They approved a vax that I’m pretty sure nobody in the United States can get. So misleading. Media is culpable for pushing the lie that the Pfizer vax (implying bnt162b2) is approved so begin the mandates. I believe you can buy time demanding the fda approved jab. Anyone says they’re the same - clarify that you need the jab witb optimized codons! Who would want a jab that’s unnaproved witb suboptimal codons! (I’m laughing as I write this).
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.
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.
They approved a vax that I’m pretty sure nobody in the United States can get. So misleading. Media is culpable for pushing the lie that the Pfizer vax (implying bnt162b2) is approved so begin the mandates. I believe you can buy time demanding the fda approved jab. Anyone says they’re the same - clarify that you need the jab witb optimized codons! Who would want a jab that’s unnaproved witb suboptimal codons! (I’m laughing as I write this).
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.
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.