Newly Approved COVID-19 Vaccine Not Yet Available in US

[muichimotsu]

More like a way of smearing an entire organization.



A claim is not a fact. Especially not the one against Epoch Times.

So show that Epoch Times has promoted something that is true and not misrepresenting facts. If you think it has made a true positive claim, burden is on you to demonstrate and back it up, right?

 

[muichimotsu]

Sarcasm don't elude me at all. I even used it in my sig line.

Then you appear to be selectively reading, which is more dishonest than disingenuous

 

[muichimotsu]

Actually, no. Otherwise, joe biden could be called the name of the Afghanistan pullout debacle, but it's not very good grammar.

Except Joe Biden is not the only one involved in that process: why are you being so petty and partisan about this? Again, are you triggered because someone's attacking your sacred cow? Just admit it or explain this reaction in a rational way instead of rationalizing

 

[Aldebaran]

When the shoe fits. You keep trying to deflect any responsibility, it's more than a bit suspicious, like you want to act like QAnon has some "legitimacy" because maybe you agree with some of that and don't like it being called a conspiracy theory. Are you perhaps..."triggered"?

I'll keep your logic in mind that it's ok to smear an entire organization based on your own personal opinions. Facts only matter until they don't.

 

[FreeinChrist]

Physically, chemically and biologically they are the same or very similar*. Legally they are distinct. And 'legally distinct' are the exact words used by the FDA. And for some reason the FDA don't seem very keen on elaborating on exactly what those legal distinctions are.

Last time. Again, "legally distinct" is in regards to place of manufacture and where they buy supplies.


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

...“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.”
​

It is not rocket science.
A simplistic example - Two different manufacturing plants produce a tote bag made of blue canvas. They use the same material, but one plant buys it from one fabric store and the other plant buys it from a different fabric store. One plant uses commercial Singer sewing machines, and the other plant uses a different commercial sewing machine. But both plants produce the same tote in terms of color, quality of material and pattern, despite being made in different locations, using different suppliers and different machines. The company selling the totes can certify they are the same.


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.
​

There is no 'bait and switch' when they are the same vaccine. It isn't like you can sue for monetary rewards for injuries from either of them, and they both are under the PREP act and one can apply for compensation for injuries from both of them. They are interchangeable.
Your OP is making something out of nothing.

If you don't want the vaccine, don't take it. Just don't misrepresent it.

 

[FreeinChrist]

I'll keep your logic in mind that it's ok to smear an entire organization based on your own personal opinions. Facts only matter until they don't.

A reminder to a few of you regarding the discussion of Qanon. See the rules.

 

[muichimotsu]

I'll keep your logic in mind that it's ok to smear an entire organization based on your own personal opinions. Facts only matter until they don't.

Not opinions when factually they are spreading misinformation. Or do you think they're right? In which case, support those claims with evidence that doesn't have to reference their article, but independent verification. After all, it shouldn't matter what the source is, right? Unless you care more about it being a minority publication than whether it's independently verifiable?

 

[muichimotsu]

Physically, chemically and biologically they are the same or very similar*. Legally they are distinct. And 'legally distinct' are the exact words used by the FDA. And for some reason the FDA don't seem very keen on elaborating on exactly what those legal distinctions are.

* subject to manufacturing tolerances, and slight differences caused by different equipment used at different manufacturing sites


The text I've quoted above proves that the FDA and MSM have achieved their objective, of making people think there is no difference. I'm sure they're very pleased.


Really? All I saw was a load of posts from you and others that could best be described as a Genetic Logical Fallacy. Not once did I see any evidence to refute the Epoch Times's assertion that Comirnaty is currently unavailable.

So, for the last time. Can you prove that Comirnaty is currently available for administration in the US?

Do you understand what proof means? It's not one unified meaning. And by the property of basic identity, merely because we have pre FDA approval vaccines that are demonstrably the same composition in essence and only differing in not being named Comirnaty, that means that it is available even if we don't have supplies of it post FDA approval versus caches that have been available because of practical and logistical concerns.

