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-2021-5683-1072763
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-2021-5683-1072764
FDA-CBER-2021-5683-1072765
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-2021-5683-1072766
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-2021-5683-1072767
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-2021-5683-1072768
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-2021-5683-1072769
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-2021-5683-1072770
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-2021-5683-1072771
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-2021-5683-1072772
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-2021-5683-1072773
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-2021-5683-1072774
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-2021-5683-1072775
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-2021-5683-1072776
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-2021-5683-1072777
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-2021-5683-1072778
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-2021-5683-1072779
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-2021-5683-1072780
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-2021-5683-1072781
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-2021-5683-1072782
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-2021-5683-1072783
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-2021-5683-1072784
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-2021-5683-1072785
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-2021-5683-1072786
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-2021-5683-1072787
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-2021-5683-1072788
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-2021-5683-1072789
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-2021-5683-1072790
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-2021-5683-1072791
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-2021-5683-1072792
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-2021-5683-1072793
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-2021-5683-1072794
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-2021-5683-1072795
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-2021-5683-1072796
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-2021-5683-1072797
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-2021-5683-1072798
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-2021-5683-1072799
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-2021-5683-1072800
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-2021-5683-1072801
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-2021-5683-1072802
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-2021-5683-1072803
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-2021-5683-1072804
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-2021-5683-1072805
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-2021-5683-1072806
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-2021-5683-1072807