I am not seeing any indication that there is anything "misleading" here.
If you have further evidence that approving the BioNTech is not the same as approving the Pfizer, when they both co-developed this exact vaccine (with the exact same serial number), please let me know.
As for the CORMIRNATY having "optimized codons" thats just jargon. All of the vaccines have "optimized codons". That just means that they changed some of the nucleosides to increase half-life of the mRNA in the cytosol (allowing for longer "effectiveness") and/or changed some of the nucleosides for other reasons. The way RNA to Amino acid coding works, with many redundancies in the code, allows for many potential modifications in RNA for whatever reason, while producing the same exact protein.
The information presented suggests that both Pfizer and CORMIRNATY have the exact same "optimized codons", suggesting this is only evidence of their sameness, not evidence of something different.
As for what it says on page 14:
The repeat dose toxicity evaluations were conducted on COMIRNATY and a similar
vaccine termed BNT162b2 (V8). COMIRNATY and BNT162b2 (V8) have identical amino
acid sequences of the encoded antigens but COMIRNATY includes the presence of
optimized codons to improve antigen expression.
I can't rectify that. Maybe whoever wrote it misunderstood, or maybe there is something more to be found, but by the serial number they appear to be the exact same.
Great research. Over the course of the day I have found evidence that Comirnaty is used outside the US (Germany and Australia so far). Based on your research, and weasel wording in the FDA announcement, I think they might have the exact same formulation.
Here's why this is still smoke in mirrors:
If the FDA wanted to approve Pfizer's vaccine, they would have. Instead, on Aug 23 they sent Pfizer a letter simply extending the EUA on the existing vaccine, and notifying them that they had provided BionTech with an approval for Comirnaty.:
Here's the letter to Pfizer, https://www.fda.gov/media/150386/download
Here's the updated (as of Aug 23) fact sheet for the 'Pfizer Vaccine' which even lists Comirnaty as an FDA approved alternative. The words emergency use authorization appears 12 times.
https://www.fda.gov/media/144413/download
The FDA was very weaserly here, intentionally announcing these drugs can be used interchangeably (which they very well might), but specifically held in place the EUA for the only vaccine available in the United States. This could be for a number of reasons:
The FDA approval process did not need to review the VAERS data, because Comirnaty is not in the VAERS database as it's not US manufactured. Had they tried approving BNT162B2, they would have had to address the thousands of deaths and other serious adverse effects reported. Since the US doesn't have any reports of deaths/adverse reactions to Comirnaty, go ahead and approve away. After all it has the presence of optimized codons for improved antigen expression.
Everyone who is being fooled into thinking the Pfizer Vaccine is FDA approved will be shocked if they need to file a claim. Because it's under EUA you can't use the standard National Vaccine Injury Compensation Program, but instead use the Countermeasures Injury Compensation Program created for vaccine immunity under the Prep Act.
Bottom line, this looks like smoke in mirrors to me. Please let me know if you can find evidence of a single dose of Comirnaty in the United States for use. This is simply to 'fool' as many as possible that the FDA approved the Pfizer vax, so mandate away without fear.
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
That does change things. I have no idea what those distinctions are. They are not clear from the other document. The ingredients listed are identical. The approved vaccine is by serial number, and the numbers match.
Legally distinct however means what you suggest; that the Pfizer that is out there now, and the COMIRNTY are distinct, and if it is mandated through the justification of it no longer being experimental one can insist on the COMIRNTY and reject the Pfizer. I'm not sure if that's important, but it may buy some time for some.
FYI: I'm officially changing the name of COMIRNTY to Comorbidity. In addition to making it easier to say and type, I am going to save the CDC some time with this name change. That way when they blame all the deaths COMIRNTY causes due to pathogenic priming on the virus, they can instead list them as Comorbidity deaths. It should help with their fear graphs.
I personally use commiRnaughty. I believe this is only a mechanism to buy time,until/if comirnaty shows up in the US. I did some searches and see no press deleases of shipments and find none available in the US. Using this argument might also wake some folks that this was a giant psyop to encourage mandating unnaproved vaxes.
OK, you win with CommieRnaughty. In addition to being a very accurate description of the vaccine, I can't even look at it now without saying that in my head.
The FDA approval process did not need to review the VAERS data, because Comirnaty is not in the VAERS database as it's not US manufactured. Had they tried approving BNT162B2, they would have had to address the thousands of deaths and other serious adverse effects reported. Since the US doesn't have any reports of deaths/adverse reactions to Comirnaty, go ahead and approve away. After all it has the presence of optimized codons for improved antigen expression.
