Any updates on the approval status?

Page 2 of the letter the FDA sent to Pfizer clearly states:

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.


What does it mean to approve an application? Is that the same as full approval of a vaccine?

'AUTHORITY FOR ISSUANCE OF THE EUA
The Secretary of Health and Human Services (HHS) has declared a public health
emergency that justifies the emergency use of drugs and biological products during
the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved
product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization against
COVID-19 in individuals 12 years of age and older and to provide a third dose to
individuals 12 years of age and older who have been determined to have certain
kinds of immunocompromise. FDA-approved COMIRNATY is also authorized in
individuals 12 through 15 years and to provide a third dose to individuals 12 years
of age and older who have been determined to have certain kinds of
immunocompromise.'


This paragraph of page 1 doesn't make sense for 'full approval'.

First they're talking about EUA use then say 'COMIRNATY is also authorized'.

So its authorized under EUA?

Fkin' word salad man.

'This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end
when the Secretary of HHS determines that the circumstances justifying the EUA
no longer exist or when there is a change in the approval status of the product such
that an EUA is no longer needed.'




Last Edited by JustI on 08/27/2021 05:36 PM