Newly Approved COVID-19 Vaccine Not Yet Available in US

JustSomeBloke

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Newly Approved COVID-19 Vaccine Not Yet Available in US

I posted about this in another thread, because I suspect that there's a bait-and-switch operation being perpetrated with Comirnaty (FDA approved, but currently unavailable) and Pfizer-BioNTech (hundreds of millions of doses reportedly still available, but only on an Emergency Use Authorisation). However, I thought it was worth creating a specific thread on the issue, because I think a lot of people may be being duped into thinking that the vaccine they are taking has been FDA approved, when the reality is that there is reportedly no FDA approved Comirnaty covid vaccine that is currently available for use.

The first COVID-19 vaccine approved for use in the United States is not available yet and it’s unclear when the first doses will be ready for administration.


The Food and Drug Administration (FDA) on Aug. 23 approved a vaccine from Pfizer and its German partner, BioNTech. But at the same time, drug regulators extended (pdf) emergency use authorization (EUA) for existing doses of the vaccine.


The FDA and the Centers for Disease Control and Prevention (CDC) declined to answer or did not respond to questions about when the approved vaccine, dubbed Comirnaty, would be available.


Pfizer did not answer directly when asked and BioNTech did not return an inquiry.


But health officials from states across America confirmed to The Epoch Times that they do not have any Comirnaty doses, and that none are expected soon.


Maybe Comirnaty doses will start to become available in future, maybe not. If Comirnaty never becomes available, then it's probably safe to assume that the total lack of the FDA approved covid vaccine is a legal dodge to avoid liability, and a bait-and-switch tactic to try and make people think they're taking an FDA approved treatment (many people wrongfully think that the Pfizer-BioNTech vaccine is FDA approved but in reality it only has Emergency Use Approval).
 
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pitabread

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I posted about this in another thread, because I suspect that there's a bait-and-switch operation being perpetrated with Comirnaty (FDA approved, but currently unavailable) and Pfizer-BioNTech (hundreds of millions of doses reportedly still available, but only on an Emergency Use Authorisation).

It's the same vaccine. Comirnaty is just a brand name for it.
 
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JustSomeBloke

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It's the same vaccine. Comirnaty is just a brand name for it.
Yes, it's physically, chemically, and biologically the same vaccine. However, even the FDA have admitted that the Comirnaty and Pfizer-BioNTech vaccines are 'legally distinct'. Once you realise that, and the fact that Comirnaty is unavailable, while there are still hundreds of millions of doses of Pfizer-BioNTech reportedly still available on Emergency Use Authorisation, then the intelligent response is to question why that situation exists. My suspicion is that it's most likely a legal liability dodge and a bait-and-switch.
 
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BeyondET

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Yes, it's physically, chemically, and biologically the same vaccine. However, even the FDA have admitted that the Comirnaty and Pfizer-BioNTech vaccines are 'legally distinct'. Once you realise that, and the fact that Comirnaty is unavailable, while there are still hundreds of millions of doses of Pfizer-BioNTech reportedly still available on Emergency Use Authorisation, then the intelligent response is to question why that situation exists. My suspicion is that it's most likely a legal liability dodge and a bait-and-switch.
It’s legally distinct because of the different name, the two are the same so it doesn’t matter if comirnaty isn’t Pfizer’s is approved.
 
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JustSomeBloke

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Do you have anything that supports this?
It's called circumstantial evidence.

If you read the entire Epoch Times article, my posts in the other thread, and regard how all the MSM are reporting this (not the Epoch Times obviously), then it all points suspiciously at an agenda to deceive.

I notice from the link helpfully provided by @GOD Shines Forth! that the FDA is playing the 'logistical reasons' card. In that case, if the vaccines are identical, why not just upgrade Pfizer-BioNTech to approval status?

I guess time will tell whether the Comirnaty vaccine becomes available (I suspect it won't). But at the moment this situation looks and smells very fishy.

It’s legally distinct because of the different name, the two are the same so it doesn’t matter if comirnaty isn’t Pfizer’s is approved.
It's a legal liability issue, so it very much does matter. One has approval, one only has Emergency Use Approval (EUA). I'm sorry if you can't appreciate the importance of that, because when someone suffers an adverse effect, it's the difference between getting a payout, and having the vaccine manufacturers just shrug their shoulders, and say "it was only on an EUA, nothing to do with us".
 
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BeyondET

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It's a legal liability issue, so it very much does matter. One has approval, one only has Emergency Use Approval (EUA). I'm sorry if you can't appreciate the importance of that, because when someone suffers an adverse effect, it's the difference between getting a payout, and having the vaccine manufacturers just shrug their shoulders, and say "it was only on an EUA, nothing to do with us".

it appears to be trying to make a mountain out of a mole hill. It is the same product rather it is approved for emergency use or not, they can not be sued over it.
 
