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The FDA did NOT grant full approval to the Pfizer shots !!

 
DeploraVision ™
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08/26/2021 12:22 PM
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The FDA did NOT grant full approval to the Pfizer shots !!
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.

There's just one problem.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.

The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.

The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials..

MORE:

[link to www.americanthinker.com (secure)]
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Scorched

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08/26/2021 12:25 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Nope, but they keep testing to see if they broke the will of the Americans which they have not. They don't have the guys to mandate anything like that without experiencing their demise. They wont stop until they are removed or fly away in fear

Last Edited by Scorched on 08/26/2021 12:26 PM
They have us completely surrounded...those poor bastards
Yahella777

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08/26/2021 12:26 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.

There's just one problem.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.

The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.

The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials..

MORE:

[link to www.americanthinker.com (secure)]
 Quoting: DeploraVision ™


From what I understand they have fully approved it, but the catch is they have to disclose all the ingredients in the vaccine by 7th of Sept.

This will be their FALL...
CNews113p

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08/26/2021 12:27 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Thread: Dr Robert Malone Pfizer mRNA "Shot" Inventor Explains - (SURPRISE) The Media Are Lying About Pfizers FDA Approval
Dr Robert Malone Pfizer mRNA "Shot" Inventor Explains - (SURPRISE) The Media Are Lying About Pfizers FDA Approval
08/24/2021 07:12 PM

[x]Dr Malone Media Are Lying About Pfizers FDA Approval
4m25s
[link to youtu.be (secure)]

Dr Robert Malone Pfizer mRNA "Shot" Inventor Explains - Media Are Lying About Pfizers FDA Approval!


6m54s
[link to www.brighteon.com (secure)]
The Pfizer Jab FDA approval is not real.
harrier808

Last Edited by CNews113p on 08/26/2021 12:29 PM
CN
Anonymous Coward
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08/26/2021 12:37 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Im so confused lol
This former Pfizer employee says it has been approved!
[link to www.bitchute.com (secure)]
Yahella777

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08/26/2021 12:39 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Im so confused lol
This former Pfizer employee says it has been approved!
[link to www.bitchute.com (secure)]

 Quoting: Oce@n


She has the letter to prove it as well. She is the one who said that they have 14 days from Aug 23 to disclose all ingredients in the vaccines.
deplorable recollector

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08/26/2021 12:39 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Reading comprehension.


Gotta have it, before posting a comment.



The FDA APPROVED the Pfizer vaccine. It's black on white, man.


Where the hell did you see it's not...it's beyond me.
Anonymous Coward
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08/26/2021 12:44 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Im so confused lol
This former Pfizer employee says it has been approved!
[link to www.bitchute.com (secure)]

 Quoting: Oce@n


Shes says it at about 04:05
Anonymous Coward
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Im so confused lol
This former Pfizer employee says it has been approved!
[link to www.bitchute.com (secure)]

 Quoting: Oce@n


She has the letter to prove it as well. She is the one who said that they have 14 days from Aug 23 to disclose all ingredients in the vaccines.
 Quoting: Yahella777


I don’t understand why they approved it before knowing all the ingredients.
Makes no sense!
MountainTux NLI

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08/26/2021 02:28 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Reading comprehension.


Gotta have it, before posting a comment.



The FDA APPROVED the Pfizer vaccine. It's black on white, man.


Where the hell did you see it's not...it's beyond me.
 Quoting: deplorable recollector


And YET, you managed a post, so your assertion isn't exactly true, is it?

The FDA approved the BLA for A Pfizer drug - but NOT the one that is currently in use and will be for the forseeable future.

The approved drug, while "interchangeable" with the current shot, is "legally distinct" from the current shot due to different ingredients. Conveniently it is ALSO not covered by the legal indemnification that the current shot is - no suprise this "approved" drug is not available and won't be for some time.

But don't worry - the EUA for the CURRENT drug has been extended so that they can keep providing an EXPERIMENTAL, NON-APPROVED therapy. Interestingly, even though the NEW drug is "approved," it was ALSO added to the EUA... seems odd, no?

So yeah, maybe READING the info freely available on the FDA's OWN WEBSITE might help with your comprehension?

Glad to be able to help!

