There are established regulatory pathways for “vaccines” but not for “gene therapies”. In 2020 a gene therapy technology that encoded an “antigen protein” was accepted as a “vaccine”. If the only change to that product (now considered a platform technology) was to change the mRNA code to one that encodes a human protein, would it still be accepted as a “vaccine”?

Other pages on this website with additional information and context –

• Australia’s Gene Technology Regulator (OGTR) – HERE
• Australia’s OGTR did NOT assess the new gene technology vaccines – HERE
• Australia’s TGA and Regulation Timeline – HERE
• COVID-19 enquiries – HERE
• Revelations from the Pfizer FOIA Documents – HERE, and Moderna FOIA docs – HERE
• Lipid Nanoparticle (LNP) Technology (gene therapy delivery vehicle, for gene transfer) – HERE
• Can “vaccine” modified RNA impact human DNA? – HERE

Links in reverse chronological order

This page is continuously be updated as new data points come to my attention

2024

April 11, 2024 – Report 98: FDA Selected Its ‘Vaccines Advisory Committee’ – Not Its Gene Therapy Advisory Committee – to Recommend the COVID Injections for Emergency Use, to Hide the Fact that the Products Are Not Vaccines But Gene Therapies – READ includes notes from VRBPAC meetings

• “Why Did the CDC Change the Definition of ‘Vaccine’ and ‘Vaccination’ in September 2021, 10 Months After EUA Was Granted to Pfizer and Moderna for Their COVID-19 Drugs?…Was this for commercial reasons?
• “The Pfizer and Moderna COVID-19 drug products were labelled as “vaccines” well before the “vaccine” definition changed, and the FDA assigned VRBPAC as the advisory committee reviewing the COVID “vaccines”-related data as early as May of 2020. But, are these COVID drugs truly “vaccines,” or are they gene therapies, as defined by the FDA? The distinction matters since it drives the review and approval processes for the drugs.” See Table 1: VRBPAC or CTGTAC?
• “This improper categorization of the drugs as “vaccines” rather than gene therapies, provided the public a false sense of security that they would be protected from illness, when in fact the modified mRNA drugs were built on a novel platform with no long-term safety or efficacy record.”…The gene therapy testing and approval process is decidedly more demanding”
• FDA’s guidance regulations for vaccines…vaccine products “shall meet generally accepted standards of purity and quality.” versus Gene Therapy products “only product lots that meet defined specifications or acceptance criteria are administered during all phases of clinical investigation and following market approvals.” In “FDA’s own words, that gene therapy products undergo a much more thorough level of scrutiny.”

March 7, 2024 – Therapeutic Goods Regulations (1990) – definition of “gene therapy” – READ, PDF

• “gene therapy means the in vivo transfer of DNA or RNA into the cells of human recipients”
  (nothing is stated about integrations into DNA) – source, PDF

January 17, 2024 – The European lobby Kangaroo Group, hosted a lunch in the European Parliament with Members with BioNTech and Moderna as key speakers, to discuss the forthcoming revision of “European Commission’s proposal for a reform of the EU General Pharmaceutical Legislation (GPL)”. EU- ARCHIVE, KG – ARCHIVE, PDF, CREDIT

• Their objective to effectively change the definition of gene therapy, under which their COVID-19 mRNA vaccines are classified, and to create a “definition of Platform Technologies, as well as a clear demarcation between Gene Therapies Medicinal Products that alter human genomes, and those that do not (e.g. mRNA).”

January, 2024 – FDA: Guidance for Industry: Human Gene Therapy Products Incorporating Human Genome Editing –PDF (updated!), ARCHIVES, Jessica Rose – CREDIT GE = genome editing

• “Viral vectors may support sustained expression of GE component transgenes, and nanoparticles may allow the temporal delivery of GE components as DNA, RNA, or proteins” [lipid nanoparticles can replace the virus vector!]
• “When administered in vivo in the form of DNA, RNA and/or protein via nanoparticles, the GE components are considered the active pharmaceutical ingredients or drug substances.” i.e. the genome editing materials are for the sake of the regulator considered the active ingredient!
  • The SV40 promoter contaminant is also a GE component of the Pfizer mRNA injectable products
• “Assessment of bio-distribution should be conducted to characterize the distribution, persistence, and clearance of the GE product, any expressed GE components in vivo, editing activity in target and non-target tissues, and the potential for inadvertent germline modification.” [they skipped this step with the mRNA injectable products]

2023

January 12, 2023 – Full Fact: Andrew Bridgen wrong to call mRNA vaccines gene therapy – READ

January 6, 2023 – Fierce BioTech: Pfizer pivots from early-stage rare disease R&D, shifting to external innovation and putting assets up for sale – READ

• They will “pullback from new viral-based gene therapies and early-stage rare disease work in general”. [so much for being a gene-therapy leader announced in 2016 – REF], now wanting to be “best positioned to generate high-impact medicines and vaccines.” [of course they do!]

2022

July 4, 2022 – TGA Advanced Therapies: Report on ‘Cell, Gene and Tissue Regulatory Framework in Australia – A stakeholder engagement report on Advanced Therapies prepared for the Therapeutic Goods Administration – READ, Report – PDF, ARCHIVE

• In November 2021 the Therapeutic Goods Administration (TGA) commissioned MTP Connect to conduct a stakeholder review of the regulatory framework for gene, cell and tissue therapies in Australia.
  • Medical Technologies and Pharmaceuticals Growth Centre (MTP Connect) “is Australia’s Life Sciences Innovation Accelerator – supporting Australia’s vibrant medical products sector…an independent, not-for-profit organisation established by the Australian Government to champion the continuing growth of Australia’s vibrant medical products sector” – WEB, Established November 2015 as part of the $248 million Industry Growth Centres Initiative – ARCHIVE, Factsheet –
• “Any biological or prescription medicine that involves genetic modification must also be approved by the Office of the Gene Technology Regulator (OGTR). OGTR approval is needed before TGA approval… ” REF
  • [Yet COVID-19 mRNA “vaccines” and their approved “platform”, which are genetically modified, gene therapy, biological medicines escaped this oversight!]
• European Medicines Agency (EMA) guidance
• Reference to FDA – Cellular & Gene Therapy Products which is regulated by Center for Biologics Evaluation and Research (CBER) including vaccines – READ, ARCHIVE
• MTP Connect: mRNA Lecture Series 2: Lecture Three – Preparing for Disease X , speakers Moderna, WHO and Doherty institute [Moderna’s factory is being built in Mebourne!] – READ, ARCHIVE
  • First lecture series “mRNA Victoria” – READ, ARCHIVE, WEB
  • Monash RNA – home to Australia’s largest network of RNA and mRNA researchers. – WEB
  • August 9, 2022 – Victorian mRNA Innovation Hub (VMIH) – $5.4M – VMIH is a world-first collaboration between Monash University, the University of Melbourne, Doherty Institute and Monash Institute of Pharmaceutical Sciences to develop next-generation vaccines and therapeutics to treat a range of diseases. – REF, WEB
    • The funding, which is part of the state government’s mRNA Victoria Activation Program initiative aims to develop new technologies that will underpin mRNA therapeutics and vaccines that are more effective, cheaper and faster to produce.

May 10, 2022 – Australian Dept Health: Is it true? Can COVID-19 vaccines alter my DNA? – ARCHIVE

• “The Pfizer/BioNTech COVID-19 vaccine uses a fragment of messenger RNA (mRNA) to instruct your body to make an immune response against COVID-19.” [Deceptive initial comment, and only 5 short sentences]
  • [The mRNA instructs the body to produce a foreign protein, which is hoped that the body produces an immune response to the protein, not the mRNA. The hope is that mRNA does not elicit an immune response, which is why they changed uridine to pseudouridine]
• No mention of the DNA contamination in the “vaccine” vials!

March 3, 2022 – Dave Martin files lawsuit in Utah: lawsuit, Griner v. Biden et al in the U.S. District Court in Utah on behalf of Devan Griner, MD – READ, Uncover DC – PDF – READ, LISTEN, WATCH

• Dave Martin insists Insists the Injections are Gene Therapy Medical Devices – the body becomes a biological (weapons) factory, manufacturing foreign protein (in the case of an antigen code), the product does not stimulate any immunity, it is an instruction to make a “scheduled pathogen” – a genetic sequence derived from SARS coronavirus – WATCH
• Using the term “vaccination” was intended to mislead the public”, confuse and build expectation. It should have been called “gene therapy” as stated in the SEC filing in 2019 and 2020 – REF
• Moderna was set up as an outgrowth of 10 year National Science Foundation study on “gene therapy”
• In the The United States, since 1905, the Public Health Policy, says that the state public health agencies are entitles to do police powers on public health if they can disrupt infection or transmission. There is NO police power that has ever been granted, in any circumstance, for any reason, for a treatment.”

