Comments (with some additions) posted on Sasha Latypova post:
In my view, there is no commercial market from which FDA could remove the Covid shots, or any vaccines.
EUA [emergency use authorization], BLA [biologics license application], doesn’t matter.
Covid vaccines, like all vaccines, are used in war, not in commerce, not in commercial markets.
“Approval” is a legal fiction. All acts of FDA “approval,” “authorization,” and “licenses” are legal fictions.
All interactions between FDA (and precursor “regulators”) and vaccine-bottlers have all been fiction, all the way back to 1902.
Vaccines
are legalized weapons, trafficked for maiming and killing purposes, not
medical products labeled or regulated for purity, safety or efficacy.
The
labels are part of the legalized weapon delivery system; the purpose of
the labels is to deceive the targets into seeing a bottle of poison as a
bottle of standardized, regulated medicine.
Further, FDA has no authority to regulate manufacture of any biological products, not just vaccines, and not just Covid vaccines.
There
are no physical standards for product identity, purity, stability,
non-adulteration, non-contamination, toxicity, or potency in statute or
regulation governing manufacture of any biological products, and there
are no analytical test procedures that poison-bottlers or FDA could
apply to determine whether contents of any container meet, fail to meet,
or exceed such standards (which standards don’t exist.)
The
simulation for such standards in earlier decades was printed in the
“Additional Standards” sections of fictional biological products
regulations.
Those
have been removed and replaced, since about 1996, with the current form
of simulation: the “Chemistry Manufacturing and Control” or CMC
package, through which poison-bottlers notify the FDA about what they
(the bottlers) will pretend to have the technical capacity to do, and
will pretend to do, and will pretend to self-monitor and self-report
having done.
FDA
then issues “approval” letters pretending that the poison-bottlers
actually carried out the pretend processes using the pretend techniques,
actually did self-monitor, and actually found themselves in compliance
with the simulation of standardization.
Sometimes
FDA also issues fake “lot release” documents, pretending that FDA has
the technical capacity to corroborate the poison-bottlers lies, and has
applied its technical capacity to confirm that the poison-bottlers
properly used the fake-techniques the bottlers claim to have used.
FDA
and poison-bottlers jointly use CMC packages, and labels, and “fact
sheets” and fake “lot release” documents, to deceive the public into
seeing bottles of poison as bottles of standardized, regulated medicine.
True
physical standards don’t exist for biological products because they
can’t exist. Analytical tests for assessing biological products for
conformity with standards don’t exist because they can’t exist.
Such standards and analytical tests can’t exist because of the nature of biological matter.
All
vaccines are intrinsically heterogeneous, unstable mixtures of
biological cells, tissues, sub-components thereof, synthetic chemicals,
nutrient solutions, carrier substances and other biologically-active
junk.
Vaccine contents are not designed to specifications to cause predictable, controllable, beneficial effects.
Their
contents are incubated, cultured, fermented, putrefied and decanted
into bottles of ill-characterizable mixtures, then refrigerated, frozen
and/or freeze-dried, then defrosted, dissolved and injected into
bloodstream of targets to cause unpredictable, harmful effects with
plausible deniability for those who recommend, bottle, transport and use
the weapons.
Reader reply:
That
is my understanding too. That is, that manufacture of 'biologics' class
of drugs is so high-tech that GMP have yet to be developed. Thusly, one
could test for a 100 adulterants and not find another 100 that were
actually in the product...
Reply:
It's not that biologics manufacturing is so "high-tech."
It's not manufacturing in a technical way at all.
It's
more like making yogurt, bread, beer or sauerkraut — which are made
with limited, discernible, digestible bacteria and which are consumed
through the digestive tract, which has the capacity to break down and
use the food. And with fermented foods, or foods in which fermentation
is one step in the process, humans and animals have senses (smell,
taste, sight) that enable us to recognize when the food is not fit for
consumption (contaminated, moldy etc.) and avoid eating or drinking it.