This suggests to me that they changed the name (or gave it the name it was always intended to have) from BNT162B2 (Mr. Unpronounceable) to Comirnaty (slightly better).
But changing the name on a product does not require additional trials, or anything except a formal submission of name change (which is likely part of the approval process). It is the same product by serial number. It is the serial number that has been approved. It may very well be weasely, but how exactly is not obvious, nor would such an act be among their more heinous crimes.
Please let me know if you can find evidence of a single dose of Comirnaty in the United States for use.
If it is in fact just a name change, approval for the serial number would be approval for the vaccine by any name.
Slyver,
I hear you saying they are the same vax. Even if true, that’s irrelevant to the issue about getting FDA approval.
The vax that just received FDA approval, identified as Comirnaty, is ‘new’ and not manufactured in the US and therefore, the FDA approved it based on a less extensive paper trail regarding safety and adverse effects than the vax that was given the EUA and manufactured in the US and has a pretty sketchy safety record.
The FDA specifically did NOT appprove the vax that was manufactured in the US and had the EUA. So, even if they are essentially the same vax, the legal distinction is extremely important. If there were no serious safety issues with the US version of the vax, why go to the the trouble of manufacturing the same vax under a new name in another country? Because it appears the FDA is well aware of the serious safety concerns associated with the vax and doesn’t want to issue an approval for it. But, the FDA is willing to issue an approval for a rebranded Comirnaty vax because they will likely make sure it’s not available in the US and so when safety issues do start to arise, the FDA will have a factual basis to distance itself from backlash for giving approval to an unsafe vax that was manufactured in another country.
A little legal fuckery goes a long way. Yes, I am a lawyer.
I'm looking for proof that the Cormirnaty shot is not available in the United States, and I can't seem to find it anywhere. Do you happen to have a source? I'm building my case.
Wording is everything. Contracts and other legal instruments use precise language for a reason.
I am aware of this, and suggested that whatever the difference is, its NOT in the mRNA nor any of the ingredients of the nanoparticle. I presented evidence to that effect.
"similar" used here is not oversight, it's deliberate. If it were identical, it would say it.
Did you look at the evidence I presented? The molecules are identical. The serial number of the mRNA is identical. You can't have a unique identifier apply to multiple molecules.
All of the ingredients share the same unique designations with their Pfizer counterparts. They are exactly the same molecules across the board.
The only ingredient that has a chance of being different within the unique identifier system is the bottom one on the top of page 8 which is a redacted excipient (rated as an inert molecule).
Amino acid sequences can still have different protein expression depending on differing external signals even if identical.
I don't know what you are trying to say here.
The mRNA molecule is identical. Identical mRNA molecules produce identical proteins every time (within the statistical limits of the protein machinery aka ribosomes, ER, golgi, etc.).
I don’t doubt the two drugs are interchangeable, even the documents say so, however the two are LEGALLY distinct, and only comirnity was approved. The better question would be, why wasn’t the Pfizer-Biontech Covid-19 Vaccine also approved? I don’t think we’re looking at much of a technical argument here, other than clarifying they are different (the codons man😄), and the docs clarify they are different but have similar safety attributes. This IS a legal slight of hand convincing employers and employees they are dealing with an approved vax, when they aren’t, or at least until there’s a supply of comirnaty.
however the two are LEGALLY distinct, and only comirnity was approved
Yes, I pointed this out in my response to you above.
The better question would be, why wasn’t the Pfizer-Biontech Covid-19 Vaccine also approved?
This is a very good question to ask.
I don’t think we’re looking at much of a technical argument here, other than clarifying they are different (the codons man😄
A "codon" is a sequence of (in this case) RNA that codes for the same amino acid. Changing a "codon" changes the molecule (RNA). If you change the RNA molecule, it would have a different unique identifier. It would be a different molecule.
I really think you are barking up the wrong tree here.
the docs clarify they are different but have similar safety attributes
I suggest the docs clarify nothing. On the contrary, they obfuscate, likely by intention.
This IS a legal slight of hand convincing employers and employees they are dealing with an approved vax, when they aren’t, or at least until there’s a supply of comirnaty.
I'm not arguing against this point. I think this is likely true. What I am saying is that your initial assertion; that the difference is in the mRNA "codons", is not supported by any evidence except one sentence on one page. That sentence sounds to me like it was written by an intern that didn't understand what the person in charge was saying. I say that because I have seen such things happen in my own similar work.
