“pretending that the FDA didn’t actually authorize the vaccine”
Well they did not. They reissued the existing Emergency authorization and approved the new version (without the hold harmless clause on side effects) which won’t be available for 2 years.
So, they are right the FDA Lied about it. I read the FDA announcement. They used legal weasel words.
That simply isn’t what happened. I’m sorry that you’ve been lied to.
I don’t like what the FDA did. I have been very clear that I think the approval was rushed, political, and had no regard for the actual safety of the drug. However, pretending that it wasn’t approved is absolutely asinine and it makes conservatives look like fools.
The FDA approval process is complicated and full of government red-tape.
In short, this is what actually happened.
The BLA (Biologics License Application) that was submitted by Pfizer-BioNTech was APPROVED. It is NOT conditional. It was approved. Period.
That’s how the process works.
Here is the actual letter: Contrary to the various blogger lies, it is NOT conditional. It’s approved as of the 23rd.
https://www.fda.gov/media/151710/download
Once approval is issued, the regulations require packaging and marketing. That’s why there is now a proprietary name being used.
COMIRNATY is nothing more than the proprietary name. It is the same drug. Formulated exactly the same, and it is interchangeable with the Pfizer label.
It has been distributed under that name in Europe since January and in Australia since July.
The existing Pfizer label had the EUA reissued for 12-15 year olds and for third doses.
The approval is for usage. It has nothing to do with a “new” drug.
You can read through all the legalese and red tape here:
https://www.fda.gov/vaccines-blood-biologics/comirnaty
I don’t like it. You might not like it. But it is what it is. Pretending otherwise is asinine, stupid and not productive.