Vaccine
propagation methods do not use only limited, discernible, digestible
bacteria, and they're not subject to effective procedures that destroy
most competing microorganisms to allow only the required fermenting
microorganisms to outgrow all the others.
And vaccines are injected into the blood.
Vaccine
propagation, as I understand it, involves throwing a bunch of living
organisms (i.e. bacteria), plus cells and tissues taken out of living
organisms (fungi, plant, bird, insect, animal, human) and other junk in
an incubation vat with nutrient solutions; fermenting it while some of
the material dies and decays; bottling it;
refrigerating/freezing/freeze-drying it; and then reconstituting it at
room temperature and injecting into living bodies where some of the
processes resume at body temperature and many of the fragments of the
dead organisms, cells and tissues (i.e. proteins) are biologically
active in the form of evoking anaphylactic/allergic reactions and
inducing chronic diseases known as cancer, asthma, leaky gut, and so on.
I
agree that one could test for 100 adulterants or contaminants (also
referred to as extraneous proteins, adventitious agents, bioburden, and
other terms in pretense-regulations and Guidance for Industry documents)
and not find another 100 that were in the product, and therefore there
can't be GMP [good manufacturing practices] standards, but not because
manufacturing is "high-tech."
It's
because living organisms exist in so many forms, and are involved in so
many transformations and interactions with each other over time, no one
can reliably predict what might be in any sample to test for, nor can
anyone predict what the effect of each thing that might be found, might
be in the life and organ functioning of any person or animal into whose
blood that sample might be injected, nor can anyone reliably predict
whether the form that the sample contents were in at the time of
testing, will be the same form that the sample contents were in at the
time if injection, and there's a high probability that the two
compositions will not be the same, because the contents of the bottle
are not stable, and are not homogeneous.
While
preparing the above comment exchange for posting, I also began drafting
a more detailed exposition on the relationship between 42 USC 262(d),
which relates to HHS Secretary authority since the 1986 National
Childhood Vaccine Injury Act to “recall” biological products “upon a
determination that a batch, lot or other quantity of a product licensed
under this section presents an imminent or substantial hazard to the public health” and 42 USC 300aa-28(a), which relates to vaccine-bottlers non-substantive pseudo-obligation since the 1986 NCVIA to:
“(1)
prepare and maintain records documenting the history of the
manufacturing, processing, testing, repooling, and reworking of each
batch, lot, or other quantity of such vaccine, including the
identification of any significant problems encountered in the
production, testing, or handling of such batch, lot, or other quantity,
(2) if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard
is presented, report to the Secretary within 24 hours of such safety
test which the manufacturer (or manufacturer's representative)
conducted…”
I
have located no definitions in statute or regulation for what
constitutes an “imminent and substantial hazard,” and again: there are
no validated, standardized tests or assays, or techniques or equipment,
capable of fully identifying or characterizing the constituents of
vaccine containers during or after processing, because those
constituents are, by nature, impure mixtures of many different organisms
and organic substances, and unstable or dynamic.
Thus,
any process or batch testing that a vaccine-bottler might conduct will
not be able to fully identify the biological and chemical matter
contained in any “batch, lot or other quantity,” and will not be able to
meaningfully characterize any product in terms of safety, efficacy, or
“potential imminent or substantial public health hazard.”
Further,
vaccine-bottlers are not required to collect or report information
about adverse effects experienced by recipients of the products after
the containers leave the bottling facilities.
Thus,
there can be no product-quality-based information about “imminent or
substantial hazards” for a vaccine-bottler to report to the HHS
Secretary, and there can be no product-quality based grounds for the HHS
Secretary to “determine” that a batch, lot or other quantity “presents
an imminent or substantial hazard” and order a recall.
