Thanks for the cites MasterAce. This document isn't the easiest to parse for people outside of Biotech, at least for me. On page 2 it contains this paragraph:
"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."
So having a BLA approved would let them introduce a biologic product into interstate commerce according to that bastion of truth wikipedia (https://en.wikipedia.org/wiki/Biologics_license_application). I think is a very verbose way of saying it's approved.
Footnote 9 also states: "Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older ..."
MasterAce has pointed out on page 12, while talking about allowed advertisements "This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and"
So is this thing approved or not? I think the general public will say of course. The skeptical part of me thinks that contradiction on page 12 is there to limit people from liability or somesuch.
Xeros 8 points 2.8 years ago
Thanks for the cites MasterAce. This document isn't the easiest to parse for people outside of Biotech, at least for me. On page 2 it contains this paragraph:
"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."
So having a BLA approved would let them introduce a biologic product into interstate commerce according to that bastion of truth wikipedia (https://en.wikipedia.org/wiki/Biologics_license_application). I think is a very verbose way of saying it's approved.
Footnote 9 also states: "Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older ..."
MasterAce has pointed out on page 12, while talking about allowed advertisements "This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and"
So is this thing approved or not? I think the general public will say of course. The skeptical part of me thinks that contradiction on page 12 is there to limit people from liability or somesuch.