Pfizer vaccine gets full FDA Approval in the USA

[placeholder]

4 hours ago, codemonkey said:

Whats clear about the judges ruling is that Comirnaty and Phizer CANNOT be used interchangably: "A federal district court judge rejected a claim by the U.S. Department of Defense that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s fully licensed Comirnaty vaccine.

 

In this case, an EUA is considered illegal and invalid if there is a fully licensed alternative available. This appears to be the case with Pfizer’s licensed Comirnaty while its EUA Pfizer-BioNTech is still on the market.

Pfizer retains EUA status and people cannot be mandated to take it. Comirnaty is FDA approved. It's exactly that, nothing terribly complicated about it. I think you are not seeing the implication here or refuse to admit it, and conveniently confused now that pfizer has EUA and NO FDA approval. Simple simple, no confusion for me. I expected this would come to light eventually. It's a good ruling based on sound legal principles.

 

And, all bidens vaccine mandates are being litigated currently and have all been blocked by all courts to date and will be settled at a later date. If the mandates were so critical, life and death critical path in nature, then maybe the people in the know would support and implemt vaccine mandates. They are not and that's very telling. Time will tell, but don't expect any vaccine mandates anytime soon.

 

FDA committed "bait and switch", the entire FDA pfizer "approval process" was underhanded and they have been called out on it by the courts and should come as no surprise.

Comirnaty case-FDA.pdfUnavailable

What the judge explicitly said was that because the vaccines being administered to armed forces members were manufactured under the EUA and don't bear the name "Comirnaty" that the government didn't have the authority to compel members of the armed forces to be inoculated with the vaccine labeled as such. The govt had argued that the only distinction was the name change and the FDA finding that the Comirnaty was just a name change. The judge specifically noted that scientific statement of equivalence was not sufficient to satisfy the legal requirements.

And no, the courts, including this one, have not ruled that the FDA approval process was underhanded. 

And, by way, the court denied a petition from the plaintiffs to issue a preliminary injunction against the military mandate.

[placeholder]

4 hours ago, codemonkey said:

 

 

They most certainly are not identical, impossible if they have different properties /additional chemicals.

FDA

If they are identical, why not just grant FDA approval to both Comirnaty and Phizer. Drop the EUA and be done with it and maybe more people would trust pfizer and the FDA.

Yes, you're right, they are not  identical. But vaccine manufacturers can change the codons without reapplying for approval of a vaccine provided that they have performed the necessary toxicity studies. Codons are optimized to increase the expression of the desired mRNA sequence in targeted cells.

But your point about why the FDA gave BLA approval only to Comirnaty and not the Pfizer vaccine is invalid. When a vaccine gets BLA approval, only then is it allowed to acquire a marketing name. When the FDA gave its BLA approval, Pfizer was allowed to call it Comirnaty. There is no law requiring Pfizer to call it Comirnaty. The company could have gone on calling it by whatever scientific name it had been referred to. So the Pfizer vaccine was approved. The name change is about marketing only.  You might want to consult Shakespeare about this: "A rose by any other name..."

[codemonkey]

1 hour ago, placeholder said:

you're right

Of course I am, or I would not have said it.

[placeholder]

Just now, codemonkey said:

Of course I am, or I would not have said it.

Given the errors I pointed out in your previous posts, that assertion is laughable.

[codemonkey]

Just now, placeholder said:

Given the errors I pointed out in your previous posts, that assertion is laughable.

Laughable to you, but 100% correct.

[placeholder]

Just now, codemonkey said:

Laughable to you, but 100% correct.

Yours is a troll's notion of what a rebuttal consists of. No specific replies to facts, but just ungrounded assertions.

[codemonkey]

2 minutes ago, placeholder said:

errors I pointed out in your previous posts

You have failed to disprove ANYTHING and EVERYTHING as an "error". Please show us all the errors and include typos's, grammar, etc if you find any.

[codemonkey]

1 minute ago, placeholder said:

ungrounded assertions.

Please share these.

[placeholder]

 

1 minute ago, codemonkey said:

You have failed to disprove ANYTHING and EVERYTHING as an "error". Please show us all the errors and include typos's, grammar, etc if you find any.

Here's one:

"But your point about why the FDA gave BLA approval only to Comirnaty and not the Pfizer vaccine is invalid. When a vaccine gets BLA approval, only then is it allowed to acquire a marketing name. When the FDA gave its BLA approval, Pfizer was allowed to call it Comirnaty. There is no law requiring Pfizer to call it Comirnaty. The company could have gone on calling it by whatever scientific name it had been referred to. So the Pfizer vaccine was approved. The name change is about marketing only.  You might want to consult Shakespeare about this: "A rose by any other name..."

[codemonkey]

2 minutes ago, placeholder said:

Yours is a troll's notion

Instead of this amateur behavior, try to see the implication here.

[codemonkey]

trools, i mean trolls, trolling, calling me a troll, is /was your last bullet.

[placeholder]

3 minutes ago, codemonkey said:

You have failed to disprove ANYTHING and EVERYTHING as an "error". Please show us all the errors and include typos's, grammar, etc if you find any.

