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Key animal tests and biodistribution tests were not done as there is no agreed standard for them as yet for gene editing or gene replacement therapies - which mRNA injections are:

https://awkwardgit.substack.com/p/why-no-meaningful-biodistribution

On here is listed those organisations who agree to follow the guidelines on drug trails:

https://www.ich.org/page/members-observers

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

Bill and Melinda Gates Foundation are on the list.

There also a lot of in-depth documents on how to run trials:

https://www.ich.org/page/search-index-ich-guidelines

All of which are being ignored for covid vaccines.

Section 1.1 states:

"1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions (my highlighting) . The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out (my highlighting). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).”

So in other words - with experimental medicines err on the side of caution and assume the problem was caused by the drug unless or until proven otherwise.

MHRA and other regulators are not doing this but the complete opposite.

Why?

Then there is this, the ICH have been trying to agree trials standards (since mid-2021) for gene therapies:

https://database.ich.org/sites/default/files/S12_Step2_Presentation_2021_0618_0.pdf

https://database.ich.org/sites/default/files/S12_FinalConceptPaper_2019_1118.pdf

Which is part of following on from this in 2018:

https://www.iprp.global/working-group/gene-therapy

And 2015:

https://admin.iprp.global/sites/default/files/2018-09/IPRF_Gene_Therapy_WG__Meeting_Summary_May_2015_0.pdf

So no agreed requirement on what biodistribution studies are required for gene therapies, which the Pfizer and other mRNA jabs and treatments are, so that is why in the EMA’s public assessment report it states “not required” or something similar.

https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

Notice also that the MHRA is not on the list of participants.

Why?

Because the EMA is and under CHMP if they say “all’s good, approve it” then the MHRA just says “OK will do” and rubberstamps it.

Admitted to in a FOI to me.

And just to give you all the EMA PARs used to issue the EUAs in the EU and UK here are the other 3:

https://ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf

https://ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf

https://ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf

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I'm beginning to be very thankful I was born in a time when very few vaccines were given to kids. Also the time when this horrid corruption in agencies was far less entrenched and honour and honesty were still admired.

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Sep 3, 2022Liked by A Midwestern Doctor

I have some additional remarks that may find useful for the article:

1) The Pfizer-contract was accidentally leaked by Albania and Brazil (you can find out more about it by reading about Ehden Biber, the Israeli now living in Britain who wrote about it.

The Albanian contract can be found here:

https://gogo.al/wp-content/uploads/2021/01/LEXO-KONTRATEN-E-PLOTE.pdf

At the end of page 19 it is written that

"Further, to the extent applicable, Purchaser acknowledges that the Product shall not be serialized"

People in quality control remarked that this was a major red flag, since it made the tracing of hot lots nearly impossible, since it is not clear, how big the lot sizes of the toxic lots are and a lot of adverse events could be due to a large lot number.

2) Regarding the cationic nano-particles, I found a presentation by German cell-biologist Vanessa Schmidt-Krueger, who talked about the experiences with cationic lipids in mice

https://aexperia1974.wixsite.com/factual4u/post/interview-with-dr-vanessa-schmidt-kruger

3) I have seen two videos of researchers in Germany analyzing the vaccines and both groups found impurites.

The first group analyzed only Astra-Zeneca and found, that all 4 vials from different batches were heavily polluted by foreign protein (the worst batch had 66% impurities)

The other was a German vaccinologist talking about analyzing different batches from different manufacturers. He said that all vaccines were really dirty. I can only remember that he found some heavy metals in the Pfizer vials (antimon),. If you are interested I can look for these videos, but they are in German and do not have transcripts.

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When a billionaire sociopath , whose passion is depopulation, urges a jab in every arm, do not listen. Run for the hills as fast as you can.

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Sep 3, 2022·edited Sep 3, 2022

Thanks AMD!

I disagree with:

"Vaccine susceptibility being dependent upon pre-existing health status of the recipient".

