Document text
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
QUERY 1 ................................ ................................ ................................ ................................ ...2
RESPONSE 1 ................................ ................................ ................................ ................... 2
QUERY 2 ................................ ................................ ................................ ................................ ...3
RESPONSE 2 ................................ ................................ ................................ ................... 3
QUERY 3 ................................ ................................ ................................ ................................ ...5
RESPONSE 3 ................................ ................................ ................................ ................... 6
QUERY 4 ................................ ................................ ................................ ................................ ...8
RESPONSE 4 ................................ ................................ ................................ ................... 8
090177e197d285b6\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
FDA-CBER-2021-5683-1149596
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 2QUERY 1
A.Regarding the RNA integrit y assa y by CGE: Please explain how the
If available, provide the work
instructions for CGE or commit to generating these instructions.
RESPONSE 1
Pfizer Kalamazoo uses
As Pfizer Kalamazoo does not have work instruction s for
, we commit to formalizing these instructions by 30 September 2021.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149597
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 3QUERY 2
B. Regarding lot release of the 7 EUA lots:
1. Please send samples (20 vials) of each lot to the address noted below as soon as possible.
We can receive them an y day and prefer that they be received NO LATER THAN
Wednesday 18 August 2021. Please c ontact Mr. Quander at
[email protected] for specific shipping instructions and to notify him of
shipments.
Shipments should be sent to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Sample Custodian
10903 New Hampshire Avenue
WO75 -G707
Silver Spring, MD 20993 -0002
2.Please confirm your intent to accept all our instructions for the Lot Release Protocol
template in the section below. Please request a telecon for clarification if needed. Please
note that because we have expe dited the review process, we may request changes to the
protocol in the future.
3.Although we cannot commit to a 48 -hour turnaround time for lot release as y ou have
requested, we are committed to completing the required review and testing expeditiously .
RESPONSE 2
1. 20 vials of each of the identified EUA lots will be shipped to the provided address for
receipt no later than Wednesday 18 August 2021.
2. Pfizer accepts all instructions included in this IR for the Lot Release Protocol template for
the initi al identified EUA lots. Pfizer respectfully requests the opportunit y to propose
changes to the Lot Release Protocol template for future lots.
3. Pfizer acknowledges that CBER cannot commit to a 48 -hour turnaround time for lot
release but will complete the review and testing expeditiously .
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
090177e197d285b6\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
FDA-CBER-2021-5683-1149598
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 4Previously submitted supporting documentation
None
090177e197d285b6\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
FDA-CBER-2021-5683-1149599
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 5QUERY 3
C. Comments on lot release protocol (LRP) template submitted t o BLA 125742/0.40
NOTE: Page numbers referenced below are from Adobe page numbering (not the page
numbers on the footer).
It has been determined that lot release protocols will be submitted electronically . Due to that
the following is requested regarding pages 1 and 2.
i. Throughout document
Renumber the entire document with the Electronic Protocol Signature Page as Page 1
ii. Page 2 of 12
Please remove the reason for submission as that is now on page 1 of 12.
Please replace the Fill Information with the t able of Fill Information form Page 3 of 12.
iii. Page 3 of 12
Please remove the Reason for Submission.
Please remove the following:
All lot release tests conducted on this lot, as per the product license are reported and pass
specifications as required.
Prepared By : Approved By :
iv. Page 6 of 12:
RNA encapsulation and content test
Sponsor question: What is required for R2 for standard A and B?
CBER Response: Regarding your RNA encapsulation and content test: The test described in
TM#100010402 requir es the coefficient of determination (R2) for to be
Please provide the R2 values for standards A (standard in ) and B (standard
in ) for each test performed. We note that y ou have not incorporated all requested
information for this test in the LRP. Please include Encapsulated RNA and Total RNA
results in mg/mL units, as requested previously .
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FDA-CBER-2021-5683-1149600
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 6v. Page 8 of 12
In Vitro Expression Assay
Sponsor Question: What is required for Average Number of Cells Counted for sample and %
cell viability ?
CBER Response: Regarding your in vitro expression assay : The SOPs for this assay
(SOP#113198 and TM# 100010380) include assay acceptance criteria for number of cells
counted cells) and cell viability Please provide the % cell viability
and the average number of cells counted for the test sample (the average number of
as described in the Data Anal ysis section of the test method).
vi. Page 10 of 12
Please replace the Limulus Amebocy teLysate Test template with the template in Attachment
1 of this information request.
RESPONSE 3
The requested changes have been made to the Lot Release Protocol (LRP).
On Saturday 14 August 2020 provided an updated Lot Release Protocol to CBER via email
with the following introduction:
Pfizer has modified the Lot Release Protocol template to comply with each of
CBER’s requests, except that we believe there is a ty po in the template provided by
CBER for page 10, where units of “IU/mL” were prescribed, but these should
actuall y be “EU/mL”. If there is some other reason for this difference, we commit to
aligning with CBER on the correct units to be used.
Please notify us as soon as CBER has confirmed that this template is acceptable. We
will then use the agreed template to begin to populate data from the first lots that will
be sent for CBER release under the lot release program. Alternativel y if there are an y
questions or issues, please contact me b y phone at the mobile number below to
resolve them.
CBE R subsequently confirmed that the correct units on page 10 were EU/mL and that the
template provided was acceptable.
The L RP provided as a part of this response is identical to the one provided to CBER via
email on 14 August 2021.
Literature References
None
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FDA-CBER-2021-5683-1149601
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 7SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Lot Release Protocol, replaced
Previously submitted supporting documentation
None
090177e197d285b6\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
FDA-CBER-2021-5683-1149602
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Aug 2021 FDA queries –LRP Template IR
PFIZER CONFIDENTIAL
Page 8QUERY 4
We have the following questions to y our response (dated 08/11/21) to our IR (dated
08/06/21), regarding submission of diagrams with
the L ot Release Protocols (L RP):
i. Regarding the L ipids assay (TM100010322): Your assay requires visual inspection of
(SOP # TM100010322 section 15.2, which states “For identity testing the
Hence, please
attach the as requested. These can be at tached as a separate page at the end of
your LRP if the cannot be inserted into the template itself. In addition, please provide
the following information in Table format: Retention times (RT) for each lipid component of
the standard and the sample and the
Please include a statement at the top or bottom of the table to indicate the assay has a
limit as acceptance criterion and indicate if the assay results meet the criterion.
ii. Regarding the RNA integrit y assay (TM100010392):
The SOP does not provide instructions on how the
In addition, the
provided suggest the could be subjective. Hence,
please provide the in your LRPs as requested in our previous information
request. These can be submitted as PDFs that are attached at the end of your LRP if they
cannot be inc orporated into the report automatically .
RESPONSE 4
i. Pfizer commits to providing for the L ipids assay as attachments at the end
of the Lot Release Protocol. A table will be included which contains the retention times for
each lipid compon ent of the standard and sample and
A statement at the top of the table will specify the assay
acceptance criterion of and will indicate if the assay results meet the criterion.
ii. Pfizer commits to providing for the RNA integrit y assay as attachments
at the end of the Lot Release Protocol.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted suppo rting documentation
None
090177e197d285b6\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
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FDA-CBER-2021-5683-1149603