Tuesday, August 24, 2021

Letter to Pfizer

https://www.fda.gov/media/150386/download

DOES NOT GIVE FULL APPROVAL
Extends EUA to allow supply of current Pfizer under EUA because limited supply of
BioNTech version.
The products are legally distinct with certain differences that do not impact safety or
effectiveness. (page 2, Pfizer letter) 

https://static1.squarespace.com/static/550b0ac4e4b0c16cdea1b084/t/6124fdd27da16f3e2c51aecb/1629814226387/Key+points+to+consider+FDA+letters+and+press+release.pdf 

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