read the “authorization” from yesterday again - it’s just an extension of the EUA - not a full approval.
https://www.fda.gov/media/150386/download
Has anyone done a dig on Rear Admiral Denise M. Hinton, the FDA's "Chief Scientist"?
All I can find out from surface searches is that she's got a degree in Nursing and a Masters of Science in something or other. She seems to have been in "management" positions and I can find nothing that qualifies her as a "scientist". Doesn't even seem to have a Wiki page.
I think it is confusing, because they co-mingled the approval of the 16yr and older with the EUA for the younger group still being tested. And they also are accepting either the EUA or Licensed product to be used interchangeably.
Note from pg 2:
10, 2021,
5 June 25, 2021,
6 and August 12, 2021.7
“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.”
From pg 12:
Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of PfizerBioNTech 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).