Document text
InterimClinical Study Report
Protocol C4591001
PFIZER CONFIDENTIAL
Template date: 01-July-2020
Page 116.1.5.1 S PONSOR
CLINICAL STUDY REPORT APPROVAL FORM
PROTOCOL NUMBER: C4591001
REPORTTITLE: 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 COVI D-19 in Healthy Individuals
AUTHOR: Dzung Nguy en
I have reviewed this clinical study report, which is fro m its definitive source and final in
content. I confirm that itis a complete and accurate repre sentation of the relevant data and
statistical analy sesforthis report.
Known deviations in the study did not impact overall compliance with Good Clinical Practice
and local regulations .
Organization/Institut ion: BioNTechSE
Name/Position: Ugur Sahin, MD , Chief Executive Officer
Signature: _____________________________________ Date:__________________
090177e196c6a5da\Approved\Approved On: 14-Apr-2021 00:55 (GMT)
Page 1
FDA-CBER-2022-5812-0235379
Interim Clinical Study Report
Protocol C4591001
PFIZER 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 –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 COVI D-19 in Healthy Individuals
AUTHOR: Dzung Nguy en
I have reviewed this clinical study report , which is fro m its definitive source and final in
content . I confirm that it is a complete and accurate representation of the relevant data and
statistical analy sesforthis report.
Know n deviations in the study did not impact overall compliance with Good Clinical Practice
and local regulations .
STATISTICS LINE HEAD: Kenn ethKoury, PhD
CLINICAL LEAD: John L. Pere z, MD, MBA, MA
090177e196be4e96\Approved\Approved On: 14-Apr-2021 02:26 (GMT)
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FDA-CBER-2022-5812-0235380
Document Approval Record
Document Name:
Document Title:
Signed By: Date(GMT) Signing Capacity
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090177e196be4e96\Approved\Approved On: 14-Apr-2021 02:26 (GMT)
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FDA-CBER-2022-5812-0235381