placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. 1 Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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..." 1 Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 1 hour ago, placeholder said: you're right Of course I am, or I would not have said it. Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. 1 Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 Just now, placeholder said: Given the errors I pointed out in your previous posts, that assertion is laughable. Laughable to you, but 100% correct. Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. 1 Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 1 minute ago, placeholder said: ungrounded assertions. Please share these. Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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..." Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 2 minutes ago, placeholder said: Yours is a troll's notion Instead of this amateur behavior, try to see the implication here. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 trools, i mean trolls, trolling, calling me a troll, is /was your last bullet. Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 Anything else before I go? Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. 1 Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 (edited) be right back, maybe, have to go to the toilet....big time! Edited December 3, 2021 by codemonkey Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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/ Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 (edited) 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 Link to comment Share on other sites More sharing options...
Jeffr2 Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
placeholder Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 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. 1 Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 2 minutes ago, placeholder said: allegations are facts. I didn't say that either, incorrect again. Link to comment Share on other sites More sharing options...
Jeffr2 Posted December 3, 2021 Share Posted December 3, 2021 3 minutes ago, codemonkey said: Sorry, I was preoccupied on the porcelain throne. Did I miss anything. Please go back. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 1 minute ago, Jeffr2 said: Please go back. I can take a pic and show you,,,, Link to comment Share on other sites More sharing options...
Jeffr2 Posted December 3, 2021 Share Posted December 3, 2021 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. Link to comment Share on other sites More sharing options...
codemonkey Posted December 3, 2021 Share Posted December 3, 2021 (edited) 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 Link to comment Share on other sites More sharing options...
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