" Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug substance... The final formulated product will be manufactured, filled, labeled and packaged at Pfizer. ..
You may label your product with the proprietary name, COMIRNATY, and market it in 2.0 mL glass vials, in packages of 25 and 195 vials"
"The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the
EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same
formulation and can be used interchangeably to provide the COVID-19
vaccination series.1"
"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. "
= Comirnaty has now BOTH EXTENDED EUA AND a BLA APPROVAL .
You can bitch whether it is legally sound to have an EUA while you have also a full market approval, but that's how it currently stands, directly from the FDA.
Primary sources show full BLA approval for Pfizer Cominarty AND an EUA extension for the Pfizer-BioNTech COVID-19 vaccine.
https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Approval LetterAugust 23, 2021
https://www.fda.gov/media/151710/download
Fact Sheet:
https://www.fda.gov/media/144413/download
Letter of Authorization (Reissued)
https://www.fda.gov/media/150386/download
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. "
= Comirnaty has now BOTH EXTENDED EUA AND a BLA APPROVAL .
You can bitch whether it is legally sound to have an EUA while you have also a full market approval, but that's how it currently stands, directly from the FDA.