For
more information on this element of legalized vaccine deception, see 42
USC 262(d); 42 USC 300aa-28(a); 42 USC 300aa-33(5) —
“(5)
The term "vaccine-related injury or death" means an illness, injury,
condition, or death associated with one or more of the vaccines set
forth in the Vaccine Injury Table, except that the term
does not include an illness, injury, condition, or death associated with
an adulterant or contaminant intentionally added to such a vaccine”
and 2017 paper, Recalibrating Vaccination Laws, Efthimios Parasidis, Boston University Law Review, Vol. 97 at p. 2224:
…In
addition to adjusting physicians’ reporting incentives, lawmakers
should amend the Vaccine Act to incentivize manufacturers to analyze
post-market data on vaccine safety and efficacy. Manufacturers currently
are responsible for documenting “the history of the manufacturing,
processing, testing, repooling, and reworking” of vaccines, “including
the identification of any significant problems encountered in the
production, testing, or handling.” If safety testing reveals “a
potential imminent or substantial public health hazard,” manufacturers
must notify the government within twenty-four hours of the test…While
these recording and reporting requirements are important, a key element
is missing. Specifically, the Vaccine Act does not mandate that vaccine
manufacturers collect or analyze safety and efficacy data from patients
in which their vaccines are administered. Rather, the bulk of this work
is left to regulators. As detailed, however, VAERS—the FDA’s primary
mechanism for post-market review—is a “passive” surveillance system and
“no active effort is made to search for, identify and collect
information…”
See also, FDA Regulatory Procedures Manual,
Ch. 5 (Administrative Actions) and Ch. 7 (Recall Procedures), which
mention “imminent or substantial hazard” but under Implementing
Regulations, Procedures and Industry Guidance [Guidance for Industry],
at p. 16 of 153 of Ch. 7, simply note: “N/A” for “not applicable.”
Adoration of the Trinity. Albrecht Dürer
Related:
March 15, 2024 - Deregulation of biological product manufacturing, mid-1990s to present.
Don't-ask-don't-tell as applied to vaccines and other
difficult-to-characterize, highly-susceptible-to-contamination
medical-military poisons.
The
ostensible reason was to relieve paperwork burdens and costs on
pharmaceutical manufacturers. The changes are scientifically
pseudo-justified with assertions that manufacturers have developed such
excellent internal quality-control processes and technologies, that FDA
validation of manufacturer claims about product purity, sterility and
safety are no longer needed.
This is nonsense, as are many other FDA claims to be found in Federal Register notices and guidance documents.
Biological
products, including but not limited to vaccines, are inherently
heterogeneous, impure, non-sterile, immuno-toxic, and unstable.
FDA
lawyers, pharmacologists, toxicologists, factory inspectors and product
reviewers know those truths. They have known those truths for many,
many decades.
The
real reason for the rule changes was to enable biological product
factories to be more fully converted to non-regulated, black-box poison
factories and to increase the toxicity of the poisons distributed from
their loading bays.
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.
“…The
NIH/FDA regulatory record for biological products is non-existent,
because the object of the vaccination program was and still is to
systematically poison people and induce chronic disease…
the
most important thing [to facilitate systematic poisoning] 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…
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…”
June 17, 2024 - Pretense of biological product manufacturing de-regulation layered on pretense of biological product manufacturing regulation.
…For
FDA and pharma, they’re deregulating a system that wasn’t regulating
even before the deregulation: it’s pretense of deregulation layered on
pretense of regulation…
Sept. 10, 2024 - 1901-1910:
Federal government licensing of virus and toxin propagation
establishments; criminalization of traffic in adulterated or misbranded
drugs.
…The 1902 Virus-Toxin law did not prohibit adulteration or misbranding of virus, toxin and serum package contents…
Oct. 9, 2024 - 1911-1943:
Continued non-existence of legal provisions directing federal agencies
to establish and enforce biological product definitions and standards.
…Viruses,
toxins, serums, vaccines and related biological products manufactured
or propagated at licensed establishments under the 1902 Virus-Toxin law
were not subject to any of the provisions of the 1906 Pure Food and Drug
Act. Virus and toxin manufacturers were not required to provide, on
package labels, any information about ingredient identity, volumes,
weights, concentrations, or effects. Congress was silent on the
adulteration and misbranding of virus and toxin products…
Feb. 28, 2025 - 1944-1972:
Law and public policy imbued with scientific misconduct to better
induce irrational fear of disease and irrational trust in vaccination.