Cheers!

penguin
ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.”
Inspector Hoolihan

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08/26/2021 02:46 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
The "Pfizer Vaccine" is an mRNA treatment just like Moderna.
MR.GGG

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08/26/2021 02:59 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
So when the marxist media tell us the FDA just FULLY APPROVED the VAX they are either LYING or too stupid to be able to READ the link where it only states the EUA is being continued.

The MARXIST MEDIA lying to us AGAIN!! The FDA did NOT NOT NOT fully approve the VAX. They don't DARE approve it at this point. They merely EXTENDED the EUA order - which in itself is a fucking LIE. An EUA can ONLY be issued if there is NO OTHER VIABLE TREATMENT and we all know there are a host of highly successful, SAFE (but cheap) treatments for this virus.
[link to www.fda.gov (secure)]
Reality Czar dodger007

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.

There's just one problem.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.

The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.

The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials..

MORE:

[link to www.americanthinker.com (secure)]
 Quoting: DeploraVision ™


From what I understand they have fully approved it, but the catch is they have to disclose all the ingredients in the vaccine by 7th of Sept.

This will be their FALL...
 Quoting: Yahella777


Comirnaty not even on market yet. They worked out some dodgy language to use up their current stock of vaxx in its place. Meanwhile they remain free of liability like the EUA.

If you employer mandates the shot require them to ensure you only required to take actual Comirnaty. Or fuck Pfizer and take the JnJ, one and done. By the time they come up with a booster this nightmare may be ending
You can count on America to do the right thing after exhausting every other alternative."
Winston Churchill
Anubis

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
[link to www.fda.gov (secure)]

For Immediate Release:
August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
MountainTux NLI

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08/26/2021 03:50 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
[link to www.fda.gov (secure)]

For Immediate Release:
August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
 Quoting: Anubis


Page 2 – Pfizer Inc.
10, 2021,
5 June 25, 2021,6 and August 12, 2021.7
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.


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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).
Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.8
5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. In addition, FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include the following Warning: “Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.” In addition, the Fact Sheet for Recipients and Caregivers was revised to instruct vaccine recipients or their caregivers to tell the vaccination provider about fainting in association with a previous injection.
6 In the June 25, 2021 revision, FDA clarified terms and conditions that relate to export of Pfizer-BioNTech COVID‑19 Vaccine from the United States. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning about myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine. The Fact Sheet for Recipients and Caregivers was updated to include information about myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID‑19 Vaccine.
7 In the August 12, 2021 revision, FDA authorized a third dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least 28 days following the two dose regimen of this vaccine in individuals 12 years of age or older who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
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.



_________________________________________________________



THEIR words, not mine - THE JAB BEING USED PREVIOUSLY, CURRENTLY and for the FORSEEABLE FUTURE is NOT the FDA "approved" drug. The two are, in THEIR OWN statement, "legally distinct."

They are playing semantic games while still using the experimental drug which provides an indemnification shield, and I BET that they will ALSO play games with what ingredients that they divulge... Oh, the APPROVED one doesn't have graphene...

Don't buy the lies, do the research.

penguin
ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.”
Sungaze_At_Dawn

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08/26/2021 03:57 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Thread: Robert Barnes Took A Look At The Strange Wording In The Fda Approval and Dr. Robert Malone's Take On It


They didn't approve it. The approval is for a product not yet manufactured, a kind of place holding, as they have a few more tests to do for it. Comirnarty or something.


And they do know, there apparently are 2 distinct legal entities being named in the 2 different contracts or papers.

And the citizens groups/lawyers, applying for the stay order from the Commissioner and Monday were not able to do so.

Because that FDA product doesn't exist yet.
The Devil tries to convince everyone he doesn't exist.
The state tries to convince everyone they cannot resist.
Do not go quietly into the good night. Rage Rage against the dying light!
Anonymous Coward
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08/26/2021 04:15 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Fully approved means they have looked at how it'$ manufactured. Clinical trial data $atisfied their criteria off $afety and efficacy. AND they can now market and $ELL in under the brand name Comirnaty.

The renewed EUA is for the working name Pfizer-biotech COVID-19, which has million$ of dose$ they don't want to lo$e money on.

The other EUA is for use of comi-r-naughty in ages 12-15.


Get ready for ad$ all over the net and TV...

Next they will charge you or your in$urance too...

