On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).
From first paragraph. 16+ years old is fully FDA approved (not that means anything to me)
"the vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older."
Cuz it's a social media site masquerading as a research board. Also we rely on stickies and mods aren't always around. You could always spend more time in New or Rising but that takes a lot more effort than waiting on the front page to move.
I literally found this in Rising. I don't understand why you're gatekeeping. There's plenty of mods, and rotating actual news into the sticky is more important than some cringe theory of Taliban SOF sending a signal to to 8kun.
LOL how is he gatekeeping? He simply said it takes more effort to find certain things, hence why it is difficult for things that should be up top, to be up top. There actually have to be people here constantly lurking.
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.
By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved.
...On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA)
That sounds like something was approved. I am not sure what a " biologics license application" is vs a vaccine approval.
Aside from making vaccine mandates/passports easier to implement, I'm not sure this will change any behavior regarding COVID. Pfizer was already manufacturing and selling it's product.
A subsidiary of Phizer, so that if anything bad happens they can strip it of assets and sell off the company to avoid any financial penalties, lawsuits, etc.
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.
Damned legal double speak to get people to do this thing. I have never seen such zeal to get people to do something against their own best interests EVER, except for gun control.
I am not a lawfag or a medicalfag but according to the pdf
"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."
"The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards"
Sounds to me they approved the sale of the jab or making sure its available in every state under the new name?
I would not be surprised if COMIRNATY is touted as the third jab or fourth jab but people have to pay for to combat the variants.
So my understanding on this is that the jab has been FDA approved, but because they are marketing it as a different name (COMIRNATY), they are revising this EUA to include COMIRNATY as well.
Hysterical they want their cake and they want to eat it too. The deep state can’t decide what they want and they are arguing with each other. Each little part wants to further it’s cause but the others don’t want to be sacrificed! Juicy!
Someone else posted a link the other day:
from the FDA trial site::
""STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS"?"
Are they not corrupting the trial if they force people to take it who may have other issues?
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA. In addition, the Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide
updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to
update language regarding warnings and precautions related to myocarditis and pericarditis. The
Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for
Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech
COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).
We REALLY need a lawfag to help on this. What does "under this EUA for
certain uses that are not included in the approved BLA" mean?
This reads to me like the COMIRNATY shot is now included in the EUA ... and NOT "Fully Authorized".
from the document...
From first paragraph. 16+ years old is fully FDA approved (not that means anything to me)
"the vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older."
This is bad news.
They’re calling it “Comorbidity”? 🤨
Comirnaty. Co(vid) mirna (mRNA) ty (thank you for being good little citizens and taking our poison jabs)
Thanks, but yeah, all I can see is “Comorbidity.” 🤷♂️
They can market the shots, and the boosters, with the catchy and descriptive catchphrase “How many comorbidities can you get, slave?”
I see an asian trying to say the word "community"
That too.
And no slight on based Asian-accented English-speaking pedes. Because if I were to talk Asian... well, I couldn't.
I see it as a “commie” injection.
Yeah why is this not trending more on this sub
Cuz it's a social media site masquerading as a research board. Also we rely on stickies and mods aren't always around. You could always spend more time in New or Rising but that takes a lot more effort than waiting on the front page to move.
I literally found this in Rising. I don't understand why you're gatekeeping. There's plenty of mods, and rotating actual news into the sticky is more important than some cringe theory of Taliban SOF sending a signal to to 8kun.
LOL how is he gatekeeping? He simply said it takes more effort to find certain things, hence why it is difficult for things that should be up top, to be up top. There actually have to be people here constantly lurking.
Yeah, just read that myself on the FDA web site - Fully approved for 16 y/o+, continued EUA for 12-15 Y/O. Here's the link to their press release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
I imagine the new name will cause some normies to think it's an entirely different variety of shot, and then they'll want one because 'safety'.
