No more EUA - does away with one of the anti-vax arguments (not that it will change their minds)

FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. 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. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of ....

https://www.fda.gov/news-events/press-a ... 19-vaccine

Cross posted from the Coronavirus thread since it's important enough to stand alone

I read about that. Tried posting it on a couple of local Facebook pages, but it was deleted from one. Then I post it in another, but turned off the comments so there wouldn't be a shit show. The manager turned them back on and said if I turned them off again, she would delete it. I said "fine, but if it's gets nasty I will delete it myself" I obviously struck a nerve with a couple of people who piled on right away so I deleted it. Because the moderator of the group gave a thumbs up to someone who tried to rip me a new one, I also unjoined that page. Fuck 'em all. I just wanted the people who said they wouldn't get vaccinated because it was not approved could see it. Maybe now they will. I'm so sick and tired of the fucking deniers, anti-vaxxers and anti-maskers I could scream.