January 10, 2022 – Therapeutic Goods Administration (TGA): A NEW catagory has been added to TGA website called Advanced Therapies, under which gene therapies suddenly appears! – ARCHIVE, READ,

• Quitely added to the website with NO press release or statement – ARCHIVE, unable to find regulatory change around this time – READ
• Any biological or prescription medicine that involves genetic modification must also be approved by the Office of the Gene Technology Regulator (OGTR) [WOW! COVID-19 mRNA vaccines missed that step in 2020!]
• “We regulate therapies that involve in-vivo genetic manipulation of human cells as prescription medicines under section 23 of the Act. This includes small silencing RNAs, CRISPR and other gene editing technologies, and gene therapies administered by vectors.”
• Advanced Therapies defined : Advanced therapies or advanced therapy medical products is a term used to describe innovative therapies. International regulators use this term to include gene, cell and tissue therapies. – READ
  • November 21, 2019 : Good Manufacturing Practice (GMP) for new and emerging technologies: Advanced Therapy Medicinal Products (ATMPs) – Presentation – ARCHIVE

2021

November 29, 2021 – World Health Summit 2021: Stefan Oelrich (Bayer): mRNA vaccines are Gene Therapy – WATCH, BACKUP, CREDIT, more VIDEOS

“Ultimately the mRNA vaccines are an example for that cell and gene therapy. I like to say that if we had surveyed two years ago, in the public, ‘Would you be willing to take gene or cell therapy and inject it into your body?’ we would have probably had a 95% refusal rate.”

Stephan Oelrich from Bayer at World Health Summit in 2021 (Nov 29, 2021)

August 10, 2021 – Reuters Fact Check: mRNA vaccines are distinct from gene therapy, which alters recipient’s genes – READ

January 4, 2021 – CDC: Bust Myths and Learn the Facts about COVID-19 Vaccines – COVID-19 vaccines do not alter DNA – ARCHIVE, all ARCHIVES, READ

Messenger RNA vaccines—also called mRNA vaccines—are the first COVID-19 vaccines authorized for use in the United States. mRNA vaccines teach our cells how to make a protein that triggers an immune response. The mRNA from a COVID-19 vaccine never enters the nucleus of the cell, which is where our DNA is kept. This means the mRNA cannot affect or interact with our DNA in any way. Instead, COVID-19 mRNA vaccines work with the body’s natural defenses to safely develop immunity to disease.

At the end of the process, our bodies have learned how to protect against future infection. That immune response and making antibodies is what protects us from getting infected if the real virus enters our bodies.

CDC: Will a COVID-19 vaccine alter my DNA?

2020

December 18, 2020 – CDC: Understanding mRNA COVID-19 Vaccines – New Approach to Vaccines – ARCHIVE [The plan all on one page – no mention of gene therapy though]

• “mRNA vaccines are a new type of vaccine to protect against infectious diseases.”
• “…That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.” [that failed!]
• “They do not affect or interact with our DNA in any way.”
• “mRNA Vaccines Are New, But Not Unknown…Researchers have been studying and working with mRNA vaccines for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means the process can be standardized and scaled up, making vaccine development faster than traditional methods of making vaccines.” [there you have it in a nut shell – the platform goal, taking a gene therapy model to vaccine]
  • “mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV)” – optative word “studied”, not fully assessed or ever before brought to market.
• “As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.”
• “Future mRNA vaccine technology may allow for one vaccine to provide protection for multiple diseases, thus decreasing the number of shots needed for protection against common vaccine-preventable diseases.” [Frankenstein territory]

December 15, 2020 – GAVI: Will a mRNA vaccine alter my DNA? – ARCHIVE

June 30, 2020 – The FDA termed these COVID-19 mRNA drugs gene therapies. Moderna’s Q2 2020 quarterly report stated, “mRNA is considered a gene therapy product by the FDA…” – REF

January 12, 2020 – Moderna design mRNA “gene therapy” vaccine sequence in one hour, two days after the Chinese novel-CoV virus gene sequence was made public, and following discussions with their partner the NIH – TIMELINE

2019

November 21, 2019 : Good Manufacturing Practice (GMP) for new and emerging technologies: Advanced Therapy Medicinal Products (ATMPs) – Presentation – ARCHIVE, PDF

• Advanced Therapies which include gene, cell and tissue treatments was added to TGA industry Jan 10, 2022

August 21, 2019 – AskBio Applauds Pfizer’s Continuing Investments in Gene Therapy – READ, (see 2003 below)

• Pfizer announced a $500 million investment in a state-of-the-art gene therapy manufacturing facility that is based on Dr. Samulski’s and AskBio’s AAV technology discoveries.” Using adeno-associated virus (AAV) to deliver corrected genes to cells with genetic defects.
• Pfizer’s AAV therapeutic platform was made possible when they purchased Bamboo Therapeutics from AskBio in 2016 – READ
  • The AAV groundbreaking gene therapy technology is the basis for treating a wide variety of diseases, including several diseases in AskBio’s clinical portfolio such as Duchenne Muscular Dystrophy (transferred to Pfizer as part of the Bamboo acquisition)
• 2024: AAV is driving today’s therapeutic discoveries and is used in the only two FDA-approved gene therapies currently available – READ, ARCHIVE

May 7, 2019 – Moderna Blog: Advancing the Frontiers of Our Platform Science – ARCHIVE

• “Today, we described our program of advancing new delivery technologies toward creating a generation of mRNA-based immune system therapeutics. This includes exciting translational work demonstrating that our novel immune nanoparticles are able to deliver mRNA to a significant proportion of T cells, Natural Killer cells, B cells and myeloid cells.We demonstrated that we can express functional proteins in vivo across multiple preclinical species, and ex vivo in human blood.” [sounds a lot like gene therapy]
• The latest science behind evading the innate immune system

March 13, 2019 – Moderna submitted their Form 10-K Annual Report to the Securities & Exchange Commission (SEC) – FDA recognises mRNA products as “gene therapy” and regulatory pathway uncertain – TIMELINE, IMG,

• “Currently, mRNA is considered a gene therapy product by the FDA“
• In that same filing they state “because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established…”

2018

July 25, 2018 – FDA: What is Gene Therapy? – ARCHIVE, READ

• July 2018 – Draft Guidance for Industry: Long Term Follow-Up After Administration of Human Gene Therapy Products – PDF
• “Gene therapy is a technique that modifies a person’s genes to treat or cure disease.” As noted in the diagram below the direct delivery of RNA can be non-viral such as lipid nanoparticles

• “Clinical studies in humans require the submission of an investigational new drug application (IND) prior to initiating clinical studies in the United States.”
  • So what are the IND rules? (July 20, 2022) – READ

2017

December 14, 2017 – PRESS RELEASE: Asklepios BioPharmaceutical, Inc. Launches New Portfolio Company – Actus Therapeutics, Inc. – READ, ARCHIVE (enzyme replacement therapy), Actus website – ARCHIVE

• Feb 1, 2017 – Scientists ready to test gene therapy for Pompe disease “…gene therapy designed by Duke University researchers to improve treatment for the genetic disorder Pompe disease is set to enter a Phase 1 clinical trial” – READ, STUDY, REF

November 15, 2017 – Moderna’s first in-human Phase 1 “cancer vaccine” clinical trial – TIMELINE

2016

November 29, 2016 – AGTC: Gene Therapy Explained – how gene therapy, delivered by AAV vectors, works – WATCH, AGTC is a startup company – WATCH,

• Applied Genetic Technologies Corporation (AGTC) was founded by five scientific leaders in the use of viral vectors for Gene Therapy and began operations in 2001 – REF, AGTC website dates back to 1996 – ARCHIVE, and was founded 5 years earlier ~1991 – REF ,begining with DNA/RNA lab tool – REF

August 1, 2016 – Pfizer: Pfizer aims to become industry leader in Gene Therapy with Aquisiton of Bamboo Therapeutics Inc – ARCHIVE, Pfizer gene therapy – WEB

• Jude Samulski, Chief Scientific Officer and Executive Chairman of Bamboo Therapeuitics and a leading expert in the field of rAAV vectors with more than 25 years of experience, will be joining Pfizer. Dr. Samulski, together with the Bamboo team, will play a key role in helping to develop and accelerate Pfizer’s capabilities in gene therapy.” (Dr R. Jude Samulski consults to the FDA on gene therapies, also see AskBio 2003 below)

July 12, 2016 – NIH | Genetics Home Reference: What is gene therapy? (page launch) – ARCHIVE, PDF, CREDIT

• Several approaches to Gene therapy. Simply introducing the new gene into a patient’s cells. One key intent is to get the body to make protein.

“Gene therapy is designed to introduce genetic material into cells to compensate for abnormal genes or to make a beneficial protein.

