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BNT162b2 1.16 Risk Management Plan (Non -REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COMIRNATY® ( PFIZER -BIONTECH COVID -19 VACCINE , mRNA, BNT162b2, PF-07302048 ) Date of Report: 14December 2021 Version 1.4 090177e198e191a8\Approved\Approved On: 15-Dec-2021 10:11 (GMT) FDA-CBER-2022-5812-0220544 BNT162b2 1.16 Risk Management Plan (Non -REMS) for Biologic License Application # 125742 CONFIDENTIAL Page…
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BNT162b2 1.16 Risk Management Plan (Non -REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1 PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COMIRNATY® ( PFIZER -BIONTECH COVID -19 Vaccine VACCINE , mRNA, BNT162b2, PF -07302048 ) Date of Report: 26 August 15 December 2021 Version 1.24 090177e198e19252\Final\Final On: 15-Dec-2021 09:55 (GMT) FDA-CBER-2022-5812-0220675 BNT162b2 1.16 Risk Management Plan (Non -REMS) for…
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BNT162b2 Module 1.3.1.4 Transfer of Obligations Pfizer Confidential 1 TRANSFER OF OBLIGATIONS In compliance with 21 CFR 312.52, Table 1 below lists the Spons or responsibilities* that were transferred from BioNTech SE to Pfizer Inc. in the conduct of t he C4591001 clinical study, with the specific obligations that we re transferred. Any obligation not provided in the written description below shall be deemed not to have been transferred. Table 1. Sponsor Obligations…
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BNT162b2 2.5 Clinical Overview CONFIDENTIAL Page 12.5 CLINICAL OVERVIE W 090177e198d7f76f\Approved\Approved On: 11-Dec-2021 18:37 (GMT) FDA-CBER-2022-5812-0220822 BNT162b2 2.5 Clinical Overview CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF IN -TEXT TABL ES................................ ................................ ................................ ....5 LIST OF IN -TEXT FIGU RES................................ ................................ ................................ ...9 ABBREVIAT…
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16.2.7.1 Adverse Events Legend Page Category Abbreviation Text Action - Stud y Vaccine Dose NA Not applicable P Investigational product withdrawn Action - Sub ject TC Concomitant dru g treatment given TCN Concomitant non-dru g treatment given W Withdrawn from stud y Cause of AE CD Concomitant dru g treatment CND Concomitant non-dru g treatment O Other Outcome F Fatal N Not recovered/not resolve d R Recovered/resolve d RS Recovered/resolved with sequelae RG…
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C4591001 Page 1of 26 CONFIDENTIAL 26-Mar-2021 09:43:07 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 ité Institucional 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 090177e196a1cc59\Approved\Approved On:…
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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-Two (22) investigator site audits were performed between 29-A pr-2020 and 13-Mar-2021 for Study C4591001 Phase 2/3*. Investigator Name Center NumberCountry Dates of AuditType of AuditName of Auditor Seger,…
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16.2.5.1.1 Listing of Subjects Who Received Vaccine Not as Randomized – Subjects 12 Through 25 Years of Age Vaccine Group (as Randomized) Age Group (Years) Subject Randomization Date Vaccination Date Dose No. Vaccine Received No subject meets the reporting criteria. PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:45) (Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001…
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16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) 12-15 C4591001 1005 10051317 12 Female 145.54 51.18 24.1 White Non-Hispanic/non- Latino20OCT2020 C4591001 1005 10051328 14 Female 160.02 57.09 22.2 White Non-Hispanic/non- Latino20OCT2020 C4591001 1005 10051339 14 Female 161.29 54.64 21 White …
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16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – Subjects 12 Through 25 Years of Ag e Age Group (Years) Subject Dose No. Rel Daya Withdrawal Date Study Phase Withdrawal Reason Commentb 12-15 C4591001 1006 10061272 1 22 06JAN2021 VACCINATION ADVERSE EVENT ADVERSE EVENT/ANXIETY 1 22 06JAN2021 VACCINATION ADVERSE EVENT ADVERSE EVENT/DEPRESSION C4591001 1007 10071409 1 10 31OCT2020 VACCINATION NO LONGER MEETS …