Now that I'm going through the detail of your reply - I question if your a troll. Several ingredients are redacted on page 7 so there's absolutely no way for you to check that the ingredients are the same. Do you have the ability to unredact the ingredients? The FDA paper clarified they used the same antigen encoding, which yes would be the same. But don't forget about those optimized codons man.
Now that I'm going through the detail of your reply - I question if your a troll.
If you have questions ask them. Calling me a troll is an ad hominem attack designed specifically to discredit me without addressing an argument. Please do not do that again.
Several ingredients are redacted on page 7 so there's absolutely no way for you to check that the ingredients are the same
None of the ingredients are redacted. They are listed right there. For example:
The ingredient is here. It is the exact same lipid as in Pfizers vaccine. Whatever is redacted is NOT the ingredient. In this case it looks like whatever name they gave it was redacted and the UNII was redacted. Why? I have no idea. They are easy to look up. The name is ALC-0315 as it shows on the link above. This list of ingredients of the Pfizer vaccine shows it. The second "redacted" ingredient can be found in the same way. They are the exact same molecules.
But don't forget about those optimized codons man.
As I explained, every single vaccine uses "optimized codons". Its just a term. The fact that they use rhetoric that suggests it is exclusive to COMIRNTY on page 14 suggests to me the person who wrote that section didn't understand what someone told them, because the Pfizer vaccine also has optimized codons, as I explained above.
The design of Pfizer/BioNTech and Moderna mRNA vaccines involves many different types of optimizations. Proper optimization of vaccine mRNA can reduce dosage required for each injection leading to more efficient immunization programs. The mRNA components of the vaccine need to have a 5′-UTR to load ribosomes efficiently onto the mRNA for translation initiation, optimized codon usage for efficient translation elongation, and optimal stop codon for efficient translation termination. Both 5′-UTR and the downstream 3′-UTR should be optimized for mRNA stability. The replacement of uridine by N1-methylpseudourinine (Ψ) complicates some of these optimization processes because Ψ is more versatile in wobbling than U. Different optimizations can conflict with each other, and compromises would need to be made. I highlight the similarities and differences between Pfizer/BioNTech and Moderna mRNA vaccines and discuss the advantage and disadvantage of each to facilitate future vaccine improvement. In particular, I point out a few optimizations in the design of the two mRNA vaccines that have not been performed properly.
It is so common in our society to attack the person instead of their argument. I have been doing a serious dig into the media (report coming soon) and realize we have been trained our entire life to do exactly that. We rely on credentials to make an argument. It allows us to skip over parts of an argument we don't understand, or that don't seem quite right. We assign our critical thinking during those moments over to the authors credentials, relying on what other people think of them, and not on the argument itself.
Looking back in my life I used to do this all the time. Occasionally I still find myself doing it. It is so deeply ingrained in us to look to credentials, or to ignore an argument that makes sense (but that we otherwise disagree with) by doing the opposite, denying the right to speak through lack of credentials or some imagined nefarious intent.
But an argument is an argument. The words, presentation of facts, logic, and even bias do not change based on how many letters a person has, or doesn't have, after their name. All education and experience do for an argument is help someone to make a sound argument. It doesn't actually have anything to do with the argument itself once presented.
For me, I do everything I can now to make sure I take every argument on its face. The person speaking is irrelevant, only the argument matters. From my view each argument deserves full consideration, no matter what I may think of anything else a person has said, or what expectations I have based on what I know about them.
That doesn't mean I look at every possible argument, but if I am going to engage at all, I try very hard to engage with full consideration. There is no reason to do anything half-assed, nor ever attack the person instead of their argument.
I'm having a difficult time rectifying this statement. I believe they are the exact same vaccine.
According to the FDA release above, the COMIRNATY vaccine has the exact same ingredients, including the exact same mRNA strand (bnt162b2).
On page 7 (bottom) it lists the ingredients. Every ingredient is the same as the Pfizer vaccine, including the first one (mRNA).
Looking up UNII: 5085ZFP6SJ it says:
Looking up TOZINAMERAN it says:
They are the exact same molecule.
I am not seeing any indication that there is anything "misleading" here.
If you have further evidence that approving the BioNTech is not the same as approving the Pfizer, when they both co-developed this exact vaccine (with the exact same serial number), please let me know.
As for the CORMIRNATY having "optimized codons" thats just jargon. All of the vaccines have "optimized codons". That just means that they changed some of the nucleosides to increase half-life of the mRNA in the cytosol (allowing for longer "effectiveness") and/or changed some of the nucleosides for other reasons. The way RNA to Amino acid coding works, with many redundancies in the code, allows for many potential modifications in RNA for whatever reason, while producing the same exact protein.
