125742 S56 M1 response 13aug2021

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COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA Commitment to Implement an  Endotoxin Method on  DP
PFIZER CONFIDENTIAL
Page 1As follow up from the teleconference with CBER on 16 August 2021 and recognizing 
CBER’s previous request of 06 August 2021 to:
identify  a  for testing DP within the  
, and to
provide a date b y which results from the test using  samples can be included of 
DP lot release.
Commitment to Implement Endotoxin Test Method
Pfizer commits to implement ing a new method that includes testing the  sample for 
routine lot release testing of Drug Product b y 06 December 2021. Implementation of the 
method would occur following method transfer and verification steps. A new routine test 
 of the  sample will be established based on the  
determined from the method verification stud y.   
 
090177e197d4e0eb\Approved\Approved On: 17-Aug-2021 14:50 (GMT)
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FDA-CBER-2021-5683-1149871