"Get it now or pay later." Biden'time.

$orry, it was fully approved for 16 and over.
Anubis

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
sorry I still don't get it. are you trying to say the pfizer stock that is distributed and on hand right now,
the same stock that has already been administered is not the same as what was just approved?


the full footnote says:

"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."

same formulation.

Last Edited by Anubis on 08/26/2021 04:28 PM
Sungaze_At_Dawn

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08/26/2021 04:23 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Fully approved means they have looked at how it'$ manufactured. Clinical trial data $atisfied their criteria off $afety and efficacy. AND they can now market and $ELL in under the brand name Comirnaty.

The renewed EUA is for the working name Pfizer-biotech COVID-19, which has million$ of dose$ they don't want to lo$e money on.

The other EUA is for use of comi-r-naughty in ages 12-15.


Get ready for ad$ all over the net and TV...

Next they will charge you or your in$urance too...

"Get it now or pay later." Biden'time.

$orry, it was fully approved for 16 and over.
 Quoting: Space DJ


Cominarty is approved, doesn't exist yet, and has to still do some testing.
The Devil tries to convince everyone he doesn't exist.
The state tries to convince everyone they cannot resist.
Do not go quietly into the good night. Rage Rage against the dying light!
DeploraVision ™  (OP)

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Thread: Robert Barnes Took A Look At The Strange Wording In The Fda Approval and Dr. Robert Malone's Take On It


They didn't approve it. The approval is for a product not yet manufactured, a kind of place holding, as they have a few more tests to do for it. Comirnarty or something.


And they do know, there apparently are 2 distinct legal entities being named in the 2 different contracts or papers.

And the citizens groups/lawyers, applying for the stay order from the Commissioner and Monday were not able to do so.

Because that FDA product doesn't exist yet.
 Quoting: Sungaze_At_Dawn


hesright
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Anonymous Coward
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08/26/2021 04:38 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Fully approved means they have looked at how it'$ manufactured. Clinical trial data $atisfied their criteria off $afety and efficacy. AND they can now market and $ELL in under the brand name Comirnaty.

The renewed EUA is for the working name Pfizer-biotech COVID-19, which has million$ of dose$ they don't want to lo$e money on.

The other EUA is for use of comi-r-naughty in ages 12-15.


Get ready for ad$ all over the net and TV...

Next they will charge you or your in$urance too...

"Get it now or pay later." Biden'time.

$orry, it was fully approved for 16 and over.
 Quoting: Space DJ


Cominarty is approved, doesn't exist yet, and has to still do some testing.
 Quoting: Sungaze_At_Dawn


It's the same vaccine. They trademarked brand name while the working name was still under clinical trials.

[link to qz.com (secure)]

"BioNTech filed to register “Comirnaty” as a trademark in June 2020"

"the word is intended to evoke “community,” a Brand Institute executive said."

It's the same as when Acetaminophen became the brand name Tylenol.

The license means they found it "safe and effective" using the data from clinical trials so now they can market it.

It will be fun to listen to the side effects they rattle off at the end of commercials. No one died in trial so not sure if that will be the last word heard.

Yes the documents are confusing. Takes a few read through to understand what they're saying.

The approval allows them to manufacture the same vaccine that Pfizer biotech covid 19 is under the brand name.

All about the profits.

.
MountainTux NLI

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08/26/2021 04:42 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
sorry I still don't get it. are you trying to say the pfizer stock that is distributed and on hand right now,
the same stock that has already been administered is not the same as what was just approved?


the full footnote says:

"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."

same formulation.
 Quoting: Anubis


Your first statement is correct - the current shot is NOT approved, as the documentation CLEARLY states, while the NEW shot, which is not in production or available in the US, IS approved. It's quite clear.

And yes, they use the term SAME FORMULATION - but in the same footnote are very SPECIFIC to say that they are legally distinct, with certain differences - they tell you very clearly that they are two different things. Formulation means how the product is MADE, not what the product CONTAINS.

They also CLEARLY state that the new one is approved, BUT that they have extended the EUA for the other - which would be unneccesary in an approved drug. Further, they ADD the new drug to that EUA - which would be unneccesary if the two were the same. Additionally, they then ADD the NEW one to the EUA - because it's specific licensing doesn't allow for it to be used in 12-16 year olds. This would NOT be necessary if they were the same, as the EUA already COVERED that for the previous shot.

