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What full FDA approval? It is still only allowed under emergency act

 
Sheepster
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08/24/2021 12:08 AM
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What full FDA approval? It is still only allowed under emergency act
I'm not sure if anyone read the FDA docs from today:

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

page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation.

------

This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
-------


The rest of the documents are here:

[link to www.fda.gov (secure)]
Sheepster
PHUKKKU

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08/24/2021 12:14 AM
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Re: What full FDA approval? It is still only allowed under emergency act
fact
bxd
PHUKKK U
MISTER-BEE

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08/24/2021 03:59 AM
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Re: What full FDA approval? It is still only allowed under emergency act
can you make this like a

FDA APPROVAL for DUMMIES
5th grade level edition?

there r many of us
OGEBY

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08/24/2021 04:00 AM

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Re: What full FDA approval? It is still only allowed under emergency act
Seems like it is still under the Emergency Use Act...

It would be nice if they FUCKING used PLAIN English without all that confusing BULLSHIT!!!

Their judgement will be GLORIOUS!!!

Shalom...

burnit
OGEBY

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08/24/2021 04:14 AM

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Re: What full FDA approval? It is still only allowed under emergency act
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19
vaccine made by Pfizer for BioNTech.
• It is approved as a 2-dose series for prevention of COVID-19 in
individuals 16 years of age and older.
• It is also authorized under EUA to be administered to:
o prevent COVID-19 in individuals 12 through 15 years, and
o provide a third dose to individuals 12 years of age and older who
have been determined to have certain kinds of
immunocompromise.


The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
• prevent COVID-19 in individuals 12 years of age and older, and
• provide a third dose to individuals 12 years of age and older who have
been determined to have certain kinds of immunocompromise.

Seems like they approved COMIRNATY, but Pfizer-BioNtech is still under EUA?

[link to www.fda.gov (secure)]
Subway Prophets
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08/24/2021 04:27 AM

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Re: What full FDA approval? It is still only allowed under emergency act
n/m

Last Edited by Subway Prophets on 08/24/2021 04:32 AM
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TheExPatrioticGirl

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08/24/2021 04:48 AM

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Re: What full FDA approval? It is still only allowed under emergency act
I'm not sure if anyone read the FDA docs from today:

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

page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation.

------

This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
-------


The rest of the documents are here:

[link to www.fda.gov (secure)]
 Quoting: Sheepster


No, I don't think it's about re-naming. Something else is going on here.

The letter to Pfizer from the FDA basically says that there are two vaccines, one is the Pfizer-BioNTech, the one in current use today. For THIS vaccine, they are hereby RENEWING THE EMERGENCY APPROVAL to basically continue on. That's all. The second vaccine is called COMIRNATY, also made by Pfizer, and THIS IS THE VACCINE THAT WAS SUBMITTED FOR APPROVAL AND IS NOW BEING APPROVED.

HOWEVER, the letter goes on to say that while the COMIRNATY vaccine is interchangeable with the BioNTech, the problem is that THERE ARE NOT ENOUGH DOSES AVAILABLE TO EVEN BEGIN TO GIVE IT TO THE PUBLIC. Before they begin to make and distribute COMIRNATY, all the (KILLER) doses of the EXPERIMENTAL BioNTech must be used up.

These people are sick!! This is another HOAX. There IS a vaccine approved but it's not the one they are handing out and since they made SO MANY, they have to use up the deadly one first. It's a very sneaky letter.
It's all fun & games until the Dogman stands up

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aningeniousname

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08/24/2021 05:20 AM
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Re: What full FDA approval? It is still only allowed under emergency act
[link to www.fda.gov (secure)]

Just reading the insert for the Comirnaty (link above) and as well as admitting the heart problems associated with it's use especially in young men it also says:

"COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of
male fertility"

So they basically are saying in the product insert we don't think it causes female infertility or miscarriages, we aren't sure whether it is safe for breast feeding, young healthy men can definitely die from from heart attacks, we didn't even bother to check for cancer causing, gene damaging, or male fertility problems.

I wonder why they didn't bother to check for those problems?
Now reading the leaflet that comes in the box do you still want to take it?

If that was on the side of any other product would you take it?
Milo_Jeeder

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08/24/2021 06:46 AM
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Re: What full FDA approval? It is still only allowed under emergency act
The Pfizer Vaccine has been fully approved by the FDA.
One Smooth Stone

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08/24/2021 06:49 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Pay attention to the ages is the diff.

