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PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 1
Title: Raw Data in S upport of VR -MVR -10080
Study Number: N/A
Parent Compound Number(s): PF-07302048
Alternative Com pound Identifiers: N/A
Pfizer Vaccine Research and Development
401 N. Middletown Rd.
Pearl River, NY
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
FDA-CBER-2021-5683-0779418
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 2Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779419
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 3Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779420
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 4Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779421
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 5Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779422
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 6Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779423
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 7Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779424
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 8Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779425
PF-07302048 : Raw Data in Support of VR -MVR -10080
VR-MVR -10080 -ATT01, Ver. 2.0
PFIZE R CONFIDENTIAL
Page 9Table 1.Data Listing for Detection Limit, Clinical Sensitivity Specificity Evaluation
SampleBarcode Result E Ct N2 Ct
090177e1949f3f44\Approved\Approved On: 18-Aug-2020 18:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779426