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pitabread

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It's called circumstantial evidence.

IOW, no.

It's a legal liability issue, so it very much does matter. One has approval, one only has Emergency Use Approval (EUA). I'm sorry if you can't appreciate the importance of that, because when someone suffers an adverse effect, it's the difference between getting a payout, and having the vaccine manufacturers just shrug their shoulders, and say "it was only on an EUA, nothing to do with us".

Which is why I am asking if you have anything to actually support your contentions. If this is a legal issue, as you claim, do you have any examples of other legal cases where this happened? Any legal precedent?

Anything at all?
 
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JustSomeBloke

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it appears to be trying to make a mountain out of a mole hill. It is the same product rather it is approved for emergency use or not, they can not be sued over it.
I don't think that's true at all.

If you read this article then you'll understand what is really going on here, and the various Federal and international laws that apply to using experimental drugs and treatments, as compared to fully approved and licensed drugs and treatment.

Two Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine


Which is why I am asking if you have anything to actually support your contentions. If this is a legal issue, as you claim, do you have any examples of other legal cases where this happened? Any legal precedent?

Anything at all?
Please see the link above that I provided to BeyondET.
 
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pitabread

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Please see the link above that I provided to BeyondET.

It just seems like a rehash of what you're posting, coupled with the anti-vax nonsense de jour about the Nuremberg Code and VAERS database.

Do you have any credible sources for this?
 
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JustSomeBloke

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It just seems like a rehash of what you're posting, coupled with the anti-vax nonsense de jour about the Nuremberg Code.

Do you have any credible sources for this?
What do you mean by credible sources? He's already done all of the relevant work for you, by linking to the applicable Federal Laws and FDA documents. Are you saying the Federal Law source he uses is not credible? The Federal Laws he links to are not written in complex legalese, and are not difficult for a non-lawyer to understand, so I don't understand the nature of your problem or complaint.

By the way, the Nuremberg Code is still in force, it still applies to experimental medical treatments, the Pfizer-BioNTech vaccine (the only Pfizer covid vaccine currently available) is still classified as an experimental treatment, and it's still a breach of the Nuremberg Code to force anyone to take this experimental medical treatment. So please stop going on about 'anti-vax nonsense'.
 
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pitabread

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What do you mean by credible sources?

Sources that aren't anti-vax propaganda machines.

The Federal Laws he links to are not written in complex legalese, and are not difficult for a non-lawyer to understand, so I don't understand the nature of your problem or complaint.

That's why I am asking if there is any legal precedent (e.g. court cases)? That's how one usually argues a legal point.

By the way, the Nuremberg Code is still in force

The Nuremberg Code is not a law. It can't be "in force".

Pfizer-BioNTech vaccine (the only Pfizer covid vaccine currently available) is still classified as an experimental treatment

No it is not.

So please stop going on about 'anti-vax nonsense'.

Stop posting anti-vax nonsense and I'll stop going on about it.
 
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FreeinChrist

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Newly Approved COVID-19 Vaccine Not Yet Available in US

I posted about this in another thread, because I suspect that there's a bait-and-switch operation being perpetrated with Comirnaty (FDA approved, but currently unavailable) and Pfizer-BioNTech (hundreds of millions of doses reportedly still available, but only on an Emergency Use Authorisation). However, I thought it was worth creating a specific thread on the issue, because I think a lot of people may be being duped into thinking that the vaccine they are taking has been FDA approved, when the reality is that there is reportedly no FDA approved Comirnaty covid vaccine that is currently available for use.

The first COVID-19 vaccine approved for use in the United States is not available yet and it’s unclear when the first doses will be ready for administration.


The Food and Drug Administration (FDA) on Aug. 23 approved a vaccine from Pfizer and its German partner, BioNTech. But at the same time, drug regulators extended (pdf) emergency use authorization (EUA) for existing doses of the vaccine.


The FDA and the Centers for Disease Control and Prevention (CDC) declined to answer or did not respond to questions about when the approved vaccine, dubbed Comirnaty, would be available.


Pfizer did not answer directly when asked and BioNTech did not return an inquiry.


But health officials from states across America confirmed to The Epoch Times that they do not have any Comirnaty doses, and that none are expected soon.


Maybe Comirnaty doses will start to become available in future, maybe not. If Comirnaty never becomes available, then it's probably safe to assume that the total lack of the FDA approved covid vaccine is a legal dodge to avoid liability, and a bait-and-switch tactic to try and make people think they're taking an FDA approved treatment (many people wrongfully think that the Pfizer-BioNTech vaccine is FDA approved but in reality it only has Emergency Use Approval).
Your source is highly questionable.

