Posted on 08/26/2021 8:16:23 AM PDT by SeekAndFind
Sounds like approval to me
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See post 15
bkmk
You are wrong. The PREP act already in force grants immunity until at least 2024 for vaccine manufacturers the FDAs BLA has zero effect on the PREP act it’s issued to the manufacturers and those medical providers doing the jabs in a blanket act.
Here is the official entry into the Fed register and with it entry into force of law.
Oh, I forgot to add.
If they ever happen to run out of the experimental one, they can still produce more of it, instead of the approved one.
There are not two different drugs. Pfizer put a brand name on it.
Great you posted the link I was just about too do the same.
Yes anyone with basic reading comprehension skills can read that letter and specifically the part you quoted and see the FDA issued a biologics licence to Pfizer. Don’t let facts get in the way of good old fashioned political butthurt by all means let the gnashing of teeth continue. Won’t change a thing Pfizer is the first of three to get the FDA approval moderna is a month at most behind them. Mandates are coming just like smallpox , polio as well the virus represents a clear danger to society whit large and as such governments have the authority to mandate vaccinations as they have done so for other diseases for hundred plus years now. No different than polio which didn’t kill but 2 to 5 % CFR and the world decided to.vaccinate a whole planet against it.
https://www.cdc.gov/vaccines/pubs/pinkbook/polio.html
You are wrong.
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No, I’m not. You don’t get it.
The FDA issued approval on basically the same vaccine, but called it a different name, that vaccine is not covered under the PREP act. It is also not even manufactured yet.
It was bait and switch and illegal as hell but there are no laws anymore that can’t easily be ignored by Fedgov.
Interesting theory except that the product “approved”, Comirnaty has been used and manufactured since January in Europe. It is the same product as the Pfizer “vaccine used in the United States. You shouldn't believe everything claimed on the internet.
Who knows what the reasons for the wording in the press release and the actual “approval” letters are... It is all trying to push this harmful “vaccine” that no longer works as advertised against quickly evolving variations of the original function of gain version.
"Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future."
This has got to be the largest amount of money that big-pharma has ever hauled in. And they didn't even have to cure heart disease or cancer to do it. Amazing!
Yep. Either way, damages claims go to a federal agency. In the case of experimental, one agency with its set of regulations (Countermeasures Injury Compensation Program), and the The National Vaccine Injury Compensation Program for vaccines approved by the federal government. This was set up by The National Childhood Vaccine Injury Act of 1986.
If the bottle doesn't say COMINARTY (or whatever the name is), it is not approved, even if it is the same thing.
Congressional Research Service LSB10584 Compensation Programs for Potential COVID-19 Vaccine Injuries, March 22, 2021
There are not two different drugs. Pfizer put a brand name on it.
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YES, they are the same drugs. However, they are very, very, very different when it comes to the legal aspect of them. That is the scam!
I trust the corrupt government,and the propagandist media, to do the right thing.
As me eyes go blank like jo bib me having a spell of dementia.
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 AmericanThinker 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.
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.
The first time anyone who has been fooled by these blogs puts “But it hasn’t really been approved” in a request for a medical or religious exemption, they are going to get laughed out of HR and court.
That’s why these blog lies are so dangerous.
If people want actual exemptions, then they need to understand what happened, and be prepared to fight with real facts, not made up garbage.
Yes. They are.
AmericanThinker is lying.
AmericanThinker is lying.
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They are not lying. You just don’t understand the bait and switch the FDA just pulled off.
RE: SeekAndFind spreading dis-info, and American Thinker being stupid.
Don’t lump me in with the disinformation spreaders. The FR Forum is meant to be a DISCUSSION FORUM to clarify anything unclear or to correct mistaken ideas.
Just because someone posts something does not necessarily mean he agrees with what was written in the article.
I absolutely understand what happened. I just posted the actual source documents. The bloggers at AT routinely lie and then have to retract when they get called on it:
https://www.americanthinker.com/blog/2021/01/statement.html
I am as upset about the FDA approval as anyone. I think it was rushed, political and dangerous.
However, I want people to be prepared to fight employer mandates with facts and the law and not internet fantasy.
I am already tired of the Biden regime’s many lies.
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