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16.2.3 Listing of Subjects Excluded From the Safety Population – All Subjects 12 Through 15 Years of Age Vaccine Group (as Randomized) Subject Reason for Exclusion BNT162b2 (30 μg) C4591001 1057 10571413 Subjectdid not receive stud y vaccine. C4591001 1091 10911451 Subject did not receive stud y vaccine. C4591001 1140 11401346 Subject did not receive stud y vaccine. Placebo C4591001 1077 10771293 Subject did not recei ve study vaccine. PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021…
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Protocol C4591001 16.1. 10List of Labo ratories Under Vaccine Rese arch & De velopment Over sight Page 1 CONFIDENTIALList of La boratories–Interim–Adolescent 6-Month Update Organization Address Service (s)Provided Pfizer Vaccine Research & Development401 N Middletow n Road Pearl River, NY 1 0965 USAN-binding antibody as say (serum) and RT -PCR (nasal swabs )for SARS -CoV -2 Abbre viations: N = SARS -CoV- 2 nucleoprotein; RT-PCR = reverse tran scription –polymerase chain reaction; SARS -CoV…
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C4591001 1231 ARGENTINA Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION BNT162b2…
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INVESTIGATOR DECLARATION Clinical Study Report Protocol Number: C4591001 Report Title: Interim Report – Adolescent 6-Month Update: A Phase1/2/3, 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: 12 December 2021 I, Dr. Stephen Thomas, 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 Vaccine Group (as Randomized) Subject (Country/Age in Years/Sex) Dose/Rel DayaStart Date Stop DateVisit 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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EXTERNAL DATA MONITO RING COMMITTEE PFIZER INTERNAL USE ONLY The official version of this form is located in the electronic document management system. CT22- GSOP -RF02 6 .0External Data Monitoring Committee and Internal Review Committee Charter Template 01-Nov-2019 Page 1of 38 TMF Doc ID: 64.05 and 713.02 C459 Investigational BNT162 Vaccine Program PF-07302048 Version : 13 Date : 16-Ju ly-2021 090177e1979a5738\Approved\Approved On: 22-Jul-2021 12:54 (GMT) FDA-CBER-2022-5812-0224657…
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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. 3. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid -19 Vaccine. N Engl J Med.…
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16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1006 10061272/ BNT162b2 (30 μg) 1006 Inclusion/exclusion Participant met exclusion criterion #01 (participant having other medical or psychiatric condition) 16DEC2020…
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Interim Clinical Study Report Protocol C4591001 CLINICAL STUDY REPORT SYNOPSIS CONFIDENTIAL Page 1Vaccine Name and Compound Number: BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF-07302048 Report Title: Interim Report –Adolescent 6 Month Update: A Phase 1/2/3, Placebo- Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safet y, Tolerability , Immunogenicity , and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVID -19 in Healthy …
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16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age Vaccine Received Subjecta USUBJID Randomization Date Randomization Number Randomized Vaccine GroupDate/ Dose 1 Date/ Dose 2 Date/ Dose 3 Date/ Dose 4 10051317 C4591001 1005 10051317 20OCT2020 20158 BNT162b2 (30 μg) 20OCT2020/ BNT162b2 (30 μg)12NOV2020/ BNT162b2 (30 μg) 10051328 C4591001 1005 10051328 20OCT2020 20159 BNT162b2 (30 μg) 20OCT2020/ BNT162b2 (30…
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Interim Clinical Study Report Protocol C4591001 CONFIDENTIAL Page 1of 1521.TITLE PAGE Vaccine Name and Compound Number:BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF -07302048 Report Title: Interim Report –Adolescent 6- Month Update : A Phase 1/2/3, Placebo- Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safet y, Tolerability , Immunogenicity , and Efficacy of SARS -CoV- 2 RNA Vaccine Candidates Against COVID -19 in Healthy Individuals…
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Protocol C4591001 (PF-07302048 ) Statistical Analysis Plan CONFIDENTIAL Page 1 TMF Doc ID: 98.03Protocol C4591001 A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER -BLIND , DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERAB ILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV - 2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Statistical Analysis Plan (SAP) Version: 8 Date: 11 Nov 2021 090177e198935790\Approved\Approved On: 11-Nov-2021 17:30 (GMT) …
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090177e198d9dae1\Approved\Approved On: 13-Dec-2021 02:06 (GMT) Page 1 FDA-CBER-2022-5812-0228959 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…
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CLINICAL STUDY REPORT AMENDMENT SUMMARY OF CHANGES Protocol Number: C4591001 CONFIDENTIAL Page 1Study Report Title: Interim Report –Adolescent 6- Month Update : A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose -Finding Study to Ev aluate the Safety , Tolerability , Immunogenicit y, and Efficacy of SARS -CoV- 2 RNA Vaccine Candidates Agains t COVID -19 in Healthy Individuals Clinical Study Report Date: 03December 2021 Date o f Form Completion: 10December 2021 The…
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C4591001 1231 ARGENTINA Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813…
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PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591001 Protocol Amendment 14, 02March 2021 CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (05 December 2019) Page 1A PHASE 1/2 /3, PLACEBO -CONTROLLED , RANDOMIZED, OBSERV ER-BLIND, DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERABI LITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV - 2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Study Sponsor: BioNTech Study Conducted By: Pfizer Study…
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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. 3. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid -19 Vaccine. N Engl J Med.…
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16.2.2.1 Listing of Important Protocol Deviations – Subjects 12 Through 25 Years of Ag e Protocol Deviation Category Protocol Deviation Subcategory Number of Subjects Age Group/Subject (Number of Deviations if >1) Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 14 16-25 Years/C4591001 1007 10071082 (2) 16-25 Years/C4591001 1007 10071556 12-15 Years/C4591001 1007 10071593 16-25…
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16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age Vaccine Received Subject Study IdentifieraSubject Age Group (Years) Randomization Date Randomization Number Randomization Vaccine Group Date Dose 1 Date Dose 2 10051317 C4591001 1005 10051317 12-15 20OCT2020 20158 BNT162b2 (30 μg) 20OCT2020 BNT162b2 (30 μg) 12NOV2020 BNT162b2 (30 μg) 10051328 C4591001 1005 10051328 12-15 20OCT2020 20159 BNT162b2 …
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BNT162b2 5.3.6 Cumulative Analysis of Po st-authorization Adverse Event Reports CONFIDENTIAL Page 1CUMULATIVE ANALYSIS OF POST -AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B 2) RECEIVED THROUGH 30 SEPTEMBER 2021 IN INDIVIDUALS AGED BETWEEN 12 AND 15 YE ARS OF AGE 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…