Newly Approved COVID-19 Vaccine Not Yet Available in US

JustSomeBloke

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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.
So you think a so-called 'fact checking' site is a reliable source of information? You do realise that anyone can set up a website and proclaim themselves a fact-checker? I could do it. You could do it. Absolutely anyone could do it. But funnily enough, 'fact checking' appears to be a mostly left-wing hobby, same as Wikipedia has been completely taken over by people with a Left wing bias.

And as yet, you haven't come up with a single decent post on why the Epoch Times article is wrong ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
 
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FreeinChrist

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GOD Shines Forth!

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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.

Their assessment was "MIXED". That doesn't sound as bad as you're making it out to be, frankly. Not that I care what a leftist (are there any other kind?) "fact-checking" site assesses, but for them that's generous.

MBFCMixed.png
 
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FreeinChrist

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I think more research is needed into the issue

Saw this:
You can’t sue Pfizer or other COVID-19 vaccine manufacturers | verifythis.com

It is worth a read as it says that one still cannot sue for injuries by the fully approved Pfizer vaccine, but one can apply for compensation via the Countermeasures Injury Compensation Program (CICP) .


https://www.washingtonpost.com/poli...ed-pfizer-vaccine-lacks-liability-protection/


“The little trick that they have done here: They have issued two separate letters for two separate vaccines. The Pfizer vaccine which is currently available is still under emergency use authorization and it still has the liability shield … The product that’s licensed … it’s called Comirnaty. … that’s the one that liability waiver will no longer apply to.”


— Robert Malone, interview on Bannons War Room, Aug. 24


The FACTS

...“The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”

Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act)....

In early 2020, after the coronavirus emerged, Health and Human Services Secretary Alex Azar invoked the PREP Act to “provide liability immunity for activities related to medical countermeasures against covid-19.” So that covers all vaccines that might be produced to combat the coronavirus, whether fully authorized or not.

The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits.

In other words, a person cannot sue a manufacturer for an injury caused by a vaccine or other product listed as a countermeasure, but they can seek compensation from CICP filing a claim. The intent of the law is to urge manufacturers to quickly gear up to combat a possible pandemic without fear of lawsuits. (There is an exception in the law if a person can prove “willful misconduct” by a manufacturer.)


The vaccine under the EUA as well as the fully approved vaccine are the same, and have the same legal liability protection.

 
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JustSomeBloke

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I think more research is needed into the issue

Saw this:
You can’t sue Pfizer or other COVID-19 vaccine manufacturers | verifythis.com

It is worth a read as it says that one still cannot sue for injuries by the fully approved Pfizer vaccine, but one can apply for compensation via the Countermeasures Injury Compensation Program (CICP) .


https://www.washingtonpost.com/poli...ed-pfizer-vaccine-lacks-liability-protection/


“The little trick that they have done here: They have issued two separate letters for two separate vaccines. The Pfizer vaccine which is currently available is still under emergency use authorization and it still has the liability shield … The product that’s licensed … it’s called Comirnaty. … that’s the one that liability waiver will no longer apply to.”


— Robert Malone, interview on Bannons War Room, Aug. 24


The FACTS

...“The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”

Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act)....

In early 2020, after the coronavirus emerged, Health and Human Services Secretary Alex Azar invoked the PREP Act to “provide liability immunity for activities related to medical countermeasures against covid-19.” So that covers all vaccines that might be produced to combat the coronavirus, whether fully authorized or not.

The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits.

In other words, a person cannot sue a manufacturer for an injury caused by a vaccine or other product listed as a countermeasure, but they can seek compensation from CICP filing a claim. The intent of the law is to urge manufacturers to quickly gear up to combat a possible pandemic without fear of lawsuits. (There is an exception in the law if a person can prove “willful misconduct” by a manufacturer.)


The vaccine under the EUA as well as the fully approved vaccine are the same, and have the same legal liability protection.

I don't think it's usually permissible to remove legal liability for FDA approved treatments. Maybe there's some special arrangement here, but if the Comirnaty vaccine is completely unavailable then it hardly matters, because there will never be a Comirnaty vaccine injury, there will never be a Comirnaty claim for damages, and there will never be a Comirnaty court case. From that point of view it's a purely academic argument, and has no practical relevance in the real world. They know they can safely say what they like about Comirnaty and its legal liability, safe in the knowledge that there will never be any legal test case. Short answer, if they're lying, we'll probably never find out they were lying.