The difference is hair splitting and bordering on willful ignorance to try and feel like there's some conspiracy instead of your own fear and potential paranoid delusions coloring your perception of events

 

[JustSomeBloke]

Last time. Again, "legally distinct" is in regards to place of manufacture and where they buy supplies.


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

...“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.”

It is not rocket science.
A simplistic example - Two different manufacturing plants produce a tote bag made of blue canvas. They use the same material, but one plant buys it from one fabric store and the other plant buys it from a different fabric store. One plant uses commercial Singer sewing machines, and the other plant uses a different commercial sewing machine. But both plants produce the same tote in terms of color, quality of material and pattern, despite being made in different locations, using different suppliers and different machines. The company selling the totes can certify they are the same.

If all of that is really true, why don't you give me the same information from the FDA website? Why is it available at the Washington Post, but not the FDA?

And seeing as you refuse to accept articles from the Epoch Times, why should I accept articles from the Washington Post?

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.
There is no 'bait and switch' when they are the same vaccine. It isn't like you can sue for monetary rewards for injuries from either of them, and they both are under the PREP act and one can apply for compensation for injuries from both of them. They are interchangeable.
Your OP is making something out of nothing.

I've already explained that as long as Comirnaty is unavailable, the compensation issue is a purely academic argument with no practical application in the real world. If you didn't understand the first time, I'm not going to try explaining it again.

If you don't want the vaccine, don't take it. Just don't misrepresent it.

If you want the vaccine, take it. Just don't misrepresent it.

And as you expended so much effort desperately trying to discredit the Epoch Times, I'm somewhat curious to see that you have not responded to my request to prove that Comirnaty is currently available in the US.

Do you understand what proof means? It's not one unified meaning. And by the property of basic identity, merely because we have pre FDA approval vaccines that are demonstrably the same composition in essence and only differing in not being named Comirnaty, that means that it is available even if we don't have supplies of it post FDA approval versus caches that have been available because of practical and logistical concerns.

The difference is hair splitting and bordering on willful ignorance to try and feel like there's some conspiracy instead of your own fear and potential paranoid delusions coloring your perception of events

The words the FDA used are 'legally distinct'. Are you denying that basic fact?

 

[muichimotsu]

The words the FDA used are 'legally distinct'. Are you denying that basic fact?

How are you sure it's not on the FDA's website in regards to this thing you think only the Epoch Times is covering? Do you have NO other sources? Seems like you're being more than a bit biased yourself

And legally distinct does not mean they are distinct in their essence, only in accident. They're literally the same composition, your only quibble doesn't even appear to be based in facts because the legal recourse for any of this exists, but is not the same as one might think in terms of a lay opinion about legal issues


If you're going to fixate on the distinct and not the qualifier before that, you're showing major confirmation bias here with selective reading of terms

 

[Pommer]

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.

​

So the TLDR:
Adverse reactions cases under the Pfizer EUA are covered under Countermeasures Injury Compensation Program.

The Comirnaty vaccine is covered under National Vaccine Injury Compensation Program.

 

[Pommer]

Q Anon isn't a conspiracy theory. It's the name of a group.

And what do they group around?

 

[essentialsaltes]

Q Anon isn't a conspiracy theory. It's the name of a group.

Topics Requiring Special Consideration:

• Qanon conspiracy theories are not allowed on CF.

 

[JustSomeBloke]

How are you sure it's not on the FDA's website in regards to this thing you think only the Epoch Times is covering? Do you have NO other sources? Seems like you're being more than a bit biased yourself

Did you really think that the FDA would put a huge banner on their website saying:

We approved a covid vaccine,
but it will never be available
​

And given that the MSM have acted as the FDA's uncritical mouthpiece, would you expect them to do the same? No! I don't think so! And it's ridiculous to think that the FDA or MSM would do that.​

And legally distinct does not mean they are distinct in their essence, only in accident. They're literally the same composition, your only quibble doesn't even appear to be based in facts because the legal recourse for any of this exists, but is not the same as one might think in terms of a lay opinion about legal issues


If you're going to fixate on the distinct and not the qualifier before that, you're showing major confirmation bias here with selective reading of terms

Let's wait and see what happens. The EUA for the unapproved vaccine is still in place, and that cannot be denied, because it's on the FDA website. My prediction is that Comirnaty will quite likely never be available.

