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Note also, FDA bypassed normal advisory and public comment before approval.
1 posted on 08/25/2021 7:50:05 PM PDT by Missouri gal
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To: Missouri gal

How can you approve something that has not been produced yet?


2 posted on 08/25/2021 8:01:01 PM PDT by Safrguns
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To: Missouri gal

“There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and it will only be initiated at the time BioNTech product becomes available…“

Wrong. The actual BLA approval letter is here:
https://www.fda.gov/media/151710/download

It’s the exact same product labeled under the proprietary name COMIRNATY. It can now be marked and packed in 2.0 mL glass vials, in packages of 25 and 195 vials.

Pfizer-BioNTech have already been distributing the drug under the COMIRNATY label in Europe since January and since July in Australia.

Claims that it doesn’t exist is a bold faced lie.

Here is what it looks like: https://thumbor.forbes.com/thumbor/711x490/https://specials-images.forbesimg.com/imageserve/61241aea6a73959e462e80fa/Comirnaty-Pfizer-BioNTech-Covid-19-vaccine/960x0.jpg?fit=scale

“The liability coverage, the blanket coverage that allows Pfizer to not be liable for any adverse event, only applies to the Pfizer product, which is still under emergency use authorization.”

Wrong. Vaccine makers are immune from liability regardless. A EUA is irrelevant.

https://www.law.cornell.edu/uscode/text/42/300aa-22


3 posted on 08/25/2021 8:05:00 PM PDT by TexasGurl24
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To: Missouri gal
I am getting lost following this. The news and FDA say one thing. Others are saying something else happened.

So what actually happened? Who got what authorization? Is it correct to say that Pfizer got the EUA extended, and BioTech got full approval?

9 posted on 08/25/2021 8:40:23 PM PDT by Widget Jr
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To: Missouri gal

if only the following would lead to so-called “essential” media reporting more honestly about the jabs! doubt it will happen, though:

26 Aug: news.com.au: Channel 7 journalist hospitalised with pericarditis after Pfizer vaccine
Channel 7 reporter Denham Hitchcock has spoken from hospital after being diagnosed with pericarditis, a rare side effect of the Pfizer vaccine.
by Natalie Brown
In a post to Instagram, the Channel 7 journalist wrote that he’d “battled over whether” to share his experience or not, “but decided after 27 years of being a journalist who’s primary goal is to discover the truth – it would be hypocritical not to”.

“I’m NOT anti-vax. But I’m really not pro vax either. I’m pro choice – and pro information to make that choice. Above all I’m PRO opening the bloody country up and to do that I don’t see any way around getting the majority of Australia vaccinated. So I got the Pfizer shot,” Hitchcock said.

“The first week was like any vaccine. Feeling off. But nearing the end of the second week my heart started to race, I was getting pins and needles in the arms, extreme fatigue and a very strange sensation of dizziness. I took Nurofen, and I kept working.

“By the end of the third week I was getting steadily worse – sharp chest pain – cold shivers and chills – and the dizziness was intense. 25 days after the shot and probably a little late to hospital – but here I am – diagnosed with pericarditis – or inflammation of the heart due to the Pfizer vaccine.”...

“My present thought would be – in the current vaccine frenzy, no one is talking about this but it’s clearly happening – and if you want the vaccine and have any heart history it would be worth talking to your GP about your vaccine choice, especially as AZ is readily available and does not have this side effect,” Hitchcock advised...

Hitchcock’s diagnosis comes after Georgia Clark, a reporter with (Murdoch’s) The Daily Telegraph, also revealed that she was being treated for pericarditis – but urged Aussies to continue coming forward to get vaccinated.
“If this is what the vaccine has done to me, who knows what would happen if I actually caught Covid, I could die,” the 27-year-old told The Daily Telegraph...
https://www.news.com.au/lifestyle/health/health-problems/channel-7-journalist-hospitalised-with-pericarditis-after-pfizer-vaccine/news-story/43e3d637eeea6827962aa973db8cda7e


11 posted on 08/25/2021 9:00:18 PM PDT by MAGAthon
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To: Missouri gal

Fastest approval of any vaccine in the history of mankind….by orders of magnitude.

How on the earth do you give approval for something with absolutely zero long term data? Coupled with short term data showing no ability to stop infection nor transmission.

And I have not even brought up our adverse events database…..

This approval is a complete and utter farce.


13 posted on 08/25/2021 9:38:07 PM PDT by walkingdead (We are sacrificing American youth's future on the altar of our own fear. And it is a travesty.)
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To: Missouri gal

The FDA approval is a political answer to a medical problem.


24 posted on 08/26/2021 4:41:46 AM PDT by Mashood
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To: Missouri gal

They should license the time machine they used to get approval in 11 months vs 5-10 years. Why doesn’t the Pfizer CEO take his own vaccination? What is he afraid of? I think I know.


30 posted on 08/26/2021 10:51:04 AM PDT by cp124 (Focus on treatment and not an experimental vaccine/flu shot.)
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