Document text
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Fonn Approved: OMB No. 0910-0396
Report Date: 03/31/2021
BLA
DISCLOSURE: FINANCIAL INTERESTS AND
ARRANGEMENTS OF CLINICAL INVESTlGATORS
TO BE COMPLETED BY APPLICANT
The following information concerning (see who participated as clinical investigators in the
submitted study (see is submitted in accordance with 21 CFR part 54. The named
individuals have participated in one or more of the following financial arrangements or hold financial
interests that are required to be disclosed as follows:
D
D
Please mark the applicable check boxes.
any financial arrangement entered into between the sponsor of the covered study and the ciinical
investigator involved in the conduct of the covered study, whereby the value of the compensation to
the clinical investigator for conducting the study could be influenced by the outcome of the study;
any significant payments of other sorts made on or after February 2, 1999, from the sponsor of the
covered study, such as a grant to fund ongoing research, compensation in the form of equipment,
retainer for ongoing consultation, or honoraria;
any proprietary interest in the product tested in the covered study held by the clinical investigator;
any significant equity interest, as defined in 21 CFR 54.2(b) , held by the dinical investigator in the
sponsor of the covered study.
Details of the individuals' disclosable financial arrangements and interests are attached, along with a
description of steps taken to minimize the potential bias of clinical study results by any of the d1sdosed
arrangements or interests.
NAME
FIRM/ORGANIZATION
Pfizer Inc.
SIGNATURE TITLE
DATE 03/31/2021
This section applies only to the requi rements of the Paperwork Reduction Act of 1995. Do NOT send your completed fonn to
the PRA Staf email address below.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Department of Health and Human Services
information unless it displays a currently valid OMB control number. Public reporting burden for this Food and Drug Ad i i trati
collection of information is estimated to average 5 hours per response, including time for reviewing Of f 0 ti m n s on
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completing and reviewing the collection of information . Send comments regarding this burden RAStaff@fda .hhs.gov
estimate or any other aspect of this collection of information to the address to the right:
FORM FDA 3455 •An agency may not conduct or sponsor, and a person is not required to respond to, a coltion of
information unless it displays a currently valid OMB Number.•
PSC Publishing Se� (301) 443-6740 EF
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
SUMMARY TABLE
Li
st of investigators List of Protocol NumbersSIGNIFICANT PAYMENTS OF OTHER SORTS
Dr. Nicola Penny Klein C4591001
Dr. Stephen Ira Pelton C4591001
Margaret Tiktin C4591001
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
ANY SIGNIFICANT EQUITY INTEREST
Li
st of investigators List of Protocol Numbers
Dr. Diego Wappner C4591001
Dr. Jill A. Sangree C4591001
Dr. Robert Joel Heller C4591001
Dr. Susan Edwards C4591001
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
Product's Established Name: BNT162b2 DISCLOSURE DETAILS: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS
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BLA BNT162b2 Sec tion 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Rel
ated Entity:
Clinical Investigator ID:
Product's Established Name:Dr. Di
ego Wappner
BNT162b21466818
C4591001: A
PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDOM
IZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Cen
ter Number(s): C4591001:1231
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Section 1.3.4 Financial Disclosure
Inve
stigator Name: Dr. Diego WappnerDISCLOSURE T
YPE: EQUITY SNAPSHOT SUMMARY *
Protocol Number: C4591001
Disclosure Date Number of Shares Value at Disclosure Date
[USD]Value Disclosed
[USD]
Stud y Number
Publicly Held Company
BioNTech ech 07/28/2020 C4591001
* The Equ
ity Snapshot Summary contains equity details disclosed by an investigator through one or more Financial Disclosure
Forms completed from the start of the study through one year after the completion of the study. Please note the value disclosed
is the value determined at the provided Disclosure Date and should not be accumulated with any other listed value.
Confidential Page 5 o f 17
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Re
lated Entity:
Clinical Investigator ID:
Product's Established Name:Dr
. Jill A. Sangree
BNT162b2281831
C4591001: A PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDO
MIZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Ce
nter Number(s): C4591001:1150
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Sectio n 1.3.4 Financial Disclosure
Inv
estigator Name: Dr. Jill A. SangreeDISCLOSURE
TYPE: EQUITY SNAPSHOT SUMMARY *
Protocol Number: C4591001
Disclosure Date Publicly Held Company Number of Shares Value at Disclosure Date
[USD]Value Disclosed
[USD]
Study Number
Pfiz
er Inc. 08/03/ 2020 C4591
001
* The Eq
uity Snapshot Summary contains equity details disclosed by an investigator through one or more Financial Disclosure
Forms completed from the start of the study through one year after the completion of the study. Please note the value disclosed
is the value determined at the provided Disclosure Date and should not be accumulated with any other listed value.
