Terms, phrases and organizations involved in worldwide regulatory and manufacturing deception surrounding vaccines and other biological products.
Part 7 of series.
American Domestic Bioterrorism Program
Tools for dismantling kill box anti-law
I'm still working to better understand (and better write about) the legal mechanisms that have enabled the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention (CDC), European Medicines Agency (EMA), World Health Organization (WHO) and other US federal agencies, national drug regulators, and regional and supranational organizations, to construct a worldwide regulatory deception through which mercenary pharmacists and nurses can legally mutilate and kill people, using manufactured, distributed pharmaceutical products that are intentionally toxic poisons.
As I've written previously (prior reports linked below), a lot of the legal mechanisms are suspensions, waivers, exemptions and exclusions from drug manufacturing quality control rules, known as current Good Manufacturing Practice (cGMP); along with suspensions/waivers/exemptions/exclusions of clinical trial conduct rules (including Institutional Review Board and informed consent rules), known as current Good Clinical Practice (cGCP); laboratory rules (cGLP); distribution rules (cGDP); and other rules.
For Emergency Use Authorization (EUA) countermeasure products, exemptions are legally justified by emergency declarations issued for specific communicable disease outbreaks (public health emergencies). Public health emergency declarations and determinations are issued unilaterally without any legal requirement for validated evidence that morbidity and mortality are attributable to a communicable disease pathogen, and without any legal mechanisms for legislatures, courts, or political subdivisions (states, tribes, municipalities) to challenge, counteract or otherwise "call the bluff" of lying government officials who promulgate groundless emergency declarations.
For biological products as a general class — at all times, not only during declared emergencies — the exemptions are legally justified by claims that manufacturers have assessment equipment and techniques, and an honorable disposition toward product users, sufficient to self-police product safety, purity and potency without independent, public verification of their claims, and that deregulation saves time and money for regulators, product manufacturers, and taxpayers without endangering consumer health and safety.
These legal non-regulation structures have become more visible since January 2020 through Covid-19 — a simulation of a deadly global pandemic, conducted through prearranged policy coordination (false information, non-validated diagnostic testing/surveillance, social/psychological/economic behavior manipulation, lockdowns, masking, hospital homicide, product review and vaccination programs) among individuals representing the World Health Organization, US-FDA, US-CDC and affiliated co-conspirator government agencies and non-governmental organizations.
For context, I began to understand FDA's deceptive role in EUA product non-regulation in early 2022, and have learned and written more about public health emergency law since then.
I learned about the FDA's deceptive role in non-regulation of the broader class of biological products — in which vaccines are a putative subcategory, and EUA vaccines are a putative sub-sub-category — in December 2023. I’ve been learning and writing more about biological product law since then.
To repeat a key point: a lot of the legal mechanisms that enable health care workers to mutilate and kill people with impunity using EUA countermeasures (including vaccines) under declared emergency conditions, and to also mutilate and kill people with impunity using non-EUA biological products and vaccines under routine, non-emergency conditions, are suspensions, waivers, exclusions and exemptions from clinical trial conduct rules and drug manufacturing quality control rules.
Because of that legal framework, one of the best ways to understand what’s happened, is to draw the negative or adverse inferences that can be drawn from the absence of valid regulatory and quality control records.
'Smoking gun' documents, through which identifiable regulators and vaccine factory employees would disclose which toxic ingredients were added to which batch on which date and time, with foreknowledge as to subsequent molecular stability or decay, and foreknowledge as to harmful biological effects on recipients, are unlikely to appear.
Instead, ingredients and processing techniques are redacted from publicly-available regulatory review and manufacturing contracts. Package inserts are blank. When asked for unredacted, complete, accurate clinical trial and manufacturing quality control compliance records, regulators and manufacturers simply and accurately state that they cannot produce such records, because they are not legally obligated to produce such records, and therefore those records do not exist.
If entities with subpoena power — Congress members, state Attorneys General, state legislative investigatory commissions, or well-informed private attorneys using well-aimed litigation — someday decide to request clinical trial and manufacturing quality control evidence from pharmaceutical companies and FDA regulatory divisions involved in the development and production of drugs and biological products during, prior to and subsequent to Covid, I anticipate that they will receive responses similar to the July 2018 response that Informed Consent Action Network received from the Department of Health and Human Services in response to ICAN's request for records of HHS vaccine safety assessments between 1986 and 2018:
"The [Department]'s searches for records did not locate any records responsive to your request."
