FDA: Design and Analysis of Shedding Studies

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  • Fri, Jul 02, 2021 - 07:24am

    #1
    davefairtex

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    FDA: Design and Analysis of Shedding Studies

So it turns out shedding is a thing.  A well-known thing.  Since 2015 at a minimum.

https://21a86421-c3e0-461b-83c2-cfe4628dfadc.filesusr.com/ugd/659775_26d788ad58e244ee8236992fe6099051.pdf

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

Apologies if this has been posted before.  I didn’t see it.  [H/T Dr Richard Fleming – I got it from his website]

Note #1: I have saved a copy of this pdf in case it gets Orwelled.

Note #2: this is an official FDA document.   Abstract here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-and-analysis-shedding-studies-virus-or-bacteria-based-gene-therapy-and-oncolytic-products

Here’s a partial Table of Contents.

4. WHY COLLECT SHEDDING DATA DURING PRODUCT DEVELOPMENT?

5. COLLECTION OF SHEDDING DATA IN PRECLINICAL STUDIES

6. DESIGN OF SHEDDING STUDIES: GUIDING PRINCIPLES

7. COLLECTION OF SHEDDING DATA IN CLINICAL STUDIES

8. ANALYTICAL ASSAYS TO MEASURE SHEDDING

9. ANALYSIS OF SHEDDING DATA

10. WHAT TO INCLUDE IN A CLINICAL SHEDDING STUDY REPORT

11. ASSESSING THE POTENTIAL FOR TRANSMISSION TO UNTREATED INDIVIDUALS DUE TO SHEDDING

Looks like some QAnon-Anti-Vaxxer-Extremists were able to infiltrate the FDA…way back in 2015!  They cleverly called their document “Guidance for Industry.”

The plan to collect shedding data in clinical studies can be based on prior clinical experience with the same or similar product, but when there is no such experience, as in the case of first-in-human VBGT [Virus/Bacteria-based Gene Therapy] or oncolytic products, the shedding profile generated in animals can be informative. We recommend that sponsors prospectively design and incorporate the sampling plan in the clinical study to collect shedding data. There are four critical choices in the design of a sampling plan:

•Frequency of sample collection;

•Duration of sample collection;

•Type(s) of samples collected; and

•Storage conditions for types of samples collected.

Frequency of sample collection: Shedding is most likely to occur in the period immediately following product administration, irrespective of replication competence of the VBGT or oncolytic product. A second peak of shedding may be noted in the days/weeks after administration of a replication competent product as a result of its multiplication/amplification in vivo. Accordingly, sampling should start immediately after product administration, with frequent sampling during the initial weeks following treatment to capture the shedding pattern accurately (e.g., sampling on day 1, 3, 7, 10 and then weekly). Analysis of samples should continue until three consecutive data points are obtained at or below the limit of detection (LOD) of the shedding assay. If the level of shedding does not reach the LOD of the assay but there is a continual decreasing trend, collection should continue until the results demonstrate that a plateau has been reached in at least three consecutive data points.

So, PFE/MRNA/JNJ did all this with their test rabbits, right?

One caveat: the document largely doesn’t talk about shedding through skin (except for a hypothetical “herpesvirus” product, where that might be expected) or through the nose – except for a replication-competent adenovirus VBGT product.

I haven’t read it more than once – I might have missed something – I may have misunderstood something – its not my field.

“Submitted for your approval…”

  • Fri, Jul 02, 2021 - 09:44am

    #2
    MGRS

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    Reply To: FDA: Design and Analysis of Shedding Studies

Great find, Dave.  Added to the reading list.

From the description/abstract, for those that don’t have time to read the whole thing:

“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).

So yeah, shedding is a wild conspiracy theory… from the FDA in 2015.

edit: Dang, I reeeeeeally hope this spike protein exhibiting prion-like behavior doesn’t come to pass.  Prion + shedding = I should have moved to a cabin in the forest.

  • Fri, Jul 02, 2021 - 09:58am

    #3
    Mike from Jersey

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    FDA: Design and Analysis of Shedding Studies

Great finds, Dave.

I am saving these articles and others in case I am called upon to help one of my relatives in fighting a University mandated vaccine.

