Gene Based Therapies (Vaccine) Shedding

Gene-Based Therapies (Vaccine) Shedding

This is Not Science Fiction

The Covid19 vaccine does not meet the criteria to be called a vaccine. These are gene therapies. Here is information on the transmission of gene therapies. Introducing a gene therapy that can be transmitted from person to person, some refer to as shedding, is a completely unnatural act and a crime against humanity. We also discuss CRISPR, which alters the genetic makeup of the human body. Altering the DNA of the human body brings with it many ethical concerns not only for our group but the average person should be very concerned.

Health authorities have approved few gene therapeutics because of safety concerns. The following article is on virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) and the guidelines for conducting studies on shedding.

The link above to the gene-based therapies states it uses a harmless viral vector. That is absolutely not true in the case of mRNA vaccines. The viral vector is toxic. It is not harmless, but more on that when we discuss the ingredients in these products.

For the article, the state “shedding” means the release of VBGT or oncolytic products from the patient through feces, urine, saliva, and the nasal cavity along with skin sores or wounds, also known as the fecal-oral route.

Biodistribution means within the body, whereas shedding means releasing it and possibly spreading it to others.

You can also read about how they discuss people not in the study obtaining vaccine side effects in the Pfizer protocol documents.

This website is for information purposes only; we are not diagnosing, treating, curing, mitigating, or preventing any disease or medical condition by providing the information contained herein. Before beginning any natural treatment regimen, seek the advice of a licensed healthcare professional.

Gene Therapy Definitions

The Food and Drug Administration (FDA) defines gene therapy as products that “mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms,” and the European Medicines Agency (EMA) describes gene therapy medicinal product (GTMP) as a “biological medicinal product that contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to humans to regulate, repair, replace, add or delete genetic sequences and its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence” (32, 34). Typically, DNA, mRNA, siRNA, miRNA, and anti-sense oligonucleotides are the genetic materials used for therapeutic delivery into a defective target cell or tissue to restore a specific gene function or turn off a gene responsible for disease or disorder development (35).

Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products

From the article: After shedding data are collected in early phase studies, it is not uncommon that dose, route, regimen (frequency of product administration, concomitant therapy, preconditioning regimens, etc.), or indication are modified. These changes can alter how the product is shed. In such cases, shedding data collected in early clinical trials may not be adequate or relevant to predict the shedding profile of the product in its current state.

We do not see any studies on the Covid19 vaccine shedding. The establishment is not referring to the injections as gene therapies, but thousands of doctors worldwide refuse to use the word vaccine when discussing this product.

This study is not about collecting information on the adverse events when the product is shed to another person. We clearly see information in Pfziers’s documentation that they are collecting that data but compiling the data separately.

The study states: that the shed of these products may be infectious and raise safety concerns; therefore, understanding the risk may be appropriate before licensure.

Why would anyone ever allow a product that could be transmitted to an unsuspected, unknowing individual, which has potential life-altering, even permanent effects, to be allowed to exist in the first place? This is a crime against humanity. The Nuremberg Code states you must have complete informed consent before participating in any medical trial. If they are doing trials and using these medical products spreading to others without their knowledge, this violates the Nuremberg Code.

Is this information on the package insert for the Biologics License Application (BLA) of the Covid-19 vaccine? Where are the studies, and are they accessible to us?

It is recommended that since replication-competent products are associated with a higher potential for release as infectious viruses or bacteria, studies be conducted in all 3 phases of clinical trials.

Immediately following product administration is when shedding is most likely to happen, whether it is replication-competent or not.

immunosuppressed patients may become persistently infected and may shed the product for extended periods of time

The author’s current understanding is that during shedding, in most cases, the potential for transmission is extremely low.

Gene Therapy Leaves a Vicious Cycle

Because it often uses repurposed viruses to deliver therapeutic genes, gene therapy has been caught in a vicious cycle for nearly two decades owing to immune response, insertional mutagenesis, viral tropism, off-target activity, unwanted clinical outcomes (ranging from illness to death of participants in clinical trials), and patchy regulations (23, 28–31). This led to a sharp decline in research funding for basic, preclinical development and vector production via individual investigators grants such as R01 and program grants. Thus, with limited information of preclinical data and vector production, the number of clinical trials conducted worldwide did not rise steadily from 1999 to 2015 (32).

Insertional mutagenesis – phenomena in which exogenous DNA sequence is integrated with the genome of the host.

Viral tropism – Ability of the virus to infect cell or host species.

Off-target activity – Biological activity of a drug that is the intended target that commonly produces side effects—an unwanted result.