In the meantime, since Congress members, AGs, state lawmakers, and private attorneys have been silent and immobile on the subject of legalized non-regulation of EUA countermeasures, vaccines and biological products, it falls to individual men and women in every country, to stop worldwide vaccination programs by clearly understanding how vaccine and biological product regulatory deceptions work; by drawing the adverse inferences from the non-existence of complete, accurate, unredacted, public regulatory and manufacturing records; and by confidently declining vaccine and biological product recommendations, endorsements and offers made by public health officials, product regulators, manufacturers and health care workers.
It may help build understanding and confidence, to know the names of key organizations running the regulatory deception programs, and some of the legally-undefined terms for the intrinsically unstable, and therefore physically-indeterminate, compounds categorized as "biological products."
Organizations whose members conduct regulatory deception campaigns, primarily through promulgation of official reports, guidance documents and regulations:
World Health Organization Expert Committee on Biological Standardization. "…commissioned [1947] to coordinate activities leading to the adoption of international requirements for the production and control of vaccines and other biologicals and the establishment of international biological reference materials."
WHO International Conference of Drug Regulatory Authorities (ICDRA, 1980)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH, 1990) - “…bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines…”
Pharmaceutical Inspection Co-operation Scheme (PIC/S) - "...established in 1995 as an extension to the [European Free Trade Association] Pharmaceutical Inspection Convention (PIC) of 1970...PIC/S is a legally non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. On 31 December 2021, PIC/S comprised 54 Participating Authorities (PAs) from all continents."
International Coalition of Medicines Regulatory Authorities (ICMRA, 2013) - "An international executive-level coalition of key regulators from every region in the world. It provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges. Priorities include coordinated response to crisis situations. Members of the ICMRA include: Therapeutic Goods Administration (TGA), Australia; National Health Surveillance (ANVISA), Brazil; Health Products and Food Branch, Health Canada (HPFB-HC), Canada; China Food and Drug Administration (CFDA), China; European Medicines Agency (EMA) and European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; French National Agency for Medicines and Health Products Safety (ANSM), France; Paul-Ehrlich-Institute (PEI), Germany; Ministry of Health and Family Welfare, India; Health Product Regulatory Authority (HPRA), Ireland; Italian Medicines Agency (AIFA), Italy; Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Ministry of Food and Drug Safety (MFDS), Korea; Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; Medicines Evaluation Board (MEB), Netherlands; Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; Health Sciences Authority (HSA), Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency (MPA), Sweden; Swissmedic, Switzerland; Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; Food and Drug Administration (FDA), United States."
US FDA Center for Biologics Evaluation and Research (CBER, formerly Bureau of Biologics) - "the Center within FDA that regulates biological products for human use under applicable federal laws."
US FDA CBER Office of Vaccines Research and Review (OVRR) - “allergenic products, infectious disease vaccines and live biotherapeutic (probiotic) therapies.”
US FDA CBER Office of Biologics Research and Review (OBRR) - “blood and blood products, including plasma derivatives and their recombinant analogues.”
US FDA CBER Office of Tissues and Advanced Therapies (OTAT) - “cell, tissue and gene therapies as well as therapeutic vaccines for various disease indications.”
US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) - “responsible for supporting applications for licensure of vaccines.” (House Report 106-977, Oct. 12, 2000)
US CDC Advisory Committee for Immunization Practices (ACIP) - “Develops recommendations for U.S. immunizations, including ages when vaccines should be given, number of doses, time between doses, and precautions and contraindications.”
