Document text
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 1Title:Precision D ata Listing for VR-MVR-10083
Study Number: N/A
Parent Compound Number(s): PF-07302048
Alternative Compound Identifiers: N/A
Pfizer Vaccine Research and Development
401 N. Middletown Rd.
Pearl River, NY
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
FDA-CBER-2021-5683-0779504
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENT S
LIST OF TABLES.....................................................................................................................2
LIST OF TABLES
Table 1. for the SARS- CoV-2 mNG NT ................................ ...........3
Table2. SARS-CoV-2 mNG NT Validation Data Listing –Precision
Samples.......................................................................................................4
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779505
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 3Table1. fortheSARS-CoV-2 mNG NT
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779506
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 4Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779507
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 5Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0779508
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 6Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779509
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 7Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779510
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 8Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779511
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 9Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779512
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 10Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779513
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 11Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0779514
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 12Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779515
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 13Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779516
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 14Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779517
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 15Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779518
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 16Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779519
PF-07302048 : Precision Data Listing for VR -MVR-10083
VR-MVR-10083-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 17Table2.SARS-CoV-2 mNG NT Validation Data Listing –Precision Samples
TDV Batch Plate Barcode Assay Date Sample Sample Barcode MDP Set AnalystNeut Titer/
This data table w as provided by Early Clinical Devel opment Biostatistics.
090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779520