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Pfizer vaccine still NOT fully approved by FDA

Discussion in 'News & Current Events (Articles Required)' started by Aldebaran, Aug 24, 2021.

  1. JulieB67

    JulieB67 Well-Known Member

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    That way the mandates can roll out but they're still not liable at this point. Pretty slick operation.
     
  2. ThisIsMe123

    ThisIsMe123 This And That

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

    TLK Valentine You will be who you will be. We are our choices.

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    Not slick enough if anyone can see through it.
     
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  4. sfs

    sfs Senior Member

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    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.
     
  5. JulieB67

    JulieB67 Well-Known Member

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

    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.
     
  6. sfs

    sfs Senior Member

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    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?
     
  7. prodromos

    prodromos Senior Veteran Supporter

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    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.
     
  8. JulieB67

    JulieB67 Well-Known Member

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    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.
     
  9. Ana the Ist

    Ana the Ist Aggressively serene!

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    Well that seems rather deceptive....

    Why would the media say one thing and the FDA say another?
     
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  10. TLK Valentine

    TLK Valentine You will be who you will be. We are our choices.

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    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.
     
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  11. Ana the Ist

    Ana the Ist Aggressively serene!

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    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?
     
  12. TLK Valentine

    TLK Valentine You will be who you will be. We are our choices.

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    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.
     
  13. Pommer

    Pommer CoPcEtiC SkEpTic Supporter

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    The press has infiltrated the government?
    Quick get some priests in there too!
     
  14. Ana the Ist

    Ana the Ist Aggressively serene!

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    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.
     
  15. Ana the Ist

    Ana the Ist Aggressively serene!

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    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.
     
  16. Pommer

    Pommer CoPcEtiC SkEpTic Supporter

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    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.
     
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  17. Ana the Ist

    Ana the Ist Aggressively serene!

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    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.
     
  18. ThisIsMe123

    ThisIsMe123 This And That

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

    TLK Valentine You will be who you will be. We are our choices.

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    I did. They posted the press release on their own website.
     
  20. ThisIsMe123

    ThisIsMe123 This And That

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    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".
     
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