To guide the design of shedding studies, the following should be considered:

A. Biological Characteristics

• Replication competence: The ability of the VBGT or oncolytic product to multiply and amplify in the human host greatly affects how it is disseminated in the body and may increase the extent and duration of shedding.
• Immunogenicity: When the VBGT or oncolytic product is derived from viruses or bacteria that elicit a strong immune response, the product may be more rapidly cleared from circulation than a poorly immunogenic product, and may be shed for a shorter duration. Similarly, when a product is administered multiple times, the product may be shed for a shorter duration in the later dose cycles than after the
immune-priming first or early doses.
• Persistence and latency: The duration of a shedding study may be longer if the VBGT or oncolytic product exhibits persistence or latency-reactivation in the host, as in the case of an oncolytic herpes virus product that is capable of latency (period of time during which a virus is present in the host without producing overt clinical symptoms). Shedding of such products may be intermittent and unpredictable.
• Tropism: Tropism of the product may affect what samples should be collected to assess shedding. For example, VBGT or oncolytic products that are engineered to carry tropism modifying gene(s) or mutation(s) may exhibit an altered shedding profile than the parent virus because of retargeting of the product to different tissues or organs.

Here are some very interesting highlights direclty from the article.

Monoclonal antibody-based drugs including Humira, Rituxan, Avastin, Herceptin, Remicade, Lucentis, Enbrel, Synazis, and several others, are being used to treat cancer, diabetes, autoimmune disorders, infectious diseases, and others (8). In fact, both protein and peptide-based drugs have emerged as a major class of therapeutics with nearly 380 marketed pharmaceuticals available in the world (9). However, these protein-based therapies are facing many challenges including low solubility and bioavailability, in vivo physicochemical instability, short circulating half-life, penetrability in vivo, biodistribution, and causing toxicity in large amounts (10–15). Another adverse effect of introducing therapeutic proteins into a patient’s body is that it may result in severe immune responses, inflammation, and fever (16).

Gene therapy is an emerging experimental treatment that delivers functional genes into a patient’s body to counter or replace malfunctioning ones, thus curing disease without pharmacological intervention, radiotherapy, or surgery. This modern approach has the potential to offer complete protection against lethal nerve gases (13, 19–22) and treat monogenic and cardiovascular diseases, immunodeficiency, cancer, and more.

Part of the challenge is therapeutic DNA’s inability to pass through the cell membrane because of its large size and negative charge. Also, the therapeutic DNA needs to escape the cellular endonucleases and renal clearance.

CRISPR–Cas – (clustered regularly interspaced short palindromic repeat–CRISPR-associated) systems. Researchers are experimenting with using mRNA to deliver CRISPR gene-editing technology to treat genetic diseases. CRISPR/Cas9 makes it possible to edit the genome of any living organism.

Using [CRISPR] as a therapy for people, you need to figure out how to get these editing tools into the cells you’re trying to fix. Using CRISPR allows them to change, delete or add specific genetic information within the body.

This technology is massivly against all that we believ in. Instead of focusing what is causing all of these diseases that have greatly increased in numbers over time they are creating Frankenstien projects altering humanity.

Non-viral vectors for gene-based therapy – Published: 15 July 2014

Harvard geneticist George Church announced the intention to bring back the extinct woolly mammal. Taking the DNA from an extinct animal’s hairball and combining it with a current species, and growing it in an artificial womb is beyond ludicrous. Biological technologies will change what it means to be human. Many people ask what they can do with this technology. Building a superhuman army is often used as an example.

We are already interfering with nature on a massive scale by injecting 72 doses of 16 different vaccines into young children. This is one of the causes of many lifetime illnesses for children created by the establishment to promote their business model of sickness by design. They create customers that fuel the fire of the sickness for profits. When you realize the pharma industry has integrated itself within our government, it becomes more apparent what is being done to society.

If we removed all the toxicity from the body, we would not have the diseases we see today. For some of us who are a little older, we never saw or knew anyone with an autoimmune disease—a disease known to be caused by vaccines. Years ago, autism did not even exist. The more we vaccinated, the more prevalent it became. The argument that it was just not recognized back then is absolutely absurd. After injection, when a mother notices almost instantaneous changes in her child due to neurological impairment has never changed.

This also leads us into the ingredients of the current mRNA Covid19 vaccines. Dr. Robert Young has described is great detail what he finds inside the vaccines.

We will describe and outline what he discoverd in a seperate piece.

This is no longer accessible on their website so we post this verbatim. We found this part of this article interesting.

Shedding to a third party. We have the original article but cannot put a link since they took it down.

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH Considerations

General Principles to Address Virus and Vector Shedding – June 2009

6.0 Third-Party Transmission

In some cases, when shedding is observed, the potential for transmission to third parties might need to be investigated. These investigations would involve the evaluation of persons that come into close contact with virus/vector recipients (e.g., family members, healthcare workers) for evidence of transmission. The immunological status of the third party should be considered. A high proportion of the population might already have pre-existing immunity to the virus/vector; in this case, clearance should be effective in those individuals. However, the immune status of the third party contacts could be compromised, e.g., in the elderly or very young, and so clearance mechanisms might be inefficient. Thus the consequences of infection might be more significant in these individuals.

It might be appropriate to instruct the patient and family members in ways to minimize the exposure of others. This could also include the advice to use specific sanitation measures.