Pfizer vaccine still NOT fully approved by FDA

[JulieB67]

Yes, that is it exactly.

That way the mandates can roll out but they're still not liable at this point. Pretty slick operation.

 

[ThisIsMe123]

Read the documents. It is not in production yet. So anything anyone gets is still under the EUA, in order to maintain the liability shield. Others have addressed it as well, so read upthread.

Sfs is already in the field, so you're wrong. You're just grabbing at straws at this point. Splitting hairs.

 

[TLK Valentine]

That way the mandates can roll out but they're still not liable at this point. Pretty slick operation.

Not slick enough if anyone can see through it.

 

[sfs]

He's talking about how they are going to continue to get rid of the massive stock of the Pfizer vaccine that's branded "Pfizer"

Could you provide some documentation for the legal distinction between the different branding? In any case, that's a legal issue -- the vaccine in question is the same and is the one that's been approved.

 

[JulieB67]

Not slick enough if anyone can see through it.

Well, many will line up thinking they are getting the "FDA approved brand and that might not be the case.

Could you provide some documentation for the legal distinction between the different branding? In any case, that's a legal issue -- the vaccine in question is the same and is the one that's been approved.

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

As many have already said, the legal difference is that Pfizer is still under the EUA and the new branded Comirnaty is technically the FDA approved brand. Same vaccine but they will continue to use the Pfizer labeled ones under the guise that "it" actually has full approval. It's kind of a bait and switch. Because they will still be giving out the EUA Pfizer to people who think they are getting the FDA approved one and Comirnaty is not available yet. I've read somewhere that it's limitted and I read in another place that it's not even manufactured yet.

Q&A for Comirnaty (COVID-19 Vaccine 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. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.

 

[sfs]

It's kind of a bait and switch. Because they will still be giving out the EUA Pfizer to people who think they are getting the FDA approved one and Comirnaty is not available yet.

Thanks for the information.

Since the only difference is the packaging, in what sense is it a bait and switch? How many recipients even see the packaging?

 

[prodromos]

Thanks for the information.

Since the only difference is the packaging, in what sense is it a bait and switch? How many recipients even see the packaging?

If they believe they are receiving Comirnaty and suffer a debilitating blood clot or cardiac condition as a result of the vaccine, then find that they had in fact received the Pfizer-BioNTech COVID-19 product, they have no legal recourse to sue for damages.

 

[JulieB67]

Since the only difference is the packaging, in what sense is it a bait and switch? How many recipients even see the packaging?

I'm just using that as an analogy. Some people that have been waiting for FDA approval because of the liability issue will take the Pfizer one thinking the liabilty shield has been lifted.

Basically those people need to make sure it's the "Comirnaty" labeled one. But with it not even out there yet, they will continue to roll out the Pfizer one.

 

[Ana the Ist]

As of August 23rd, it has been widely reported that the Pfizer drug has now been fully approved by the FDA to be used to vaccinate against Covid19. Up until that time, it was authorized for emergency use.

Lo and behold, on the FDA's own website, it is shown that the Pfizer drug is still under Emergency Use Authorization. Here's text from page 2 of the link:

"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."

Also from the end of page 4 and continuing to the middle of page 5:

"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or Page 5 – Pfizer Inc. to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. I. Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.

https://www.fda.gov/media/150386/download

Well that seems rather deceptive....

Why would the media say one thing and the FDA say another?

 

[TLK Valentine]

Well that seems rather deceptive....

Why would the media say one thing and the FDA say another?

Why would the FDA repeat the media on its own website?

FDA Approves First COVID-19 Vaccine

Or maybe Alde needs a little more experience reading government documents. I'm no legal eagle myself, but the top of page 2, it says:

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


IOW: First (top of page 2), the FDA announces that Comirnaty is fully approved, and then announces that it's revising its original Emergency authorization -- which it restates in what Alde quoted...

...or we can say the the Media's lies about the FDA authorization are so insidious that they even fooled the FDA itself. Take your pick.

 

[Ana the Ist]

Why would the FDA repeat the media on its own website?

FDA Approves First COVID-19 Vaccine

Or maybe Alde needs a little more experience reading government documents. I'm no legal eagle myself, but the top of page 2, it says:

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


IOW: First (top of page 2), the FDA announces that Comirnaty is fully approved, and then announces that it's revising its original Emergency authorization -- which it restates in what Alde quoted...

