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Comirnaty, is it or is it not fully approved ???? Pin worthy info

 
Anonymous Coward
User ID: 78987827
United States
12/26/2021 12:32 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Also says on the website that Comirnaty is also known as the PFIZER/BioNtech vaccine.
So same thing.
Anonymous Coward
User ID: 79083426
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12/26/2021 12:36 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Very Important. What happens when it is FDA approved?

Doesnt it mean they have to tell us what is in it, no trade secret BS? All Trial data? And also, they have to record better vaccine injury data from that day forward?

This may be why they are avoiding it.


..
Remedial_Rebel

User ID: 78258400
United States
12/26/2021 12:49 PM

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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Yesterday I was in a Walgreens in Chattanooga Tn. Over the intercom was an advertisement for people to get the Comirnaty Covid vaccine. Surprised me as I thought it was unavailable in US. I wonder if the vial boxes actually have Comirnaty on them.
 Quoting: MKPitBull



I just called Pfizer's help line about 2 weeks ago. After navigating a maze of ARU menus, the recorded message very briefly said,"There is NO information on the availability of Comirnaty".

I then checked the CDC's covid vaccine finder site, here are the available vaccines

Pfizer-BioNTech (age 5-11)
Pfizer-BioNTech (age 12+)
Moderna (age 18+)
Johnson & Johnson/Janssen (age 18+)

[link to www.vaccines.gov (secure)]

Where is Comirnaty?? No where.

What's real are the FOIA court cases filed against the FDA and Pfizer on the "approval" of Comirnaty.

FDA "APPROVAL" of Comirnaty is total smoke and mirros.
uscrusader1

User ID: 79524545
United States
12/26/2021 01:34 PM

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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
It was an approved license to manufacture , a biologic license which means gene therapy not a vaccine.
Frogs legs
User ID: 81660893
France
12/26/2021 01:43 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Just check FDA site, its just play with word it took me long to understand their shady as fuck.

Pfizer COVID-19 vaccine was produced under universal patent for COVID-19 vaccine, its not theirs product as it is under patent "COVID-19 vaccine", EUA approval only.

Comirnaty is Pfizers own product, but still only under EUA approval.

Smoke and mirrors.
Anonymous Coward
User ID: 78129808
Belgium
12/26/2021 02:36 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Shady as Fuck for sure
Anonymous Coward
User ID: 81528700
Mexico
12/26/2021 02:49 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Comirnaty has only been granted a conditional use authorization by the EU, yet somehow, the FDA "approves" a and licenses a product unavailable in the US and unlicensed in Europe, where it is available. Clearly, words like "approved" are being thrown about as if they are legal terms, which they are not. Is the product actually a licensed product? if so where is the standard set of data required to prove safety and efficacy. Well, the trial is still going on.

The conditional use was set for review on 12/21/2021. I tried to find a re-authorization, as the original was obtained on 12/22/2020, but so far I haven't seen it.

Package insert and other links...

[link to godlike.com (secure)]

[link to ec.europa.eu (secure)]
noyznextdoor

User ID: 81130062
Canada
12/26/2021 03:17 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Back it September, Canada announced name changes for all 3, spikevax, comirnaty etc.. was this done to just add to the confusion of it all??

[link to www.cbc.ca (secure)]
Anonymous Coward
User ID: 78551315
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12/26/2021 04:11 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Very good article with answers to several questions

With regard to Comirnaty, is it or is it not fully approved and licensed? The answer is more complex than a simple yes or no. Mayer explains:

“Comirnaty’s quasi approval is just for BioNTech. It doesn’t have to do with Pfizer, and this is why I’m doing this presentation because I’m going to explain what’s going on with that.

This is the race to get liability protection. Remember, that’s the other stranglehold that they want. They really want to get this liability protection. Once the COVID shots are fully approved, the manufacturer has full liability.

There’s all this confusion about Comirnaty. Was it fully approved? Is it on the market? Is it interchangeable with the Pfizer shot? And does it make the COVID shot mandate legal? It’s all the same answer. No, no, no, no.

The FDA issued an intentionally confusing biological license application approval for Comirnaty. It was an unprecedented approval to both license the Comirnaty shot, saying it’s ‘interchangeable’ with the Pfizer shot. But they also said it’s ‘legally distinct.’

In that same approval, they retain the vaccine’s liability shield by designating it EUA as well. They want it to be fully approved, but they want the liability protection, so they did this BS dual approval.

So, [Comirnaty] is licensed to be manufactured, introduced into state commerce and marketed, but it’s not licensed to be given to anyone, and it’s not available in the United States. It’s available in the U.K., New Zealand and other places, but it is not available in the United States because they’re really scared of liability.

