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PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 1Title: Supportive Data for VR -MVR -10081
Study Number: C4591001
Parent Compound Number(s): PF-07302048
Alternative Compound Identifiers: N/A
Pfizer Vaccine Research and Development
401 N. Middletown Rd.
Pearl River, NY
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
FDA-CBER-2021-5683-0779449
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................2
LIST OF TABLES
Table 1. Data Listing for Clinical Sensitivity and Clinical Specificit y
Evaluation ................................ ................................ ................................ ...3
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
FDA-CBER-2021-5683-0779450
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 3Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779451
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 4Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779452
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 5Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779453
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 6Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779454
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 7Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779455
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 8Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779456
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 9Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779457
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 10Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779458
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 11Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779459
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 12Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779460
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 13Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779461
PF-07302048 : Supportive Data for VR -MVR -10081
VR-MVR -10081-ATT01, Ver. 1.0
PFIZER CONFIDENTIAL
Page 14Table 1.Data Listing for Clinical Sensitivity and Clinical Specificity Evaluation
Sample IDaTest Result
(COI)Final Outcome
n-Negative
r-PositivePCR COVID Result
a.Refer to Supportive Table 10.2 and Supportive Table 10.3 in VR -MVR -10081 for positive and negative
donor sample identification, respectively.
090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779462