Some of the terms and phrases used in official reports, plans, guidance documents, recommendations and regulations promulgated by the organizations listed above and their military and corporate pharmaceutical counterparts:
allergen
allergenic product
analogous product
antigen
antitoxin
arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound)
attenuated infectious vaccine
bacteria
biopharmaceutical
biosimilar
biosimilar biological product
biotechnology
biotechnology product
blood, blood component or derivative
cell therapies
cells pulsed with immunogen
cellular therapy products
component of pathogen
conjugates
crude or purified antigens isolated from killed or living cells
crude or purified antigens secreted from living cells
diagnostic antigen
emerging technology in the context of the pharmaceutical and related industries
first interchangeable biosimilar biological product
fraction of pathogen
gene
gene therapies
genetically-modified organism (GMO)
human blood and blood components
human cellular and gene therapy products
human somatic cell therapy and gene therapy
immunogen
immunotoxin
intentionally altered genomic DNA
living vectored cells expressing specific heterologous immunogens
microbial culture
microbial derived proteins
monoclonal antibody
parasite
pathogen
peptide
plasma-derived pharmaceutical
plasma-derived product
plasmid
plasmid DNA vaccine
polynucleotides
polypeptide
protein
recombinant nucleic acid molecules
recombinant or synthetic carbohydrate, protein or peptide antigens
recombinant protein
reference product
regenerative medicine therapies
regenerative medicine advanced therapy
somatic cell therapy
synthetic biological product
synthetic nucleic acid molecules
therapeutic biological product
therapeutic biotechnology
therapeutic biotechnology-derived biological product
therapeutic recombinant DNA-derived product
therapeutic serum
toxin
toxoid
vaccine
virus
well-characterized platform technology
well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products
whole, inactivated pathogen
Stop taking vaccines.
Interpret public statements, reports, guidance documents and regulations by World Health Organization Expert Committee on Biological Standardization, ICDRA, ICH, ICMRA, PIC/S, US-FDA, FDA-CBER, CBER-OVRR, CBER-OBRR, CBER-OTAT, CBER-VRBPAC, US-CDC, CDC-ACIP and pharmaceutical company officials as presumptive lies and misrepresentations.
Pray the Rosary.
Related
Sept. 19, 2022 - In Nov. 2020, Pfizer told FDA reviewers, led by Marion Gruber, that safety studies were neither needed nor conducted. In making that argument, Pfizer cited WHO guidance written in 2002 by a team led by Marion Gruber.
Nov. 16, 2022 - Some thinking about tampering with evidence and spoliation
Jan. 16, 2023 - Dual-use government officials of concern
Feb. 7, 2023 - On the impalement of embedded, treasonous, DOD-HHS bioterrorists on the horns of their dilemmas. Revisiting double-bind challenges to the Covid-19 cullers and culling agents.
March 17, 2023 - Contracting for facilitation of crimes: contract killing and biomunitions hitmen. A third double-bind argument built on the truth that the products are prohibited bioweapons designed to injure and kill, not regulated medicinal products designed to protect and heal.
April 13, 2023 - Vaccine production facilities are indistinguishable from bioweapon production facilities, and vaccines are indistinguishable from bioweapons
May 26, 2023 - 93 biochemical weapons to decline whenever a medical mercenary offers them to you or your children
March 8, 2024 - Part 1: Mutual Recognition Agreements. First in series on legal links connecting domestic and international non-regulation of non-medicines
March 12, 2024 - Part 2: Statutory and regulatory definitions for drugs, biological products, and biosimilars
March 15, 2024 - Part 3: Deregulation of biological product manufacturing, mid-1990s to present
March 20, 2024 - Part 4: Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals
March 21, 2024 - Part 5: Vaccine and related biological product manufacturing as US government-licensed poison manufacturing Evidence from November 1986 'mandate for safer childhood vaccines' codified at 42 USC 300aa-27, and July 2018 stipulation by HHS. - “…HHS has never systematically collected or reported information from parents, pediatricians, toxicologists, manufacturers, or anyone else about harms caused by childhood vaccines administered in single doses, combined doses (i.e. measles-mumps-rubella), or cumulative doses (the childhood schedule), and HHS has never collected or reported information about the harmful effects of biological components, chemical adjuvants, preservatives or any other ingredients…”
April 3, 2024 - Part 6: On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.
April 19, 2024 - Current Congress members have legal authority and moral agency to stop vaccine-mediated mutilation and killing programs worldwide. PREP Act and other emergency laws are already operationalized globally through the manufacturing, sales, supply and purchasing contracts.