...or we can say the the Media's lies about the FDA authorization are so insidious that they even fooled the FDA itself. Take your pick.

I'm not a legal scholar either....

Did it give non-Emergency Authorization or not?

I'm confused as to why it would require an amendment to emergency authorization if it's been given full approval....unless the amendment is to just remove emergency authorization.

Here's the confusing part....from your post....

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.

Why would the EUA remain in place if it had full approval? Isn't the whole point of an EUA for products and uses that don't have full approval?

 

[TLK Valentine]

I'm not a legal scholar either....

Did it give non-Emergency Authorization or not?

I'm confused as to why it would require an amendment to emergency authorization if it's been given full approval....unless the amendment is to just remove emergency authorization.

Here's the confusing part....from your post....

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.

Why would the EUA remain in place if it had full approval? Isn't the whole point of an EUA for products and uses that don't have full approval?

It is a confusing jumble, but close enough for government work, I suppose. Nothing is official until after at least five trips through the redundant department of redundancy department.

The upshot is that if the big bad media's announcement of Pfizer's full approval was in any way premature or misleading, it seems highly unlikely that the FDA would carry the "fake news" on its own website.

Now that's something I'd like to see explained.

 

[Pommer]

It is a confusing jumble, but close enough for government work, I suppose. Nothing is official until after at least five trips through the redundant department of redundancy department.

The upshot is that if the big bad media's announcement of Pfizer's full approval was in any way premature or misleading, it seems highly unlikely that the FDA would carry the "fake news" on its own website.

Now that's something I'd like to see explained.

The press has infiltrated the government?
Quick get some priests in there too!

 

[Ana the Ist]

It is a confusing jumble, but close enough for government work, I suppose. Nothing is official until after at least five trips through the redundant department of redundancy department.

The upshot is that if the big bad media's announcement of Pfizer's full approval was in any way premature or misleading, it seems highly unlikely that the FDA would carry the "fake news" on its own website.

Now that's something I'd like to see explained.

Well it doesn't appear to say that it got full approval from the part you quoted on the website...

It says...

clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses,

The key thing there seems to be that the EUA is remaining in place, with some amendments.

Why it would remain in place if it was given full authorization, I have no idea.

 

[Ana the Ist]

It is a confusing jumble, but close enough for government work, I suppose. Nothing is official until after at least five trips through the redundant department of redundancy department.

The upshot is that if the big bad media's announcement of Pfizer's full approval was in any way premature or misleading, it seems highly unlikely that the FDA would carry the "fake news" on its own website.

Now that's something I'd like to see explained.

Can you just quote from where the FDA says they gave full approval to the vaccine? Not just EUA?

Surely that's in there somewhere.

 

[Pommer]

Can you just quote from where the FDA says they gave full approval to the vaccine? Not just EUA?

Surely that's in there somewhere.

Footnote 8 at the bottom of page two of the OP’s link,

“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…”

The vaccine that has been in use, is what got the EUA, it now has a Brand Name “COMIRNATY” and a license to market the full approved vaccine.

 

[Ana the Ist]

Footnote 8 at the bottom of page two of the OP’s link,

“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…”

The vaccine that has been in use, is what got the EUA, it now has a Brand Name “COMIRNATY” and a license to market the full approved vaccine.

Does it say it was granted full approval somewhere though? I understand they changed the brand name of the vaccine to something goofy. That wasn't the question.

 

[ThisIsMe123]

Does it say it was granted full approval somewhere though? I understand they changed the brand name of the vaccine to something goofy. That wasn't the question.

Well it doesn't appear to say that it got full approval from the part you quoted on the website...

It says...

clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses,

The key thing there seems to be that the EUA is remaining in place, with some amendments.

Why it would remain in place if it was given full authorization, I have no idea.

I am not seeing this on the FDA website. So, not sure what you're talking about.

 

[TLK Valentine]

Can you just quote from where the FDA says they gave full approval to the vaccine? Not just EUA?

Surely that's in there somewhere.

I did. They posted the press release on their own website.

 

[ThisIsMe123]

I did. They posted the press release on their own website.

I have to say, from these posts, I think some here are anticipating a flaw or fault or at least looking for one....only to be pointed out that there isn't one..and they are like "oh".