What is gene therapy? – PDF, READ

• Some types of virus, such as retroviruses, integrate their genetic material (including the new gene) into a chromosome in the human cell. Other viruses, such as adenoviruses, introduce their DNA into the nucleus of the cell, but the DNA is not integrated into a chromosome”

• Adeno virus vector – just like Oxford/AstraZeneca’s “COVID-19 vaccine”

January 20, 2016 – NC biotech Center Press Relase: Bamboo Therapeutics Gearing Up to Treat Deadly Childhood Neurological Diseases – ARCHIVE, Bamboo Therapeutics website – ARCHIVE

• Bamboo Therapeutics – latest biotechnology company co-founded by entrepreneurs Sheila Mikhail and R. Jude Samulski, Ph.D., director of the Gene Therapy Center at the University of North Carolina at Chapel Hill – to treat devastating childhood neurological diseases with next-generation gene therapy – ARCHIVE, SOURCE, Bamboo is a spinout of Asklepios Biopharmaceutical (AskBio) a gene-delivery technology company co owned by Samulski et al.

• Bamboo has been operating as a virtual company in Chapel Hill with seed money from angel investors, foundations and the motivated parents… [22% stake or $43 million by Pfizer – REF]
• August 1, 2016 – Bamboo Therapeutics acquired by Pfizer for total of $645M – ARCHIVE, Pfizer Gene Therapy – READ

2015

2015 – TGA website: Acronyms & Glossary – Definitions – ARCHIVE, READ

• no definition for “Gene Therapy” on the web page yet it is defined in the TG Regulations!

2014

2014 – In 2014, Pfizer established within the company’s Rare Disease Research Unit the Genetic Medicines Institute (GMI) in London, UK, which is a dedicated gene therapy research group under the direction of leading gene therapy researcher Michael Linden. …Pfizer has research agreements with several leading academic institutions… –REF

2010

September 2010 – In September 2010, the Food and Drug Administration issued final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) – REF

• “The emergency use of an unapproved investigational drug or biologic requires an IND…The need for an investigational drug or biologic may arise in an emergency situation that does not allow time for submission of an IND.” – REF

2009

May 28, 2009 – CDC: Cellular & Gene Therapy Products – first ARCHIVE

The Center for Biologics Evaluation and Research (CBER) regulates human gene therapy products – products that introduce genetic material into the body to replace faulty or missing genetic material, thus treating or curing a disease or abnormal medical condition.

• FDA has not yet approved any human gene therapy product for sale, but R&D is happening at a fast pace.

2006

March 29, 2006 – Uni North Carolina Chapel Hill | News Relese: First human clinical trial in the United States for gene therapy for muscular dystrophy now under way – ARCHIVE , Today AskBio has a divesture and license agreement with Pfizer – REF [This on post took me down a rabbit hole – Dr Samulski evolved into an FDA influencer,his journey started ~2000]

• The clinical trial for Duchenne muscular dystrophy (DMD) tests the safety and effectiveness of a therapy that was developed over two decades by scientists at the University of North Carolina at Chapel Hill’s School of Medicine and the University of Pittsburgh.
• In the trial, six boys with DMD will receive replacement genes for an essential muscle protein. Each of the boys will receive replacement genes via injection into a bicep of one arm and a placebo in the other arm.
• “The therapy was made possible by the pioneering research in [adeno-associated virus] AAV by Dr. Richard Jude Samulski, professor of pharmacology and director of the Gene Therapy Center at UNC…”
• Using new Biostrophin^TM therapy – by Asklepios BioPharmaceuticals, Inc. (AskBio) is cross licensed with GlaxoSmithKline, …AskBio will gain exclusive access to selected recombinant adeno-associated virus vector (“rAAV”) serotypes that GSK licensed from the University of Pennsylvania – REF, Biostrophin product claimed launched 2010 – REF, but not in their news? – HERE
  • AskBio is a private development-stage biotechnology company, which was spun out of the University of North Carolina – Chapel Hill.
  • [curously University of Pennsylvania (UPenn) owns an Aug 2006 patent for mRNA pseudouridine with Weissman and Karikó – TIMELINE, READ, then worked with Acuitas Therapeutics’ LNP in Nov 2014 ]
• Jan 7, 2021 – AskBio Applauds Commencement of Pfizer’s Pivotal Trial for Duchenne Muscular Dystrophy – Phase 3 trail begins with new drug candidate PF-06939926 in CIFFREO trial [seems Biostrophin didn’t work out] – READ
• “Dr. Samulski is a former member of the Recombinant DNA Advisory Committee (RAC), a committee tasked with assisting the FDA with approving or disapproving gene therapy clinical trials in the United States. Dr. Samulski also frequently serves as a gene therapy consultant to the FDA. In 2008, Dr. Samulski was recognized by the American Society of Cell and Gene Therapy with the Inaugural Lifetime Achievement Award for his work.” – REF

2004

July 9, 2004 – US Department of Energy: Human Genome Project – “Gene Therapy” – ARCHIVE

• “In most gene therapy studies, a “normal” gene is inserted into the genome to replace an “abnormal,” disease-causing gene. A carrier molecule called a vector must be used to deliver the therapeutic gene to the patient’s target cells. Currently, the most common vector is a virus that has been genetically altered to carry normal human DNA. Viruses have evolved a way of encapsulating and delivering their genes to human cells in a pathogenic manner. Scientists have tried to take advantage of this capability and manipulate the virus genome to remove disease-causing genes and insert therapeutic genes.”
• “Another nonviral approach involves the creation of an artificial lipid sphere with an aqueous core. This liposome, which carries the therapeutic DNA, is capable of passing the DNA through the target cell’s membrane.”
• “The Food and Drug Administration (FDA) has not yet approved any human gene therapy product for sale. Current gene therapy is experimental and has not proven very successful in clinical trials. Little progress has been made since the first gene therapy clinical trial began in 1990. In 1999, gene therapy suffered a major setback with the death of 18-year-old Jesse Gelsinger….”
• “”Another major blow came in January 2003, when the FDA placed a temporary halt on all gene therapy trials using retroviral vectors in blood stem cells. FDA took this action after it learned that a second child treated in a French gene therapy trial had developed a leukemia-like condition…”
• Limitations of gene therapy includes:
  • “Immune response – Anytime a foreign object is introduced into human tissues, the immune system is designed to attack the invader. The risk of stimulating the immune system in a way that reduces gene therapy effectiveness is always a potential risk. Furthermore, the immune system’s enhanced response to invaders it has seen before makes it difficult for gene therapy to be repeated in patients”.
  • Also Short-lived nature of gene therapy, Prombles with viral vectors and multigene disorders

2003

2003 – Asklepios Biopharmaceutical Inc. (AskBio) is a private development-stage biotechnology company, which was spun out of the University of North Carolina – Chapel Hill (UNC) Biotech Centre. – ARCHIVE, website ARCHIVES

• AskBio is “engaged in the development and delivery of novel protein and cellular based therapies through design of proprietary Biological Nano Particles^TM (BNP)” technology platform – ARCHIVE, which will become known as adeno-associated virus (AAV) – READ
• By 2021 AskBio claim they started in 2001,and are a subsidiary of Bayer AG acquired in 2020, and Pfizer launches first Phase 3 trial for DMD – REF

February 14, 2003 – Dolly the Sheep, the first cloned mammal, is euthanised at age 6 (1996-2003) – READ

• “Dolly, the first mammal to be cloned from adult DNA, was put down by lethal injection Feb. 14, 2003. Prior to her death, Dolly had been suffering from lung cancer and crippling arthritis. Although most Finn Dorset sheep live to be 11 to 12 years of age, postmortem examination of Dolly seemed to indicate that, other than her cancer and arthritis, she appeared to be quite normal. The unnamed sheep from which Dolly was cloned had died several years prior to her creation. Dolly was a mother to six lambs, bred the old-fashioned way.”

January 14, 2003 – FDA: FDA placed temporary halt on all gene therapy trials using retroviral vectors in blood stem cells – ARCHIVE, CREDIT

• The FDA’s Biological Response Modifiers Advisory Committee (BRMAC) – “took this action after it learned that a second child treated in a French gene therapy trial had developed a leukemia-like condition.” Treated for “bubble baby syndrome.”

2002

May 12, 2002 – New Scientist: DNA nanoballs boost gene therapy – ARCHIVE, CREDIT – nano particles enter nucleus!

• “Scrunching up DNA into ultra-tiny balls could be the key to making gene therapy safer and more efficient. The technique is now being tested on people with cystic fibrosis.”
• Researchers at Case Western Reserve University and Copernicus Therapeutics are able to create tiny liposomes 25 nanometers across small enough to enter the nuclear pores and carry therapeutic DNA through pores in the nuclear membrane!
• “The nanoparticles consist of a single DNA molecule encased in positively charged peptides and are themselves delivered to cells via liposomes. In cells grown in culture, there was a 6000-fold increase in the expression of a gene packaged this way compared with unpackaged DNA in liposomes.”
  • [Now think short length DNA contamination wrapped in LNP in Pfizer’s mRNA COVID-19 “vaccine” – does that have the potential to get into the cell nucleus and incorporate into chromosomes?]

