Formulation

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notmartha
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Formulation

Post by notmartha »

From: https://www.fda.gov/news-events/press-a ... 19-vaccine
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
From: https://www.fda.gov/vaccines-blood-biol ... ccine-mrna
How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?

The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses.
What does this mean? Are the BioNTech and Comirnaty jabs one and the same?

Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005
formulation
The process of preparing a drug in a particular way or in a specific form, such as a tablet, capsule, linctus, ointment, or for one of the various forms of injection.
https://en.wikipedia.org/wiki/Pharmaceu ... ormulation
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.
Why the name change if they are the exact same jab?
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Firestarter
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Re: Formulation

Post by Firestarter »

notmartha wrote: Thu Aug 26, 2021 12:23 pmWhat does this mean? Are the BioNTech and Comirnaty jabs one and the same?
Yes they are the same in contents, but only "legally" are different.
I'm no lawyer though, so please don't ask me to explain...

.
notmartha wrote: Thu Aug 26, 2021 12:23 pmWhy the name change if they are the exact same jab?
Just to be on the safe side the newly named Comirnaty not only has the full approval, but also the (continued) emergency approval. This was done because the "full approval" is limited, while the emergency approval is broader in scope (for example also for children aged 12 to 15 years).

The "full approval" was needed so people can't refuse with the argument that it wasn't fully approved.
Maybe has something (legal) to do with the Nuremberg code according to which "experimental" vaccines can't be forced upon the population (which is genocide per definition): https://blog.nomorefakenews.com/2021/08 ... wait-what/
For some reason internet “search” engines block my posts: http://www.ronpaulforums.com/showthread ... orld/page2

The Order of the Garter rules the world: viewtopic.php?p=5549#p5549
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notmartha
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Re: Formulation

Post by notmartha »

Thanks Firestarter.

Digging a little deeper, I found a letter from FDA to Pfizer, differentiating a bit more the "approved" vs. the "licensed" jabs.

https://www.fda.gov/media/150386/download
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
So there are apparently some differences. One of the main differences, if I'm reading the letter correctly, is that the Comirnaty shots ARE NOT AVAILABLE! It is a bait and switch!

"Here, now all you vaccine hesitant can stop your whining - the Covid-19 jab is now licensed and approved!"

"Pst, medical people...you are really going to be giving all these people the old EUA jab because there is no new jab available, and that will keep us all out of legal hot water, because we can't be sued when someone gets a test jab! Aren't we creative and smart!"

These are the reported ingredients in the Comirnaty "approved" and "licensed" jab:
COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use. COMIRNATY is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of COMIRNATY contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each 0.3 mL dose of the COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N, N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

COMIRNATY does not contain preservative.

The vial stoppers are not made with natural rubber latex.
These are the reported ingredients in the BioNTech "EUA" jab:

mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2
[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-
phosphocholine, and cholesterol), potassium chloride, monobasic potassium
phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
The Pfizer vaccine does not contain eggs, preservatives, or latex.
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