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COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742.0
Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
QUERY 1 ................................ ................................ ................................ ................................ ...2
QUERY 2 ................................ ................................ ................................ ................................ ...4
QUERY 3 ................................ ................................ ................................ ................................ ...6
090177e197ce220a\Approved\Approved On: 13-Aug-2021 12:58 (GMT)
FDA-CBER-2021-5683-1149588
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742.0
Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures
PFIZER CONFIDENTIAL
Page 2The review team has the below three question for you regarding the measurement of
endotoxins using the LAL procedures. They have
requested a response as soon as possible and no later than Friday , August 13, 2021.
QUERY 1
Your procedure for measuring endotoxin in Drug Product (DP) includes a
step. While y ou provide data demonstrating the does not
impact the activity of endotoxin that is you have not provided data to
evaluate the potential endotoxin -like activity of the
Please provide data to address potential
endotoxin -like activity of .
RESPONSE 1
090177e197ce220a\Approved\Approved On: 13-Aug-2021 12:58 (GMT)
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FDA-CBER-2021-5683-1149589
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742.0
Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures
PFIZER CONFIDENTIAL
Page 3Literature References
“The Bacterial Endotoxins Test: A Practical Approach” b y Karen Zink McCullough 2011
PDA, available upon request
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197ce220a\Approved\Approved On: 13-Aug-2021 12:58 (GMT)
FDA-CBER-2021-5683-1149590
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742.0
Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures
PFIZER CONFIDENTIAL
Page 4QUERY 2
You state that the step is performed to
is the usual approach to . Please provide data from a
RESPONSE 2
Literature References
“The Bacterial Endotoxins Test: A Practical Approach” b y Karen Zink McCullough 2011
PDA , available upon request
“Pre-clinical immunotoxicity studies of nanotechnology -formulated drugs: Challenges,
considerations and strategy ” Marina A. Dobrovolskaia Journal of Controll ed Release Vol.
220 ( 2015), pages 571 -583, available upon request
090177e197ce220a\Approved\Approved On: 13-Aug-2021 12:58 (GMT)
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FDA-CBER-2021-5683-1149591
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742.0
Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures
PFIZER CONFIDENTIAL
Page 5SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197ce220a\Approved\Approved On: 13-Aug-2021 12:58 (GMT)
FDA-CBER-2021-5683-1149592
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742.0
Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures
PFIZER CONFIDENTIAL
Page 6QUERY 3
From the data generated in the preceding request, we ask that you identify a for
testing DP within the .
Please use this information to establish the endotoxin limit and establish a specification for
DP endotoxin activity levels for samples that are . Please comment and
provide a date b y which results from the test using samples can be included for DP
lot release, together with the endotoxin results for samples .
RESPONSE 3
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197ce220a\Approved\Approved On: 13-Aug-2021 12:58 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
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FDA-CBER-2021-5683-1149593