Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 4 pages
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 Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 9 pages
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,…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 23 pages
PF-07302048: Report on Method Validation of a Cepheid Xpert® Xpress PCR Assay to Detect SARS -CoV -2 VR-MVR -10080, Ver. 3.0 PFIZER CONFIDENTIAL Page 1 Title: Report on Method Validation of a Cepheid Xpert ® Xpress PCR Assay to Detect SARS -CoV -2 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 090177e194e5352d\Approved\Approved On: 16-Sep-2020 13:48 (GMT)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
PF-07302048 : QCS Infection Ratio Data Listing VR-MQR- 10214-ATT03, Ver. 1.0 PFIZER CONFID ENTIAL Page 1 Title: QCS I nfection Ratio Data L isting 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 090177e19474664e\Approved\Approved On: 28-Jul-2020 14:01 (GMT) FDA-CBER-2021-5683-0779389 FDA-CBER-2021-5683-0779390 PF-07302048 : QCS Infection Ratio Data Listing VR-MQR-…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
PF-07302048 : QCS Data Listin g VR-MQR- 10214-ATT02, Ver. 1.0 PFIZER CONFID ENTIAL Page 1 Title: QCS Data L isting 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 090177e194744851\Approved\Approved On: 28-Jul-2020 13:57 (GMT) FDA-CBER-2021-5683-0779383 PF-07302048 : QCS Data Listin g VR-MQR- 10214-ATT02, Ver. 1.0 PFIZER CONFID ENTIAL Page 2TABLE OF CONTENTS LIST OF…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 9 pages
PF-07302048 : Precision Experiment Data List ing VR-MQR- 10214-ATT01, Ver. 1.0 PFIZER CONFID ENTIAL Page 1 Title: Precision Experiment Data Listing 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 090177e194744534\Approved\Approved On: 28-Jul-2020 13:56 (GMT) FDA-CBER-2021-5683-0779374 PF-07302048 : Precision Experiment Data List ing VR-MQR- 10214-ATT01, Ver. 1.0 PFIZER…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 21 pages
PF-073020 48: Qualificati on of the SARS -CoV -2 mNeon Green Virus Micron eutralization Assay VR-MQR -1021 4, Ver. 2.0 PFIZER CONFIDENTIAL Page 1 Title: Qualification of the SARS- CoV -2 mNeonGreen Virus Microneutralization Assay Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vacc ine Research and Development 401 N. Mi ddletow n Rd. Pearl River, NY 090177e194a57b00\Approved\Approved On: 18-Aug-2020 17:57 (GMT) FDA-CBER-2021-5683-0779353…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 43 pages
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-2021-5683-0779310 PF-07302048 : Supportive Data for VR -MQR -10212 VR-MQR -10212 -ATT01, Ver. 2.0…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 29 pages
PF-07302048 : Qualification Report for a Single -plex Direct Luminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS -CoV -2 RBD Protein in Human Sera VR-MQR -10212 , Ver. 2.0 PFIZER CONFIDENTIAL Page 1 Title: Qualification Report for a Single -plex Direct L uminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS- CoV -2 RBD Protein in Human Sera Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 45 pages
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-2021-5683-0779236 PF-07302048 : Supportive Data for VR -MQR -10211 VR-MQR -1021 1-ATT01, Ver. 2.0 PFIZER…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 29 pages
PF-07302048 : Qualification Report for a Single -plex Direct Luminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS -CoV -2 S1 Protein in Hum an Sera VR-MQR -10211 , Ver. 2.0 PFIZER CONFIDENTIAL Page 1Title: Qualification Report for a Single -plex Direct L uminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS- CoV -2 S1 Protein in Human Sera Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 19July 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologic s Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 524 pages
BioNTech SE An der Goldgrube 12 55131 Mainz, Germany Phone: +49 (0)6131 9084 -0 Telefax: +49 (0)6131 9084 -390 R&D STUDY REPORT No . R-20- 0253 NEUTRALIZIN G ANTIBODY TIT ER AND SARS-COV-2 S1- AND RBD-SPECIF IC ANTIBODY CONCENTRATION IN SERUM FROM PARTICIPANTS I N THE BNT162- 01 TRIAL Version 02 Date: 28 NOV 2020 Reported by Alexander Muik Test item: SARS-CoV-2 vaccines BNT162b1 and BNT162b2 Key words: BNT162-01 trial , BNT162b1 , BNT162b2, virus neutralization, antibody …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 178 pages
Page 1 of 178 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161198 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 840 pages
Page 1 of 840 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161224 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 565 pages
Page 1 of 565 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161253 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 279 pages
Page 1 of 279 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1127 Site Name: (1127) Heartland Research Associates Subject No: 11271023 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:25 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 129 pages
Page 1 of 129 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1127 Site Name: (1127) Heartland Research Associates Subject No: 11271112 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:25 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 432 pages
Page 1 of 432 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada Subject No: 11361029 Subject Initials: --- Generated By: Generated Time (GMT): 19-Apr-2021 21:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 224 pages
Page 1 of 224 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada Subject No: 11361082 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…