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PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 1Title:LOD Data 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
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
FDA-CBER-2021-5683-0779521
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
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 –LOD Samples ............4
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779522
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 3Table1. for the SARS-CoV-2 mNG NT
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779523
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 4Table2.SARS-CoV-2 mNG NT Validation Data Listing –LODSamples
TDV Batch Plate
BarcodeAssay Date Sample S ample Barcode MDP Set Analyst Neut Titer/
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779524
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 5Table2.SARS-CoV-2 mNG NT Validation Data Listing –LODSamples
TDV Batch Plate
BarcodeAssay Date Sample S ample Barcode MDP Set Analyst Neut Titer/
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779525
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 6Table2.SARS-CoV-2 mNG NT Validation Data Listing –LODSamples
TDV Batch Plate
BarcodeAssay Date Sample S ample Barcode MDP Set Analyst Neut Titer/
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779526
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 7Table2.SARS-CoV-2 mNG NT Validation Data Listing –LODSamples
TDV Batch Plate
BarcodeAssay Date Sample S ample Barcode MDP Set Analyst Neut Titer/
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779527
PF-07302048 : LOD Data Listing for VR-MVR-10083
VR-MVR-10083-ATT03, Ver. 1.0
PFIZER CONFIDENTIAL
Page 8Table2.SARS-CoV-2 mNG NT Validation Data Listing –LODSamples
TDV Batch Plate
BarcodeAssay Date Sample S ample Barcode MDP Set Analyst Neut Titer/
This data table w as provided by Early Clinical Development Biostatistics.
090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779528