Document text
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 Individuals
AUTHOR: Dzung Nguyen
I have reviewed this clinical study report, which is from its definitive source and final in
content. I confirm that it is a complete and accurate representation of the relevant data and
statistical analyses for this report.
Known deviations in the study did not impact overall compliance with Good Clinical Practice
and local regulations.
Organization/Institution: BioNTech
Name/Position: Ugur Sahin, MD, Chief Executive Officer
Signature: _____ _______________________ Date: __ _
g
________________________________
_________________
______________________________________________________________________________________________________________________
090177e195afddb9\Approved\Approved On: 03-Dec-2020 15:14 (GMT)
Page 1
FDA-CBER-2021-5683-0024759
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 : Final Analy sis Interim Report: A Phase 1/2/3,
Placebo- Controlled, Randomized, Observer -Blind,
Dose -Finding Study to Evaluate the Safety , Tolerabilit y,
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 t hat 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: Kennet h Koury, PhD
CLINICAL LEAD: John L. Pere z, MD, MBA, MA
090177e195a87f6c\Approved\Approved On: 03-Dec-2020 14:12 (GMT)
Page 2
FDA-CBER-2021-5683-0024760
Document Approval Record
Document Name:
Document Title:
Signed By: Date(GMT) Signing Capacity
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090177e195a87f6c\Approved\Approved On: 03-Dec-2020 14:12 (GMT)
Page 3
FDA-CBER-2021-5683-0024761