2000

September 2000 – FDA: Fundamentals of Gene Therapy – ARCHIVE, FDA Consumer Magazine – SOURCE

• “DNA, carry the information needed to make proteins, the building blocks of our bodies. The body buries genes deep in the heart of every cell, the nucleus, and organizes them in the chromosomes that hold the DNA. But when your DNA is damaged, it no longer makes all the needed proteins and disease results….”
• “To reverse disease caused by genetic damage, researchers isolate normal DNA and package it into a vector, a molecular delivery truck usually made from a disabled virus. Doctors then infect a target cell —usually from a tissue affected by the illness, such as liver or lung cells—with the vector. The vector unloads its DNA cargo, which then begins producing the missing protein and restores the cell to normal.”

September 2000 – Human Gene Therapy and The Role of the Food and Drug Administraion – ARCHIVE, TIMELINE

• FDA’s Center for Biologics Evaluation and Research (CBER) began to regulate the emerging market of human gene therapy products, which fall under the legal definition of a “biologic”
• It was reported that since 1989 to September 2000, the FDA had “received about 300 requests from medical researchers and manufacturers to study gene therapy and to develop gene therapy products” – purpose to find cures for genetic diseases.

July 14, 2000 – Australian Children’s Hospital at Westmead and Children’s Medical Research Institute joint initiative: Gene Therapy Research Unit – ARCHIVE, REF

1999

December 15, 1999 – NIH | Secretary of Health and Human Services | Secretary’s Advisory Committee on Xenotransplantation (SACX) – ARCHIVE, SACX – ARCHIVE, with in the Office of Biotechnology Activities

November 19, 1999 – NIH | Office of Biotechnology Activities: Recombinant DNA and Human Gene Transfer – ARCHIVE, ARCHIVE

1998

March 1998 – HHS | FDA: Guidance for Industry – Guidance for Human Somatic Cell Therapy and Gene Therapy – PDF

• “Recently, various innovative therapies involving the ex vivo manipulation and subsequent reintroduction of somatic cells into humans have been used or proposed”…
• “Gene therapy is a medical intervention based on modification of the genetic material of living cells. Cells may be modified ex vivo for subsequent administration to humans, or may be altered in vivo by gene therapy given directly to the subject.”

1996

July 5, 1996 – Roslin Institute, Edinburgh: Dolly the Sheep is born, marking the first mammal to be cloned from adult DNA – ARCHIVE, CREDIT, WIKI, Roslin Institute – CLONING – READ Dolly is euthanised in Feb 2003

• “In 1996, Roslin Institute and collaborators PPL Therapeutics created Dolly, the first animal cloned from a cell taken from an adult animal….Nuclear transfer is not a new technique. It was first used in 1952 to study early development in frogs and in the 1980’s the technique was used to clone cattle and sheep using cells taken directly from early embryos.” – REF
• PPL Therapeutics is a world leader in the application of transgenic technology to the production of human proteins for therapeutic and nutritional use.” – ARCHIVE, The web domain discontinued by 2005 – ARCHIVES
• Dolly was mated Nov 1997 and “had a little lamb” called Bonnie – ARCHIVE

1996 – University of North Carolina (UNC) at Chapel Hill: The University of North Carolina School of Medicine created the Gene Therapy Center in 1996 with the goal of merging molecular genetics research with healthcare delivery. The facilities comprise the Vector Core (est 1994) and the Human Applications Laboratories ,- ARCHIVE, WEBSITE

• Dr. Richard Jude Samulski, professor of pharmacology became the first director of Gene Therapy Center– REF
  • Jude Samulski and team pioneered the research & developed of a virus known as adeno-associated virus (AAV), and in 1996 published a report of the first muscle gene delivery involving an AAV vector.
  • “Samulski has long pioneered methodologies for making viruses deliver genes. As a graduate student at the University of Florida in the early 1980s, his thesis project was developing the AAV as a vector for therapeutic genes.” In 1986 he moved to University of Pittsburgh and his first graduate student was Xiao Xiao, who had just come from China.
  • “Xiao and Samulski put their projects together and formed Asklepios BioPharmaceutical Inc. (AskBio) in 2003. Along with the rights granted by UNC to Samulski’s AAV vector technology, AskBio acquired the intellectual property rights to Xiao’s uniquely miniaturized dystrophin gene

Gene transfer can be broadly defined as the introduction of new “foreign” genes, usually in the form of DNA, into the individual cells of the body.

If a normal copy of the defective gene can be transferred into a cell, it is anticipated that the normal protein product derived from the “new” gene would supply the missing function in a cell and consequently cure the cellular dysfunction.

UNC Gene Therapy Centre

1995

July 11-12, 1996 – FDA & NIH: FORUM 1996: GENE THERAPY – PDF, SOURCE

1993

October 14, 1993 – HHS | FDA: Federal Register: Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products – PDF, CREDIT

• The Food and Drug Administration (FDA) is making available, through this document, a statement of the manner in which FDA’s current statutory authorities governing therapeutic products apply to human somatic cell therapy products and gene therapy products.

Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use. FDA generally considers human gene therapy products to include all products that mediate their effects by transcription or translation of transferred genetic material, or by specifically altering host (human) genetic sequences.

Some examples of gene therapy products include nucleic acids, genetically modified microorganisms (e.g., viruses, bacteria, fungi), engineered site-specific nucleases used for human genome editing, and ex vivo genetically modified human cells…

• Additionally

Public Health Service Act (the PHS Act)… (42 U.S.C. 262(a)) identifies a biological product as “any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compouod), applicable to the prevention, treatment, or cure of diseases or injuries of man.”

Licenses are to be issued upon a showing that the establishments and products “meet standards, designed to insure the continued safety, purity, and potency of such products * * *.”…A biological product’s effectiveness for its intended uses must be shown as part of the statutory requirement for potency (21 CFR600.3(s)).

• At the investigational stages, when the products are being studied in clinical trials to gather safety and
  effectiveness data, biological products must meet the requirements…
• The “safety” and “effectiveness” for a biological product i.e. vaccine, is (maybe only) assessed during clinical trials. Thus COVID-19 vaccines only had barely 2 months of “safety” assessment before unblinded – TIMELINE
• “Some products may contain a combination of biological products and drugs or devices. Under a provision of the Safe Medical Devices Act of 1990, FDA determines the primary mode of action of the combination products (21 U.S.C. 353(g)), then assigns the primary jurisdiction for review of the product within the agency based on that determination.”
  • LNP/mRNA complex products are such combination chemical LNP + synthetic modified gene code (biological or chemical?)

Gene therapy products are defined for the purpose of this statement as products containing genetic material administered to modify or manipulate the expression of genetic material or to alter the biological properties of living cells.

Some gene therapy products (e.g., those containing viral vectors) to be administered to humans fall within the definition of biological products and are subject to the licensing provisions of the PHS Act, as well as to the drug provisions of the act. Other gene therapy products, such as chemically synthesized products, meet the drug definition but not the biological product definition and are regulated under the relevant provisions of the act only.

September 1993 – Janet Woodcock was the Director of FDA’s Office of Therapeutics Research and Review. – REF

• Why is this interesting? Woodcock was the FDA rep in 2020 that thwarted hydroxychloroquine and ivermectin’s use for COVID-19 early treatment, an act that allowed novel COVID-19 vaccines to be authorised under EUA. – Steven Hatfill EXCERPT, EXCERPT, EXCERPT

1993 – The Biotechnology Industry Organization (BIO) a biotech lobby group, is created through the merger of two existing organsation – ARCHIVE, TIMELINE

• The merger of the Industrial Biotechnology Association and the Association of Biotechnology Companies both small Washington-based biotechnology trade (and lobby) organizations…

1990

September 14, 1990 – First gene therapy clinical trial was conducted on a 4-year-old girl named Ashanthi DeSilva to fix a genetic defect – TIMELINE, FDA: Human Gene Therapy – ARCHIVE

1975

February 24, 1975 – Asilomar Conference on Recombinant DNA is held – TIMELINE

• In 1975 Berg organised the Asilomar Conference on Recombinant DNA ( rDNA), to put safeguards in place as making hazardous microorganisms now became possible, the guidelines were adopted but have “have gradually been diluted and disregarded.”
• “Genetic engineering has always worried the general public. When scientists first learned to clone genes in the mid-1970s, public reaction ranged from antipathy to hostility. Opponents, fearing that genetically engineered bacteria might escape from a laboratory, shut down the research at Harvard University and the Massachusetts Institute of Technology for months. Twenty-five years ago, in response to public concern, American scientists organized a voluntary moratorium on certain types of gene engineering experiments until safety questions could be resolved.” FDA Human Gene Therapy- REF, Read more – HERE

1971

1971 – Gene Splicing Technique is Discovered – genetic engineering is born – TIMELINE,

• In 1975 US biochemist Paul Berg founded the gene-splicing technique which opened the door to the invention of recombinant-DNA technology i.e. genetic engineering
• The terms “recombinant DNA technology,” “DNA cloning,” “molecular cloning,”or “gene cloning” all refer to the same process (using plasmids) – READ

The post Gene Therapy first appeared on Totality of Evidence.

