and policy at
Johnson & Johnson.
Vaccine
production is centuries old, he noted, with the use of antisera
products to treat infections going back to the 1890s. Monoclonal
antibodies and cell and gene therapies are examples of more recent
biologic products used to treat disease.
Although each of these biologics has its unique manufacturing obstacles, he said, they share common challenges, such as difficulty
in characterizing the final product and the variations that inherently
occur when living cells and tissues from several different sources are
used.
Unlike the case with non-biologic drugs, there is no method to sterilize a cell-based biologic in its final packaging, Siegel said, and the cell-based biologics can be reactive, immunogenic, and relatively unstable.
Related:
May 21, 2024 - There
is no legal limit to the amount of so-called contamination that can
legally be included in vaccines or any other biological products.
July 11, 2024 - On "unavoidable, adverse side effects" as deceptive language used to conceal the intentionality of vaccine toxicity. - “…SCOTUS is on board with the vaccine-mediated cull; they've already addressed it through Bruesewitz v. Wyeth (2011)…A key phrase from Bruesewitz, citing Hurley v. Lederle (1988),
identifies the FDA as a “passive agency,” which is code for
non-regulatory, having no legal authority or historical record of
setting or enforcing standards for vaccine design, identity, safety, or
efficacy…Scalia opinion at p. 13: “Design defects…do not merit a single
mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s
regulations. Indeed, the FDA has never even spelled out
in regulations the criteria it uses to decide whether a vaccine is safe
and effective for its intended use.”
Aug. 26, 2024 - Intentional elusivity of definitions for virus and vaccine.
St. Augustine and St. Monica. Gioacchino Assereto.
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