Pfizer Documents (PHMPT/FDA)
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BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 26July 2021 Information Request Regarding Disposition of Participants in Safety Populations Who Experienced Pregnanc y July2021 090177e197b21f4e\Approved\Approved On: 30-Jul-2021 18:41 (GMT) FDA-CBER-2021-5683-0950146 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2LIST OF ABBREVIATIONS…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 30July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research DocumentControl 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)
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BNT162b2 BLASTN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to 27 July 2021 CBER Information Request Regarding Assessment of Vaccine Effectiveness 30July 2021 090177e197b1d030\Approved\Approved On: 30-Jul-2021 14:59 (GMT) FDA-CBER-2021-5683-0950154 FDA-CBER-2021-5683-0950155 BNT162b2 BLASTN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 3LIST OF ABBREVIATIONS Abbreviation Term BLA…
Pfizer Documents (PHMPT/FDA)
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· 181 pages
Page 1 of 181 ***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: 1101 Site Name: (1101) Prairie Fields Family Medicine Subject No: 11011115 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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)
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· 583 pages
Page 1 of 583 ***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: 1107 Site Name: (1107) Coastal Clinical Research Subject No: 11071031 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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…
Pfizer Documents (PHMPT/FDA)
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· 372 pages
Page 1 of 372 ***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: 1107 Site Name: (1107) Coastal Clinical Research Subject No: 11071044 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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…
Pfizer Documents (PHMPT/FDA)
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· 206 pages
Page 1 of 206 ***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: 1107 Site Name: (1107) Coastal Clinical Research Subject No: 11071065 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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…
Pfizer Documents (PHMPT/FDA)
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· 142 pages
Page 1 of 142 ***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: 1107 Site Name: (1107) Coastal Clinical Research Subject No: 11071116 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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…
Pfizer Documents (PHMPT/FDA)
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· 243 pages
Page 1 of 243 ***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: 1107 Site Name: (1107) Coastal Clinical Research Subject No: 11071191 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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…
Pfizer Documents (PHMPT/FDA)
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· 112 pages
Page 1 of 112 ***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: 1107 Site Name: (1107) Coastal Clinical Research Subject No: 11071196 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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…
Pfizer Documents (PHMPT/FDA)
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· 176 pages
Page 1 of 176 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091036 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 303 pages
Page 1 of 303 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091074 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 242 pages
Page 1 of 242 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091084 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 399 pages
Page 1 of 399 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091111 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 195 pages
Page 1 of 195 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091164 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 224 pages
Page 1 of 224 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091204 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 223 pages
Page 1 of 223 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091269 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 165 pages
Page 1 of 165 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091276 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 195 pages
Page 1 of 195 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091284 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 131 pages
Page 1 of 131 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091387 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…