Since March 2020 he has published many articles using this approach to better inform the public about COVID-19 risk and misinformation. This includes highlighting the multiple problems that arise from equating PCR positive test results with ‘cases’. Norman is a member of the HART (Health and Recovery Team) group. [BIO]

• Where are the Numbers? Substack – HERE
• Website – HERE
  • Videos – HERE
  • Media Appearances – HERE
• YouTube – HERE
• Agena Risk – WEBSITE
• Videos on YouTube explaining statistic and data analysis and the tricks that are used! – HERE
• Twitter – HERE
• HART group – HERE
• Last list of COVID-19 Papers written by Fenton et al – HERE

Excess Mortality data points – HERE

Interviews and articles in reverse chronological order

2024

September 11, 2024 – Dr John Campbell: Fighting Goliath (new Book) with Norman Fenton – WATCH

September 8, 2024 – Where are the Numbers? Substack: Covid, flu and excess deaths in Northern Ireland
The data corroborates the thesis in our book – READ

• many flu deaths were likely classified as covid & responses to covid cause excess deaths. – …”Flu suddenly disappeared during the main covid mortality period March 2020 – Oct 2022 and then just as suddenly reappeared after that.” – TWEET

May 23, 2024 – Where are the Numbers?: We were right! The UK ONS now admit that deaths in the vaccinated were categorised as unvaccinated in 2021– The ONS denied it then but admit it now. – Fenton et al – READ, Lies, Jupplandia: Damned Lies and Statistics – READ

• “Why is this so important? Because the ONS data – possibly more so than any other source of data in the world – was used to bolster the claim that the vaccines were highly effective and safe.“…The ONS “therefore lied and intentionally created and spread misinformation.”

March 16, 2024- Norman Fenton: Helping understand what ‘false positives’ in diagnostic testing really mean – WATCH, READ

• Many still fail to understand the ‘elephant in the room’ – the impact of the underlying population infection rate.

February 16, 2024 – Randy Bock: Prof. Fenton’s Mathematical Search for Covid Truth. Is the Lancet an Ally?- WATCH, From Zika to Covid and the corruption of science – READ

2023

October 18, 2023 – Too Many Dead and Australian excess deaths inquiry – Prof Norman Fenton – WATCH, READ

July 30, 2023 – Where are the numbers? Substack: The very best of Cheap Trick…..How widespread is the (mal)practice of miscategorising vaccination status? – READ, DarkHorse Podcast discuss – WATCH

• “The ‘cheap trick’ is simple: categorise those who are vaccinated as unvaccinated up until some arbitrarily defined time period after vaccination takes place. The time period might be 7, 14 or 21 days. The supposed justification for this practice being that the benefits of the vaccine do not accrue until it has had time to ‘kick in’.”
  • [i.e. a person that has been injected with a product labelled “vaccine” is not – for the purposes of paperwork and statistical data collection purposes, categorised as “vaccinated” until we says so! Anything that happens to that person before that time period is reached, the system will categorise them as “unvaccinated”.]
• This article is a first attempt a list of articles (observational and other studies) that have employed the ‘cheap trick’ when assessing vaccine effectiveness for either infection, hospitalisation or death.

May 29, 2023 – Doc Malik: COVID, Statistics, Anti-semitism, Net Zero and more with Norman Fenton – WATCH

May 24, 2023 – Norman Fenton and John Campbell discuss Canadian excess deaths – WATCH

May 2, 2023 – Where are the numbers? Substack: The illusion of vaccine efficacy revisited – How to make a placebo vaccine look 95% effective and guarantee repeat business – READ, WATCH, ARCHIVE

• Demonstrating “why a vaccine that is actually merely a placebo will inevitably appear to have high efficacy if there is a time delay after vaccination during which the participant is classified as ‘unvaccinated’.”

“We are talking about observational population studies here during a vaxx rollout, so there is no meaningful notion of ‘classifying everybody as unvaxxed for first 2/3 weeks post jab’. That’s why they were able to use this method of deceit. This is exactly what they did.”

Prof Norman Fenton – in Commnets

• May 7, 2023 – Matthew Crawford Substack | Rounding the Earth: Adding to Fenton‘s Miscategorization Illusion, Part 1 – Shattering the Efficacy Illusion, Part 8 – READ

April 21, 2023- Norman Fenton Substack | Where are the numbers?: Interviews: covid data update, academic censorship, and net zero implications – READ

April 20, 2023 – Gareth Icke: Interview with Professor Norman Fenton – discussing net zero and how the covid lockdowns were a dry run – EXCERPT, TRANSCRIPT, CREDIT

April 20, 2023 – Out of the Blank podcast #1393 with Prof Nornan Fenton on academic censorship and more – LISTEN

April 17, 2023 – Coffee and a Mike Podcast Ep #591: Interview with Prof Norman Fenton – discussion on covid, vaccine injured, academia in the UK, being woke, climate change, the WEF and much more – LISTEN, Substack – READ

April 13, 2023 – NTD UK News: Climate Change: What Is ‘Absolute Zero’? – WATCH

April 11, 2023 – Fox News : 2050 Net Zero target: Laura Ingraham interview with Norman Fenton – WATCH, what ‘net zero’ really means – TWEET

April 10, 2023 – Prof Norman Fenton on Twitter: Reminder of what ‘net zero’ really means – THREAD

March 15, 2023 – Norman Fenton Substack: The Lancet heavily redact their response to our subject access request for internal correspondence relating to rejection of our letter about Pfizer study – What have they got to hide? – READ, Undeclared conflict of interest in Lancet paper (interview excerpt) – WATCH, CREDIT

February 20, 2023 – TNT interview with James Freeman on Bayesian probability, covid data and censorship – WATCH

January 23, 2023 – UK Office for Statistics Regulation: Ed Humpherson to Norman Fenton, Martin Neil, Clare Craig and Scott McLachlan: ONS Deaths by Vaccination Status statistics – READ, Prof Martin Neil – TWEET

January 17, 2023 – ResearchGate: The Lancet and the Pfizer Vaccine: A Case Study in Academic Censorship and Deceit in the Covid Era by Fenton & Neil – READ, TWEET

January 15, 2023 – Hearts of Oak: Prof Norman Fenton – How Statistics Are Used to Manipulate and Trick Us – WATCH

January 10, 2023 – Norman Fenton Substack: The curious case of Dr Sharon Alroy-Preis and the claims of safety and effectiveness of the Pfizer vaccine – READ

• Re May 5, 2021 – Israel observational study published in The Lancet: Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data – READ, PDF
• “Its claim of 95% effectiveness – which happened to be exactly the same figure claimed by Pfizer in its original Phase 3 randomised controlled trial…”
• “[This Lancet study] was widely used as the ultimate confirmation of how incredibly effective the vaccine was (the study did not consider safety… But the study was flawed in many ways and on 17 May 2021 we submitted a rapid response (just 450 words) to The Lancet explaining why the claim was exaggerated…” [20 months later the Lancet responded, see below]

January 9, 2023 – Norman Fenton: “In May 2021 we submitted a rapid response to .@TheLancet
paper claiming 95% effectiveness of Pfizer vaxx in large observational trial. We explained why the claim was exaggerated (see https://wherearethenumbers.substack.com/p/important-caveats-to-pfizer-vaccine). After 20 months we finally got this response. Lancet is a disgrace.” – TWEET, CREDIT

• Re May 17, 2021 – Is the Pfizer vaccine as effective as claimed? – SUBSTACK

January 3, 2023 – Norman Fenton & Martin Neil | Where are the Numbers? Substack: How many lives did the Covid vaccines really save? – A response to Steve Kirsch’s challenge “Based on your analysis, what is the decrease in all-cause mortality from Covid specifically attributable to the vaccines? – READ, Geoff Pain – GETTR

• “All-cause mortality following a vaccine roll-out is the only rational way to assess the efficacy of the vaccine because it tells us whether the benefits of the vaccine outweigh the risks; if all-cause mortality rates are lower in the vaccinated then we can conclude that the vaccine must be saving more people from dying from the disease than it is killing from adverse reactions to it.”
• “Even if the vaccines really did save 20 million from covid deaths then it would not be effective if it led to more than 20 million deaths from adverse events.”
• “In fact, not only is there now strong evidence of an increase in all-cause mortality among the vaccinated, but we do not believe there is any objective reliable evidence that the covid vaccines saved any PREVENTABLE deaths from covid.” Nine reason…

2022

December 22, 2022 – Norman Fenton: Why we cannot ignore the Lancet [FLAWED] claim that the vaccines saved 20 million lives – WATCH

