The court-ordered FDA release of Pfizer's COVID-19 vaccine BLA submission (~450K pages across 4 sub-collections), mirrored from PHMPT.org. Searchable with AI explain.
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Clinical Study Data Reviewer’s Guide BLA Analysis for Participants ≥16 Years of Age BioNTech SE and PFIZER INC. Study C4591001 090177e196e7f4d8\Final\Final On: 29-Apr-2021 02:24 (GMT) FDA-CBER-2021-5683-0057952 Study C4591001 Clinical Study Data Reviewer’s Guide This document is confidential Page 2 of 86 Clinical Data Reviewer ’s Guide Revision history Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of Clinical Data…
Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 14.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM January 14, 2021 12:00PMAnnotated Study Book - C4591001 Page 1 of 131 090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT) FDA-CBER-2021-5683-0058038 Visits SCR MAIN INFORMED CONSENT DEMOGRAPHY DATE OF VISIT INCLUSION/EXCLUSION CRITE RIA (INC EXC S) INCLUSION/EXCLUSION CRITERIA…
Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 14.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM January 14, 2021 12:00PMAnnotated Study Book - C4591001 Page 1 of 131 090177e196e7f4d7\Final\Final On: 29-Apr-2021 02:24 (GMT) FDA-CBER-2021-5683-0057821 Visits SCR MAIN INFORMED CONSENT DEMOGRAPHY DATE OF VISIT INCLUSION/EXCLUSION CRITE RIA (INC EXC S) INCLUSION/EXCLUSION CRITERIA…
Clinical Study Data Reviewer’s Guide Pfizer Inc. BioNTech SE Study BNT162 -01 This document contains confidential information belonging to Pfizer Inc. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor to use it for unauthorized purposes. In the event of actual or suspected breach…
090177e196e9a156\Approved\Approved On: 29-Apr-2021 13:44 (GMT) Page 1 29.04.2021 FDA-CBER-2021-5683-0035550 Interim Clinical Study Report Protocol C4591001 CONFIDENTIAL Template date: 01- July-2020 Page 116.1.5.1 S PONSOR AGENT CLINICAL STUDY REPORT APPR OVAL FORM PROTOCOL NUMBER: C4591001 REPORT TITLE : Interim Report –6 Month Update: A Phase 1/2/3, Placebo-Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safety ,…
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Page 1 of 355 ***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn Subject No: 10811194 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS ST AGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Page 1 of 435 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151238 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151225 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
Page 1 of 207 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151134 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
BNT162b2 2.5 Clinical Overview CONFIDENTIAL Page 12.5 CLINICAL OVERVIE W 090177e196ecb562\Approved\Approved On: 30-Apr-2021 20:12 (GMT) FDA-CBER-2021-5683-0002381 BNT162b2 2.5 Clinical Overview CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF IN -TEXT TABL ES................................ ................................ ................................ ....4 LIST OF IN -TEXT FIGU RES................................ ................................ ................................ .11 ABBREVIAT…
Page 1 of 364 ***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: 1128 Site Name: (1128) Ventavia Research Group Subject No: 11281009 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS ST AGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE…
Page 1 of 145 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151089 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151047 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
Page 1 of 155 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151071 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
Page 1 of 154 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151035 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
Page 1 of 205 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151011 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…
Page 1 of 629 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131786 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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,…