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Official FDA.gov Documents Confirm Vaccine “Shedding” Is Real and Dangerous!


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It seems too coincidental that the spike in Covid cases and a new variant occurred immediately following mass vaccination.

Whether or not this new Covid Delta Variant was caused by “shedding” remains to be concluded.

However, it is worth looking into and seems highly plausible, as the FDA noted back in 2015.

Documents from the FDA surfaced from 2015 showing that they KNEW about “vaccines” and viruses shedding.

Yet, we have heard “health officials” tell us that shedding is a conspiracy theory during the whole pandemic.

The documents from FDA.gov about shedding recommend to scientists what should be included in “shedding studies”.

The FDA defines the term “shedding” as a “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).”

Below is part of the full FDA.gov report, which discusses shedding in detail:

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

  1. 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.

One smart doctor, Richard Fleming, makes a valid point that the FDA spent a good deal of time and money on shedding, and they wouldn’t if it wasn’t real.

He also sounds the alarm that the vaccine is making antibodies to the nucleocapsid- another part of the virus that is supposedly not in the vaccine.

So what’s in the vaccine that causes the body to make these extra antibodies?

 

Clearly, the safety of vaccines remains questionable, and shedding exists!

Is this why the mainstream media keeps dodging the truth with fact checks about shedding?

USA TODAY reports this week that there is no shedding:

Vaccinated people do not shed spike protein or the vaccine itself

Vaccine shedding can rarely occur with some types of vaccines, but not with the ones currently available for COVID-19.

“As none of the current COVID-19 vaccines authorized for emergency use in the USA contain live SARS-CoV-2 virus, viral shedding is not an issue for these vaccines,” Dr. Matthew Laurens, an infectious disease specialist and vaccine researcher at the University of Maryland School of Medicine, said in an email to USA TODAY.

Live attenuated vaccines, or LAVs, refer to shots that contain a weakened version of the virus stripped of its ability to replicate. This form prevents it from stirring up serious disease and infection while still provoking a strong immune response. LAVs include those for smallpox, chickenpox and the combined vaccine for measles, mumps and rubella.     

The Johnson & Johnson COVID-19 vaccine does use a common cold virus to carry and deliver the genetic instructions for the COVID-19 spike protein to cells (a technology known as a viral vector). But again, the virus is unable to make copies of itself to cause disease, said John Grabenstein of the Immunization Action Coalition and a former director of the Defense Department’s immunization program.      

Similarly, the spike protein encoded by the messenger RNA, or mRNA, of the Pfizer and Moderna vaccines, can’t be transmitted from one vaccinated person to another unvaccinated person

“The mRNA vaccines make the spike protein for a few hours and then stop. They don’t ever get outside the body,” Grabenstein told USA TODAY. 

The post’s claim that white pine tea can stop “inappropriate replication/modification of genetic material” also has no basis in science; mRNA can’t be incorporated into human DNA because it doesn’t enter the nucleus, the cell’s genetic powerhouse. 

Grabenstein explained that if the cell were a chicken egg, the nucleus would be the yolk and the cytoplasm – the area outside of the nucleus where other cellular structures like the mitochondria are found – would be the white of the egg. The mRNA strictly works in this “white” region and is degraded there once the cell produces the spike protein.

There is still a small chance vaccinated people can get sick and spread the virus, called vaccine breakthrough cases. But this is expected since the vaccines don’t confer 100% protection. And research suggests these individuals are less likely to transmit COVID-19 compared with unvaccinated people. This spread isn’t related to any kind of vaccine shedding, it’s just natural disease spread as happens far more often between the unvaccinated.

If we’re being told to follow the science, isn’t it best to listen to the FDA’s 2015 report about shedding over “fact-checkers”?



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