• “Despite being easily debunked, the paper published in The Lancet claiming the covid vaccines saved 20 million lives in the first year alone is being used to shut down debate about vaccine injuries and deaths.”
• The Lancet: Global impact of the first year of COVID-19 vaccination: a mathematical modelling study by Watson et al – PAPER

December 14, 2022 – Where Are The Numbers Substack by Norman Fenton and Martin Neil: The Devil’s Advocate: An Exploratory Analysis of 2022 Excess Mortality – What is causing excess deaths: Covid, long-covid, lockdowns, healthcare or the vaccines? – READ

November 2022 – Researchgate: What the ONS Mortality Covid-19 Surveillance Data can tell us about Vaccine Safety and Efficacy – Norman Fenton, Clare Graig et al – READ

• ” …all-cause mortality rate in the vaccinated (1,367 deaths per 100k person years) being much higher than in the unvaccinated (671 deaths per 100k person years)”
• “…major anomalies in the mis-categorization of deaths by vaccination status (especially in the first part of 2021)”
• “There is also now strong evidence that the ONS underestimates the proportion of unvaccinated, which leads to inflated mortality rates for the unvaccinated relative to the vaccinated.” Is it 8%, 20% or 26%? “…either the ONS is underestimating the proportion of unvaccinated in its sample or the sample is so unrepresentative of the whole population that any inferences made using the ONS data are worthless.”
• “Either way, the ONS estimate of the proportion unvaccinated must not be used for any comparisons of vaccine efficacy or safety of the whole England population.”

October 25, 2022 – Dr John Campbell: Office of National Statistics (ONS) sample group discussion with Professor Norman Fenton – WATCH

October 24, 2022 – Fenton Video: How an illusion of efficacy can be established for any treatment – Illustration of a Highly Effective Placebo! – WATCH

October 2, 2022 – Fenton Substack: More on the illusions of vaccine efficacy – READ

September 18, 2022 – The Delingpod: A James Delingpole Podcast with Norman Fenton – WATCH

September 2, 2021 – Pandemic Podcast with Dan Astin-Gregory: CAN WE BELIEVE ANY OF THE COVID NUMBERS? | PROFESSOR NORMAN FENTON – WATCH

August 21, 2022 – DarkHorse Podcast: Wikipedia and the War on Science: Bret Weinstein Speaks with Norman Fenton – WATCH

• “Bret speaks with Norman Fenton on the failure of academia and our medical system that Covid has revealed. They discuss how Wikipedia, the greatest encyclopedia to date, has become a political weapon, and how big an issue this actually is”
• Wikipedia smears and spreads lies about COVID dissidents – EXCERPT

July 31, 2022 – Radical w/Maajid Nawaz #15 – On Responding to the BBC’s Propaganda Documentary “Unvaxxed” – We speak at length to Nazarin Veronica and Vicky Borman, who both featured in the BBC’s propaganda documentary “Unvaxxed”, and we present to them University of London Professor Norman Fenton who addresses the unanswered questions from their negative experience with the BBC. – WATCH

July 22, 2022 – Rise with BNT: Norman Fenton interview with Sonia Poulton:
Part 1 “Problems with the basic Covid data” – WATCH
Part 2 “What proportion of the population is unvaxxinated – WATCH

July 8, 2022 – Norman Fenton Blog: BBC wants “to understand why 8% of the population remains unvaccinated against Covid” – READ The BBC [TNI] edited their article within 2 hours of this post!

March 2022 – ResearchGate: Official mortality data for England reveal systematic undercounting of deaths occurring within first two weeks of Covid-19 vaccination- Clare Craig, Norman Fenton et al – READ

March 5, 2022 – Norman Fenton Blog: Why are UKHSA obfuscating data on stillbirths by vaccine status: just another statistical illusion? – READ

Explained in Another common statistical illusion arising from a drug trial – WATCH In the video Norman shows a statistical illusion whereby a hypothetical drug that is definitely not safe for pregnant women can be shown to be safe because of a simple ‘trick’ in the way the data is handled.

February 23, 2022 – Norman Fenton: When is trial data sufficient to determine treatment effectiveness? in reducing mortality – WATCH

February 10, 2022 – Voice for Science and Solidatiry: The data noose – Is it time for those responsible to pay? Negative Efficacy in the vaccinated – graphs from UK weekly reports – with Norman Fenton – WATCH, original source unknown

“The official [UK] data is massively compromised by the definition of what constitutes a vaccinated person.”

[A fully vaccinated person]…had their second jab less than six months ago or already has had their third jab. Now when it come to recording cases, hospitalisations and deaths a person who’s not fully vaccinated based on this definition is often classified as unvaccinated.”

“The only simple, and truly objective way to evaluate the overall risk-benefit of the vaccines is to compare, all cause mortality for vaccinated against unvaccinated…the count of all cause death should be higher among the unvaccinated than the vaccinated…[and] as far as we’re concerned any person who’s had at least one dose is vaccinated and any other definition is flawed!“

“We can’t find evidence, overall, that the all-cause mortality is reduced with vaccines!”

Norman Fenton

February 5, 2022 – TrialSite News – Sonia Elijah interview with Prof Norman Fenton: Did UK Office of National Statistics Manipulate Data on Covid Deaths by Vaccination Status? – WATCH

January 4, 2022 – PANDA: Open Science Sessions: How flawed data has driven the narrative with Prof Norman Fenton – WATCH

January 2022 – ReserchGate: Official mortality data for England suggest systematic miscategorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination – Martin Niel, Norman Fenton, Clare Craig, Joel Smalley – READ, SOURCE

• May 2024 ONS finally admit that deaths in the vaccinated were categorised as unvaccinated in 2021 – READ

2021

December 29, 2021 – Probability & Law: Covid-19: Definitions matter – and these are REAL – READ, TWEET
A response to : “How definitions influence perceptions of covid lethality, and vaccines safety and effectiveness” – How the UK Government and CDC defines COVID-19 cases and deaths.

December 16, 2021 – The Highwire Ep 246: COVID COVER-UP – FULL, Norman Fenton: Mathematician Uncovers Disturbine Mortality Data – WATCH, BACKUP

November 14, 2021 – Norman Fenton Substack: Is vaccine efficacy a statistical illusion? “Placebo Vaccination” – READ, Analysing Covid vaccine efficiency and safety statistics – WATCH Placebo vaccine illusion demonstrated in Excel – WATCH

December 13, 2021 – World Council for Health | General Assembly: Prof Norman Fenton: Latest Data on Vaccine Efficacy & Safety From the UK – WATCH, FULL

December 9, 2021 – GB News hosted by Nigel Farage: guests Norman Fenton and Sally Cutler. Covers the isue of ethicacy of vaccine mandates and the data to support vaccine effectiveness – WATCH

December 3, 2021 – Researchgate: Latest statistics on England mortality data suggest systematic mis-categorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination – Neil, Fenton, Smalley, Crag – READ, TWEET, (July 2023 – SUBSTACK)

December 1, 2021 – The impact of misclassifying deaths in evaluating vaccine safety: the same statistical illusion – READ

November 17, 2021 – Norman Fenton Lecture: Analysing Covid vaccine efficiency and safety statistics – Systematic flaws in COVID-19 vaccine efficacy and safety statistics – WATCH, SUBSTACK, EXCERPT

• Norman shows how easy it is to create a statistical illsusion showing high efficacy rate for a drug even if it has no effect at all.

Novembe 14, 2021 – Is vaccine efficacy a statistical illusion? – READ

• Demonstration of if there was a one-week delay in reporting deaths then a vaccine that was a placebo would be seen to have a decreased mortality rate for the vaccinated compared to the unvaccinated.

July 17, 2021 – The ‘Lockdowns Summit’ was hosted by Question Everything: – SOURCE, SUMMIT on YouTube

• Why the statistics driving COVID-19 are flawed | Professor Norman Fenton – WATCH

June 24, 2021 -Marta da Silva Gameiro interviews Norman Fenton about mathematical bias of COVID-19 PCR testing – Covers a range of issues on how the COVID-19 narrative has been misrepresented because of reliance on equating a ‘case’ with a PCR-postive test. – WATCH
Covid lockdowns: just the precursor for climate lockdowns? – EXCERPT

April 9, 2021- Norman Fenton: Smashing the “1 in 3 people with Covid-19 have no symptoms” claim – WATCH

Over the period Dec 2020 – Feb 2021, the UK government, and its scientific advisers, made the persistent and widely publicised claim that “1 in 3 people with the SARS-Cov-2 virus have no symptoms”. We use a contemporaneous study of asymptomatics at Cambridge University to show that the claim is contradicted by the government’s own case numbers over that same period... PAPER

2020

November 6, 2020 – Norman Fenton: What machine learning from big data can never learn; causation without correlation – Most people know you can have correlation without causation, but most also assume you cannot have causation without correlation. This 2-minute video provides a simple example. – WATCH

The post Professor Norman Fenton first appeared on Totality of Evidence.