Here's another in response to your claim that the courts have ruled that the FDA engaged in "bait and switch."

"And no, the courts, including this one, have not ruled that the FDA approval process was underhanded."

What this particular court proposed is that FDA's BLA approval of the Pfizer vaccine was irrelevant to the question of whether vaccines manufactured before BLA approval was given was legally adequate for the government to enforce mandates for armed service members. It was in no way a judgement of the FDA's approval of the Pfizer vaccine.

 

[codemonkey]

4 minutes ago, placeholder said:

There is no law requiring Pfizer to call it Comirnaty.

Facts not in evidence, pretty sure I didn't say that. Also, irrelevant.

[codemonkey]

Anything else before I go?

[placeholder]

Just now, codemonkey said:

Facts not in evidence, pretty sure I didn't say that. Also, irrelevant.

But you claimed that the Pfizer vaccine and Comirnaty are 2 distinct vaccines. They are not. The Pfizer vaccine was approved by the FDA. The name it's called is irrelevant.

[codemonkey]

2 minutes ago, placeholder said:

Pfizer vaccine and Comirnaty are 2 distinct vaccines

But, but,....but....THEY ARE!  Even the FDA and pfizer refer to them as "distinct", legally and as per the Summary Basis for Regulatory Action.

Please read the docs, enjoy your day while doing so.

[codemonkey]

8 minutes ago, placeholder said:

And no, the courts, including this one, have not ruled that the FDA approval process was underhanded."

Another one of your porkies, the court, the judge is not on the record quoting those incorrect statements you have again put forward here.

[codemonkey]

be right back, maybe, have to go to the toilet....big time!

Edited December 3, 2021 by codemonkey

[placeholder]

5 minutes ago, codemonkey said:

But, but,....but....THEY ARE!  Even the FDA and pfizer refer to them as "distinct", legally and as per the Summary Basis for Regulatory Action.

Please read the docs, enjoy your day while doing so.

More nonsense

“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.”

https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/

[placeholder]

3 minutes ago, codemonkey said:

Another one of your porkies, the court, the judge is not on the record quoting those incorrect statements you have again put forward here.

You're the one who maintained that the courts have found that FDA was underhanded in its approval of the vaccine. You have provided no evidence for that.

[codemonkey]

1 hour ago, placeholder said:

courts have found that FDA was underhanded in its approval of the vaccine.

Can you clarify this, where this was stated.. You are misquoting, TOTALLY misstating the facts.

The plaintiffs have alleged bait & switch and claims FDA are intentionally misrepresenting the law in their request for the temporary restraining order and will be argued in court Sept 2022.

Edited December 3, 2021 by codemonkey

[Jeffr2]

12 minutes ago, codemonkey said:

Can you clarify this, where this was stated.. You are misquoting, TOTALLY misstating the facts.

Give it a rest, please.  You're nit picking this to death.

[placeholder]

11 minutes ago, codemonkey said:

Can you clarify this, where this was stated.. You are misquoting, TOTALLY misstating the facts.

The plaintiffs have alleged bait & switch and claims FDA are intentionally misrepresenting the law in their request for the temporary restraining granted by the judge and will be argued in court Sept 2022.

What do plaintiffs allegations have to do with court judgments? Plaintiffs can allege whatever they like. That doesn't mean their allegations are facts. This has no bearing on your assertion that courts have found that the FDA has engaged in bait-and-switch.

[codemonkey]

It is likely that all EUA vaccines in the US (moderna, pfizer BioNTech, J&J) would be shelved if there is an FDA approved vaccine, such as Comirnaty, but it seems not to be available. Even so, you can't force people to accept unapproved, experimental emergency use authorized vaccines if FDA approved alternatives exist.

[codemonkey]

2 minutes ago, Jeffr2 said:

Give it a rest, please.  You're nit picking this to death.

Sorry, I was preoccupied on the porcelain throne. Did I miss anything.

[codemonkey]

2 minutes ago, placeholder said:

allegations are facts.

I didn't say that either, incorrect again.

[Jeffr2]

3 minutes ago, codemonkey said:

Sorry, I was preoccupied on the porcelain throne. Did I miss anything.

Please go back.

[codemonkey]

1 minute ago, Jeffr2 said:

Please go back.

I can take a pic and show you,,,,

[Jeffr2]

1 minute ago, codemonkey said:

I can take a pic and show you,,,,

Post it here, please.  It'll give us a break from you.

[codemonkey]

Did you know:

"The third-leading cause of death in US most doctors don’t want you to know about..."

Is

• Medical errors are the third-leading cause of death after heart disease and cancer.

Maybe it's 4th now, but you get the point

FDA, the medical experts, doctors, are not infallible and they do kill with mistakes,, unintended adverse effects, etc and we need stringent scrutiny at every level especially during a period of mass vaccinations with experimental drugs.

 

https://www.cnbc.com/2018/02/22/medical-errors-third-leading-cause-of-death-in-america.html

Edited December 3, 2021 by codemonkey