FDA's document-only, 2010 definition of 'viral vaccines;' FDA's 2007 recommendation that developers not assess whether vaccination causes autoimmune disease.

Katherine Watt

Aug 22

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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…”

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…