By the way, you should check out the relevant Federal Laws on Emergency Use Authorisations at uscode.house.gov (21 USC 360bbb-3: Authorization for medical products for use in emergencies)

(e) Conditions of authorization

(1) Unapproved product

(A) Required conditions

With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:


(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed-


(I) that the Secretary has authorized the emergency use of the product;


(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and


(III) of the alternatives to the product that are available, and of their benefits and risks.


(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-


(I) that the Secretary has authorized the emergency use of the product;


(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and


(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.


Notice that in the last few paragraphs, people have to be appropriately informed of their right to accept or refuse administration of a product with Emergency Use Authorisation.

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

I'd guess that means if Comirnaty is unavailable, then Joe Biden's vaccine mandate is unlawful.


Similarly, if people turn up for vaccination and are offered the Pfizer BioNTech vaccine, then failing to inform them that the product is on an Emergency Use Authorisation would be a breach of Federal Law:

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-

(I) that the Secretary has authorized the emergency use of the product;
 
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Aldebaran

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Every one of your links are for liberal news sources and only drives home the point that liberal news sources don't traditionally agree with a conservative news source.
 
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muichimotsu

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I don't think it's usually permissible to remove legal liability for FDA approved treatments. Maybe there's some special arrangement here, but if the Comirnaty vaccine is completely unavailable then it hardly matters, because there will never be a Comirnaty vaccine injury, there will never be a Comirnaty claim for damages, and there will never be a Comirnaty court case. From that point of view it's a purely academic argument, and has no practical relevance in the real world. They know they can safely say what they like about Comirnaty and its legal liability, safe in the knowledge that there will never be any legal test case. Short answer, if they're lying, we'll probably never find out they were lying.

By the way, you should check out the relevant Federal Laws on Emergency Use Authorisations at uscode.house.gov (21 USC 360bbb-3: Authorization for medical products for use in emergencies)

(e) Conditions of authorization

(1) Unapproved product

(A) Required conditions

With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:


(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed-


(I) that the Secretary has authorized the emergency use of the product;


(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and


(III) of the alternatives to the product that are available, and of their benefits and risks.


(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-


(I) that the Secretary has authorized the emergency use of the product;


(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and


(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.


Notice that in the last few paragraphs, people have to be appropriately informed of their right to accept or refuse administration of a product with Emergency Use Authorisation.

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

I'd guess that means if Comirnaty is unavailable, then Joe Biden's vaccine mandate is unlawful.


Similarly, if people turn up for vaccination and are offered the Pfizer BioNTech vaccine, then failing to inform them that the product is on an Emergency Use Authorisation would be a breach of Federal Law:

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-

(I) that the Secretary has authorized the emergency use of the product;
Dude, I have the handout from when I got the Moderna, still not FDA approved, that tells you about all the technicalities with EUA, so don't act like people aren't getting the facts.

It's sounding more like you don't like the facts, so you spin them in a way that you can dismiss them and act like you're smarter somehow or that you know something and you're not gonna conform (when you still are conforming to other aspects, I'm pretty sure UK has vaccine requirements, among other things, but feel free to call them communist too, or whatnot)

Is it so bad to admit that a source is questionable? Unless of course that's the one source that fits your narrative and thus acknowledging it's mistaken or has significant bias would expose cognitive dissonance, and we don't like that as people
 
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muichimotsu

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Every one of your links are for liberal news sources and only drives home the point that liberal news sources don't traditionally agree with a conservative news source.
In other news, fire is hot and water is wet, you got anything of substance and not partisan quibbling?
 
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muichimotsu

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I think more research is needed into the issue

Saw this:
You can’t sue Pfizer or other COVID-19 vaccine manufacturers | verifythis.com

It is worth a read as it says that one still cannot sue for injuries by the fully approved Pfizer vaccine, but one can apply for compensation via the Countermeasures Injury Compensation Program (CICP) .


https://www.washingtonpost.com/poli...ed-pfizer-vaccine-lacks-liability-protection/


“The little trick that they have done here: They have issued two separate letters for two separate vaccines. The Pfizer vaccine which is currently available is still under emergency use authorization and it still has the liability shield … The product that’s licensed … it’s called Comirnaty. … that’s the one that liability waiver will no longer apply to.”