The Epoch Times - Wikipedia

The Epoch Times is a far-right[12] international multi-language newspaper and media company affiliated with the Falun Gong new religious movement.[17]
Falun Gong - Wikipedia

Falun Gong (UK: /ˌfɑːlʊn ˈɡɒŋ, ˌfæl-, - ˈɡʊŋ/, US: /- ˈɡɔːŋ/)[1] or Falun Dafa (/ˈdɑːfə/; Standard Mandarin Chinese: [fàlwə̌n tâfà]; literally, "Dharma Wheel Practice" or "Law Wheel Practice") is a new religious movement.[2][3] Falun Gong was founded by its leader Li Hongzhi in China in the early 1990s. .....

Falun Gong combines meditation and qigong ('Qi/Chi cultivation') exercises with a moral philosophy. The practice emphasizes morality and the cultivation of virtue, and identifies as a practice of the Buddhist school, though its teachings also incorporate elements drawn from Taoist traditions. Through moral rectitude and the practice of meditation, practitioners of Falun Gong aspire to eliminate attachments, and ultimately to achieve spiritual enlightenment.[7]....

Falun Gong's founder, Li Hongzhi, has stated that he believes space aliens walk the Earth, and that modern science and race-mixing are part of their ploy to overtake humanity, and he has reportedly said that he can walk through walls and make himself invisible. Li says that he is a being who has come to help humankind from the destruction it could face as the result of rampant evil. When asked if he was a human being, Li replied "You can think of me as a human being."[32][33][34]
Christians, in particular, should have great hesitancy to view that source as having credibility. It has been banned on Facebook for promotin Qanon and other conspiracies.


From the FDA:

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.





 
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pitabread

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BeyondET

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I don't think that's true at all.

If you read this article then you'll understand what is really going on here, and the various Federal and international laws that apply to using experimental drugs and treatments, as compared to fully approved and licensed drugs and treatment.

Two Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine



Please see the link above that I provided to BeyondET.

Hmm that is interesting, so from what the link said, the American Pfizer jabs are from the EUA stock pile and not a Pfizer-BioNTech label because there is a non liability clause in the EUA stockpile.

even though it is in law to refuse experimental vaccines I doubt that will stop the companies from demanding it especially with dems in control sadly.
 
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JustSomeBloke

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Your source is highly questionable.

The Epoch Times - Wikipedia

The Epoch Times is a far-right[12] international multi-language newspaper and media company affiliated with the Falun Gong new religious movement.[17]
Two can play at that particular game. I'd say your source is highly questionable, and I bet my references are better than yours.

Wikipedia Founder Says the Project Has Abandoned Neutrality Policy, is ‘Badly Biased’

Wikipedia co-founder Larry Sanger blasts site for left-wing bias: ‘The word for it is propaganda’

Wikipedia Is Badly Biased - Larry Sanger Blog

Wikipedia Co-Founder: Site's Neutrality Is 'Dead' Thanks to Leftist Bias

From the FDA:

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.
It looks like you've missed the point of the thread.

Is this against the Statement of Purpose of this subforum?

All news and current events threads must be documented or validated with a link to a credible online news source (articles, not videos) in the original post (OP).
Statement of Purpose - News & Current Events Forum Statement of Purpose
Well, now this is getting really interesting!

Looks like the pro-vaxxers don't like anyone who challenges their vaxx religion.
 
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pitabread

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Well, now this is getting really interesting!

Looks like the pro-vaxxers don't like anyone who challenges their vaxx religion.

I didn't write the forum rules requiring credible sources for news stories.

Do you have a credible source for anything you are posting, or are you just reliant on conspiracy-theory pushing anti-vax propaganda outlets?
 
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JustSomeBloke

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I didn't write the forum rules requiring credible sources for news stories.

Do you have a credible source for anything you are posting, or are you just reliant on conspiracy-theory pushing anti-vax propaganda outlets?
Responding by saying 'conspiracy-theory' should be banned on this forum, for the exact same reason that responding with 'fake-news' is already banned. It adds absolutely nothing useful to the debate, and is a form of trolling.

We have been receiving complaints about posters responding to threads they disagree with "#fakenews" and only that. We have seen some even admit they don't read the articles and just base it off the source, without checking for a better source. It's trolling and from this point forward will be treated as such. It's not intended to add to the conversation, it's not intended to be a legitimate discussion of whether a source or story is credible. It's drive-by posting that's meant to disrupt the thread and goad other posters into responding in a similarly poor way, thus bringing down the thread.

See the link below for more information:

Announcement: Trolling- 'Fake News'
 
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pitabread

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Responding by saying 'conspiracy-theory' should be banned on this forum, for the exact same reason that responding with 'fake-news' is already banned.

Except it's true about the Epoch Times:
  • Overall, we rate The Epoch Times Right Biased and Questionable based on the publication of pseudoscience and the promotion of propaganda and conspiracy theories, as well as numerous failed fact checks.
The Epoch Times

The fact they promote conspiracy theories is, well, a fact.
 
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