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FDA as not approved Pfizer “vaccine” they have extended the emergency use of it.

submitted by MasterAce to whatever 3.7 yearsAug 23, 2021 11:59:53 ago (+17/-3)     (whatever)



27 comments block

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[ - ] ItsBacon 10 points 3.7 yearsAug 23, 2021 12:30:57 ago (+10/-0)

The news release is on the FDA website. It says it is approved for over 16 years old. The emergency use is still in effect for 12-16 year olds. How is it not approved as you say? Am I missing something?

[ - ] MasterAce [op] 6 points 3.7 yearsAug 23, 2021 14:48:44 ago (+6/-0)

[ - ] Xeros 8 points 3.7 yearsAug 23, 2021 15:50:41 ago (+8/-0)

Thanks for the cites MasterAce. This document isn't the easiest to parse for people outside of Biotech, at least for me. On page 2 it contains this paragraph:

"On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older."

So having a BLA approved would let them introduce a biologic product into interstate commerce according to that bastion of truth wikipedia (https://en.wikipedia.org/wiki/Biologics_license_application). I think is a very verbose way of saying it's approved.

Footnote 9 also states: "Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older ..."

MasterAce has pointed out on page 12, while talking about allowed advertisements "This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and"

So is this thing approved or not? I think the general public will say of course. The skeptical part of me thinks that contradiction on page 12 is there to limit people from liability or somesuch.

[ - ] MasterAce [op] 3 points 3.7 yearsAug 23, 2021 17:15:46 ago (+3/-0)

Thanks for being smarter than me.
Really tho thanks for summing this up.

[ - ] ItsBacon 3 points 3.7 yearsAug 23, 2021 17:55:40 ago (+3/-0)

Thank you OP and @Xeros for the info. I guess the bottom line, no matter what the approval status, is that they've said it's approved and that's the line they'll stick with. I appreciate all the Goats that do the leg work for those of us that don't always have time to dig so deep.

[ - ] MasterAce [op] 1 point 3.7 yearsAug 23, 2021 20:04:34 ago (+1/-0)

No problem thanks for acknowledging!!

[ - ] Spaceman84 1 point 3.7 yearsAug 24, 2021 01:25:37 ago (+1/-0)

Liability? What liability? Vaccination manufacturers have no liability, per our jewish legal system.

[ - ] account deleted by user 4 points 3.7 yearsAug 23, 2021 12:46:08 ago (+4/-0)

account deleted by user

[ - ] MasterAce [op] 2 points 3.7 yearsAug 23, 2021 15:24:39 ago (+2/-0)

[ - ] derpfroot 3 points 3.7 yearsAug 23, 2021 17:57:37 ago (+3/-0)

On pages 3 it mentions how they got the "95% effective" number...

FDA’s analysis of the available efficacy data from 36,523 participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirmed the vaccine was 95% effective in preventing COVID-19 occurring at least 7 days after the second dose.

So as long as the test subject didn't have the coof after 7 days of their 2nd shot, it was counted as successful?
Am I reading that correctly?

[ - ] MasterAce [op] 3 points 3.7 yearsAug 23, 2021 20:06:25 ago (+3/-0)

That’s how I’d interpret

[ - ] dassar 2 points 3.7 yearsAug 24, 2021 01:24:53 ago (+2/-0)

Yea, so 5% still contracted the holo-cough despite vaccination and iirc two there are completed studies that were for - the first, monitoring for one month after the second dose and the second study, monitored for 6 months after the 2nd dose. While a longer one year long trial/ study is still in progress. The results of which are then 'extrapolated and adjusted' for population size to base overall efficacy etc on 7 billion people, just lol.

[ - ] virge 5 points 3.7 yearsAug 23, 2021 12:27:23 ago (+5/-0)

Newspeak is real.

[ - ] MasterAce [op] 5 points 3.7 yearsAug 23, 2021 14:47:30 ago (+5/-0)

Check my reply above for links
It has been and yet hasn’t been approved.
So ya I’m agreeing with you
Newspeak is real.
But we already knew that.

[ - ] mememeyou 3 points 3.7 yearsAug 23, 2021 17:02:43 ago (+3/-0)

test isn't even done of the safety & effectiveness until Oct 2022

[ - ] dingbat 3 points 3.7 yearsAug 23, 2021 12:03:55 ago (+3/-0)

Because they can’t. Mandates can be challenged now. That’s great news.

[ - ] Yargiyankooli 1 point 3.7 yearsAug 23, 2021 23:01:47 ago (+1/-0)

Mandates can always be challenged. Just say no

[ - ] Cynabuns 3 points 3.7 yearsAug 23, 2021 12:50:33 ago (+3/-0)

Naww dude, they did, but they extended the EUA for teens and a third shot for sickies. I had to look after I saw your post.

https://www.voat.xyz/viewpost.php?postid=6123cfdb3e9c9

[ - ] MasterAce [op] 1 point 3.7 yearsAug 23, 2021 13:35:26 ago (+1/-0)

[ - ] account deleted by user -2 points 3.7 yearsAug 23, 2021 13:47:31 ago (+0/-2)

account deleted by user

[ - ] MasterAce [op] 4 points 3.7 yearsAug 23, 2021 14:41:14 ago (+4/-0)*

It’s a PDF
But here it is
Eat a bag of dicks
https://www.fda.gov/media/150386/download

[ - ] account deleted by user 3 points 3.7 yearsAug 23, 2021 18:37:34 ago (+3/-0)

account deleted by user

[ - ] MasterAce [op] 2 points 3.7 yearsAug 23, 2021 20:08:27 ago (+2/-0)

Thanks for staying tuned.
Also put that bag of dicks away.

[ - ] account deleted by user 2 points 3.7 yearsAug 24, 2021 04:03:35 ago (+2/-0)

account deleted by user

[ - ] account deleted by user 0 points 3.7 yearsAug 28, 2021 15:27:52 ago (+0/-0)

account deleted by user

[ - ] MasterAce [op] 0 points 3.7 yearsAug 28, 2021 16:21:59 ago (+0/-0)

This valuable info on what is basically an archived thread.
Post as it’s own submission to let others know please.