Now, are you ready for this one? The BLA actually states that Comirnaty is only ‘ready for approval.’5 It doesn’t say it’s approved anywhere in the document. And they buried this language in a pediatric section to confuse people even more.

Here’s what they said; ‘We’re deferring submission of your pediatric studies for ages younger than 16. For this application, because this product is ready for approval for use in individuals 16 years of age and older, as pediatric studies for younger ages have not been completed.’

Why did they do this? Sixteen is a very important number. You would think the age break would be 18. That’s a very typical age break for everything else that we do in this country. Why 16?
 Quoting: scioto


Yes it is approved and no it is not dispensed, given out or sold in the U.S.

At least it wasn't, perhaps now it is but I doubt it.

Why?
 Quoting: Victor Vectors


It's not given out because the "approved" version isn't covered in the legal immunity agreement.

The EUA version is covered in the legal immunity agreement.

If they started using the "approved" version, and people kept dying & having major health problems from it like they do from the EUA version, Pfizer would be bankrupt in 2-3 years.

The legal immunity granted to Pfizer, Moderna, and J&J is the WORST idea anyone has ever had.

It's a blanket immunity meaning they could literally put cyanide in each vial with 100% of the people being jabbed croaking on the spot 1-2 minutes after injection, and there's nothing anyone could do to them legally.
Anonymous Coward
User ID: 80234974
United States
12/26/2021 04:59 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Institutional deception on a massive level with only money as the incentive, and fuck everyone else
 Quoting: Anonymous Coward 76626437


It's also genocide.

Not just the money.

also genocide

Which is more important to them?

The money, or the mass human sacrifice ritual? scratching
 Quoting: Anonymous Coward 79224423


You mean the money they print?
Anonymous Coward
User ID: 80234974
United States
12/26/2021 05:00 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Also says on the website that Comirnaty is also known as the PFIZER/BioNtech vaccine.
So same thing.
 Quoting: Anonymous Coward 78987827


No, legally distinct
Anonymous Coward
User ID: 31876261
United States
12/26/2021 05:04 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
It is approved, however until they disclose the insert with the laundry list of possible side effects you can sue them and therefore it’s not being used as of now in the US (other countries have different laws).

So, right now, it’s easier for them to get around putting that info out there by using the one that is authorized via emergency use- which has liability built into it.

They’re both the same thing.

Fastest and easiest way for them to get blanket immunity?

Have it accepted as safe and mandatory for CHILDREN. That’s what they’re waiting on. Because if it’s deemed safe enough to mandate for children then it’s safe enough for everyone.

This is all legal bullshit that they’ve designed to get around putting out any real information for the public to assess.

Like the possibility that it causes heart attack, stroke, cancer, autoimmune disease, etc.

They’ll put all that out eventually but first they need to make sure they’re not liable.
Eilonwy

User ID: 81328201
United States
12/26/2021 05:15 PM

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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Comirnaty is such a festeringly gay frankenword that has no place in the human lexicon.
 Quoting: Anonymous Coward 80883936


Yes, why haven't people figured out what this word means yet. I'm sure it's horrible.
“A grower of turnips or shaper of clay, a commot Farmer or a king--every man is a hero if he strives more for others than for himself alone.”
Lloyd Alexander, The Castle of Llyr
MKPitBull

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United States
12/26/2021 05:24 PM

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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Comirnaty is such a festeringly gay frankenword that has no place in the human lexicon.
 Quoting: Anonymous Coward 80883936


Yes, why haven't people figured out what this word means yet. I'm sure it's horrible.
 Quoting: Eilonwy


All they have to do is add an s and it’ll be pronounced comehearnasty
"Be like water my friend”- Bruce Lee
monkmode

User ID: 81221984
12/26/2021 06:24 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Comirnaty is Not available in the US now. In fact, it has not been produced yet.

It’s a big false game to even say it got approval.

I think, not sure though, they cannot use it due to EU. Anyone know?
 Quoting: Texas Best Anti-Faucist


The application for comirnaty was approved.

Yes, that's correct. Comirnaty is not available in the US. It was the application only that was approved. MSM omitts that fact implying that it is the vaccine.
MISTER-BEE

User ID: 80287538
United States
12/26/2021 06:26 PM
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Re: Comirnaty, is it or is it not fully approved ???? Pin worthy info
Also says on the website that Comirnaty is also known as the PFIZER/BioNtech vaccine.
So same thing.
 Quoting: Anonymous Coward 78987827



please stfu

They are 100% legally "distinct" in AMERIKA





GLP