— Robert Malone, interview on Bannons War Room, Aug. 24


The FACTS

...“The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”

Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act)....

In early 2020, after the coronavirus emerged, Health and Human Services Secretary Alex Azar invoked the PREP Act to “provide liability immunity for activities related to medical countermeasures against covid-19.” So that covers all vaccines that might be produced to combat the coronavirus, whether fully authorized or not.

The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits.

In other words, a person cannot sue a manufacturer for an injury caused by a vaccine or other product listed as a countermeasure, but they can seek compensation from CICP filing a claim. The intent of the law is to urge manufacturers to quickly gear up to combat a possible pandemic without fear of lawsuits. (There is an exception in the law if a person can prove “willful misconduct” by a manufacturer.)


The vaccine under the EUA as well as the fully approved vaccine are the same, and have the same legal liability protection.

Had to remind myself, but I almost like it better that I got Moderna, even though both it and Pfizer's are mRNA, because Moderna's brandname is SpikeVax.

Comirnaty sounds like a typo of sorts by contrast, even knowing the justification for the portmanteau.
 
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FreeinChrist

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I don't think it's usually permissible to remove legal liability for FDA approved treatments. Maybe there's some special arrangement here, but if the Comirnaty vaccine is completely unavailable then it hardly matters, because there will never be a Comirnaty vaccine injury, there will never be a Comirnaty claim for damages, and there will never be a Comirnaty court case. From that point of view it's a purely academic argument, and has no practical relevance in the real world. They know they can safely say what they like about Comirnaty and its legal liability, safe in the knowledge that there will never be any legal test case. Short answer, if they're lying, we'll probably never find out they were lying.

By the way, you should check out the relevant Federal Laws on Emergency Use Authorisations at uscode.house.gov (21 USC 360bbb-3: Authorization for medical products for use in emergencies)

(e) Conditions of authorization

(1) Unapproved product

(A) Required conditions

With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:


(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed-


(I) that the Secretary has authorized the emergency use of the product;


(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and


(III) of the alternatives to the product that are available, and of their benefits and risks.


(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-


(I) that the Secretary has authorized the emergency use of the product;


(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and


(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.


Notice that in the last few paragraphs, people have to be appropriately informed of their right to accept or refuse administration of a product with Emergency Use Authorisation.

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

I'd guess that means if Comirnaty is unavailable, then Joe Biden's vaccine mandate is unlawful.


Similarly, if people turn up for vaccination and are offered the Pfizer BioNTech vaccine, then failing to inform them that the product is on an Emergency Use Authorisation would be a breach of Federal Law:

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed-

(I) that the Secretary has authorized the emergency use of the product;
okay.....this really adds nothing. I got the Moderna vaccine, both my daughters got Pfizer and all of us got handouts about what we received.
It does not matter whether you get the Pfizer vaccine or Comirnaty as they are the same and have the same legal liability. You can get compensation for injuries.
But key about all this is that the argument that they are two different vaccines or have differring liabilities is false. It is a weak excuse not to get the Pfizer vaccine for Covid.
 
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FreeinChrist

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pitabread

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Every one of your links are for liberal news sources and only drives home the point that liberal news sources don't traditionally agree with a conservative news source.

Reality does have a liberal bias. ;)
 
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JustSomeBloke

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Dude, I have the handout from when I got the Moderna, still not FDA approved, that tells you about all the technicalities with EUA, so don't act like people aren't getting the facts.

It's sounding more like you don't like the facts, so you spin them in a way that you can dismiss them and act like you're smarter somehow or that you know something and you're not gonna conform (when you still are conforming to other aspects, I'm pretty sure UK has vaccine requirements, among other things, but feel free to call them communist too, or whatnot)

Is it so bad to admit that a source is questionable? Unless of course that's the one source that fits your narrative and thus acknowledging it's mistaken or has significant bias would expose cognitive dissonance, and we don't like that as people
If you received your vaccinations before the FDA approved Comirnaty (23 Aug 2021), then it wasn't possible for you to be duped into taking an experimental treatment on Emergency Use Authorisation, because all the vaccines had that status. My concern is that following FDA approval of Comirnaty, there appears to be a bait-and-switch operation, fuelled by MSM misinformation. Certainly some of the responses in this thread suggest that people have been duped into thinking that Comirnaty and Pfizer-BioNTech are the same, so the evidence is right here in front of you.

