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.
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.
Archive: https://web.archive.org/web/20210823163939/https://www.fda.gov/media/150386/download
Here’s what is confusing everybody, maybe you can sticky this shit in a post so all these faggots can figure this shit out:
The FDA is differentiating between “Pfizer-BioNTech COVID-19 vaccine” and “COMIRNATY (COVID-19 Vaccine, mRNA)”. Essentially they are the same exact vaccine, the only difference is the name and manufacture date. COMIRNATY (COVID-19 Vaccine, mRNA) has received full authorization - not EUA - for use in persons 16 years and older. It will still be EUA in persons 12 - 15 years of age. The original vaccine - Pfizer-BioNTech COVID-19 vaccine - will remain EUA for “logistical reasons”. In other words they still have a shit ton of these doses sitting around, but they can’t call them by the new name because they were manufactured under a different name and before the full authorization date.
Here’s a link to Q&A’s on the FDA website about the authorized vaccine:
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
I know, only a kike lawyer could draft something that appears to be in English but is unintelligible to most of the population, so I hope that clears things up…
(post is archived)