Document text
PF-07302048 : Supportive Data for VR -MVR -10080
VR-MVR -10080-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 1Title: Supportive Data for VR -MVR -10080
Study Number: C5491001
Parent Compound Number(s): PF-07302048
Alternative Compound Identifiers: N/A
Pfizer Vaccine Research and Development
401 N. Middletown Rd.
Pearl River, NY
090177e19485a15b\Approved\Approved On: 30-Jul-2020 23:37 (GMT)
FDA-CBER-2021-5683-0779427
PF-07302048 : Supportive Data for VR -MVR -10080
VR-MVR -10080-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................2
LIST OF TABLES
Table 1. Personnel and Roles ................................ ................................ .................... 3
Table 2. Study Batches ................................ ................................ ............................. 4
090177e19485a15b\Approved\Approved On: 30-Jul-2020 23:37 (GMT)
FDA-CBER-2021-5683-0779428
PF-07302048 : Supportive Data for VR -MVR -10080
VR-MVR -10080-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 3Table 1.Personnel and Roles
Name Role
Protocol Approver , Summary Report Author, Functional
Manager
Contributing Scientist , Laboratory Anal yst
Contributing Scientist , Laboratory Anal yst
Joanna Wresilo Contributing Scientist , Laboratory Anal yst
Contributing Scientist , Laboratory Anal yst
Contributing Scientist , Laboratory Anal yst
Jason Bennett Contributing Scientist , Laboratory Anal yst
Tyler Garretson Contributing Scientist , Laboratory Anal yst
Contributing Scientist
Statistician, Summary Report Author
Statistician, Protocol Author
Charles Tan Statistician, Validation Approver
David Cooper Validation Approver
Michael Pride Validation Approver
Warren Kalina Validation Approver , Laboratory Supervisor
Quality and Compliance, Validation Approver
090177e19485a15b\Approved\Approved On: 30-Jul-2020 23:37 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0779429
PF-07302048 : Supportive Data for VR -MVR -10080
VR-MVR -10080-ATT02, Ver. 1.0
PFIZER CONFIDENTIAL
Page 4Table 2.Study Batches
Assay Date Batches BSC Analyst PCR Analyst Reagent Kit
Lot
090177e19485a15b\Approved\Approved On: 30-Jul-2020 23:37 (GMT)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779430