Wake Up! The FDA Has NOT Approved ANY COVID19 Vaccine
It seems so many people still remain fooled by the media’s depiction of the FDA announcement of the ‘approval’ of the first COVID19 vaccine. For the avoidance of any doubt, NO such authorisation has yet been issued by the U.S. Food and Drug Administration.
On August 23, 2021, the FDA appeared to have announced it had approved the Pfizer-BioNTech COVID-19 Vaccine, to be marketed as Comirnaty. The announcement appeared extensively in the media and on the FDA website.
However, the announcement is misleading, probably deliberately so, and as such actionable in a court of law.
The reality is far removed from the fiction depicted in the media, known for being the spin doctors for Big Pharma’s snake oil. Despite what CNN, ABC the BBC or any other of the Rothschild-controlled organs tell you, BioNTech Comirnaty has NOT been granted FDA full approval.
Comirnaty was ONLY approved under the generic express approval rules for bio identical drugs and subject to all restrictions of the original Bio Identical “Emergency Use Authorization” (EUA) approved Vaccine it was copied from.
The ‘vaccine’ (in quote marks because this potion fails the legal definition) has not passed any approved testing protocol for safety, as is the case for all the other experimental treatments rushed out in the wake of the Sars-CoV-2 pandemic.
Readers should note the data submitted in this ‘approval process’ was the same data that Pfizer-BioNTech submitted. Nothing new, nothing changed. So why re-examine the same data?
A simple rubber-stamping procedure for fellow crony capitalists? This explains why the FDA did not examine any of the data submitted.
How Do We Know This May be Malpractice and Probably Unlawful?
The FDA may have intentionally violated their express approval rules by granting approval of BioNTech’s COMIRNATY as they were required to have packaging and labeling approved at the same time. The key is in the label to have all information of the copied drug – vaccine except what needs to be changed such as manufacturer and location of manufacture.
The legal codes for references:
21 US CODE 355 (J) (2) (A) (ii) (II)
if the listed drug referred to in clause (i) has more than one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed drug.
Now how can they get away with this? It is in what else they left out.
21 US CODE 355 (J) (2) (V)
Identifying the Incrimination Evidence for a Prosecution
For a litigant/attorney to present a cogent case to a court of law for prosecuting an action against the FDA for the above the following evidence should be cited:
Information must be available to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug preferred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers;
So the labeling would have to say EUA….. EMERGENCY USE AUTHORIZED” Emergency Use Authorized “ is on the Pfizer-BioNTech label.
Incriminating Evidence #1 When a drug – Vaccine is approved the company is allowed to advertise. See any BionNTech ads? NO
Incriminating Evidence #2 Location of manufacture is required to be disclosed. Please notice the location of manufacture is blanked out in the FDA letter.
Incriminating Evidence #3 Try to the Patient informational Pamphlet for COMIRNATY – YOU CANNOT GET ONE
Approved Drugs – Vaccines are required by law to have a Patient informational Pamphlet with. #1 All chemicals #2 All chemical structures #3 Mechanism of action #4 Drug interactions, #5 Location of Manufacture.
What is Missing?
If fully approved there would be words in the FDA press release of full acceptance as a new drug, such as: “The FDA reviewed your data and the FDA accepts your drug as safe” With such plain language words the drug becomes fully FDA accepted.
but THERE ARE NO WORDS LIKE THAT IN THE RULING
Such words also do not appear in the Summary Basis for Regulatory Action. As such, the August 23rd announcement by the FDA “approving” the Pfizer-BioNTech COVID-19 Vaccine, marketed as Comirnaty is not an approval recognised in law.
To confirm this, check the labeling now appearing on the Comirnaty packaging, which will still only show EUA….. EMERGENCY USE AUTHORIZED (photo right)
Will those diligent investigative journalists from the mainstream media be reporting on the above? Of course they won’t because the job of the mainstream media isn’t journalism!
About John O’Sullivan John is CEO and co-founder (with Dr Tim Ball) of Principia Scientific International (PSI). John is a seasoned science writer and legal analyst who assisted Dr Ball in defeating world leading climate expert, Michael ‘hockey stick’ Mann in the ‘science trial of the century‘. O’Sullivan is credited as the visionary who formed the original ‘Slayers’ group of scientists in 2010 who then collaborated in creating the world’s first full-volume debunk of the greenhouse gas theory plus their new follow-up book.
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richard
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https://realclimatescience.com/2021/09/pfizer-contract-long-term-effects-and-efficacy-of-the-vaccine-are-not-currently-known/
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Ken Hughes
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Nice one John.
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JaKo
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I think there was an article of the same conclusion by Dr. Qureshi already, but thanks John, we all need a reminder in these extra-contentious issues…
Cheers, JaKo
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Yo MaMa
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I Trust My Government and Medical Establishment – Says NO ONE Nowhere in 2021!!!
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MattH
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Hi John. Thank you for the great work.
One of the unanswered questions in western media is the phenomenal death rate in Uttar Pradesh, India, which made the headlines, and now the phenomenaler (new word) successful treatment with Ivermectin protocols that we no longer hear about. It appears to be called the “ivermectin blackout”.
https://www.thedesertreview.com/opinion/columnists/indias-ivermectin-blackout—part-iii-the-lesson-of-kerala/article_ccecb97e-044e-11ec-9112-2b31ae87887a.html
Pathological reports on vaccine deaths and a good article on the India situation with Ivermectin appears to be a front line strategy in printing in hard copy and placing in the hands of doctors.
You gettem John.
Best wishes. Matt
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very old white guy
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people today seem to have difficulty understanding who and what is killing them.
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Colin Henderson
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If you put dog poop into a container labelled Chocolate Pudding does it then become chocolate pudding?
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Rudgar
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“To confirm this, check the labeling now appearing on the Comirnaty packaging, which will still only show EUA….. EMERGENCY USE AUTHORIZED (photo right)”
Sorry, but this label does not show a “Cominarty” packaging, at least “Corminarty” is not written on it. Please show a photo of a label with “Corminarty” and “EUA” on it at the same time. Otherwise I assume it is just the well known initial vaccine.
Please also show a real Corminaty vaccine container “in the wild” – just to see if it really is delivered for vaccination at all or just a media fake for getting the “full approval”.
And yes – I agree that the roaring silence of Pfizer regarding marketing of the “approved” product tells us a lot …
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JaKo
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Hi R,
I can’t find any genuine pictures of Comirnaty vials with EUA. There are plenty of pix Without EUA note on the label, possibly fake, but no Comirnaty with this crucial info…
Cheers, JaKo
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Rudgar
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So it seems Cormirnaty is delivered at least in Germany and without any hint regarding the release state. But I would not expect “EUA” there anyway.
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Tom
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I couldn’t care less if this crap is approved by the Heavens above. I will never take it for any reason. If I want garbage in my body, I will go to McDonald’s.
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hannah horton
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This article is very interesting some people do need to start waking up .. its just a shame that they don’t
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George
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Still don’t understand the definition of the word people says they are protected after the vaccine. If my dog can’t escape from the fence round the house 🏘️ that is protection. If the dog can escape that is not protection ( definition of the word). If you still can contract the virus after vaccine that is not protection to me.
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Mathilde Zwagerman
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Kaley Brinson
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