Document text
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 read the above-referenced clinical study report
for study C4591001, which I have undertaken with Pfizer.
I confirm that to the best of my knowledge, it accurately describes the conduct and results of the
study.
Signed:
Stephen J. Thomas, MD
State University of New York
Upstate Medical University
Date: 29 April 2021
The above lead investigator is acting as coordinator and signing on behalf of all centers involved
in the above study.
Infectious Disease s Division
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090177e196ebc24e\Approved\Approved On: 30-Apr-2021 07:41 (GMT)
FDA-CBER-2021-5683-0029224