I'm sorry - are you trolling? Not picking a fight, just genuinely confused. I mean, this LITERALLY can't be any clearer - the FDA's own document is clearly defining two different but "interchangeable" shots, one which is approved and one which is not. Read morfe of the actual letter and it explains why the new one will NOT be in use for the time being, but that's ok, because they are interchangeable (not "the same," but INTERCHANGEABLE.)

In other words, they are still trying to mandate a non - approved shot - which they can't do.

I hope that clears it up for you!

cheers

penguin
ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.”
MountainTux NLI

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08/26/2021 04:45 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Fully approved means they have looked at how it'$ manufactured. Clinical trial data $atisfied their criteria off $afety and efficacy. AND they can now market and $ELL in under the brand name Comirnaty.

The renewed EUA is for the working name Pfizer-biotech COVID-19, which has million$ of dose$ they don't want to lo$e money on.

The other EUA is for use of comi-r-naughty in ages 12-15.


Get ready for ad$ all over the net and TV...

Next they will charge you or your in$urance too...

"Get it now or pay later." Biden'time.

$orry, it was fully approved for 16 and over.
 Quoting: Space DJ


Cominarty is approved, doesn't exist yet, and has to still do some testing.
 Quoting: Sungaze_At_Dawn


It's the same vaccine. They trademarked brand name while the working name was still under clinical trials.

[link to qz.com (secure)]

"BioNTech filed to register “Comirnaty” as a trademark in June 2020"

"the word is intended to evoke “community,” a Brand Institute executive said."

It's the same as when Acetaminophen became the brand name Tylenol.

The license means they found it "safe and effective" using the data from clinical trials so now they can market it.

It will be fun to listen to the side effects they rattle off at the end of commercials. No one died in trial so not sure if that will be the last word heard.

Yes the documents are confusing. Takes a few read through to understand what they're saying.

The approval allows them to manufacture the same vaccine that Pfizer biotech covid 19 is under the brand name.

All about the profits.

.
 Quoting: Space DJ


Sorry DJ, I get what you're saying, but it's incorrect - the two are NOT the same, and the current vaccine is NOT approved. That's from the FDA's VERY own documentation, which is quite clear on the matter.

They are theorectically REPLACING the shot with a newly branded shot that has different ingredients and is NOT available yet - what they have now is still the old, different, UNLICENSED shot. Very cut and dried.

penguin
ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.”
NLPAstrology

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
bsflag

First of all, the 'vaccine' is bullcrap. Don't take it.

But...


This is a bad argument designed to make people look like fools.

I read the official documentation.

FDA absolutely approved 'comirnity', and consequently admit it has the SAME ingredients as the current experimental 'vaccine', which will STILL be under emergency use authorization.

So, FDA says they are keeping the current 'vaccine' for emergency use authorization for children and others that don't fall into the 'general use' category.

That's it.

In other words, they're both approved. One is approved for 'non general' purposes in those that 'couldn't' get regular approved, aka children.

You people need to re-read the official documentation and not just HEADLINES.

In-fact, John Rappaport (who has been calling out this ENTIRE COVID HOAX from day one) already wrote a detailed article dismantling this 'not approved' theory.

Read the inside of the FDA documents:

[link to blog.nomorefakenews.com (secure)]


---------------------------------------------
EDIT, FOR THE ILLITERATE MORONS THAT FREQUENT THIS SITE:

Here, right from the FDA:


Comirnaty and Pfizer-BioNTech COVID-19 Vaccine,” August 23, 2021

"“On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”


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

It's literally right there pal. It's approved.

They are authorizing comirnaty for GENERAL USE and KEEPING the other EUA (same vaccine, same ingredients, different authorization') for emergency use in CHILDREN under 16 years of age.

Also:

"“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty…”"

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

ALSO:

“BLA Approval.” BLA stands for “Biologics License Application.”

“Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA.”

“We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany…Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA…You may label your product with the proprietary name, COMIRNATY…”

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


The FDA literally says that 'Comirnity' is the PROPRIETARY name of the old vaccine for MARKETING / LEGAL copyright purposes.