1938
FDCA, Section 505(d) authorized the Secretary of Agriculture (later
Federal Security Agency Administrator, later Health, Education and
Welfare Secretary) to issue orders refusing to permit new non-biological
drugs to enter interstate commerce on several grounds.
The
manufacturing-related grounds to deny permission for distribution were:
"upon finding...that the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of such drug
are inadequate to preserve its identity, strength, quality and purity.”
1944
PHSA, Section 351(d) authorized the Federal Security Agency
Administrator (formerly Treasury Secretary, later HEW Secretary) to
issue "licenses for the maintenance of establishments" to "propagate or
manufacture" any biological product designated as a "virus, therapeutic
serum, toxin, antitoxin or analogous product, or arsphenamine or its
derivatives (or any other trivalent organic arsenic compound)."
The
manufacturing-related standards for issuing licenses were: "upon a
showing that the establishment and the products for which a license is
desired meet standards designed to insure the continued safety, purity, and potency of such products..."
The most important word in the FDCA section is identity, and that's the most crucial omission from the PHSA section.
Biological products are not legally required to be identifiable or identified.
Without
an identified, identifiable, stable product, it is not practically or
theoretically possible to insure qualities, properties, characteristics
or attributes of propagation materials and methods, or to insure
attributes that could inhere in a product itself, such as safety, purity
or potency, in initial or in continued form…
From
1903 to 1944, biological product regulations set forth standards for
contents of product labels. Labels were required to contain the name of
the manufacturer; address of the manufacturer; license number (assigned
to the establishment, not to any specific product prepared within the
establishment); proper name of product; minimum potency of product if
any; "No U.S. standard of potency" if no potency standard established;
lot number; and date of manufacture or issue with period of potency, or
expiration date.
Labels
were not required to contain any information about the identity of any
substances, quantity, mass, volume, concentration, purity, sterility, or
predicted effects. The absence of these information items on labels
rendered it impossible for any product to be deemed adulterated,
contaminated or misbranded through any assessment method analogous to
the requirements of the FDCA for non-biological drugs and rendered it
impossible for any recipient to obtain information necessary to provide
informed consent to treatment.
From
1903 to 1944, biological product regulations set forth procedures for
examination of products by PHS NIH laboratory staff, but (as stated
above), it was optional for an inspector to collect samples and forward
them to the PHS laboratory. If NIH officers tested the samples at all,
they tested the samples using unpublished, unvalidated test methods,
comparing unstable mixtures of biological material bottled at the
commercial facility to unstable mixtures of biological material bottled
at NIH laboratories.
...
Standards for Products: General
[After
enactment of the 1944 Public Health Service Act] The 1947 biological
product regulations, at sections 42 CFR 73.70 to 73.79, introduced the
early form of what would later become known as "lot release."
These
provisions suggested enforcement mechanisms to insure relative (not
objective) qualities for products that mimicked the standards under the
FDCA that authorized removal of drugs from interstate commerce if "the
methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to
preserve its identity, strength, quality and purity.” Recall: these
qualities of non-biological drugs were defined by the USP-NF compendia
(now known as Critical Quality Attributes or CQAs), and USP-NF was
responsible for designating quality control testing materials and
methods.
The lot release system set up for biological products was riddled with get-around clauses.
Examples include:
"[n]o
lot of any licensed product shall be released by the manufacturer prior
to the completion of tests for conformity with the standards applicable
to such product" in a context in which there are no applicable
standards;
"[t]ests
for potency shall be made on each lot only after completion of those
processes of manufacture which may affect the potency of the final
product" in a context in which none of the processes of manufacture can
be defined with specificity, and potency is an unmeasurable, infinitely
variable factor of the interaction of the biological organisms in the
starting materials with each other and with the animal or human
recipient; and
"[t]he
contents of a final container of each filling of each lot shall be
tested for identity, if such a test is available, and for safety either
after the labels have been affixed to the final container or affixed,
both outside and inside, to the multiple container storage receptacle
just prior to its sealing for storage purposes, except that exceptions
to this procedure may be authorized by the Institute to apply when the
volume of the final container is very large and when more than one lot
is processed each day," in a context in which there are no available
identity tests, and in a context in which general safety tests (added in
1960 at 42 CFR 73.72, eliminated in 2015, 80 FR 37971) are comprised of
injecting "maximum volume tolerated" into two mice and two guinea pigs,
and assessing whether or not they sicken or die in the next seven days,
and "variations of this test, either in the volume injected or in the
species of test animal used" are authorized.
