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.
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.
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.
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.