The information presented suggests that both Pfizer and CORMIRNATY have the exact same "optimized codons", suggesting this is only evidence of their sameness, not evidence of something different.
As for what it says on page 14:
I can't rectify that. Maybe whoever wrote it misunderstood, or maybe there is something more to be found, but by the serial number they appear to be the exact same.
Great research. Over the course of the day I have found evidence that Comirnaty is used outside the US (Germany and Australia so far). Based on your research, and weasel wording in the FDA announcement, I think they might have the exact same formulation.
Here's why this is still smoke in mirrors:
Here's the updated (as of Aug 23) fact sheet for the 'Pfizer Vaccine' which even lists Comirnaty as an FDA approved alternative. The words emergency use authorization appears 12 times. https://www.fda.gov/media/144413/download
The FDA was very weaserly here, intentionally announcing these drugs can be used interchangeably (which they very well might), but specifically held in place the EUA for the only vaccine available in the United States. This could be for a number of reasons:
Bottom line, this looks like smoke in mirrors to me. Please let me know if you can find evidence of a single dose of Comirnaty in the United States for use. This is simply to 'fool' as many as possible that the FDA approved the Pfizer vax, so mandate away without fear.
These people are stupid.
Now this is interesting:
(bottom of page 1) from your second link above.
Legally distinct...
That does change things. I have no idea what those distinctions are. They are not clear from the other document. The ingredients listed are identical. The approved vaccine is by serial number, and the numbers match.
Legally distinct however means what you suggest; that the Pfizer that is out there now, and the COMIRNTY are distinct, and if it is mandated through the justification of it no longer being experimental one can insist on the COMIRNTY and reject the Pfizer. I'm not sure if that's important, but it may buy some time for some.
FYI: I'm officially changing the name of COMIRNTY to Comorbidity. In addition to making it easier to say and type, I am going to save the CDC some time with this name change. That way when they blame all the deaths COMIRNTY causes due to pathogenic priming on the virus, they can instead list them as Comorbidity deaths. It should help with their fear graphs.
I personally use commiRnaughty. I believe this is only a mechanism to buy time,until/if comirnaty shows up in the US. I did some searches and see no press deleases of shipments and find none available in the US. Using this argument might also wake some folks that this was a giant psyop to encourage mandating unnaproved vaxes.
OK, you win with CommieRnaughty. In addition to being a very accurate description of the vaccine, I can't even look at it now without saying that in my head.
This suggests to me that they changed the name (or gave it the name it was always intended to have) from BNT162B2 (Mr. Unpronounceable) to Comirnaty (slightly better).
But changing the name on a product does not require additional trials, or anything except a formal submission of name change (which is likely part of the approval process). It is the same product by serial number. It is the serial number that has been approved. It may very well be weasely, but how exactly is not obvious, nor would such an act be among their more heinous crimes.
If it is in fact just a name change, approval for the serial number would be approval for the vaccine by any name.
Slyver, I hear you saying they are the same vax. Even if true, that’s irrelevant to the issue about getting FDA approval.
The vax that just received FDA approval, identified as Comirnaty, is ‘new’ and not manufactured in the US and therefore, the FDA approved it based on a less extensive paper trail regarding safety and adverse effects than the vax that was given the EUA and manufactured in the US and has a pretty sketchy safety record.
The FDA specifically did NOT appprove the vax that was manufactured in the US and had the EUA. So, even if they are essentially the same vax, the legal distinction is extremely important. If there were no serious safety issues with the US version of the vax, why go to the the trouble of manufacturing the same vax under a new name in another country? Because it appears the FDA is well aware of the serious safety concerns associated with the vax and doesn’t want to issue an approval for it. But, the FDA is willing to issue an approval for a rebranded Comirnaty vax because they will likely make sure it’s not available in the US and so when safety issues do start to arise, the FDA will have a factual basis to distance itself from backlash for giving approval to an unsafe vax that was manufactured in another country.
A little legal fuckery goes a long way. Yes, I am a lawyer.
Thankyou for summarizing this well.
I'm looking for proof that the Cormirnaty shot is not available in the United States, and I can't seem to find it anywhere. Do you happen to have a source? I'm building my case.
Wording is everything. Contracts and other legal instruments use precise language for a reason.
"conducted on COMIRNATY and a similar vaccine termed BNT162b2"
"similar" used here is not oversight, it's deliberate. If it were identical, it would say it.