Rhymes with Illuminati
I was thinking the same thing. 😐
Incorrect. From the linked pdf in the OP:
BLA Approval = FDA Approval
From FDA's site:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101
Thank you for posting that.
The Pfizer "vaccine" is still only under Emergency Use Authorization, which was just extended by the FDA. It's still emergency and experimental.
Why re-issue EUA on just Pfizer? Pfizer has more reported adverse reactions and deaths than all others combined!
When will we ever learn - always give "Breaking News" time to ferment before we jump to conclusions. Thanks for posting Fren.
At least 48 hours - I literally just got done telling my husband that- it’s been my motto the last 5 years!
Do your research frens! They will use your ignorance against you.
Here is the formal approval letter:
https://www.fda.gov/media/151710/download
...On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA)
That sounds like something was approved. I am not sure what a " biologics license application" is vs a vaccine approval.
You may be right.
I'm reading and re-reading this to make sense of it.
There is a lot of smoke and mirrors going on with this.
Based on this (https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101) it looks like a BLA is pretty much FDA approval. Companies can manufacture and sell the vaccine for the approved purpose.
I guess the FDA just exposed itself for what it most likely has always been. A system to protect big Pharma by blocking any competition
Aside from making vaccine mandates/passports easier to implement, I'm not sure this will change any behavior regarding COVID. Pfizer was already manufacturing and selling it's product.
It seems we get package insert info now, though! (https://www.fda.gov/media/151707/download)
Who is BioNTech?
A subsidiary of Phizer, so that if anything bad happens they can strip it of assets and sell off the company to avoid any financial penalties, lawsuits, etc.
The vaccine was approved for people ages 16+. The EUA was extended for minors. This is a loss for us.
Comirnaty = The End of Days in gematria. Just sayin'...
Wow! Why is the media and politicians lying with the documentation of a new EUA! I mean the documentation is right here black and white!!
Because sheep do not take the time to read or do their own research. The sheep still watch and believe the MSM.
Yep. Says right on page 5 and includes ages 12-18, it is an EUA.
Yes very odd wording.
I'm sorry but they most definitely approved it
Damned legal double speak to get people to do this thing. I have never seen such zeal to get people to do something against their own best interests EVER, except for gun control.
I am not a lawfag or a medicalfag but according to the pdf
"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."
According to the FDA https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber
"The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards"
Sounds to me they approved the sale of the jab or making sure its available in every state under the new name?
I would not be surprised if COMIRNATY is touted as the third jab or fourth jab but people have to pay for to combat the variants.
This is a huge BOOM THANK YOU
Ugggh 🤦♀️ Thank u :/
Wild! Bunch of liars and crooks ruling the information stream. Still under EUA!
How can they be giving this shit to our youth 😫. We need a lot of prayers 🙏
So my understanding on this is that the jab has been FDA approved, but because they are marketing it as a different name (COMIRNATY), they are revising this EUA to include COMIRNATY as well.
Hysterical they want their cake and they want to eat it too. The deep state can’t decide what they want and they are arguing with each other. Each little part wants to further it’s cause but the others don’t want to be sacrificed! Juicy!
Trying to understand what they really mean is making my head hurt. I think the confusion is intentional.
Here is the formal approval letter:
https://www.fda.gov/media/151710/download
Looks to me like.the original jab is still under experimental approval and the new Comirnary is what got approval. Odd wording.
Someone else posted a link the other day: from the FDA trial site:: ""STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS"?" Are they not corrupting the trial if they force people to take it who may have other issues?
Archiving only puts a screenshot of the pdf. Can anyone upload it elsewhere?
We REALLY need a lawfag to help on this. What does "under this EUA for certain uses that are not included in the approved BLA" mean?
This reads to me like the COMIRNATY shot is now included in the EUA ... and NOT "Fully Authorized".
I believe what it means is that COMIRNATY is included in this EUA for purposes that it was not approved for in its BLA.
So basically, they can experiment on us with comirnaty also.
Hopefully this will put the FDA on trial. Along with everything else they've ever done.