Furthermore, the only vaccine that is FDA approved does not appear to be available. From that point of view, vaccine mandates are a breach of Federal Law. I suggest that you read the thread again, and try to understand.

As for the source being 'questionable'. Not one single critic has provided a shred of evidence that the information in the Epoch Times article is incorrect. So far nobody has proved that the FDA approved vaccine, Comirnaty, is in fact widely available in the US. Instead, what I'm getting is desperate attempts to discredit the source, also known as the Genetic Logical Fallacy, or Poisoning the Well.

okay.....this really adds nothing. I got the Moderna vaccine, both my daughters got Pfizer and all of us got handouts about what we received.
It does not matter whether you get the Pfizer vaccine or Comirnaty as they are the same and have the same legal liability. You can get compensation for injuries.
But key about all this is that the argument that they are two different vaccines or have differring liabilities is false. It is a weak excuse not to get the Pfizer vaccine for Covid.
As I previously explained, it's of little relevance if the FDA approved vaccine is unavailable and remains unavailable. And as there are still reportedly hundreds of millions of doses of Pfizer-BioNTech, I fully expect those to be in use for a long time on an EUA. I'm sorry if you can't understand that, because I don't think I can explain it any more clearly than I already have.

Do you have any information that disproves the Epoch Times article? Specifically, can you prove that the Epoch Times was incorrect when it said that the only FDA approved vaccine, Comirnaty, is unavailable?

If you have such information, please post it, because it would be highly relevant and on-topic. If you don't have such information, please stop derailing the thread by trying to discredit and smear news sources that you don't approve of. For example, taking from one of your previous posts, whether the Epoch Times is run by Falun Gong practitioners has absolutely no relevance whatsoever. All that matters to this thread is whether their claims about the unavailability of Comirnaty are correct.
 
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GOD Shines Forth!

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If you don't have such information, please stop derailing the thread by trying to discredit and smear news sources that you don't approve of.

It’s the bread and butter of bad logic.
 
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essentialsaltes

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VINCENT
And in Paris, you can buy a beer at MacDonald's. You know what they call a Quarter Pounder with Cheese in Paris?
JULES
They don't call it a Quarter Pounder with Cheese?
VINCENT
No, man, they got the metric system there, they wouldn't know what [on earth] A Quarter Pounder is.
JULES
What'd they call it?
VINCENT
They call it Royale with Cheese.
JULES (repeating)
Royale with Cheese. What'd they call a Big Mac?
VINCENT
Big Mac's a Big Mac, but they call it Le Big Mac.
JULES (repeating)
Le Big Mac. What do they call a Whopper?
VINCENT
I dunno, I didn't go into a Burger King.
 
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pitabread

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So you think a so-called 'fact checking' site is a reliable source of information? You do realise that anyone can set up a website and proclaim themselves a fact-checker? I could do it. You could do it. Absolutely anyone could do it. But funnily enough, 'fact checking' appears to be a mostly left-wing hobby, same as Wikipedia has been completely taken over by people with a Left wing bias.

The irony in your post is palpable.

At any rate, it was just support for the claim that the Epoch Times has promoted conspiracy theories. Which they have.

Now are you disputing that claim or are you just going to keep going on tangential rants every time someone responds to you?

And as yet, you haven't come up with a single decent post on why the Epoch Times article is wrong

I already responded to the OP asking if you had anything to substantiate your claims thereof. You didn't. Therefore I consider that line of discussion closed.
 
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Nithavela

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So you think a so-called 'fact checking' site is a reliable source of information? You do realise that anyone can set up a website and proclaim themselves a fact-checker? I could do it. You could do it. Absolutely anyone could do it. But funnily enough, 'fact checking' appears to be a mostly left-wing hobby, same as Wikipedia has been completely taken over by people with a Left wing bias.

And as yet, you haven't come up with a single decent post on why the Epoch Times article is wrong ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
If you want to set up a fact checking site, why don't you start with fact checking your own avatar?
 
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Nithavela

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In other news, fire is hot and water is wet, you got anything of substance and not partisan quibbling?

Looks like you wrote that to the wrong person.
 
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