125742 S22 M1 response 16jul2021

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Pfizer Bla Submission

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COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 16Jul 2021FDA queries –Sterility and Endotoxin
PFIZER CONFIDENTIAL
Page 1QUERY 1
Regarding the  sterility  method: 
a. Please confirm that both PGS -Puurs and PGS- KZOtesting facilities will conduct  
 of  sterility  tests since test results for  were not 
optimal during the validation study . 
b. Please confirm that both PGS -Puurs and PGS-KZO testing facilities will conduct visu al 
inspection for growth during the  
. 
RESPONSE 1
a. The applicant confirms that a  is used at both PGS -
Puurs and PGS- KZO.
b.The applicant confirmsthat both PGS -Puurs and PGS- KZO testing facilities conduct 
visual inspection for growth during the  
Literature Re ferences
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197ad0499\Approved\Approved On: 29-Jul-2021 00:58 (GMT)
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FDA-CBER-2021-5683-1149404
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 16Jul 2021FDA queries –Sterility and Endotoxin
PFIZER CONFIDENTIAL
Page 2QUERY 2
Regarding the endotoxin test: 
a.Please submit complete verification reports of the endotoxin tests for interfering factors
from both the PGS -Puurs and PGS-KZO facilities. These reports should include positive 
product control (PPC) percent recoveries for all drug product sample dilutions tested and the 
selected testing dilution that provided the optimal PPC percent recovery. In addition, the 
reports should identify  the product lot numbers tested instead of referring to them as Trials 1, 
2 and 3, as in the submitted summarized verification of bacterial endotoxins report. 
RESPONSE 2
Complete verification repor ts are included for both PGS -Puurs and PGS- KZO.
For Puurs, the most current version of the endotoxin verification report also covers endotoxin 
testing for 
 In addition, the report identif iesthe product lot numbers 
hem as Trials 1, 2 and 3, as in the submitted summarized 
verification of bacterial endotoxins report.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Kalamazoo  Method Verification Report.pdf
LAL-20-018-A8_PUURS.pdf
Previously submitted supporting documentation
None
090177e197ad0499\Approved\Approved On: 29-Jul-2021 00:58 (GMT)
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FDA-CBER-2021-5683-1149405