Document text
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 1LRP TEMPLATE FOR STN 125742/0:
QUERY 1:
Please submit a lot release protocol template for COVID -19 mRNA Vaccine for CBER
review b y COB Friday , July 9, 2021. Please include the assay s performed and acceptance
criteria for the drug product.
RESPONSE 1
The Lot release protocol that included the assay s performed and acceptance criteria was
previously provided with the initial submission . The same Lot Release Documentation
Package isattached here for eas y of reference.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
Lot Release Documentation Package
The requested samples and reagents were shipped to the following address infour shipments as
detailed below :
Emnet Yitbarek
Food and Drug Administration
Center for Biologics Evaluation and Research
Division of Biological Standards and Quality Control
10903 New Hampshire Avenue
WO75, G -650
Silver Spring, MD 20993
-Three drug substance batches, shipped on July 8, 2021
-Three drug product lots, shipped on July 8, 2021
-Drug substance, drug product and lipid reference materials/controls and ,
shipped on July 8, 2021
-Mate rials for In vitro expression, RT -PCR and ddPCR, shipped on July 7, 2021
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149307
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 2SAMPLE AND REAGENT IR FOR 125742/0: D RUG SUBSTANCE (DS)
QUERY 2
Please provide 50 aliquots (200 µL aliquots preferred) of DS from three different lots and the
following reagents in sufficient quantity to perform 50 independent tests for the following
DS assay s:
RESPONSE 2
The Sponsor is providing 1 X 35 ml bottle of DSeach from lots 21Y513C2301,
21Y513C2401 and 21Y513C2501. The Certificate of Anal ysis for each lot is also provided .
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
21Y513C2301 Certificate of Anal ysis
21Y513C2401 Certificate of Anal ysis
21Y513C2501 Certificate of Anal ysis
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
FDA-CBER-2021-5683-1149308
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 3QUERY 3
5’ –Cap assay
i. The current assay control (PF -07305885 DS reference material or equivalent as stated
in TM100010578)
RESPONSE 3
The Sponsor is providing 50 vials of drug substance reference material lot #
, which i s adequate to perform 50 tests. As stated on the Certificate of Analysis, this
material may be stored up to day s at °C if sampled asepticall y.
The Certificate of Anal ysis for drug substance reference material lot # is
also provided .
The Sponsor is also providing 6 vials of
, which is sufficient volume to perform the requested
number of independent tests. The concentration of the
Batch and Reference numbers are printed on the vials.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Certificate of Anal ysis
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149309
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 4QUERY 4
Poly(A) Tail
i. The current internal control as stated in TM100010379
RESPONSE 4
The Sponsor is providing 50 vials of drug substance reference material lot #
for use as internal control, which is adequate to perform 50 tests. As stated on the
Certificate of Anal ysis, this material may be stored up to day s at °C if sampled
asepticall y.
The Certificate of Anal ysis for drug substance reference material lot # is
also provided.
The sponsor is providing the following reagents inclusive of all materials required to perform
the anal ytical procedure: Refer to Table 1.
Table 1. List of Reagents
Reagent Nam e Lot
NumberVendor
Catalog, Lot
NumberExpiry
DateConcentrati
onQuantit
y (vial)Vial
Volume
(μL)Storage
Temp
(oC)
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FDA-CBER-2021-5683-1149310
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 5Table 1. List of Reagents
Reagent Nam e Lot
NumberVendor
Catalog, Lot
NumberExpiry
DateConcentrati
onQuantit
y (vial)Vial
Volume
(μL)Storage
Temp
(oC)
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149311
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 6Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
FDA-CBER-2021-5683-1149312
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 7Drug Product (DP)
QUERY 5
Please provide 170 vials of DP per lot from three different DP lots and the following reagents
for the following DP release assay s:
RESPONSE 5
The Sponsor is providing 170 vials of the drug product lots FC3181, FC3184 and FD0809.
The Certificate of Anal ysis for each lot is also provided.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
FC3181 Certificate of Analy sis
FC3184 Certificate of Analy sis
FD0809 Certificate of Analy sis
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
FDA-CBER-2021-5683-1149313
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 8QUERY 6
LNP Size
i. Current assay control - an amount (in 3 aliquots) adequate to perform 10 independent
tests
RESPONSE 6
The Sponsor is providing 10 vials of assay control lot # PF -07302048 -DP-RM, which is
adequate to perform 10 independent tests. Each vial is suitable for a single use and the
remaining material should be discarded.
The Certificate of Anal ysis for PF -0730 2048 -DP-RM is also provided.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
PF-07302048 -DP-RMCertificate of Anal ysis
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
FDA-CBER-2021-5683-1149314
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 9QUERY 7
RNA Encapsulation and RNA Content
i. Reference Standards A and B -50 vials of each standard or enough to perform 50
tests
RESPONSE 7
The Sponsor is providing 50 vials of drug substance reference material lot #
which is adequate to perform 50 tests. One aliquot is suit able to prepare both the
for determination of RNA content and RNA encapsulation. As stated on the
Certificate of Anal ysis, the drug substance reference material may be stored up to day s at
°C if maintained aseptically .