Confidential Page 7 of 17
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Re
lated Entity:
Clinical Investigator ID:
Product's Established Name:Dr
. Nicola Penny Klein
BNT162b2280164
C4591001: A PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDO
MIZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Ce
nter Number(s): C4591001:1126
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Sec tion 1.3.4 Financial Disclosure
Inv
estigator Name: Dr. Nicola Penny KleinDISCLO
SURE TYPE: SIGNIFICANT PAYMENTS OF OTHER SORTS
Amount
[USD]Purpose Chec k NumberProtocol Number: C4591001
Payment Date Clinical Investigator or Related Entity
0140480897 CLINICAL AND RESEARCH
COLLABORATIONS06/15/2020 KAISER RESEARCH FOUNDATION
PAID CLINICAL AND RESEARCH
COLLABORATIONS01/18/2021 KAISER RESEARCH FOUNDATION
Payment exceeds threshold amount of $24,999.00 Total:
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Re
lated Entity:
Clinical Investigator ID:
Product's Established Name:Dr
. Robert Joel Heller
BNT162b244801
C4591001: A PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDO
MIZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Ce
nter Number(s): C4591001:1254
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Sectio n 1.3.4 Financial Disclosure
Inv
estigator Name: Dr. Robert Joel HellerDISCLOSURE
TYPE: EQUITY SNAPSHOT SUMMARY *
Protocol Number: C4591001
Disclosure Date Publicly Held Company Number of Shares Value at Disclosure Date
[USD]Value Disclosed
[USD]
Study Number
Pfiz
er Inc. 07/24/ 2020 C4591001
* Th
e Equity Snapshot Summary contains equity details disclosed by an investigator through one or more Financial Disclosure
Forms completed from the start of the study through one year after the completion of the study. Please note the value disclosed
is the value determined at the provided Disclosure Date and should not be accumulated with any other listed value.
Confidential Page 1 1 of 17
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Re
lated Entity:
Clinical Investigator ID:
Product's Established Name:Dr
. Stephen Ira Pelton
BNT162b24633
C4591001: A PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDO
MIZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Ce
nter Number(s): C4591001:1015
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Sec tion 1.3.4 Financial Disclosure
Inv
estigator Name: Dr. Stephen Ira PeltonDISCLO
SURE TYPE: SIGNIFICANT PAYMENTS OF OTHER SORTS
Amount
[USD]Purpose Chec k NumberProtocol Number: C4591001
Payment Date Clinical Investigator or Related Entity
PAID PROFESSIONAL SERVICES-
ADMIN/ COMMERICAL (915)07/20/2020 STEPHEN I PELTON
PAID PROFESSIONAL SERVICES-
ADMIN/ COMMERICAL (915)07/24/2020 STEPHEN I PELTON
PAID HCP AUTHORSHIP (902) 09/28/2020 STEPHEN I PELTON
PAID OUTCOMES RESEARCH-
CLINICAL TRIALS12/01/2020 STEPHEN I PELTON
PAID PROF & CONSULTING-MEDICAL
EXP
ENSES (915)12/ 14/2020 STEPHEN I PELTON
PAID HCP AUTHORSHIP (902) 12/14/2020 STEPHEN I PELTON
PAID OUTCOMES RESEARCH-
CLINICAL TRIALS12/28/2020 STEPHEN I PELTON
PAID HCP CONSULTING 01/27/2021 STEPHEN PELTON MD
Payment exceeds threshold amount of $24,999.00 Total:
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Re
lated Entity:
Clinical Investigator ID:
Product's Established Name:Dr
. Susan Edwards
BNT162b251458
C4591001: A PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDO
MIZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Ce
nter Number(s): C4591001:1006
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Secti on 1.3.4 Financial Disclosure
Inve
stigator Name: Dr. Susan EdwardsDISCLOS
URE TYPE: EQUITY SNAPSHOT SUMMARY *
Protocol Number: C4591001
Disclosure Date Publicly Held Company Number of Shares Value at Disclosure Date
[USD]Value Disclosed
[USD]
Study Number
Pfiz
er Inc. 04/30/2020 C4591001
* T
he Equity Snapshot Summary contains equity details disclosed by an investigator through one or more Financial Disclosure
Forms completed from the start of the study through one year after the completion of the study. Please note the value disclosed
is the value determined at the provided Disclosure Date and should not be accumulated with any other listed value.
Confidential Page 15 of 17
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Name of Clinical Investigator or
Re
lated Entity:
Clinical Investigator ID:
Product's Established Name:Ma
rgaret Tiktin
BNT162b2404556
C4591001: A PHASE 1/2/3, PLACEBO-CONTROLLED,
RANDO
MIZED, 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
INDIVIDUALSStudy Name(s):
C4591001 P
rotocol Number(s):
Ce
nter Number(s): C4591001:1122
Disclosure Start Date(s): C4591001:4/29/2020
C4591001:3/25/2021 Disclosure Cut-off Date(s):
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BLA BNT162b2 Section 1 .3.4 Financial Disclosure
Inv
estigator Name: Margaret TiktinDISCLOSURE TY
PE: SIGNIFICANT PAYMENTS OF OTHER SORTS
Amount
[USD]Check Nu mberProtocol Number: C4591001
Payment D ate Clinical Investigator or Relat ed EntityPurpose
HCP CONSULTANT 10/26/2020MARGARET TIKTIN PAID
Payment Payment exceeds threshold amount of $24,999.00Total:
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