  • Fri, Jul 02, 2021 - 10:41am

    #4
    IAMMichael

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    FDA: Design and Analysis of Shedding Studies

davefairtex said: “So, PFE/MRNA/JNJ did all this with their test rabbits, right?”

Well that would have been inconvenient. Just like testing on pregnant women would have been inconvenient. So they did a Mulligan in both instances and nobody called them on it in the review meetings.

I another post someone asked where they could find the data backing up the term “All of the cats died”. I tried to circle back and find it but it seems I can’t find it anymore, even on duckduckgo. It was originally part of the Pfizer ExVP petition to not vaccine anyone with the mRNA vaccine in the EU. Basically he said that in cat experiments they gave the mRNA to the cats and they experienced ADE and when they were challenged by the wild virus they all died. Maybe it has been Orwelled?

  • Fri, Jul 02, 2021 - 10:48am

    #5
    davefairtex

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    search engines

When doing an “iffy” search: do it with a brand-new browser instance, with cleared cookies.  Try the search on startpage.  Then try it again on duckduckgo.

My guess: you’ll be much more likely to find your answer (if it is “iffy”) on startpage.

  • Fri, Jul 02, 2021 - 11:43am

    #6

    Jim H

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    FDA: Design and Analysis of Shedding Studies

This would seem to be a good time to post this again.  As you read this, I will tell you that outside of the two people (one a father, one a 20-something son) in my wife’s circle of friends who have died post vax… there is also a very odd third case that I have not mentioned before because this particular 20-ish son was NOT himself vaccinated.  In fact, he was a bit of a dietary health nut and he was exhorting his parents NOT to get the vax.  His mother got the vax, and the son later died mysteriously.  My wife and I both spoke to the mother, consoling her just a few days after the death.  She felt guilty in the sense that her decision to get the Vax may have further depressed her son, who was already feeling the cognitive dissonance, same as many of us.  We may never know, but I think he may have died of vax-shedding induced myocarditis, similar to the (pericarditis) case below.

https://americasfrontlinedoctors.org/blog/who-spiked-the-shot/?s=03

posted by AFLDS
May 16, 2021
4:41 am
Now that COVID-19 vaccinations are in full force, clinicians are observing many unusual illnesses that require further investigation. Oftentimes, doctors, practitioners and nurses must put on their private investigator hats when searching for the root of a condition. Here is an example. I am currently investigating a group of 4 girls in a military academy that have been on strict lockdown since January 2020. They are only allowed to socialize in their tiny cohort and live in a 4-bed dormitory. None of the girls had COVID-19 in the past nor have tested positive for antibodies. One of the girls opted to get the Pfizer mRNA vaccine due to pressure from her parents. Within 45 minutes of receiving the injection, she returned to the dorm feeling unwell, and had to lay down. Within 24 hours, 2 of her roommates spiked fevers. One of them had additional respiratory symptoms consisting of shortness of breath and dry cough, and the other, headaches and extremity pain.  These symptoms persisted for 5-6 days. On day 7 one of the non-vaccinated girls presented with a full-blown shingles outbreak, and the other with chest pains and acute leg pain, warranting a visit to the emergency department. She was later diagnosed with pericarditis and a blood clot in her leg.

This is just one of many situations I am seeing, and they bring evidence and add pieces to the puzzle with a myriad of clinical presentations. Those that advocate for the vaccine insist there is no possible way for the end product of the mRNA infusion to be transmitted to others, but we do know that the virus, measuring at roughly 0.09 microns does so. Why would we accept that the spike protein, the most pathogenic portion of the virus, couldn’t act the same way? Is it because the vaccine maker says that the spike remains within the cell where the Lipid Nano Particles (LNP’s) carried the mRNA? If so, why are some newly vaccinated subjects experiencing neurological symptoms among many others? With SARS vaccine development attempts failing over a decade, is there a reason to believe that a vaccine designed in a very short time should be of concern?

There is strong pushback by the vaccine makers and the government agencies against those who are vocal about their observations of odd “passive” symptoms in those in close contact with the newly vaccinated subjects with symptoms ranging from post-menopausal women having a full period, flulike symptoms and fever to pulmonary embolism, Bell’s Palsy and other neurodegenerative symptoms. Otherwise healthy individuals are presenting with these anomalies, yet we are told to accept that it is purely coincidental. Yet, according to Pfizer’s protocol, they warn of transference from skin contact with the vaccinated as well as inhalation and other types of passive transference.

