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sBLA BNT162b2 Section 1.3.4 Financial Disclosure
PFIZER CONFIDENTIAL
Page 1 1.3.4 FINANCIAL CERTIFICATION AND DISCLOSURE – SUMMARY N OTE
In accordance with 21 CFR Part 54 and Guidance for Clinical Investigators, Industry, and
FDA Staff: Financial Disclosure by Clinical Investigators (Final , February 2013 ), Pfizer Inc .
is submitting financial disclosure information on the Covered Studies listed in Table 1 . The
financial disclo sure information covers the time period from the start of the study through
one year after the completion of the studyi.
Please note that this disclosure reports information for clinical investigators as that term is
defined in 21 CFR Part 54. Accordingl y, it may vary from an investigator list compiled from
Forms FDA 1572 or listed in study reports.
Table 1. LIST OF COVERED STUDIES (Pfizer Sponsored)
PROTOCOL
NUMBER PROTOCOL NAME DISCLOSURE
START DATE DISCLOSURE
CUT -OFF DATE
C4591001 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 29-Apr-2020 03-Nov-2021
All investigators are assessed for equity interest, significant payments of other sorts, other
compensation by the sponsor and propriety interest. All significant payments of other sorts
are checked v ia internal Pfizer procedures.
Certification - FORM FDA 3454 Summary
Certification, using FORM FDA 3454, that none of the financial interests or arrangements
described in 21 CFR Part 54 exists, is provided for 337 of the 340 clinical investigators who
participated in the covered study listed aboveii.
Pfizer Inc. has identified 0 clinical investigator s who were full-time or part-time employee s
of the sponsor of the covered study . Due Diligence activities we re required for 0 of the
clinical investigators.
FDA-CBER-2022-5812-0220466
sBLA BNT162b2 Section 1.3.4 Financial Disclosure
PFIZER CONFIDENTIAL
Page 2 Disclosure - FORM FDA 3455 Summary
A consolidated FORM FDA 3455 , Disclosure Statement, is provided to report on each
clinical investigator who, or whose spouse or dependent child, had disclosable financial
interests in and/or arrangements with any sponsor of any of the covered clinical studies listed
in the above Table 1 of Covered Studies. The Summary Table provided w ithin the FORM
FDA 3455 on Page 1 lists the clinical investigators and the study for which each reached the
disclosure threshold for Sig nificant Payment of Other Sorts. The details of each disclosure
are reported on the subsequent pages.
3 of the 340 clinical investigators listed in the study report had financial information
to disclose, which represents 0.88% of the total number of all clinical investigators ii
who participated in the study.
All Investigator Initiated Research Grants associated with clinical investigators are paid
directly to the Institution rather than to the individual clinical investigator.
Information regarding Pfizer’s efforts to eliminate bias for the covered studies is described in
a separate Bias Statement in Module 1, Section 1.3.4 .
FDA-CBER-2022-5812-0220467
sBLA BNT162b2 Section 1.3.4 Financial Disclosure
PFIZER CONFIDENTIAL
Page 3
i This repor ting timeframe begins with the Disclosure Start Date and ends with the
Disclosure Cut -off Date + One Year . However, if the Disclosure Cut -off Date + 1 Year
falls later than the Report Date of the FDA Form s 3454 and 3455 , then the Report Date is
used as the end date for the disclosure reporting timeframe.
ii This number represents all the investigators listed on the form and is not unique. Some
investigators may have participated in more than one study and multiple financial disclosure
forms m ay have been collected for a single investigator.
FDA-CBER-2022-5812-0220468