Last Edited by NLPAstrology on 08/26/2021 05:37 PM
Yes Moran - Adolph Shitler was a Meth-Addict (pervatin) Loser who Invaded Russia in the Winter. Your 'deep research' consisting of Nazi propaganda on Bitchute only suits the dimwitted trailer-dweller.
Suc Mi Pogoda

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08/26/2021 04:55 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Robert Kennedy Jr. says the same thing, that the FDA pulled a bait a switch:

[link to childrenshealthdefense.org (secure)]
Anonymous Coward
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08/26/2021 04:59 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
Fully approved means they have looked at how it'$ manufactured. Clinical trial data $atisfied their criteria off $afety and efficacy. AND they can now market and $ELL in under the brand name Comirnaty.

The renewed EUA is for the working name Pfizer-biotech COVID-19, which has million$ of dose$ they don't want to lo$e money on.

The other EUA is for use of comi-r-naughty in ages 12-15.


Get ready for ad$ all over the net and TV...

Next they will charge you or your in$urance too...

"Get it now or pay later." Biden'time.

$orry, it was fully approved for 16 and over.
 Quoting: Space DJ


Cominarty is approved, doesn't exist yet, and has to still do some testing.
 Quoting: Sungaze_At_Dawn


It's the same vaccine. They trademarked brand name while the working name was still under clinical trials.

[link to qz.com (secure)]

"BioNTech filed to register “Comirnaty” as a trademark in June 2020"

"the word is intended to evoke “community,” a Brand Institute executive said."

It's the same as when Acetaminophen became the brand name Tylenol.

The license means they found it "safe and effective" using the data from clinical trials so now they can market it.

It will be fun to listen to the side effects they rattle off at the end of commercials. No one died in trial so not sure if that will be the last word heard.

Yes the documents are confusing. Takes a few read through to understand what they're saying.

The approval allows them to manufacture the same vaccine that Pfizer biotech covid 19 is under the brand name.

All about the profits.

.
 Quoting: Space DJ


Sorry DJ, I get what you're saying, but it's incorrect - the two are NOT the same, and the current vaccine is NOT approved. That's from the FDA's VERY own documentation, which is quite clear on the matter.

They are theorectically REPLACING the shot with a newly branded shot that has different ingredients and is NOT available yet - what they have now is still the old, different, UNLICENSED shot. Very cut and dried.

penguin
 Quoting: MountainTux NLI


Correct. Vials with the label "Pfizer-biotech covid 19" is still under EUA so they can use up the vials.

They can now begin manufacturing the same chemical formulation under the name Comirnaty. Which has an EUA for ages 12-15.

Whether you read the letters or fda site, it's pretty clear.

BLA is a license to manufacture, market and sell a drug that has passed clinical trials under a brand name. That's what FDA approval is.

People see what they want to see. Remember the people who wrote it probably are vaxxed. Have noticed in almost all the v people I know their brains are mushier every time I see them. They can't compute or comprehend. Its maddening. Show them something blue and they call it red.
MountainTux NLI

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08/26/2021 05:05 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
bsflag

First of all, the 'vaccine' is bullcrap. Don't take it.

But...


This is a bad argument designed to make people look like fools.

I read the official documentation.

FDA absolutely approved 'comirnity', and consequently admit it has the SAME ingredients as the current experimental 'vaccine', which will STILL be under emergency use authorization.

So, FDA says they are keeping the current 'vaccine' for emergency use authorization for children and others that don't fall into the 'general use' category.

That's it.

In other words, they're both approved. One is approved for 'non general' purposes in those that 'couldn't' get regular approved, aka children.

You people need to re-read the official documentation and not just HEADLINES.

In-fact, John Rappaport (who has been calling out this ENTIRE COVID HOAX from day one) already wrote a detailed article dismantling this 'not approved' theory.

Read the inside of the FDA documents:

[link to blog.nomorefakenews.com (secure)]
 Quoting: NLPAstrology


I AM reading them - are you? In fact, I have ALL of the approval documents on file, as well as the requirements for the BLA, etc. But more to the point, it's black and white, if you can read - clearly outlined in the above FDA statements. They CLEARLY specify TWO DIFFERENT DRUGS. They CLEARLY state that they are LEGALLY DISTINCT (different) and have different ingredients.

THEY ALSO clearly define that one is approved and that the other is under the EUA for continued use as the NEW drug IS NOT AVAILABLE.

