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RE: Pfizer approval-from a discussion of this last night, this is some of the specific data directly from FDA Document:

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).

472 posted on 8/24/2021, 9:24:45 AM by greeneyes ( Moderation In Pursuit of Justice is NO Virtue—LET FREEDOM RING)