Document text
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 1
Title: Supportive Data for VR -MQR-10 211
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
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
FDA-CBER-2021-5683-0779236
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................2
1.DATA LISTING OF SAM PLE PRECI SION AND LINEARITY
EVALUATIONS ................................ ................................ ................................ .................. 3
LIST OF TABLES
Table 1. Abbreviations ................................ ................................ .............................. 3
Table 2. Experimental Data L isting -Additional (Non -Clinical) Runs .................... 5
Table 3. Experimental Data L isting -Precision ................................ ........................ 9
Table 4. Experimental Data L isting - Linearity ................................ ........ 25
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779237
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 31.DATA LISTING OF SAMPLE PRECISI ON AND LINEARITY
EVALUATIONS
Thedata listing tables provide listing of precision and linearity runs in addition to
non-clinical runs t hat were performed using same reagents and process es. The tables prov ide
the batch name, date, sam ple barcode, be ad lot, analy st initials and
.
Table 2 includes all QCS da tafrom qualification runs.
Table 1.Abbreviations
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779238
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 4Table 1.Abbreviations
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779239
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 5Table 2.Expe rimental Da ta Listing -Additional (Non -Clinical) Runs
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779240
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 6Table 2.Expe rimental Da ta Listing -Additional (Non -Clinical) Runs
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779241
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 7Table 2.Expe rimental Da ta Listing -Additional (Non -Clinical) Runs
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779242
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 8Table 2.Expe rimental Da ta Listing -Additional (Non -Clinical) Runs
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779243
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 9Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779244
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 10Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779245
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 11Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779246
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 12Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779247
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 13Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779248
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 14Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779249
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 15Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779250
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 16Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779251
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 17Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779252
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 18Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779253
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 19Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779254
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 20Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779255
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 21Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779256
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 22Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779257
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 23Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779258
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 24Table 3.Experimental Data Listing -Precision
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779259
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 25Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779260
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 26Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779261
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 27Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779262
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 28Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779263
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 29Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779264
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 30Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779265
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 31Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779266
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 32Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779267
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 33Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779268
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 34Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779269
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 35Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779270
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 36Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779271
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 37Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779272
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 38Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779273
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 39Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779274
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 40Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779275
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 41Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779276
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 42Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779277
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 43Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779278
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 44Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779279
PF-07302048 : Supportive Data for VR -MQR -10211
VR-MQR -1021 1-ATT01, Ver. 2.0
PFIZER CONFIDENTIAL
Page 45Table 4.Experimental Data Listing - Linearity
090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779280