The Certificate of Anal ysis for drug substance reference material lot # is
also provided.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Certificate of Anal ysis
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149315
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 10QUERY 8
Lipid identities
i. Reference PF -07302048 - 20 vials
ii. Four (4) lipid standards -5 grams of each
RESPONSE 8
The Sponsor is providing 5 single -use aliquots of cholesterol, DSPC and ALC- 0159, and
of ALC -0315 in a multi -usebottle that may undergo 5 freeze/thaw cycles. These
materials may be used to prepare up to stock standard solutions with each preparation
having a shelf -life of and enough volume for approximately assay s. In total,
these lipid materials are sufficient to perform approximately assay s.
The Certificate of Anal ysis for cholesterol lot # 677100P -1G-A- 010, DSPC lot # 677365-1G-
A-010, ALC -0315 lot # 67735O -1G- 010 and AL C-0159 lot 677159P -1G-A- 010 are also
provided.
The Sponsor is providing 20 vials of drug product lot # PF -07302048 -DP-RM, which is
adequate to perform 20 independent tests. Each vial is suitable for a single use and the
remaining material should be discarded.
The Certificate of Anal ysis for PF -07302048 -DP-RM is also provided.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
PF-07302048 -DP-RM Certificate of Anal ysis
677100P-1G-A-010 Certificate of Anal ysis
677365 -1G-A- 010 Certificate of Analy sis
67735O-1G-010 Certificate of Anal ysis
677159P-1G-A-010 Certificate of Anal ysis
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149316
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 11QUERY 9
Identity of encoded RNA sequence
50 vials of each reagent OR enough to perform 50 tests
i. Positive PCR Control: PF -07305885 DS or equivalent as stated in TM1 00010407
ii. Positive Control: PF -07302048 DP or equivalent as stated in
TM100010407
RESPONSE 9
The Sponsor is providing 50 vials of drug substance reference material lot #
, which is adequate to perform 50 tests. As stated on the Certificate of Analy sis, this
material may be stored up to day s at °C if sampled asepticall y.
The Certificate of Anal ysis for drug substance reference material lot # is
also provided.
The Sponsor is also providing 50 vials of positive control lot # DP- CONT-
EL8983, which is adequate to perform 50 independent tests. As stated on the Certificate of
Analy sis, this material may be stored up to day s at °C if sampled aseptically .
The Certificate of Anal ysis for DP -CONT- EL8983 is also provided.
Finally , the sponsor is providing the following reagents:
Reagent
Nam eLab
Notebook
ReferenceManufacturer
Catalogue and
Lot NumbersExpiry date Sample
Concentration
(μM)Quantity
(vial)Volume
(µL)Storage
Temp
(oC)
Literature References
None
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FDA-CBER-2021-5683-1149317
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 12SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
DP-CONT- EL8983 C ertificate of Anal ysis
Certificate of Anal ysis
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149318
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 13QUERY 10
In Vitro Expression Potency assay
i.
ii. Reference Standards, Qualified -50 vials of
each or enough of each to p erform 50 tests
RESPONSE 10
The Sponsor is providing the following materials requested to perform the in vitro expression
potency assay .
Reagent Name Reagent Lot#Quantity Expiry ConcentrationStorage
Condition
(°C)
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149319
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 14QUERY 11
RNA Integrity
i. Reference Material - 50 vials of each reagent OR enough to perform 50 tests
RESPONSE 11
The Sponsor is providing 50 vials of drug substance reference material lot #
which is adequate to perform 50 tests. As stated on the Certificate of Analy sis, the
drug substance reference material may be stored up to day s at °C if ma intained
asepticall y.
The Certificate of Anal ysis for drug substance reference material lot # is
also provided.
The Sponsor is also providing 50 vials of drug product lot # DP- CONT- EL8983, which is
adequate to perform 50 independent tests.
The Certificate of Anal ysis for DP -CONT- EL8983 is also provided.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
DP-CONT- EL8983 COA
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149320
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 15DOCUMENTATION
QUERY 12
1. Please provide Certificates of Anal ysis for all reagents
2. Please provide results of the assays listed for the DS lots and DP lots submitted to CBER
Response 12
1. Certificate of anal ysis for all reagents are provided. Reference responses supporting
documentation sections.
2. The results of the assay s listed for the DS lots and DP lots submitted to CBER are
provided in the attached Certificate of anal ysis. Reference supporting documentation
sections .
Literature References
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
FDA-CBER-2021-5683-1149321
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0
PFIZER CONFIDENTIAL
Page 16SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Supporting Documentation
Certificate of Anal ysis DS reference material
FC3181 Certificate of Analy sis DP Lot COA
FC3184 Certificate of Analy sis DP Lot COA
FD0809 Certificate of Analy sis DP Lot COA
PF-07302048 -DP-RMCertificate of Anal ysis DP reference material
677100P-1G-A-010 Certificate of Anal ysis Cholesterol Lot COA
677365 -1G-A-010 Certificate of Analy sis DSPC lot COA
677315O-1G-A-010 Certificate of Anal ysis ALC-0315 Lot COA
677159P-1G-A-010 Certificate of Anal ysis ALC-0159 Lot COA
DP-CONT_EL8983 Certificate of Anal ysis Positive control
Lot 21Y513C2301 Certificate of Analy sis DS COA
Lot 21Y513C2401 Certificate of Analy sis DS COA
Lot 21Y513C2401 Certificate of Analy sis DS COA
Previously submitted supporting documentation
None
090177e1978486f8\Approved\Approved On: 09-Jul-2021 03:31 (GMT)
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FDA-CBER-2021-5683-1149322