Document text
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 1
Title: Supportive Data for VR -MQR-10 212
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
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
FDA-CBER-2021-5683-1072837
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
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
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072838
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 31.DATA LISTING OF SAMPLE P RECISION 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, sample barcode, bead lot, analy st initials and
.
Table 2includes all QCS data from qualification runs.
Table 1.Abbreviations
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072839
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 4Table 1.Abbreviations
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072840
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 5Table 2.Experimental Data Listing -Addit ional (Non- Clinical) Runs
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072841
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 6Table 2.Experimental Data Listing -Addit ional (Non- Clinical) Runs
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072842
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 7Table 2.Experimental Data Listing -Addit ional (Non- Clinical) Runs
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072843
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 8Table 2.Experimental Data Listing -Addit ional (Non- Clinical) Runs
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072844
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 9Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072845
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 10Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072846
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 11Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072847
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 12Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072848
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 13Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072849
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 14Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072850
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 15Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072851
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 16Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072852
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 17Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072853
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 18Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072854
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 19Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072855
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 20Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072856
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 21Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072857
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 22Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072858
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 23Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072859
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 24Table 3.Experimental Data Listing - Precision
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072860
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 25Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072861
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 26Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072862
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 27Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072863
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 28Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072864
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 29Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072865
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 30Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072866
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 31Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072867
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 32Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072868
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 33Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072869
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 34Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072870
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 35Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072871
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 36Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072872
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 37Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072873
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 38Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072874
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 39Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072875
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 40Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072876
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 41Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072877
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 42Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072878
PF-07302048 : Supportive Data for VR -MQR -10212
VR-MQR -10212 -ATT01, Ver. 2.0
PFIZER CONFIDENTI AL
Page 43Table 4.Experimental Data Listing - Linearity
090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1072879