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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 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: 14 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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090177e196cc8019\Approved\Approved On: 16-Apr-2021 09:34 (GMT)
FDA-CBER-2022-5812-0224077