 

[FreeinChrist]

If all of that is really true, why don't you give me the same information from the FDA website? Why is it available at the Washington Post, but not the FDA?

And seeing as you refuse to accept articles from the Epoch Times, why should I accept articles from the Washington Post?


I've already explained that as long as Comirnaty is unavailable, the compensation issue is a purely academic argument with no practical application in the real world. If you didn't understand the first time, I'm not going to try explaining it again.


If you want the vaccine, take it. Just don't misrepresent it.

And as you expended so much effort desperately trying to discredit the Epoch Times, I'm somewhat curious to see that you have not responded to my request to prove that Comirnaty is currently available in the US.


The words the FDA used are 'legally distinct'. Are you denying that basic fact?

I do not believe you will accept anything I say, and are moving goal posts.

So for others reading:

Researcher Distorts Facts on COVID-19 Vaccine Approval, Liability - FactCheck.org

David Bowman, a spokesperson for the Health Resources and Services Administration — the federal agency that oversees compensation programs for those who allege injuries following vaccination — told us in an email that there “are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval.”

Malone did not respond to our request for comment, but acknowledged in an Aug. 30 tweet that he was “wrong” about the purported differences in liability. Malone told the Washington Post‘s Fact Checker: “On this particular legal liability issue I did not hunt down the details myself, and relied on comments from a third party lawyer which were not fully correct.”.....

But the FDA said that “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.”

Pfizer’s representative told us the “legally distinct” reference relates to differences in manufacturing — for example, the licensed product may be made at different sites or use materials from different approved suppliers.​

 

[Aldebaran]

Last time. Again, "legally distinct" is in regards to place of manufacture and where they buy supplies.


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

...“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.”
​

It is not rocket science.
A simplistic example - Two different manufacturing plants produce a tote bag made of blue canvas. They use the same material, but one plant buys it from one fabric store and the other plant buys it from a different fabric store. One plant uses commercial Singer sewing machines, and the other plant uses a different commercial sewing machine. But both plants produce the same tote in terms of color, quality of material and pattern, despite being made in different locations, using different suppliers and different machines. The company selling the totes can certify they are the same.

At least the totes would be under the same brand/model name. That's not the case with the vaccine where they changed it for the approved version, but not for its experimental or emergency designation which is still available and in use while the new and approved version is nowhere to be found.

 

[Aldebaran]

Topics Requiring Special Consideration:

• Qanon conspiracy theories are not allowed on CF.

I didn't post any conspiracy theories. I simply said that a group itself is not a conspiracy theory. Equating the two would be like saying I'm not allowed to say anything against ISIS because doing so is promoting ISIS. Or mentioning the name "Hitler" being the same as calling for extermination of Jews.

I'm operating on the belief that reading comprehension still exists here at a level that allows people to understand the difference between mentioning the name of a person or group and being an endorsement of said person/group, and that any "misunderstanding" of that is an intentional act of poisoning the well.

 

[essentialsaltes]

I didn't post any conspiracy theories.

Nobody said you did. But the group and the conspiracy theory are hand in glove. The website rule demonstrates how they are joined at the hip. Whatever hair you were originally trying to split is fatuous.

 

[Aldebaran]

Nobody said you did. But the group and the conspiracy theory are hand in glove. The website rule demonstrates how they are joined at the hip. Whatever hair you were originally trying to split is fatuous.

The rule simply says:

• Qanon conspiracy theories are not allowed on CF.

That's not a demonstration of your interpretation. Your interpretation is a demonstration of adding to what is there to change the meaning.
Pointing out the fact that Q'Anon is the name of a group has not a thing to do with what they say, just as mentioning that the name of the group called BLM is not the same as telling you any of their conspiracy theories. If a rule said, "The name Q'Anon is not allowed to be posted on CF", then it would be according to your interpretation. It was also be automatically censored like profanity words are.

But, seeing that talking about CF rules are not in keeping with the rules (AFAIK), that's all I'm going to say about it.

Now back to the topic of the thread.........

 

[essentialsaltes]

That's not a demonstration of your interpretation.

Forget it. You can't seem to grasp what I'm even saying.