Lot
release testing was to be conducted by manufacturers themselves, with
an option, but no requirement, for manufacturers to send samples to NIH
for testing.
"Tests
for safety, purity and potency applicable to the product shall be
completed for each lot of any licensed product prior to its release by
the manufacturer, and samples of any lot of any licensed product may at
any time be required to be sent to the Institute for examination,"
again, in a context in which there are no valid, applicable tests for
safety, purity or potency.
"Standard
units or samples for comparison made available by the Institute shall
be applied in testing for potency all forms of diphtheria antitoxin,
tetanus antitoxin... and other products for which such units are available,"
in a context in which reference products are not held by NIH for
products, and if they are held, their potency is expressed in
probability-based, non-objective "immunity units."
Labeling
The
1947 biological product regulations, at sections 42 CFR 73.50 to 73.55,
expanded upon the earlier forms of non-identifying label contents.
As
reported above, container labels between 1902 and 1944 were required to
provide label readers with the proper name of the product; name,
address and license number of manufacturer; lot number and expiration
date.
As of 1947, the outside carton was required to contain:
(a) the preservative used and its concentration;
(b)
the volume of the contents, if a liquid, or the weight, if a solid, and
the potency or dosage if more than one strength is dispensed;
(c) the recommended storage temperature;
(d) the words "Shake Well," or equivalent, when indicated by the character of the product,
(e) the dose and route of administration recommended or reference to such directions in an enclosed circular;
(f) the source of the product when a factor in safe administration; and
(g)
minimum potency of product expressed in terms of official standard of
potency or, if potency is a factor and no standard of potency has been
prescribed, the words "No U. S. standard of potency,"
all
in a context in which there is no stable potency, strength or dose,
because the biological material is unstable and mixed, and effects vary
immeasurably and unpredictably over time and across recipients, in which
the source of the product is an unidentifiable collection of many
biological organisms.
Additional Standards
The
1947 biological product regulations, at sections 42 CFR 73.90 to 73.96,
added the first "Additional Standards" section, purported to require
that Trivalent Organic Arsenicals be tested, by manufacturers and
regulators, for "stability, solubility, arsenic content, moisture and
relative non-toxicity."
In
1956, additional standards for poliomyelitis vaccine were added, and in
1957, additional standards for adenovirus vaccine were added.
The
additional standards were inapplicable and ineffective from the day
they appeared in the regulations, because they were based on the
fictional scientific methods laid out by Leslie Webster (1939), Charles
Armstrong (1939), and Enders et al (1949-1954), by way of Jonas Salk,
Joseph Smadel and William Workman (more information below).
Mixtures
of bacterial, animal and human cells and tissues were to be cultured in
nutrient media (chicken embryos; cow, pig, horse serums; salts, sugars,
amino acids), fixed with formalin or other toxic preservatives, and
injected into mouse and monkey brains and muscles. Mouse and monkey
blood was to be tested for non-specific antibodies, which would be
reported as specific to alleged disease-causing agents. Mice and monkeys
were to be killed and necropsied. Brain tissue was to be tested for
cytopathic effect/lesions. The sick and dead proportions of mouse and
monkey groups were to be counted. And "equivalent methods" and
"alternative demonstrations" would be permitted as needed.
The
conduct of even these pretenses of NIH testing was suspended by
internal policy by 1962 (Smadel memo) and the "Additional Standards"
sections were eliminated in their entirety in 1996. (61 FR 40153)
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