Full FDA for Pfizer for age 16+
Emergency use auth for ages 12+
(They should have edited that part to say ages 12-15)
1 of 5 Smooth Stones
Anonymous Coward
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08/24/2021 06:53 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Pay attention to the ages is the diff.

Full FDA for Pfizer for age 16+
Emergency use auth for ages 12+
(They should have edited that part to say ages 12-15)
 Quoting: One Smooth Stone


We're talking about different products from Pfizer. Simply saying "Pfizer" as you did is meaningless.
aningeniousname

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08/24/2021 06:55 AM
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Re: What full FDA approval? It is still only allowed under emergency act
The Pfizer Vaccine has been fully approved by the FDA.
 Quoting: Milo_Jeeder


Why are you on this forum? I looked at your posts and you seem to be very pro Biden, pro vax. Is it just to troll or do you think you are going to change minds?
Because as far as I can see you are just trolling.
RickHarley

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08/24/2021 07:35 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Developing software requires several different steps like in this blog [link to mlsdev.com (secure)] , each of which is executed by a software development team. First, the developers create the project's "blueprint," detailing everything from start to finish. This blueprint gives developers a look at what the project will entail, including objectives, estimated time frames, estimated costs, specifications, and critical functionality requirements. A software development company may work with smaller teams or as a large outsourcing group.

Last Edited by RickHarley on 08/25/2021 09:38 AM
Handle
Levski

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08/24/2021 07:44 AM
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Re: What full FDA approval? It is still only allowed under emergency act
What about this part here:


On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older.



A friend says that the EUA was extended for under 16.

For everyone else it is approved. True or false?

Or did they simply "approve" that BLA license.

And we should read the next paragraph instead:

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.



------------------

I think I found it on page 12, like the other thread said.

Last Edited by Levski on 08/24/2021 07:51 AM
Noah was a conspiracy theorist too, until it started raining.
Copious_Sedition

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08/24/2021 07:45 AM

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Re: What full FDA approval? It is still only allowed under emergency act
They say in the insert that they did a double blind placebo study.

Then later admit they were "unblinded" and given the Vax. WTF? Also they don't actually list out what serious adverse events happened, their count, or percentage. Even if there was one death it should be called out. They only list out pain at the injection site, headache, etc...

If you report more serious events in the placebo group than the Vax group, say you gave them saline but really did saline then gave them the Vax anyways? You just split the serious events in half so you can say they were statistically significant.

They did recognize the increase in heart risk with no math on how many cases there were.
Larphillips

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08/24/2021 07:49 AM

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Re: What full FDA approval? It is still only allowed under emergency act
So essentially clear as mud.

This is the same level of total and complete confusion that has been evident for the entirety of the pandemic.

This is on purpose. Clear answers, clear direction, and clear information is NOT what they want. They want us confused, afraid, and (most importantly) bitterly fighting with one another. They are succeeding.
“A person is smart, people are stupid.”
“Nobody knows until everybody knows”
Anonymous Coward
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08/24/2021 07:51 AM
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Re: What full FDA approval? It is still only allowed under emergency act
They say in the insert that they did a double blind placebo study.

Then later admit they were "unblinded" and given the Vax. WTF? Also they don't actually list out what serious adverse events happened, their count, or percentage. Even if there was one death it should be called out. They only list out pain at the injection site, headache, etc...

If you report more serious events in the placebo group than the Vax group, say you gave them saline but really did saline then gave them the Vax anyways? You just split the serious events in half so you can say they were statistically significant.

They did recognize the increase in heart risk with no math on how many cases there were.
 Quoting: Copious_Sedition


Dr.Jane Ruby on the FDA Approval yesterday, says something that caught her attention was , "According to the new insert which is now going into the box with the medicine , 50% of those who were given the med (up until march of 2021) got a placebo!"... This fact is NOW included on the insert paper of the box by Phizer! IT should be front page news! This fact means millions did not actually get their medicine they got a saline water shot... and no one except Phizer knows who got what.

Doesn't this fact completely invalidate the so called V passport??... Stupid has gotten the upper hand.
Vidura108

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08/24/2021 08:05 AM
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Re: What full FDA approval? It is still only allowed under emergency act
I'm not sure if anyone read the FDA docs from today:

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

page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation.

