A couple of Substack notes I posted this morning, re-posting here.
Aug. 22, 2024 Note 1
I
do not believe that FDA “guidance for industry” documents are intended
by FDA or construed by pharmaceutical manufacturers, as enforceable
rules.
I
believe they are written and published as part of the regulatory
charade, and are one method through which FDA, DoD and pharmas
coordinate the militarized fraud they are jointly perpetrating on the
public.
I’m posting this 2010 FDA document-only definition of “viral vaccines” (FDA has not defined vaccine, or viral vaccine, in CFR regulations) because such definitions,
When
viewed alongside the complete absence of physical standards and
methods/techniques/equipment capable of determining product purity,
safety and efficacy;
Which
have not been established by FDA or by FDA’s allegedly private-sector
partner, the US Pharmacopeia/National Formulary — see, for example, USP
June 2020 Standards for Quality Vaccines–General Vaccine Development and Manufacturing,
indicating the non-existence of measurable standards and measurement
techniques by the phrase “Not intended to convey requirements
enforceable by regulatory agencies;”
May
help more people understand that vaccines, from the batch and lot level
at the factories, through the vial and dose level when administered to a
person, are intrinsically heterogeneous, unstable and toxic.
There is no safe dose of vaccine material.
There never will be.
And
these facts have been known for many, many decades by FDA officials,
pharmaceutical company officials, military officers and US
Pharmacopeia/National Formulary officials.
FDA (February 2010) - Guidance
for Industry - Characterization and Qualification of Cell Substrates
and Other Biological Materials Used in the Production of Viral Vaccines
for Infectious Disease Indications
“For
the purpose of this document, viral vaccines are a heterogeneous class
of preventive, and in some cases, therapeutic medicinal products that
when administered are intended to elicit immune responses that could
prevent and/or lessen the severity of one or more infectious diseases.
These products include live attenuated preparations of viruses,
inactivated (killed) whole or subunit virions, purified recombinant
proteins, synthetic antigens, or live viral vectors expressing specific
heterologous vaccine antigens…”
July 26, 2024 - On
FDA 'Guidance for Industry' documents as regulatory fraud coordination
tools for US government and pharmaceutical co-conspirators.
“…My
understanding is that all FDA "Guidance for Industry" documents, going
back to the mid-1980s, when they started issuing them [called “Points to
Consider” at that time] are instructions to pharmaceuticals, from FDA,
about how the pharmaceuticals should ignore FDA regulations (because the
regulations are non-regulations), and how they should engage in
performative acts designed to look similar to compliance, and how FDA
will (on its own side) pretend to establish and enforce regulatory
standards, but actually not establish or enforce them…”
Aug. 22, 2024 Note 2
Repeating
points from previous note — FDA guidance for industry documents are to
be understood as fraud coordination tools through which FDA and pharmas
jointly withhold and cover-up from the public, knowledge that all
vaccine material is intrinsically heterogeneous, unstable and toxic.
Here’s another example of how the fraud coordination works, from a 2007 FDA publication.
FDA (November 2007) - Guidance for Industry - Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
“Published
preclinical studies indicate that DNA vaccination can activate
autoreactive B cells to secrete IgG anti-DNA autoantibodies. However,
the magnitude and duration of this response appears to be insufficient
to cause disease in normal animals or accelerate disease in
autoimmune-prone mice. These preclinical studies suggest that systemic
autoimmunity is unlikely to result from DNA vaccination. Similarly, the
absence of an immune response against cells expressing the
vaccine-encoded antigen (including muscle cells and dendritic cells)
suggests that an autoimmune response directed against tissues in which
such cells reside is unlikely.
Yet
the possibility persists that DNA vaccines might idiosyncratically
cause or worsen organ-specific autoimmunity by encoding antigens
(including cryptic antigens) that cross-react with self. Thus, we
no longer recommend that preclinical studies be performed to
specifically assess whether vaccination causes autoimmune disease,
but recommend that the general welfare of animals in preclinical
immunogenicity and toxicity studies continue to be carefully monitored…”
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. Part 3 of series.
“Briefly,
since the mid-1990s, citing authority derived from Congressional acts
and Presidential executive orders, the Food and Drug Administration has
been quietly eliminating its own regulatory functions through Federal
Register rule-making notices and Guidance for Industry publications. FDA
has essentially told biological product manufacturers: "We're not going
to ask you what's in the products that you send out of your factories,
and you shouldn't tell us what's in the products that you send out of
your factories." 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…”
Related:
July 29, 2024 - Three true things that are really important to understand, and also very difficult to accept.
The infliction of deceptions, injuries, sterilizations and deaths is intentional.
The harms are deliberately caused. Communicable disease and other
public health emergencies (overpopulation, climate disruption) are
faked. Public officials have known and lied about fake public health
emergencies for a very long time. Products described as preventatives
and treatments are neither. These products are toxic, poisonous. Manufacturers and regulators know about the toxicity and have known and lied about it for a very long time. The damage is not accidental; the harms and injuries and deaths are not side effects.
The US military, including the Public Health Service branch of the US military, and the other branches, organizes and runs the programs.
Under current US law, the deception, injury and death programs are legal. They are beyond legal challenge and legally unstoppable, because current US law authorizes them…
The Martyrdom of Saint Symphorian. Jean-Auguste-Dominique Ingres
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