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.
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.
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?”
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.
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
Rhymes with Illuminati
I was thinking the same thing. 😐
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'.
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