The fact that the increase in Covid cases and the emergence of a novel variety coincided with widespread immunization appears far too coincidental.
It’s still unclear whether this novel Covid Delta Variant was caused by “shedding.”
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However, as the FDA acknowledged in 2015, it is worth investigating and appears to be extremely likely.
Documents from the FDA from 2015 have surfaced, revealing that they were aware of “vaccines” and virus shedding.
Despite this, we’ve seen “health officials” claim that shedding is a hoax throughout the pandemic.
The FDA.gov documents on shedding advise scientists on what should be included in “shedding research.”
Health and human services Fda 2015 shedding pic.twitter.com/vQQDraORoP
— Butch (@ButchLesco) June 30, 2021
August 2015 FDA guidance: “shedding” means release of VBGT or oncolytic products from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds). https://t.co/sOQcOfff5w
— AR (@rockwoodpr) June 30, 2021
https://twitter.com/Honnest9/status/1410649289513127953?s=20
While the CDC website denies that shedding exists, the FDA has a Guidance Document to Help Companies Design Studies to Measure the Shedding!#justwait #itsnotavaccine pic.twitter.com/0CWPwjivdv
— DR JANE RUBY – #JUSTWAIT (@RealDrJaneRuby) June 30, 2021
The word “shedding” is defined by the FDA as “the release of VBGT or oncolytic products from the patient by one or more of the following mechanisms: excreta (feces); secreta (urine, saliva, nasopharyngeal secretions, etc. ); or skin (pustules, sores, wounds).”
The following is an excerpt from the full FDA.gov study on shedding:
The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2 with recommendations on how to conduct shedding studies during preclinical and clinical development. For purposes of this guidance, the term “shedding” means release of VBGT or oncolytic products from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds). Shedding is distinct from biodistribution because the latter describes how a product is spread within the patient’s body from the site of administration while the former describes how it is excreted or released from the patient’s body. Shedding raises the possibility of transmission of VBGT or oncolytic products3 from treated to untreated individuals (e.g., close contacts and health care professionals). This guidance represents FDA’s current thinking on how and when shedding data should be collected for VBGT and oncolytic products during preclinical and clinical development and how shedding data can be used to assess the potential for transmission to untreated individuals. This guidance finalizes the draft guidance of the same title dated July 2014. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required
- SCOPE
The products covered by this guidance are VBGT and oncolytic products that OCTGT reviews. The focus of this guidance is shedding studies, including both how and when shedding data should be collected and how shedding data can be used to assess the potential for transmission to untreated individuals. This guidance does not cover plasmids, peptides, and genetically modified mammalian cells that OCTGT also reviews because, unlike VBGT and oncolytic products, there is no potential for plasmids, peptides, and genetically modified mammalian cells to be infectious or transmissible. This guidance also does not address collection or submission of adverse event information, including those adverse events that could be attributed to shedding. Please see the regulations at Title 21 of the Code of Federal Regulations (CFR) Part 312, specifically 21 CFR 312.32 and 21 CFR Part 600, specifically 21 CFR 600.80, for information on the collection and submission to FDA of adverse event information. Finally, while assessment of shedding can be utilized to understand the potential risk to the environment, the scope of this guidance does not include shedding as it may relate to potential environmental concerns with respect to a specific VBGT or oncolytic product. For more information on this topic, you may wish to consult FDA’s guidance document entitled “Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry” dated March 2015. 4
III. BACKGROUND
VBGT and oncolytic products are derived from infectious viruses or bacteria. In general, these products are not as infectious or as virulent as the parent strain of virus or bacterium because of, in part, the derivation methods and/or modifications made during product development that lead to attenuation. Hence, it is likely that these products are shed to a lesser extent than during natural infection by the parent strain. Nonetheless, the possibility that the shed VBGT or oncolytic product may be infectious raises safety concerns related to the risk of transmission to untreated individuals. To understand this risk, shedding studies that are conducted in the target patient population(s) may be appropriate before licensure. Typically, clinical shedding studies are not stand-alone studies but are integrated into the design of a safety or efficacy trial. Because there are many product-specific factors and patient-specific factors that can influence the design of a shedding study, sponsors should consult with OCTGT in the early stages of product development for specific recommendations as to their product.
IV. WHY COLLECT SHEDDING DATA DURING PRODUCT DEVELOPMENT?
Shedding studies should be conducted for each VBGT or oncolytic product to provide information about the likelihood of transmission to untreated individuals because historical data alone may not be predictive of the shedding profile. Shedding data can be used to evaluate measures to prevent transmission. Shedding data collected during product development should provide a clear and comprehensive understanding of the shedding profile of VBGT or oncolytic products in the target patient population(s). Note that it may be appropriate to describe these data in the package insert for an approved Biologics License Application (BLA). To inform the design of human shedding studies, shedding data may be collected in animals following administration of the VBGT or oncolytic product. These data can help estimate the likelihood and potential shedding profile in humans, particularly when there is concern about transmission to untreated individuals. However, such data cannot substitute for human shedding studies for several reasons. For example, a VBGT or oncolytic product may be derived from a human-specific strain; therefore, animals may not adequately predict the shedding profile in humans. Similarly, various animal species/models may not adequately address patient-specific factors, such as differences in the immune status at the time of product administration, which may contribute to the potential for shedding in humans (for more details refer to section VII.B. of this guidance). Product-specific variables may also affect shedding. For example, the biological characteristics and route of administration (entry) of VBGT or oncolytic products can be different from that of the parent strain of viruses and bacteria. Specifically, these products may be: • Derived from laboratory-adapted wild-type, attenuated or engineered strains that may not have been characterized in humans in prior studies. • Replication competent or incompetent viruses; viruses that can infect a host cell and amplify to produce progeny are replication competent and those that can infect a host cell but cannot establish an infection, amplify, and produce progeny are replication incompetent.
Dividing and/or auxotrophic bacteria; auxotrophic bacteria are unable to synthesize an organic molecule required for their growth and division but when this molecule is available with the other nutrients they require, growth and division of the bacteria may occur. • Introduced into the human body through unnatural routes and hence, the infectivity, replication, persistence and shedding from the human body may be different than that of the parental strains. • Engineered to carry transgenes, e.g., tropism-altering genes, immune modifying gene(s) or genes that enhance oncolysis.
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