One letter went to Pfizer which is still EUA because it still has the liability shield. ( https://www.fda.gov/media/150386/download )
The BioNtech vax is still in development, not ready for use yet and will be conditional until "fully approved" without a liability shield.
DHHS has issued a license to BioNTech (in Germany) controlling manufacture and sale of biological products. The license will then
authorize Pfizer to introduce or deliver for introduction into interstate commerce. That license will authorize them to manufacture
the product COVID-19Vaccine, MRNA. It will then be labeled by Pfizer as Comirnaty.
Also, the FDA completely bypassed the always necessary external advisory commissions with public comment period and unilaterally decided that there probably
wouldn't be any concerns that would have benefited from an advisory decision. Amazing. Sure. Nothing to see here. No questions. No cardio toxicity issues anywhere.
They just went ahead and authorized it. The only data they have is outdated because THIS Comirnaty is a brand new vax, not even on the market yet! Nothing in
there shows them dealing with the Delta variant. It's all about the original studies.
Plus the FDA letter only authorizes use for those 16 years of age and above. So, Deblasio needs to cool his jets on shooting up kids with this stuff. The studies
for kids won't be done until '23 or '24. Bet they'll probably shove another EUA out, this time for the kids.
The media and the pols have played a little shell game here and stated that the regular old Pfizer vax for EUA with its liability shield still in place
has the full formal approval. It does not. It will be the new one by the name of Comirnaty...in a couple years.
On page 6 they admit they do not have sufficient amount of data through VAERS system to determine risks properly. Unreal. But, they'll push it through.
They admit their system is inadequate, but again....so what. They'll just do what they want.
I see there that they at least acknowledge the myocardial issues and will require a 5 year follow-up.
They issued 2 separate letters for 2 separate vaccines.
The currant Pfizer still has the EUA classification and the liability shield. (no change) Pfizer always wants that liability shield.
The licensed BioNTech product, is similar, called Comirnaty, is not yet available until '23 or '24 and will not have a liability shield.
Nice bait and switch there lyin' fake state media! Show the public BOTH letters! Maybe just sloppy reporting and confused the two. LOL
https://www.fda.gov/media/151710/download
The BioNtech vax is still in development, not ready for use yet and will be conditional until "fully approved" without a liability shield.
DHHS has issued a license to BioNTech (in Germany) controlling manufacture and sale of biological products. The license will then
authorize Pfizer to introduce or deliver for introduction into interstate commerce. That license will authorize them to manufacture
the product COVID-19Vaccine, MRNA. It will then be labeled by Pfizer as Comirnaty.
Also, the FDA completely bypassed the always necessary external advisory commissions with public comment period and unilaterally decided that there probably
wouldn't be any concerns that would have benefited from an advisory decision. Amazing. Sure. Nothing to see here. No questions. No cardio toxicity issues anywhere.
They just went ahead and authorized it. The only data they have is outdated because THIS Comirnaty is a brand new vax, not even on the market yet! Nothing in
there shows them dealing with the Delta variant. It's all about the original studies.
Plus the FDA letter only authorizes use for those 16 years of age and above. So, Deblasio needs to cool his jets on shooting up kids with this stuff. The studies
for kids won't be done until '23 or '24. Bet they'll probably shove another EUA out, this time for the kids.
The media and the pols have played a little shell game here and stated that the regular old Pfizer vax for EUA with its liability shield still in place
has the full formal approval. It does not. It will be the new one by the name of Comirnaty...in a couple years.
On page 6 they admit they do not have sufficient amount of data through VAERS system to determine risks properly. Unreal. But, they'll push it through.
They admit their system is inadequate, but again....so what. They'll just do what they want.
I see there that they at least acknowledge the myocardial issues and will require a 5 year follow-up.
They issued 2 separate letters for 2 separate vaccines.
The currant Pfizer still has the EUA classification and the liability shield. (no change) Pfizer always wants that liability shield.
The licensed BioNTech product, is similar, called Comirnaty, is not yet available until '23 or '24 and will not have a liability shield.
Nice bait and switch there lyin' fake state media! Show the public BOTH letters! Maybe just sloppy reporting and confused the two. LOL
https://www.fda.gov/media/151710/download