------

This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
-------


The rest of the documents are here:

[link to www.fda.gov (secure)]
 Quoting: Sheepster


That says its been approved for 16 yrs and up but still EUA for 12 to 15 yr. olds.
Vidura108
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08/24/2021 08:06 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Pay attention to the ages is the diff.

Full FDA for Pfizer for age 16+
Emergency use auth for ages 12+
(They should have edited that part to say ages 12-15)
 Quoting: One Smooth Stone


It's the same vaccine, it can be used on 12+ if necessary if 16+ it doesn't nee to be emergency.
Justme C'est Moi

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08/24/2021 08:11 AM

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Re: What full FDA approval? It is still only allowed under emergency act
Brilliant! It is just a reauthorization of the emergency Use authorization of Dec 2020.





The Government didn't realize that some citizens can actually read. :)

Last Edited by JustmeTX on 08/24/2021 08:16 AM
Justme
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08/24/2021 08:28 AM
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Re: What full FDA approval? It is still only allowed under emergency act
This from dot gov is what the pro clot shots are quoting.


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

:stab:


Brilliant! It is just a reauthorization of the emergency Use authorization of Dec 2020.





The Government didn't realize that some citizens can actually read. :)
 Quoting: Justme C'est Moi


Last Edited by Deplorable TailDragger on 08/24/2021 08:28 AM
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N0vajay05

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08/24/2021 08:31 AM
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Re: What full FDA approval? It is still only allowed under emergency act
The approval is in the first paragraph of Page 2. They are keeping the emergency auth in total to cover all deployments before approval, and emergency auth for ages 12-16. full approval is granted for anyone 16 an over using pfizer.

Some of you need to learn to read.
Mason Firefly

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08/24/2021 08:31 AM

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Re: What full FDA approval? It is still only allowed under emergency act
Looks like they approved it after all. Check this out below from the FDA.



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. 


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

Last Edited by Mason Firefly on 08/24/2021 08:32 AM
Anonymous Coward
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08/24/2021 08:34 AM
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Re: What full FDA approval? It is still only allowed under emergency act
I'm not sure if anyone read the FDA docs from today:

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

page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation.

------

This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
-------


The rest of the documents are here:

[link to www.fda.gov (secure)]
 Quoting: Sheepster


...
burneracct

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08/24/2021 08:38 AM

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Re: What full FDA approval? It is still only allowed under emergency act
Read it like the junk mail I get from the banks.

Oh I’m pre-approved how wonderful
Pfizer redefining rare.
Jay.Crew

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08/24/2021 09:02 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Looks like they approved it after all. Check this out below from the FDA.



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. 


[link to www.fda.gov (secure)]
 Quoting: Mason Firefly


The fact that they are calling it conformity is actually pretty funny

If you omit the widespread murder element.
Check out this thread for important statistics which have showed (since early summer 2021) that Covid “Vaccine” is more likely to KILL YOU than save you:

Thread: COVID JAB statistically more likely to KILL YOU per official CDC DATA. You’re 3.87x more likely to die from the Pfizer vax than save your life!!
SamAdams

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08/24/2021 09:02 AM
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Re: What full FDA approval? It is still only allowed under emergency act
NOT FDA AUTHORIZED, EXCEPT UNDER EUA!!!!
Page 2
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.
SamAdams

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08/24/2021 09:13 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Or, is the BLA the official FDA approval?

On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older.

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
SamAdams

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08/24/2021 09:17 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Yes, the BLA is the actual FDA approval.

By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved.

In conclusion, it is FDA approved for ages 16+.
lil_g

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08/24/2021 09:24 AM
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Re: What full FDA approval? It is still only allowed under emergency act
Yes, the BLA is the actual FDA approval.

By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved.

In conclusion, it is FDA approved for ages 16+.

 Quoting: SamAdams


to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.


What'uses' are and are not included in the approved BLA?
dream
Happy in Nature
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08/24/2021 09:36 AM

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Re: What full FDA approval? It is still only allowed under emergency act
I shared this on a thread yesterday:

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.

[link to www.fda.gov (secure)]
Quoting: STRONGMAN SHELFORD


I interpret this as Pfizer will list the ingredients in Comirnaty (I hate that name!) without graphene dioxide and whatever other poisons they have put in their original experimental jab, but still has permission to use the original generically named jab with the poisons as a legal substitute, thereby continuing their crimes against humanity without the legal liability.

Last Edited by Happy in Nature on 08/24/2021 09:36 AM





GLP