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C4591001 CONFIDENTIAL16.1.11 PUBLICATIONS BASED ON THE STUDY 1.Mulligan MJ, L yke KE, Kitchin N, et al. Phase 1/2 study of COVI D-19 RNA vaccine BNT162b1 in adults. Nature. 2020;10.1038/s41586 -020-2639 -4. 2.Walsh EE, Frenck FW, Falsey AR, et al. Safety and immunogenicity of two RNA -based Covid -19 vaccine candidates. N Engl J Med 2020; DOI : 10.1056/NEJMoa2027906. 090177e195963efc\Approved\Approved On: 24-Nov-2020 03:07 (GMT) Page 1 FDA-CBER-2021-5683-0029194 Phase 1/2 study of…
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BNT162b2 1.2 Request for Priority Review CONFIDENTIAL Page 1REQUEST FOR PRIORITY REVIEW COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742 MAY 2021 FDA-CBER-2021-5683-0013748 BNT162b2 1.2 Request for Priority Review CONFIDENTIAL Page 2TABLE OF CONTENTS ABBREVIAT IONS ................................ ................................ ................................ ................... 3 1. OVERVIEW ................................ ................................…
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Page 1 of 156 ***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: 1085 Site Name: (1085) Ventavia Research Group Subject No: 10851216 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22 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…
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Page 1 of 158 ***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: 1085 Site Name: (1085) Ventavia Research Group Subject No: 10851246 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22 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…
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C4591001: R oadmap for Event Selection and SDTM Dataset Updates for Reactogenicity Background: As discussed with the Agency on 08 April 2021, any events reported in the general adverse event data (AE domain ) which meet criteria for reactogenicity have been added to the FACE and VS domains and used to update the summary records in the CE domain , as described below. Add a flag in SUPPDM : QNAM=REACTOFL, QLABEL=Reactogenicity Population Fl ag For vaccinated subjects…
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E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ............................................................................. 2 Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population …
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CCI_Renal MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_RenalCode: 90002943Extension: CCIReport Date/Time: 27-Oct-2020:10:54:51 AM EDT Term Code Level Category Weight Scope Renal cortical necrosis 10038422 PT Renal cell dysplasia 10078656 PT Renal atrophy 10038381 PT Renal artery thrombosis 10038380 PT Renal artery stenosis 10038378 PT Renal artery perforation 10075737 PT Renal artery occlusion 10048988 PT Renal artery hyperplasia 10038377 PT Renal artery fibromuscular dysplasia…
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CCI_Rheumatic MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_RheumaticCode: 90002944Extension: CCIReport Date/Time: 27-Oct-2020:10:55:35 AM EDT Term Code Level Category Weight Scope Scleroderma-like reaction 10039714 PT Scleroderma renal crisis 10062553 PTScleroderma 10039710 PTRheumatoid vasculitis 10048628 PTRheumatoid scleritis 10067427 PTRheumatoid nodule removal 10053291 PTRheumatoid nodule 10048694 PTRheumatoid neutrophilic dermatosis 10072362 PTRheumatoid lung 10039081…
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Page 1 of 358 ***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: 1085 Site Name: (1085) Ventavia Research Group Subject No: 10851129 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22 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…
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Page 1 of 423 ***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: 1085 Site Name: (1085) Ventavia Research Group Subject No: 10851018 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22 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…
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Page 1 of 143 ***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: 1085 Site Name: (1085) Ventavia Research Group Subject No: 10851116 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22 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…
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E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ............................................................................. 3 Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population…
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Supplemental Analysis Reviewer Guide BLA Analysis for Participants ≥16 Years of Age BioNTech SE and PFIZER INC. Study C4591001 090177e196f19a08\Final\Final On: 04-May-2021 06:41 (GMT) FDA-CBER-2021-5683-0023988 Study C4591001 2 Table of Contents Contents 1. Introduction ................................................................................................................................. 3 090177e196f19a08\Final\Final On:…
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Table 1: Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – Phase 2/3 Subjects 16- 55 Years of Age – Safety Population ................................................................................................................. 2 Table 2: Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – Phase 2/3 Subjects >55 Years of Age – Safety Population…
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CCI_Lymphoma MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_LymphomaCode: 90002957Extension: CCIReport Date/Time: 27-Oct-2020:10:47:45 AM EDT Term Code Level Category Weight Scope Waldenstrom's macroglobulinaemia stage IV 10047809 PT Waldenstrom's macroglobulinaemia stage III 10047808 PT Waldenstrom's macroglobulinaemia stage II 10047807 PT Waldenstrom's macroglobulinaemia stage I 10047806 PT Waldenstrom's macroglobulinaemia refractory 10047805 PT Waldenstrom's macroglobulinaemia…
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CCI_Hemiplegia MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_HemiplegiaCode: 90002927Extension: CCIReport Date/Time: 27-Oct-2020:10:46:23 AM EDT Term Code Level Category Weight Scope Tropical spastic paresis 10044696 PT Tick paralysis 10077336 PTThoracic spinal cord paralysis 10057277 PTSupranuclear palsy 10048327 PTSpinal cord paralysis 10057268 PTQuadriplegia 10037714 PTQuadriparesis 10049680 PTPseudobulbar palsy 10037114 PTPeripheral paralysis 10054808 PTParesis 10033985…
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CCI_Leukemia MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_LeukemiaCode: 90002928Extension: CCIReport Date/Time: 27-Oct-2020:10:46:53 AM EDT Term Code Level Category Weight Scope Leukaemic infiltration ovary 10075853 PT Leukaemic infiltration hepatic 10058671 PT Leukaemic infiltration gingiva 10067431 PT Leukaemic infiltration extramedullary 10067117 PT Leukaemic infiltration 10069360 PT Leukaemic cardiac infiltration 10077563 PT Leukaemia recurrent 10062489 PT Leukaemia…
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CCI_Periph vasc MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Periph vascCode: 90002930Extension: CCIReport Date/Time: 27-Oct-2020:10:52:56 AM EDT Term Code Level Category Weight Scope Superior mesenteric artery syndrome 10054156 PT Subclavian artery stenosis 10050180 PTSubclavian artery occlusion 10069695 PTSubclavian artery aneurysm 10042331 PTSteal syndrome 10063900 PTSpontaneous amputation 10076246 PTSplenorenal shunt procedure 10077281 PTRenal artery stent removal 10069948…
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CCI_Pulmonary MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_PulmonaryCode: 90002942Extension: CCIReport Date/Time: 27-Oct-2020:10:53:42 AM EDT Term Code Level Categor yWeight Scope Pulmonary pneumatocele 10063749 PT Pulmonary ossification 10070310 PT Pulmonary necrosis 10058824 PT Pulmonary interstitial emphysema syndrome 10037415 PT Pulmonary hypertensive crisis 10068726 PT Pulmonary hypertension 10037400 PT Pulmonary fibrosis 10037383 PT Pulmonary eosinophilia 10037382 PT…
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CCI_Peptic ulcer MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Peptic ulcerCode: 90002938Extension: CCIReport Date/Time: 27-Oct-2020:10:52:28 AM EDT Term Code Level Category Weight Scope Peptic ulcer 10034341 PT Gastric ulcer, obstructive 10017840 PTGastric ulcer perforation, obstructive 10017836 PTGastric ulcer perforation 10017835 PTGastric ulcer haemorrhage, obstructive 10017829 PTGastric ulcer haemorrhage 10017826 PTGastric ulcer 10017822 PTDuodenal ulcer, obstructive…