Using the entire spike protein as the antigenic product of the mRNA instructions, poses an issue since the spike, in and of itself, is pathogenic. The cell surface expression of the spike protein in infected cells significantly impacts viral assembly, viral spread and viral pathogenesis. Since 2005 it has been known that cell surface expression of the Spike protein is pathogenic. The mRNA therapies are dangerous with absolute certitude. The public must be informed of this. The 3a protein of SARS causes the Spike protein to internalize. Without the complete virus, it is free to signal on the cell surface making the spike is far more dangerous without the virus! This is what we are programmed to produce with each injection. For this reason, many physicians and scientists are concerned about the long-term safety of the vaccines. (see fig 1)

This author shared her experience with her large Twitter following and was promptly banned from the platform. If it is nonsense, why the harsh consequences for scientific discourse? One would think it should just be ignored. There is a large amount of money and control at stake in this vaccine rollout, and unfortunately, the mandatory stages of sharing observations and scientific discussion around patient populations receiving the experimental jab are being silenced. Is this the reason why? Now is the time to question.

  • Fri, Jul 02, 2021 - 12:39pm

    #7
    debu

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    FDA: Design and Analysis of Shedding Studies

 …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).

So, if I am understanding this correctly shedding does not occur through the breath of vaccinated persons.  Implying, therefore, close physical contact is necessary for there to be a risk to the non-vaccinated?

  • Fri, Jul 02, 2021 - 01:07pm   (Reply to #7)

    #8
    Canuck21

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    Inhalation?

The America’s Frontline Doctors text quoted in post #3 above says;

“Yet, according to Pfizer’s protocol, they warn of transference from skin contact with the vaccinated as well as inhalation and other types of passive transference.”

They do not give a source for this statement. I have previously read about one Pfizer protocol for one of the studies where Pfizer asked for reports of reactions by family members living with the vaccine test subjects but I do not have a reference.

  • Fri, Jul 02, 2021 - 01:09pm

    #9
    davefairtex

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    not sure we can say that

debu-

So, if I am understanding this correctly shedding does not occur through the breath of vaccinated persons. Implying, therefore, close physical contact is necessary for there to be a risk to the non-vaccinated?

I’m not sure we can say this.  The FDA guideline didn’t list breathing as one of the mechanisms.  But that doesn’t rule it out.  “Absence of evidence is not evidence of absence”, as they like to say.

After all, we do know that the virus comes out of the respiratory tract.  So maybe the toxic fake spike proteins can too?  Perhaps its just a question of “how much”, and “at what point in the process”, and “at what concentration?”

Ultimately, the takeaway is – FDA knows about shedding and VBGT.   For sure “close contact” will probably result in shedding.  It would have been nice for them to mention this ahead of time.

Note too that “close contact” with a newly-vaxxed person might result in lipid nanoparticle shedding also – not just the spike protein.

  • Fri, Jul 02, 2021 - 01:21pm

    #10
    Canuck21

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    Inhalation – more

This study is interesting. Entitled “Passive inhaled mRNA vaccination for SARS-Cov-2” it says in part:

“Scientists are urgently trying to develop a safe and efficacious vaccine for SARS-CoV-2, which must also be produced in large quantities to protect vulnerable populations against SARS-CoV-2.

To achieve this, we propose the massive and passive immunization of the at-risk population via cohorting with individuals who have recently contracted SARS-CoV-2, but are deemed non-infectious albeit reverse transcription-polymerase chain reaction (RT-PCR)-positive.

…The feasibility of inhaled RNA for passive transfection has also been proven in a number of studies [14]. On a mechanistic level, the inhaled RNA may lead to passive synthesis of non-infectious spike proteins using cell transfection machinery, hence leading to immunization of the individual. ”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685031/

The article they refer to as #14 is this one:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471058/

So the writers of article 1 here clearly believe it is possible. Meanwhile if you google “vaccine shedding” we find a host of mainstream media articles earnestly reassuring the reading public that such a thing is impossible. Flak above the target?

 

 

 

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