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16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age Age Group (Years) Vaccine Group (as Randomized) Subject Dose/ Sampling Time Point Date of Sample Rel DayaNT50 (Titer) 12-15 BNT162b2 (30 μg) C4591001 1005 10051328 2/1 Month 11DEC2020 31 1938 C4591001 1005 10051412 1/Prevax 14DEC2020 1 10 2/1 Month 09FEB2021 36 1192 C4591001 1006 10061184 1/Prevax 30NOV2020 1 10 2/1 Month 22JAN2021 33 1838 C4591001 1006 10061209 1/Prevax 04DEC2020 1 273 …
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C4591001 CONFIDENTIALERRATA Not applicable. There are no errata to report . 090177e196c07a8e\Approved\Approved On: 13-Apr-2021 15:10 (GMT) Page 1 FDA-CBER-2022-5812-0223847
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16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations – Subjects 12 Through 25 Years of Age (Immunogenicity Subset ) Age Group (Years) Subject Population Reason for Exclusion 12-15 C4591001 100 6 10061212 Dose 2 all- available Did not have at least 1 valid and determinate immunogenicity result after Dose 2. Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2. C4591001 1006 10061220 Dose 2 all-…
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Protocol C4591001 16.1. 10List of Laboratories Under Vaccine Research & De velopment Over sight Page 1 CONFIDENTIALList of La boratories–Interim – Adolescents Organization Address Service (s)Provided Pfizer Vaccine Research & Development401 N orthMiddletown Road Pearl River, NY 1 0965 USARBD -binding IgG level assay ; N-binding antibo dyassay; and RT-PCR on nasal s wabs for SAR S-CoV-2 Pfizer Vaccine Research & Developmen t111 Ideation Way Nutley, NJ 07110 USASARS -CoV- 2 neutralizati on …
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C4591001 Page 1of 5 CONFIDENTIAL 15-Nov-2021 11:55:00 GMT16.1.3.1 LIST OF INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB) UNITED STATES Study Site Number Independent Ethics Committee or Institutional Review Board Address(es) 1005 Copernicus Group Institutional Revie w Board 5000 CentreGreen Way, Ste 200 Cary, NC 27513 UNITED STATES 1006 Copernicus Group Institutional Revie w Board 5000 CentreGreen Way, Ste 200 Cary, NC 27513 UNITED STATES 1007 Cincinnati Children’ s…
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INVESTIGATOR DECLARATION Clinical Study Report Protocol Number: C4591001 Report Title: Interim Report – Adolescents: 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: 14 April 2021 I, Dr. Stephen J. Thomas, the undersigned, have read the…
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16.2.8.1.1 Listing of Subjects With F irst Severe COVID-19 Occur rence After Dose 1 – Subjects 12 Through 15 Years of Age – Blinded Placebo-Control led Follow-up Period – Dose 1 All-Available Efficacy Population – CDC+Protocol Subject (Country/Age in Years/Sex) Vaccine Group (as Randomized) Dose/Rel DayaStart Date Stop Date Visit 1 N-Binding Assay/ Visit 1 NAAT/ Visit 2 NAAT Signs, Symptoms, and Events SARS-CoV-2 NAAT Result (Central Lab/Local Labb), Swab Date Protocol/CDC …
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16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age Subject/ Vaccine Group (as Randomized) Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1005 10051317/ BNT162b2 (30 μg) 12 Female 145.54 51.18 24.1 White Non-Hispanic/non- Latino 20OCT2020 C4591001 1005 10051328/ BNT162b2 (30 μg) 14 Female 160.02 57.09 22.2 White Non-Hispanic/non-…
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16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects 12 Through 15 Years of Age Subject/ Vaccine Group (as Randomized) Dose No. Rel Daya Withdrawal Date Study Phase Withdrawal Reason Commentb C4591001 1005 10051413/ BNT162b2 (30 μg) 2 204 26JUL2021 FOLLOW-UP OTHER Participant enrolled in C4591031 C4591001 1005 10051441/ BNT162b2 (30 μg) 2 206 05AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031 C4591001 1006 10061200/ …
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C4591001 CONFIDENTIALERRATA Not applicable. There are no errata to report . 090177e198a74b07\Approved\Approved On: 03-Dec-2021 02:30 (GMT) Page 1 FDA-CBER-2022-5812-0224549