Long-standing definitions that were manipulated during or leading up to the COVID-19 era:

Definitions are in no particular order

• FDA Clinical trial definitions/glossary (clinical outcome, endpoint etc) – ARCHIVE

Pandemic

In May 2009 the World Health Organisation (WHO) changed the criteria that should be met in order to declare a “pandemic“, as such they changed the definition of a “pandemic”. What does this mean in the minds of the masses when they hear the word “pandemic”? Do they associate “deadly” with the word, or do they see it register it as meaning just “geographical spread” of a “new disease” no matter it’s lethality? [MORE]

• See timeline – May 6, 2009
  WHO Feb 24, 2020 – “A pandemic is the worldwide spread of a new disease.” READ

• May 2009 – “The word pandemic refers to how widely dispersed a disease is, not to how severe the disease is,”… the definition of the word is “not set in stone.” said David Ozonoff, professor of environmental health at the Boston University School of Public Health – When a pandemic isn’t a pandemic – ARCHIVE
• February 2010 – Forbes: Why The WHO Faked A Pandemic – READ & WHO’s Convenient “Pandemic” – READ
• 2001- Bulletin of World Health Organisation: The elusive definition of pandemic influenza by Peter Doshi – PDF, CREDIT
  • “WHO did not change its definition of pandemic influenza for the simple reason that it has never formally defined pandemic influenza. It has never established a formal definition and the criteria for declaring a pandemic caused by the H1N1 virus derived from “pandemic phase” definitions, not from a definition of “pandemic influenza”. Despite 10 years of pandemic preparedness activities, no formal definiton was formulated. – REF [They could just make it up!]

• October 2005 – “An influenza pandemic is a global outbreak of disease that occurs when a new influenza A virus appears or “emerges” in the human population, causes serious illness, and then spreads easily from person to person worldwide.” – ARCHIVE, ARCHIVE

Vaccine

BEFORE (Page last reviewed: May 16, 2018): “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease“

AFTER (Page last reviewed: September 1, 2021): “A preparation that is used to stimulate the body’s immune response against diseases.”

• Before: CDC Glossary – July 30, 2020 “Vaccine: A product that produces immunity therefore protecting the body from the disease.” – ARCHIVE

• After: CDC Glossary – August 16, 2020 – “Vaccine: A suspension of live (usually attenuated) or inactivated microorganisms (e.g. bacteria or viruses) or fractions thereof administered to induce immunity and prevent infectious diseases and their sequelae.” – ARCHIVE
• WHO and Gavi accept the CDC’s vaccine definition as “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease” – 2015 SLIDE 4 [A Must Read!]

TGA reference to what is a vaccine and vaccination – ARCHIVE

• Peter Doshi PhD – on What is a Vaccine? – Webster dictionary changed its definition of “vaccine” as mRNA products did not meet the definition – changed Jan 26, 2021, and Oct 23, 2021 – SLIDE

An interesting fact for Australians. We have federal legislation the Therapeutics Goods Act and the Therapeutics Goods Regulations which the TGA follows to approve products for Registration or Provisional Registration. Within the Act and Regulations a “vaccine” is not defined, but there is a committee called the Advisory Committee on Vaccines (ACV) that assesses the data that “sponsors” submit for registration of a vaccine. But who determines whether a product can be assessed as a vaccine versus a drug/medicine and on what criteria is this assessed?

Vaccines provide “immunity against infectious disease”, or at least those with adjuvants do!

The TGA document was referenced in this 2007 WHO document.

NOTE: The TGA is an accredited global training centres that contributes to the WHO Global Training Network (GTN) on vaccines. The TGA developed the 6-day training course – HERE

The Free Dictionary hasn’t received the “memo” – Vaccine confers “immunity”

World Health Organisation publication 2000 defines Vaccine as

• 1) “Biological substance that is administered to individuals to elicit immunity (protection) against a specific disease”
• 3) “The vaccine virus causes a mild infection, usually with no or minimal symptoms, that creates immunity against that virus“

WHO – April 5, 2006 “Vaccines – which protect against disease by inducing immunity” – REF

CDC – Vaccine can now be ‘or genetic material’ – READ

Vaccination

Vaccination:
BEFORE: The act of introducing a vaccine into the body to produce immunity to a specific disease.

AFTER: The act of introducing a vaccine into the body to produce protection from a specific disease.

Note the CDC’s definition of immunity: If you are immune to a disease, you can be exposed to it without becoming infected!

Vaccinated

Vaccinated: This used to be someone who has received a vaccine, but for a COVID-19 vaccine, you are not considered vaccinated until a set number of days after receiving a particular dose. CDC’s definition 14 days post second dose, prior to that you are “unvaccinated”. “Pandemic of the unvaccinated” – WATCH

If you have a reaction to the vaccine and are hospitalised or die within that 14 day period, you would be considered “unvaccinated”, according to the CDC definition! How does this affect the statistics? (WATCH)

But also remember the official treatment protocol for COVID-19 is do nothing until the patient can’t breathe, then go to hospital.

“Fully Vaccinated” changes to “Stay up to Date”

On March 8, 2021 the CDC added the term “fully Vaccinated” – ARCHIVE Nov 2021 – ARCHIVE

According to the CDC “people are considered fully vaccinated:

• 2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or
• 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine”

But when boosters were introduced they eventually removed “fully vaccinated” and moved to the term “Get Vaccinated Stay up to date” [ARCHIVE]. The time between boosters moved from 6 months down to only 3 months, which using fully vaccinated became a cumbersome and comfusing term.

On January 5, 2022 The CDC no longer use the term Fully Vaccinated but have replaced it with “Stay up to date” – ARCHIVE , which is also used by Australia’s ATAGI. –

The CDC linked fully vaccinated with being able to go back to normal: “people who have been fully vaccinated can do things that they had stopped doing because of the pandemic.”

Note ATAGI have introduced “primary dose 3” which used to be booster dose 1! See Table 1 HERE

Nov 8, 2021 – Australia TGA: “‘Fully vaccinated‘ means a person has received the required dose(s) of a COVID-19 vaccine under the national COVID-19 vaccination program to be considered fully vaccinated in accordance with the recommendations made by the Australian Sponsor of the relevant vaccine.” – REF

Immunization/Immunisation

“Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease” ~2011 – ARCHIVE

Unvaccinated

Pandemic of the “unvaccinated” – but what does that really mean?

CDC state: “Most people who get COVID-19 are unvaccinated.”

Prior to the COVID-19 vaccine rollout when someone received a vaccine (injected into their limb) they were considered vaccinated.

Post the COVID-19 vaccine rollout suddenly you are considered “unvaccinated” for 14 days post your injection, or if you have not had the injection at all! These are two separate cohorts that are being statistically lumped together and skewing the real story.

If in those 14 days post vaccine administration you happen to have an adverse reaction or you got infected or returned a positive PCR test, per CDC definition the medical system will count you as “unvaccinated”!!!

• If you get COVID-19 during the 14 days post jab you are considered “unvaccinated”
• If you die during the 14 days post jab you are considered “unvaccinated”
• If you get hospitalised during the 14 days post jab you are considered “unvaccinated”

Now consider the consequence of this “unvaccinated” status for cases , hospitalisations and deaths that occur within the14 day window post injection! – WATCH

“Vaccine Failure”

October 11, 2023 – Daily Clout: Report 88: 2.5 Months After COVID Vaccine Rollout, Pfizer Changed Criteria for ‘Vaccination Failure,’ Causing 99% of Reported Cases to Not Meet That Definition. 3.9% of Reported ‘Lack of Efficacy’ Cases Ended in Death in First 90 Days of Public Vaccine Availability – READ , more Pfizer FOIA documents HERE

• On February 15, 2021 Pfizer adopted a new definition of “vaccination failure” now requiring all three of the following criteria to be met:
  • Both doses received per local regime.
  • At least seven days since the second dose.
  • Infection with confirmed lab test positive for SARS-CoV-2.
• Revising the criteria for vaccination failure likely allowed Pfizer to shift “lack of efficacy” (LOE) cases out of the “vaccination failure” category and into “drug ineffective” category—with many unknowns and 98.5% of the “drug ineffective” cases were serious.

Herd Immunity

WHO attempted to change the definition of “herd immunity” in October 2020 to be attributed to vaccination only, totally discounting broad spectrum immunity that the body produces when it is infected naturally with a pathogen such as a virus. This was met with resistance and changed a few months later to include natural infection. [SOURCE] WATCH

WHO (Oct 15, 2020) -‘Herd immunity’, also known as ‘population immunity’, is a concept used for vaccination, in which a population can be protected from a certain virus if a threshold of vaccination is reached. – LINK

WHO (Dec 31, 2020) – ‘Herd immunity’, also known as ‘population immunity’, is the indirect protection from an infectious disease that happens when a population is immune either through vaccination or immunity developed through previous infection. LINK

Another before and after example:
WHO (June 9, 2020) – Before – HERE
WHO (Nov 13, 2020) – After – HERE
Which on Dec 31, 2020 they returned the definition to include natural infection – HERE

November 2018 – Oxford Vaccine Group, sponsored by Wellcome, explains herd immunity/protection – WATCH, SOURCE

Case

Suddenly in 2020 a disease “case” could be attributed to a healthy (not sick), asymptomatic (not symptoms) person who simply receives a positive result from a PCR test, a test which is not designed to diagnosed, is known to have a high false positive rate, and historically would be used to confirm a disease not diagnose that someone has a disease!