I've analysed a lot of photo's of people that have died from the jab, and many look very healthy. It appears to me that those with exceptional immune systems can mount a strong reaction to the jab - strong enough to kill them. Super healthy elite athletes dropping dead is an example of this.

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Another very thoughtful article.

I had been hoping to find a good article on this hot lot phenomena.

Thank you for taking the time to write this.

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As usual, this stack has information you won't find anywhere else. Thank you.

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Early on, the big deal was keeping the vials below freezing. Then, poof, in a day, never heard about it again. Made the hair on the back of my neck stand up. Big red flag.

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Sep 3, 2022Liked by A Midwestern Doctor

And people are still taking them! It’s astounding.

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I am NIAID whistleblower who reported that Fauci tried to force me to make bioweapons with the CCP and PLA in Wuhan China - back in 2011. Senator Grassley informed along with several others. He decided to watch Fauci and identify his partners in this treason. Contact me for more info: lkragie@biomedworks.com and see biomedworks.substack.com

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Sep 3, 2022Liked by A Midwestern Doctor

Thank you for writing this amazing piece as well as all your other ones. I’ve worked in HC for 25yrs and have been incredibly naive by the behind the curtain happenings. When they started mandating flu shots I was not happy. I’m healthy, I’d never had the flu and WTH would I inject something for which an illness my body isn’t susceptible to. I found a lovely MD that would charge me for the “shot” and squirt it in the garbage. He was healthy and in his 50’s when I met him. Do you get the flu shot? No I don’t. Exactly. With my job I do not have direct pt contact so it is obscene. Looking back on my medical history I’ve most likely been harmed by previous injections. They are now listed as TBI’s. I’m so sad for the industry I truly loved being a part of that can no longer be trusted. Don’t get me wrong I’ve never loved the experiences I’ve had with personally with 10min MD appts - which I avoid. But being a part of it, helping others and the fascinating human body was my motivation. Now it’s all been tainted, as have many industries.

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After the magnitude of the problem dawned on me, I tried to warn my colleagues in medicine and discovered that very few were receptive to anything questioning their faith in this modern day scientific “miracle.”

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What should be done with such people, AMD?

As society unfurls.

John O'Looney, UK Funeral Home whistleblower is concerned that they will become the victims of violence, as people cannot get to Bill Gates in his bunker.

But they can get to Dr. Head in the Sand.

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Important article. Thank you

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Thanks for good works.

In 2003 I became disabled from an mmr booster for work in autistic classroom. For years I believed it was depression because doctor said. Numerous autoimmune issues all at once.

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Sep 3, 2022·edited Sep 3, 2022

"I particularly took notice of the fact that tests to evaluate key issues that had already been identified with the mRNA vaccines (cancer, autoimmunity, infertility, ineffective protection against variants) had not been conducted"

This is astonishing!! They KNEW that there were issues with mRNA "vaccines" regarding cancer, autoimmunity, and infertility, but they did ZERO testing on the covid "vaccines" on these issues prior to the rollout?! Wow. The recipients of these experimental injections were screwed from the get go. Pfizer knew it, Moderna knew it, the FDA knew it, but they turned a blind eye.

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Sep 4, 2022Liked by A Midwestern Doctor

I received one vaccine dose last spring, which unfortunately came from one of the Janssen hot lots based on the records at howbadismybatch.com. It almost killed me because it gave me debilitating tinnitus in both ears that was like having cicadas, frogs, and crickets going full bore in my head at the same time. Western doctors offered me nothing except outright denial that it was caused by the vaccine (despite the fact that it started a few hours after the vaccine and my head was quiet all my life before that) or medicines that actually made it worse. With the help of alternative medicine, it took me over a year to recover to the point of the tinnitus not running my life. My ears still ring all the time, but I have gotten more used to it with time. It has not been an easy road. It is good to know though that there are still a few Western doctors such as yourself that are honest and not beholden to the pharmaceutical companies or medical agencies.

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