Document text
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................1
QUERY 1 ................................ ................................ ................................ ................................ ...2
RESPONSE 1 ................................ ................................ ................................ ................... 2
QUERY 2 ................................ ................................ ................................ ................................ ...6
RESPONSE 2 ................................ ................................ ................................ ................... 6
QUERY 3 ................................ ................................ ................................ ................................ ...7
RESPONSE 3 ................................ ................................ ................................ ................... 7
QUERY 4 ................................ ................................ ................................ ................................ ...8
RESPONSE 4 ................................ ................................ ................................ ................... 8
QUERY 5 ................................ ................................ ................................ ................................ .13
RESPONSE 5 ................................ ................................ ................................ ................. 13
QUERY 6 ................................ ................................ ................................ ................................ .14
RESPONSE 6 ................................ ................................ ................................ ................. 14
LIST OF TABLES
Table 1. 3
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FDA-CBER-2021-5683-1149485
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 2QUERY 1
In Section 3.2.S.2.5 Process Validation and/or Evaluation –Shipping Performance
Qualification, you stated that the expected transit time for shipment of the DS from
the Pfizer Andover DS manufacturing site to the Pfizer Kalamazoo and Pfizer Puurs DP
manufacturing site s is , respectivel y. Please provide supportive data to
demonstrate that the ph ysicochemical and biological attributes of the DS are not impacted
after exposure to the shipping hazards (e.g., shock, vibration, pressure, thermal hazards, etc.).
Please note that the data should be able to support the worst -case transit time of
DS.
RESPONSE 1
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FDA-CBER-2021-5683-1149486
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 3
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FDA-CBER-2021-5683-1149487
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 4
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FDA-CBER-2021-5683-1149488
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 5Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197c00651\Approved\Approved On: 06-Aug-2021 14:38 (GMT)
FDA-CBER-2021-5683-1149489
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 6QUERY 2
Please update the Table 3.2.S.2.5 -2 “Performance Tests for Commercial Scale
Validation and Routine Batches” in Section 3.2.S.2.5 Process Validation and/or
Evaluation –Additional Process Evaluation to include the acceptance criteria/action limit for
the performa nce-related parameters based on the results from the initial validation
studies and the experience from commercial production.
RESPONSE 2
The is monitored for validation using the performance
parameters withestablished acceptance criteria based on initial validation studies and earl y
commercial production aslisted in the Table 2 below.Table 3.2.S.2.5 -2 in Section 3.2.S.2.5
Process Validation and/or Evaluation-Additional Process Evaluation has been updated.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
3.2.S.2.5 Process Validation and/or Evaluation – Additional Process Evaluation Replaced
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149490
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 7QUERY 3
In document INX100433827 : COVID-19 Vaccine Drug Substance Process Validation Final
Report, a deviation (PR ID 5222684) described that for PPQ batches 20Y513C301 –
20Y513C601, was set
However, in Table 4-5 Results for Additional Process Inputs,
rate for all the impacted batches was recorded as Please explain this
discrepancy .
RESPONSE 3
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
INX100433827 : COVID-19 Vaccine Drug Substance Process Validation Final Report for ,
Andover, MA
Previously submitted supporting documentation
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FDA-CBER-2021-5683-1149491
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 8QUERY 4
Regarding the process validation and/or evaluation for the
in Pfizer Kalamazoo and Pfizer Puurs, please describe any process controls and
performance verification implemented at the DS during PPQ execution and
provide available data to support the use of both
. Please also confirm that the
for all evaluated PPQ lots was within the target .
RESPONSE 4
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FDA-CBER-2021-5683-1149492
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 9
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FDA-CBER-2021-5683-1149493
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 10
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FDA-CBER-2021-5683-1149494
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 11Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
090177e197c00651\Approved\Approved On: 06-Aug-2021 14:38 (GMT)
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FDA-CBER-2021-5683-1149495
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 12Previously submitted supporting documentation
None
090177e197c00651\Approved\Approved On: 06-Aug-2021 14:38 (GMT)
FDA-CBER-2021-5683-1149496
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 13QUERY 5
Please update the Table 3.2.A.3.1.1- 1 Nomenclature of ALC -0315 in Section 3.2.A.3.1.1
Nomenclature [ALC -0315] to include the product number/code for the lipid AL C-0315
manufactured in .
RESPONSE 5
does not have a unique product number/code for the ALC-0315 lipid. However on
their documentation, they report ALC-0315 as ALC-3
15. Therefore, Section 3.2.A.3.1.1
Nomencl
ature [ALC-0 315] is updated to indicate that ALC-0315 may be referred to as ALC-
315.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Section 3.2.A.3.1.1 Nomenclature [ALC -0315], Replaced
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149497
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 03 August 2021 FDA queries
PFIZER CONFIDENTIAL
Page 14QUERY 6
Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR query 3 dated
July 9, 2021, about the validation of the CGE Integrit y method, we do not agree that a
conclusion of a quantification limit of
The results as
shown in Table 3 may infer a quantification limit for
We acknowledge that the
assay is not for the assessment of impurity and theactual quantification limit for impurity
was not determined.
RESPONSE 6
We acknowledge that the Quantification Limit (QL) of is inferred
andthe actual QL for wasnotdemonstrated as part of the method validation
studies. was provided as part of the method
validation for the reportable of ) and the method has been
demonstrated to be suitable for intended use.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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