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sBLA BNT162b2 1.3.4 Financial Certificatio nand Disclosure
PFIZER CONFIDENTIAL
Page 1 1.3.4 FINANCIAL CERTIFICATION AND DISCLOSURE – BIAS STATEMENT
Protocol Number: C4591001
Study Title: 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
STEPS TAKEN TO MINIMIZE THE POTENTIAL FOR BIAS
The above -referenced trial was conducted according to ICH Good Clinical Practices. The
study was conducted according to Pfizer SOPs.
Other processes used to minimize potential bias are as follows:
•The facilities performing the safety and efficacy evaluations were determined to be
acceptable based on appropriate certification or historical performance and/or
qualifications and credentials.
•Electronic diaries were used to collect patient reported outcomes, to ensure real time
completion of outcomes questionnaires.
•Subjects were allocated randomly to vaccine group through use of an Interactive
Response System.
•An independent external data monitoring committee (DMC), operating under a
written charter, reviewed unblinded safety data on a weekly basis during Phase 2/3
and was responsible for the review of the efficacy interim analysis.
•Ongoing accrual of protocol -defined cases was monitored in a blinded manner and,
when sufficient cases were available, the unblinded analysis was performed by a
limited number of individuals who are not involved in ongoing conduct of the study
(statistical team supporting the DMC).
•Microbiological confirmation of cases by Polymerase Chain Reaction (PCR) was
performed by individuals blinded to treatment allocation in a central laboratory.
•An independent unblinded submissions team separate from the study team, operating
under a written charter, analyzed defined endpoints for regulatory submissions (EUA,
MAA). Analyses were stored on restricted sites. Access to the restricted sites was
governed by charter and tracked.
•Investigator trial sites were monitored frequently.
FDA-CBER-2022-5812-0500295
1.3.4 Financial Certificatio nand Disclosure
PFIZER CONFIDENTIAL
Page 2 •The validity of the data collected during the study was confirmed by standard
monitoring procedures.
•During the course of processing, analyzing and reporting data from clinical trials,
Pfizer applied procedures (e.g., querying data through electronic edit checks and
clinical reviews) designed to ensure that errors were eliminated.
•Appropriate statistical methods were employed by use of an approved statistical
analysis plan.
•The study report was reviewed by the Sponsor’s Quality Control Group.sBLA BNT162b2
FDA-CBER-2022-5812-0500296