125742 S17 M1 reponse 09jul2021

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COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis
PFIZER CONFIDENTIAL
Page 1QUERY 1
Please describe the spiked materials used for evaluating the  
 
 
 
 
 
 
 
 
 
RESPONSE 1
090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149349
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis
PFIZER CONFIDENTIAL
Page 2
090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149350
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis
PFIZER CONFIDENTIAL
Page 3Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
VAL100136603, REPORT FOR THE VALIDATION OF THE METHOD TM100010392; 
RNA INTEGRITY OF MRNA DRUG SUBSTANCE AND LNP -MRNA DRUG 
PRODUCT 
SAMPL ES BY FRAGMENT ANALYZER (CGE)  
090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149351
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis
PFIZER CONFIDENTIAL
Page 4QUERY 2
The acceptance criterion for the assay  Range evaluation is stated as  
 
 
  Please comment and provide additional data to support y our 
proposed acceptance criterion for the RNA integrity  Range evaluation.
RESPONSE 2
090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149352
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis
PFIZER CONFIDENTIAL
Page 5Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
VAL100136603, REPORT FOR THE VALIDATION OF THE METHOD TM100010392; 
RNA INTEGRITY OF MRNA DRUG SUBSTANCE AND LNP -MRNA DRUG 
PRODUCT SAMPL ES BY FRAGMENT ANALYZER (CGE)  
090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149353
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis
PFIZER CONFIDENTIAL
Page 6QUERY 3
You stated on Page 31 that the assay  quantitation limit (QL ) was determined from the resul ts 
study .  Please explain.
RESPONSE 3
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
VAL100136603, REPORT FOR THE VALIDATION OF THE METHOD TM100010392; 
RNA INTEGRITY OF MRNA DRUG SUBST
ANCE AND LNP -MRNA DRUG 
PRODUCT SAMPL ES BY FRAGMENT ANALYZER (CGE)  
090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149354