A “case” used to refer to someone who was sick, at a minimum has some type of symptomology.

December 29, 2021 – Probability & Law: Covid-19: Definitions matter – and these are REAL by Prof Norman Fenton – READ

Breakthrough Cases

As of May 14, 2021 the CDC will only report breakthrough cases that result in hospitalization or death. A vaccinated person who then gets COVID-19 is considered a breakthrough case. From this time the CDC also announce they would only cycle the PCR test to 28 cycles….where previously it went up to 40 to 45 cycles. – ARTICLE

CDC Breakthrough cases – Apr 2021 – HERE, May 2021 – HERE

Anti-vaxxer

According to the new Webster dictionary definition, an “anti-vaxxer” is effectively anyone who is against mandatory vaccination, whether they get vaccinated or not! – LINK, Webster Dictionary – LIVE

Before (2018): “a person who opposes vaccination or laws that mandate vaccination.”
After:

• October 29, 2021 “a person who opposes the use of vaccines or regulations mandating vaccination” – ARCHIVE
• September 1, 2022 changed again to “who opposes the use of some or all vaccines…” – ARCHIVE

• Anti-vaccination dates back 150+ years, the moment mandates imposed, it’s not new (EXAMPLE), and then as new bacterial soups emerged in the late 1800’s to early 1900s (EXAMPLE). An anti-vaxxer is not a new concept!

Gain of Function

According to web archives on October 21, 2021 the NIH set up a new web page titled “Research Involving Enhanced Potential Pandemic Pathogens” which the previous web page called “Gain-of-Function Research Involving Potential Pandemic Pathogens” now redirect to the new “definition”. [1, 2]

Gain of Function definition has been replaced with “enhanced potential pandemic pathogen (ePPP) research a type of so called ‘Gain-of-Function’ (GOF) research”.

Gain-of-Function Research

Research Involving Enhanced Potential Pandemic Pathogens (ePPP)

This update occurred a day after the NIH’s principal deputy director, Lawrence A. Tabak, wrote a letter, dated 20 Oct, 2021, to Rep. James Comer confirming “EcoHealth and the WIV conducted GOF research on bat coronaviruses” – ARTICLE, TWEET

August 8, 2016 – Science and Engineering Ethics: Gain-of-Function Research: Ethical Analysis – READ

Read more

PCR – polymerase chain reaction

In October 2004 the US National Institute of Health – Genome division defined PCR as “A fast, inexpensive technique for making an unlimited number of copies of any piece of DNA. Sometimes called “molecular photocopying”

In 2020 PCR became a “diagnostic test”, especially in healthy, asymptomatic people! – TIMELINE

Australian health officials can’t provide the definition of a woman!

Two days earlier US Representative Madison Cawthorn provided the Democrats with the definition: ‘the definition of a woman is ‘XX chromosomes’ and ‘no tallywacker'”! – WATCH

Woman and Pregnant Woman

Since naturally high-testosterone producers, formally “male” who now “identify” as a woman (think swimming), have muddied the waters of what a woman is, the “liberals” are choosing to now refer to a women as “menstruating people” and a pregnant woman as “pregnant people” or “birthing people”. [1]

Female

Around September 29, 2020 the Merriam-Webster dictionary changed its definition of “female” to “gender identity which is the opposite of male” – READ, SOURCE

June 30, 2020 – ARCHIVE
September 29, 2020 – ARCHIVE

Pregnancy

Pregnancy may no longer be “a condition unique to biological females”! (Aug 7, 2022) – READ

Sex (gender)

On July 6, 2022 the World Health Organisation (WHO) updated it’s 2011 gender guidance document used by public health officials. – ARTICLE

Stating “sex is not limited to male or female.”

Cancel Culture

”Cancel culture or call-out culture is a modern form of ostracism in which someone is thrust out of social or professional circles – whether it be online, on social media, or in person. Those subject to this ostracism are said to have been “cancelled”“ [source]

Censorship

”Censorship is the suppression of speech, public communication, or other information. This may be done on the basis that such material is considered objectionable, harmful, sensitive, or “inconvenient”. Censorship can be conducted by governments, private institutions and other controlling bodies. Governments and private organizations may engage in censorship.” [source]

Mis- Dis- & Mal- information

The US government cybersecurity agency have defined the following “information activities”:

• Misinformation is false, but not created or shared with the intention of causing harm.
• Disinformation is deliberately created to mislead, harm, or manipulate a person, social group, organization, or country.
• Malinformation is based on fact, but used out of context to mislead, harm, or manipulate

Hospital Discharge

In New Zealand in 1992, the changing of the definition of what constituted a “hospital discharge”, could have helped to justify the adding of the Chicken pox vaccine to their “immunisation” schedule. A change to how hospital discharge is defined created a spike in the data, making it appear that hospitalisation for chicken pox increased!

Recession

July 2022 – The long standing definition of a “recession” was attempted to be changed by the White House days before the quarterly report was released – WATCH, Ed Dowd – WATCH, Election consequences of their change in definition – Tucker Carlson – WATCH

The historical definition (which is around 80 years old) is that two consecutive quarters of negative GDP growth is a recession. [1, 2] Experts denying the US is in recession, that the strong job market indicates the economy is just fine. [Are there lots of jobs because of jab mandate firings and excess mortality?] [1]

Wikipedia attempting to change the definition of Recession – GETTR, Check for yourself – HERE

Vaccine injury is “rare”

I bet most people believe when the media state vaccine injuries are “rare” in their mind they believe it’s like a one in a million chance event. WRONG

The TGA have allowed pharmaceutical companies to define rare as less than or equal to 1 in 10,000 down to less than 1 in 1,000 event. So if for example myocarditis occurs 1 in every 2,500 to 5,000 children, that is defined as “rear”.

COVID-19 – The Disease i.e. symptoms

Though not an official re-defining of COVID-19, I think this image by Matthew Crawford in time will prove to be correct – SUBSTACK, Spike Protein [likely designed in a lab] has a lot to answer for!

Paralytic Poliomyelitis

Full credit to Dissolving Illusions by Suzanne Humphries & Roman Bystrianyk – Page 230-233

Before: n 1954 (before the vaccine) the poliomyelitis was diagnised by doctors with out any laboratory confirmation or presence of “residual [longer than 24 hours]” paralysis – which could be any paralytic disease from DDT, arsenic or lead poisoning to syphilis, GBS, or limb paralysis by intramuscular injection. As such “many distinct diseases were naively grouped under the umbrella of ‘polio'”

After: “Only after the [Salk polio] vaccine was widely accepted was there an effort to distinguish poliovirus from other types of paralytic disease”. From 1955, the year the Salk vaccine was introduced, a polio diagnosis required the presence of paralysis for at least 60 days. It wasn’t until 1958 that laboratory confirmitory test was introduced.

Add to this a vaccinated person was more likely to get a diagnosis of a “non-polio illness”. All giving the appearance that the vaccine reduced the incidence of polio, but it was mostly “due to the power of the pen”.

Safe – Drug Safety

March 27, 2015 – ICH Common Technical Document (CTD): The International Committee for Harmonisation (ICH) a regulator-pharma industry partnership Make the following comments about what “Safe” means: – PDF, ARCHIVE, creating M4E(R2) updating September 2002 CTD, which “has not kept pace with this progress” – ARCHIVE

The meaning of “safe” has historically been interpreted to mean that the benefits of the drug outweigh its risks. The benefit-risk assessment is the fundamental basis of regulatory decision making.

June 7, 2021 – Dept Health: New regulatory arrangements support businesses and health professionals to communicate and incentivise COVID-19 vaccination – READ, ARCHIVE, Phil Altma – CREDIT

• You can’t claim a therapeutic goods is “safe” unless it is a COVID-19 vaccine which received “permission” to make such “claims”.

Stillbirth or Stillborn Child

Defining stillbirth is important when tracking Pregnancy Loss

Stillbirth definitions vary between countries around the globe. – REF

In the US Stillbirth is a foetal death from 20 weeks gestation, prior to 20 weeks it has traditionally been considered a miscarriage – WATCH

World Health Organiation: “A baby who dies after 28 weeks of pregnancy, but before or during birth, is classified as a stillbirth.” – READ

On May 10, 2021 Singapore changed the definition of Sillborn Child to no longer be 20 weeks, but now 22 weeks – PDF, CREDIT

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