I don't know how much more clearly it can be stated - it's THEIR document saying it, not people making shit up. The NEW drug has approval - and is not what is being used. The EUA had to be extended - to keep using the OLD drug.

Why on earth do you think they'd extend the EUA if they had an approved drug? That takes AWAY from the credibility of the mandates. If they had an approval that EUA would be SPECIFICALLY for ONE drug to be used for kids under the age of 16. Instead, it lists ONE drug that needs an EUA and a SEPARATE drug which needs authorization to be used OUTSIDE of it's licensed allowance (kids under 13.)

How is this difficult to understand?

Wow, that was NOT the facepalm I was expecting, sorry! LOL

penguin

Last Edited by MountainTux NLI on 08/26/2021 05:09 PM
ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.”
Suc Mi Pogoda

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08/26/2021 05:07 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
bsflag

First of all, the 'vaccine' is bullcrap. Don't take it.

But...


This is a bad argument designed to make people look like fools.

I read the official documentation.

FDA absolutely approved 'comirnity', and consequently admit it has the SAME ingredients as the current experimental 'vaccine', which will STILL be under emergency use authorization.

So, FDA says they are keeping the current 'vaccine' for emergency use authorization for children and others that don't fall into the 'general use' category.

That's it.

In other words, they're both approved. One is approved for 'non general' purposes in those that 'couldn't' get regular approved, aka children.

You people need to re-read the official documentation and not just HEADLINES.

In-fact, John Rappaport (who has been calling out this ENTIRE COVID HOAX from day one) already wrote a detailed article dismantling this 'not approved' theory.

Read the inside of the FDA documents:

[link to blog.nomorefakenews.com (secure)]
 Quoting: NLPAstrology

John Rappaport?

epiclol
MountainTux NLI

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08/26/2021 05:08 PM

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Re: The FDA did NOT grant full approval to the Pfizer shots !!
...


Cominarty is approved, doesn't exist yet, and has to still do some testing.
 Quoting: Sungaze_At_Dawn


It's the same vaccine. They trademarked brand name while the working name was still under clinical trials.

[link to qz.com (secure)]

"BioNTech filed to register “Comirnaty” as a trademark in June 2020"

"the word is intended to evoke “community,” a Brand Institute executive said."

It's the same as when Acetaminophen became the brand name Tylenol.

The license means they found it "safe and effective" using the data from clinical trials so now they can market it.

It will be fun to listen to the side effects they rattle off at the end of commercials. No one died in trial so not sure if that will be the last word heard.

Yes the documents are confusing. Takes a few read through to understand what they're saying.

The approval allows them to manufacture the same vaccine that Pfizer biotech covid 19 is under the brand name.

All about the profits.

.
 Quoting: Space DJ


Sorry DJ, I get what you're saying, but it's incorrect - the two are NOT the same, and the current vaccine is NOT approved. That's from the FDA's VERY own documentation, which is quite clear on the matter.

They are theorectically REPLACING the shot with a newly branded shot that has different ingredients and is NOT available yet - what they have now is still the old, different, UNLICENSED shot. Very cut and dried.

penguin
 Quoting: MountainTux NLI


Correct. Vials with the label "Pfizer-biotech covid 19" is still under EUA so they can use up the vials.

They can now begin manufacturing the same chemical formulation under the name Comirnaty. Which has an EUA for ages 12-15.

Whether you read the letters or fda site, it's pretty clear.

BLA is a license to manufacture, market and sell a drug that has passed clinical trials under a brand name. That's what FDA approval is.

People see what they want to see. Remember the people who wrote it probably are vaxxed. Have noticed in almost all the v people I know their brains are mushier every time I see them. They can't compute or comprehend. Its maddening. Show them something blue and they call it red.
 Quoting: Space DJ


Correct, and while it is the same FORMULATION, it's NOT the same drug - legally distinct, different ingredients.

Regardless, as you say, smoke and mirrors - they can't mandate an unapproved drug, which is what they are still providing.

cheers

penguin
ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.”
jedidad

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08/26/2021 05:08 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
So what does an actual approval letter look like?
Anonymous Coward
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08/26/2021 05:10 PM
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Re: The FDA did NOT grant full approval to the Pfizer shots !!
There is even such a thing as post market clinical trials.

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





GLP