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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…
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Page 1 of 249 ***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated Subject No: 10551006 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS ST A GE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 December 1 3, 2021 Mr. Aaron Siri Siri & Glimstad LLP 200 Park Avenue Seventeenth Floor New York, NY 10166 Sent via email : aaron @sirillp.com Re: FDA FOIA Request 20 21-5683; Public Health and Medical Professionals for Transparency v. FDA, 21-cv-01058- P Dear M r. Siri, This is a partial response to the Freedom of Information Act…
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ETMF Copy of: 270.01|C4591001|17-Jul-2020 | Active | 15-Feb-2021 10:23:13 AM|UNITED STATES|1098090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT ) FDA-CBER-2021-5683-0000218
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ETMF Copy of: 270.01|C4591001|06-Nov-2020 | Active | 15-Feb-2021 10:23:22 AM|ARGENTINA|1231090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT ) FDA-CBER-2021-5683-0000094 ETMF Copy of: 270.01|C4591001|17-Apr-2019 | Active | 15-Feb-2021 10:23:25 AM|BRAZIL|1226090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT ) FDA-CBER-2021-5683-0000095 ETMF Copy of: 270.01|C4591001|17-Apr-2019 | Active | 15-Feb-2021 10:23:25 AM|BRAZIL|1226090177e1968ea843\Final\Final On: 18-Mar-2021 14:01…
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Site:CRSBerlin Group:PartA SubjectIdentifier: 276-02-0116 Status:Discontinued 1 090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT) FDA-CBER-2021-5683-0057640 Row oo sNo do e Reaso o do e Da e e Hea Ra e (bea s/ )I e p e a o C ca S g f ca ce F d gs, select all that apply 1 [ ]20/05/202 0 20 May 202008:21 71 [x] No a [ ] Ab o a [ ] NCS [ ] CS Please insert new row(s), if you are in visit "Unscheduled Forms" only! Subject Identifier: 276-02-0116 Site: CRS…
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16.2.2.1 Listing of Important Protocol Deviations – Phase 1, 2 Doses, 21 Days Apar t Protocol Deviation Category Protocol Deviation Subcategory Number of Subjects Subject (Number of Deviations if >1) Inclusion/E xclusion Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality) 1 C4591001 1002 10021053 Inclusion/Exclusion Participant met exclusion…
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C4591001 Page 1of 26 CONFIDENTIAL 19-Nov-2020 09:16:13 GMT16.1.3.1 LIST OF INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB) ARGENTINA Study Site Number Independent Ethics Committee or Institutional Review Board Address(es) 1231 Com itéInstitucional de Revisión de Ensayos Clínicos (C.I.R.E.C.) del Hospital Militar Central "Cirujano Mayor Dr Cosme Argerich" Av. Luis María Campos 726, Edificio PACE Piso 5 CABA, 1426 ARGENTINA 090177e1959b69d8\Approved\Approved On:…
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FDA-CBER-2021-5683-0024762
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Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t Vaccine Candidate Age Group (Years) Vaccine Group (as Randomized) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) BNT162b1 18-55 10 μg C4591001 1001 10011004 42 Female 165 58.6 21.5 White Non-Hispanic/non - Latino 01MAY2020 C4591001 1001 10011006 28 Male 175 75.3 24.6…
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1Facsimile of Original Digital SignatureTemplate Version: 26-Sep-2014 Confidential Page 1of 2Pfizer Regulatory Quality Assurance Audit Certificate I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed. Study C4591001 Sixteen (16) investigator site audits were performed between 29-Apr- 2020 and 14-Nov-2020 for Study C4591001 Phase 2/3*. Investigator Name Center NumberCountry Dates of AuditType of AuditName of Auditor Mulligan, Mark…
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INVESTIGATOR DECLARATION Clinical Study Report 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, Tolerability, Immunogenicity, and Efficacy of SARS-COV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals Clinical Lead: John L. Perez, MD, MBA, MA Date of the Report: 29 April 2021 I, Dr. Stephen J. Thomas, the undersigned, have…
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Re ports CONFIDENTIAL Page 15.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 Report Prepared by: Worldwide Safety Pfizer The information contained in this document is proprietary and confidential. Any disclosure, reproduction, distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or Regulatory…
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16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) 16-55 C4591001 1001 10011085 25 Female 174.3 53.4 17.6 White Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011086 52 Male 172.7 68.9 23.1 White Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011087 45 Male 175 83.1 27.1…
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1Facsimile of Ori ginal Di gital Si gnatureTemplate Version: January 2021 Confidential Page 1of 3Pfizer Regulatory Quality Assurance Audit Certificate I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed. Study C4591001 Twenty-Four (24) investigator s ite audits were pe rformed between 29- Apr-2020 and 13-Mar-2021 for Study C4591001 Phase 2/3*. Investigator NameCenter NumberCountry Dates of AuditType of AuditName of Auditor Mulligan,…
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Interim Clinical Study Report Protocol C4591001 CONFIDENTIAL Template date: 01-July-2020 Page 1 16.1.5.1 SPONSOR CLINICAL STUDY REPORT APPROVAL FORM PROTOCOL NUMBER: C4591001 REPORT TITLE: Final Analysis Interim Report: A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerab ility, Immunogenicity, and Efficacy of SARS-COV-2 RNA Vaccine Candidates A gainst COVID-19 in Health y…
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16.2.7.2.3 Listing of Severe and Grade 4 Local Reacti ons – Subjects With Indeterminate Vaccine – All Subjects ≥16 Years of Age Rel Daya Age Group (Years) Subject Dose No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur (Days)d No subject meets the reporting criteria. Abbreviation: Dur = duration. a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1. b. The maximum measurable size for redness and swelling in the…
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Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 11.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM October 12, 2020 8:47AMPage 1 of 101 Annotated Study Book - C4591001 10/12/202 0 file:///C:/Users/zhan gd70/A ppData/Local/A pps/2.0/7QDN0DKX.747/1YNZC0P6.4RQ/orac..63.0 _7e15c60fcb5f8c5e _0006.0003 _6f98acf734 3.. 090177e19545aee3\Approved\Approved On: 16-Oct-2020 13:18 (GMT) Page 1…
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16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 Vaccine Received Subject Study Identifiera Subject Age Group (Years) Randomization Date Randomization Number Randomization Vaccine Group Date Dose 1 Date Dose 2 10011081 C4591001 1001 10011081 56-85 28JUL2020 220015 Placebo 28JUL2020 Placebo 18AUG2020 Placebo 10011084 C4591001 1001 10011084 56-85 28JUL2020 220026 BNT162b2 (30 μg) 28JUL2020 …
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t Vaccine Received Subject Study Identifiera Subject Age Group (Years) Randomization Date Randomization Number Randomization Vaccine Group Date Dose 1 Date Dose 2 10011004 C4591001 1001 10011004 18-55 04MAY2020 1084 BNT162b1 (10 μg) 04MAY2020 BNT162b1 (10 μg) 26MAY2020 BNT162b1 (10 μg) 10011005 C4591001 1001 10011005 18-55…