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.
Perhaps you can answer a question about liability. Under the EUA the maker was immune from being sued but as an FDA approved vaccine, if I understand it correctly, that protection goes away.
Now I have no doubt big pharma is going to find a way to make them not liable but do you think they will use this vaccine in the US with no protection from liability?
With up to 200,000 deaths or serious side effects that may last forever I could see multi million dollar lawsuits coming from a lot of different directions.
I’ve read the FDA statement about the “approval”.
Yes, the COMIRNATY is for all practical purposes the same drug. But without the exclusion about liability for side effects.
BUT the liability issue is why this is a mine field legally.
You cannot buy the drug anywhere, no matter what name they call it that does not have an exemption for liability on it.
That, is what this is about. And it is about the agenda, of the people banging this Covid drum. This is not about public health it is about money and control. The ComDems and their foreign allies want to make every man, woman and child in the world their slave. It would be the death of freedom anywhere.
The “full approval” was totally political. It does not make the treatment effective or safe. It is neither. Look at Israel where it is almost universal.