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BNT162b2 Section 1.3.4 Fi nancial 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 submitti ng financial disclosure information on the Covered Studies listed in Table 1 . The
financial disclosure information covers the time period from the start of the study through
one year after the completion of the studyi.
Please no te that this disclosure rep orts information for clinical investigators as that term is
defined in 21 CFR Part 54. Accordingly, 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, Dos e-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 25-Mar-2021
All investigators are asses sed for equity interest, si gnificant payments of other sorts, other
comp ensation by the sponsor and propriety interes t. All significant payments o f other sorts
are checked v ia internal Pf izer procedures.
In accordance with 21 CFR Part 54 and the FDA Guidance, payments made under a clinical
study agreement for the cost of conducting the clinica l trial are not considered financial
interests or arrangements subject to certification or disclosure. Nonetheless , given the
extensive public interest in the COVID -19 vaccine program and in the interest of continued
transparency with respect to the COVID -19 vaccine study, Pfizer Inc. wishes to share with
FDA that the principal investigator at Site 1231 (Hospital Mili tar Central Cirujano Mayor Dr.
Cosme Argerich in Argentina) has
profits from conducting the clinical trial. Pfizer does not know the exact amount of profit
, but even a t the highest end, the per -patient costs under the clinical study
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(b) (6)
(b) (6)
(b) (6)
(b) (6)
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BNT162b2 Section 1.3.4 Fi nancial Disclosure
PFIZER CONFIDENTIAL
Page 2 agreement at this site are within the range of the per -patient costs that Pfizer pays clinical
trial sites in Argentina and elsewhere.
Certific ation - FORM F DA 3454 Sum mary
Certification, using FORM FDA 3454, that none of the financial interests or arrangements
described in 21 CFR Part 54 exists, is provided for 1,782 of the 1,793 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 a ctivities we re requ ired for 4 of the
clinical investigator s.
Disclosure - FORM FDA 3455 Summary
A consolidated FORM FDA 3455 , Disclosu re Statement, is provided t o report on each
clinical investigator who, or whose spouse or dependent child, had disclosabl e financial
interes ts in and/or arrangements with any spon sor of any of the covered clinical studies listed
in the above Table 1 of Cov ered Studies. The Summary Table provided w ithin the FORM
FDA 345 5 on Page 1 lists the clinical investigators and the stu dy for which each r eached the
disclosure threshold for Sig nificant Payment of Other Sorts. The details of each disclosure
are reported on the subsequent pages.
7 of the 1,793 clinical investigators listed in the study report had financial information to
disclose, which represents 0.3 9% of the total number of all clinical investigators ii who
participated in the study.
All Investigator Initiated Research Grants assoc iated with clinical investigators are paid
directly to the Insti tut
ion rather than to the individual clinical inve stigator.
Information regarding Pfiz er’s efforts to eliminate bias for the covered studies is described in
a separate Bias State men
t in Modul e 1, Section 1.3.4.
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BNT162b2 Section 1.3.4 Fi nancial Disclosure
CONFIDENTIAL
Page 4 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 ), BioNTech
SE 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 studyiii.
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 2. LIST OF COVERED STUDIES (BioNTech SE Sponsored)
PROTOCOL
NUMBER PROTOCOL NAME DISCLOSURE
START DATE DISCLOSURE
CUT -OFF DATE
BNT162 -01 A MULTI -SITE, PHASE I/II, 2 -PART,
DOSE -ESCALATION TRIAL
INVESTIGATING THE SAFETY AND
IMMUNOGENICITY OF FOUR
PROPHYLACTIC SARS -COV -2 RNA
VACCINES AGAINST
COVID19 USING DIFFERENT
DOSING REGIMENS IN HEALTHY
AND IMMUNOCOMPROMISED
ADULTS 22-Apr-2020 23-Oct-2020
All investigators are assessed for equity interest, significant payments of other sorts, other
compensation by the sponsor and propriety interest.
Certification - FORM FDA 3454 Summary
Certification , using FORM FDA 3454 , that none of the financial intere sts or arrangements
described in 21 CFR Part 54 exists, is provided for 41 of the 41 clinical investigators who
participated in the covered stud y listed aboveiv.
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BNT162b2 Section 1.3.4 Fi nancial Disclosure
CONFIDENTIAL
Page 5 BioNTech SE 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.
Information regarding BioNTech SE ’s efforts to eliminate bias for the covered studies is
described in a separate Bias Statement in Module 1, Section 1.3.4 .
i This repor ting timeframe begins wi th the Disclosure Start Dat e and ends wit h the
Disclosure Cut -off Date + One Year . However, if the Disclosure Cut -off Date + 1 Year
falls later t han the Report Date of the FDA Form s 3454 and 3455 , then the Report Date is
used as the end date for the discl osure reporting ti meframe.
ii This number represents all the in vestigators l isted on the form and is not unique. Some
investigators may have parti cipated in more than one study and multiple financial disclosure
forms may have been collected for a single in vestigator.
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