The drug is APPROVED! PERIOD!
“The licensed vaccine has the same formulation as the EUA-authorized vaccine”
THEY ARE THE SAME! It is just a “LEGAL” distinction.
The formulation has been approved!
FDA:
“8 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.”
They can’t be sued over the EUA-authorized vaccine, but they can be sued over the Comirnaty Covid vaccine.
The Comirnaty Covid vaccine doesn’t have the legal protections that the EUA-authorized vaccine has, but the “drug” itself is the SAME drug.
Also the Comirnaty Covid vaccine has to jump through all the usual hoops (and public protections) that other approved vaccines have to jump through.
In other words, the Comirnaty Covid vaccine will be FULLY regulated, the EUA-authorized vaccine was/is not.
That doesn’t change the FACT that the two vaccines are THE SAME DRUG and are APPROVED.
>thanks,that was pretty good but still less than perfect.
The FDA statement was confusing.I agree that A.Thinker just got it wrong.