Amino acid sequences can still have different protein expression depending on differing external signals even if identical.
I am aware of this, and suggested that whatever the difference is, its NOT in the mRNA nor any of the ingredients of the nanoparticle. I presented evidence to that effect.
Did you look at the evidence I presented? The molecules are identical. The serial number of the mRNA is identical. You can't have a unique identifier apply to multiple molecules.
All of the ingredients share the same unique designations with their Pfizer counterparts. They are exactly the same molecules across the board.
The only ingredient that has a chance of being different within the unique identifier system is the bottom one on the top of page 8 which is a redacted excipient (rated as an inert molecule).
I don't know what you are trying to say here.
The mRNA molecule is identical. Identical mRNA molecules produce identical proteins every time (within the statistical limits of the protein machinery aka ribosomes, ER, golgi, etc.).
I don’t doubt the two drugs are interchangeable, even the documents say so, however the two are LEGALLY distinct, and only comirnity was approved. The better question would be, why wasn’t the Pfizer-Biontech Covid-19 Vaccine also approved? I don’t think we’re looking at much of a technical argument here, other than clarifying they are different (the codons man😄), and the docs clarify they are different but have similar safety attributes. This IS a legal slight of hand convincing employers and employees they are dealing with an approved vax, when they aren’t, or at least until there’s a supply of comirnaty.
Yes, I pointed this out in my response to you above.
This is a very good question to ask.
A "codon" is a sequence of (in this case) RNA that codes for the same amino acid. Changing a "codon" changes the molecule (RNA). If you change the RNA molecule, it would have a different unique identifier. It would be a different molecule.
I really think you are barking up the wrong tree here.
I suggest the docs clarify nothing. On the contrary, they obfuscate, likely by intention.
I'm not arguing against this point. I think this is likely true. What I am saying is that your initial assertion; that the difference is in the mRNA "codons", is not supported by any evidence except one sentence on one page. That sentence sounds to me like it was written by an intern that didn't understand what the person in charge was saying. I say that because I have seen such things happen in my own similar work.
Now that I'm going through the detail of your reply - I question if your a troll. Several ingredients are redacted on page 7 so there's absolutely no way for you to check that the ingredients are the same. Do you have the ability to unredact the ingredients? The FDA paper clarified they used the same antigen encoding, which yes would be the same. But don't forget about those optimized codons man.
If you have questions ask them. Calling me a troll is an ad hominem attack designed specifically to discredit me without addressing an argument. Please do not do that again.
None of the ingredients are redacted. They are listed right there. For example:
The ingredient is here. It is the exact same lipid as in Pfizers vaccine. Whatever is redacted is NOT the ingredient. In this case it looks like whatever name they gave it was redacted and the UNII was redacted. Why? I have no idea. They are easy to look up. The name is ALC-0315 as it shows on the link above. This list of ingredients of the Pfizer vaccine shows it. The second "redacted" ingredient can be found in the same way. They are the exact same molecules.
As I explained, every single vaccine uses "optimized codons". Its just a term. The fact that they use rhetoric that suggests it is exclusive to COMIRNTY on page 14 suggests to me the person who wrote that section didn't understand what someone told them, because the Pfizer vaccine also has optimized codons, as I explained above.
Apologize for the troll comment. You have responded with honor as we dig. I as we dig.
It is so common in our society to attack the person instead of their argument. I have been doing a serious dig into the media (report coming soon) and realize we have been trained our entire life to do exactly that. We rely on credentials to make an argument. It allows us to skip over parts of an argument we don't understand, or that don't seem quite right. We assign our critical thinking during those moments over to the authors credentials, relying on what other people think of them, and not on the argument itself.
Looking back in my life I used to do this all the time. Occasionally I still find myself doing it. It is so deeply ingrained in us to look to credentials, or to ignore an argument that makes sense (but that we otherwise disagree with) by doing the opposite, denying the right to speak through lack of credentials or some imagined nefarious intent.
But an argument is an argument. The words, presentation of facts, logic, and even bias do not change based on how many letters a person has, or doesn't have, after their name. All education and experience do for an argument is help someone to make a sound argument. It doesn't actually have anything to do with the argument itself once presented.
For me, I do everything I can now to make sure I take every argument on its face. The person speaking is irrelevant, only the argument matters. From my view each argument deserves full consideration, no matter what I may think of anything else a person has said, or what expectations I have based on what I know about them.
That doesn't mean I look at every possible argument, but if I am going to engage at all, I try very hard to engage with full consideration. There is no reason to do anything half-assed, nor ever attack the person instead of their argument.