Anonymous ID: 34c2e1 Aug. 23, 2021, 8:54 a.m. No.14436271   🗄️.is 🔗kun   >>6335 >>6340 >>6481 >>6486 >>6545 >>6651 >>6765

>>14436258

 

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.

 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Anonymous ID: 34c2e1 Aug. 23, 2021, 9:31 a.m. No.14436538   🗄️.is 🔗kun   >>6577 >>6581

>>14436278

>>14436278

>yup, they extended the EUA

NOPE, they APPROVED it. The EUA was extended for the current Pfizer/BioNTtech shots, which they say are of the same formulation as the new 'COMIRNATY' shot..

 

COMIRNATY, the new marketing name for the vaccine has FDA APPROVAL.

Anonymous ID: 34c2e1 Aug. 23, 2021, 9:43 a.m. No.14436653   🗄️.is 🔗kun   >>6669 >>6701

>>14436577

>you liar

YOU ARE WRONG.

 

Pfizer-BioNTech COVID‑19 Vaccine is not licensed except under EUA.

 

COMIRNATY (COVID-19 Vaccine, mRNA) i is now licensed and approved by the FDA.

 

Whilst they say the are the same formulation, they are two separate items as regards approval.

Anonymous ID: 34c2e1 Aug. 23, 2021, 9:45 a.m. No.14436669   🗄️.is 🔗kun   >>6708 >>6765

>>14436653

Page 12 -

 

COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals

16 years of age and older. There remains, however, a significant amount of Pfizer-

BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with

this emergency use authorization. This authorization thus remains in place with

respect to that product for the previously-authorized indication and uses (i.e., for use

to prevent COVID-19 in individuals 12 years of age and older with a two-dose

regimen, and to provide a third dose to individuals 12 years of age or older who have

undergone solid organ transplantation, or who are diagnosed with conditions that are

considered to have an equivalent level of immunocompromise). BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19

Vaccine, mRNA) product when used to provide a two-dose regimen for individuals

aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or

older who have undergone solid organ transplantation or who are diagnosed with

conditions that are considered to have an equivalent level of immunocompromise.

Conditions A through W in this letter apply when COMIRNATY (COVID-19

Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except

that product manufactured and labeled in accordance with the approved BLA is

deemed to satisfy the manufacturing, labeling, and distribution requirements of this

authorization.

Anonymous ID: 34c2e1 Aug. 23, 2021, 9:57 a.m. No.14436760   🗄️.is 🔗kun

>>14436736

You cannot tell the difference between Pfizer/BioNTech and COMIRNATY?

 

One has EUA, the other is licensed and approved.

 

One was manufactured before approval, therefore isn't licensed - only EUA.