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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Fonn Approved: OMB No. 0910-0396
Report Date: 03/31/2021
BLA
CERTIFICATION: FINANCIAL INTERESTS AND
ARRANGEMENTS OF CLINICAL INVESTIGATORS
TO BE COMPLETED BY APPLICANT
With respect to all covered dinical studies (or specific clinical studies listed below (if appropriate)) submitted
in support of this application, I certify to one of the statements below as appropriate. I understand that this
certification is made in compliance with 21 CFR part 54 and that for the purposes of this statement, a dinical
investigator includes the spouse and each dependent child of the investigator as defined in 21 CFR 54.2(d).
Please mark the applicable check box.
(1) As the sponsor of the submitted studies, I certify that I have not entered into any financial
arrangement with the listed clinical investigators (enter names of dinical investigators below or
attach list of names to this form) whereby the value of compensation to the investigator could be
affected by the outcome of the study as defined in 21 CFR 54.2(a). I also certify that each listed
clinical investigator required to disciose to the sponsor whether the investigator had a proprietary
interest in this product or a significant equity in the sponsor as defined in 21 CFR 54.2(b) did not
disclose any such interests. I further certify that no listed investigator was the recipient of significant
payments of other sorts as defined in 21 CFR 54.2(f).
Clinical Investigators (See atached)
D (2) As the applicant who is submitting a study or studies sponsored by a firm or party other than
the applicant, I certify that based on information obtained from the sponsor or from participating
dinical investigators, the listed ciinical investigators (attach list of names to this form) did not
participate in any financial arrangement with the sponsor of a covered study whereby the value of
compensation to the investigator for conducting the study could be affected by the outcome of the
study (as defined in 21 CFR 54.2 (a)); had no proprietary interest in this product or significant
equity interest in the sponsor of the covered study (as defined in 21 CFR 54.2(b)); and was not the
recipient of significant payments of other sorts (as defined in 21 CFR 54.2(f)).
Clinical (See athed}
0 (3) As the applicant who is submitting a study or studies sponsored by a firm or party other than
the applicant, I certify that I have acted with due diligence to obtain from the listed dinical
investigators (attach list of names) or from the sponsor the information required under 54.4 and it
was not possible to do so. The reason why this information could not be obtained is attached.
NAME
J.R Meloro
FIRM/ORGANIZATION
Pfizer Inc.
SIGNATURE
Clinical investigatois ·(see Sitactied):
.. .. .. .. .. . . . .. . ....
TITLE
Global Data Dism ination, Publications and Transparency Lead
DATE 03/31/2021
This section applies only to the requi1ec1w:nts of the Paperwork Reduction Act of 1995. Do NOT send your completed form to
Al agency may not conduct or sponsor, and a person is not required to respond to, a collection of the PRA Staf email address below.
information unless it displays a currentfy valid OMB control number. Public reporting burden for this Department of Health and Human Services
collection of information is estimated to average 1 hour per response, including time for reviewing Food and Drug Adminis tration
instructions, searching existing data sources, gathering and maintaining the necessary data, and Office of Operations
oompleting and reviewing the collection of information. Send comments regarding this burden PRAStaff@fda hhs gov
estimate or any other aspect of this collection of information to the address to the right · ·
"An agency may not conduct or sponsor, and a person is not 19quired to respond to, a coUection of informatio unless it 6splays a curtly valid OMB Mimber. •
FORM FDA 3454 PSC Publishing Services (301) 4438740 EF
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Product’s Established Name:
Protocol Number:
Study Name:BNT162b2
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
Di
sclosure Cut-off Date:Di
sclosure Start Date: 04/29/2020
03/25/2021
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Protoc
ol Number: C4591001
Center Number: 1001 Institution Name: Nyu Langone Health
List of Investigator Names
Dr. Mark Joseph Mulligan
Elisabeth J. Cohen
Tamia Davis
Andrew B. Fleming
Heather Givans
Ramin Sedaghat Herati
Angelica Cifuentes Kottkamp
Dr. Alexander A. McMeeking
Mary C. Olson
Mila Brum Ortigoza
Lalitha Parameswaran
Purvi Parikh
Rebecca Pellett Madan
Kiana Piedrahita
Vanessa Raabe
Adam Jonathan Ratner
Bo Shopsin
Janine M. Sullivan
Robert J. Ulrich
Elizabeth Veneskey
Mah ja Vucetovic
Center Number: 1002 Institution Name: University Of Maryland, Center For Vaccine Development
And Global HealthList of Investigator Names
Kathleen Maletic Neuzil
Meagan Elise Deming
Kirsten Elizabeth Lyke
Monica Anne McArthur
Justin Ortiz
Rekha R. Rapaka
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col Number: C4591001
Center Number: 1003 Institution Name: Rochester Regional Health/rochester General Hospital
List of Investigator Names
Dr. Edward Epes Walsh
Dr. Ann Regina Falsey
Maryrose Laguio-Vila
Emil P. Lesho
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col Number: C4591001
Center Number: 1005 Institution Name: Rochester Clinical Research, Inc.
List of Investigator Names
Dr. Matthew Gilruth Davis
Jenna Baer
Chelsea Bork
Michelle Lyn Burgett
Julie M. Callahan
Cristina Cramer-Mills
Kara Elizabeth Cristales
Therese Eileen Dayton
Kathleen Kowaliczko Ebeling
Victoria F. Fink
Jennifer Foley
Geesue Hah
Deborah S. Hodges
Sarah Michelle Ingalsbe-Geno
Diana Lynn Kailburn
Mackay Brenna Kanaley
Patricia S. Larrabee
Joseph I. Mann
Abigail Miller
Julie A. Mooney
Katherine Anne Pagenkemper
Jennifer Rowlinson
Dr. Tammi Louise Shlotzhauer
Ms. Sally Anne Thomas
Julie E. Wentworth
Susan J. Willer
Jaclyn P. Zona
Zerina Zornic
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col Number: C4591001
Center Number: 1006 Institution Name: J. Lewis Research, Inc. / Foothill Family Clinic
List of Investigator Names
Dr. James Todd Peterson
Natalie Saley Bee
Dr. Alexander Paul Clark
Dr. Shana Kinsey Eborn
Dr. Dan C. Henry
Dr. Heather Anne Jackson
Gerald Gilbert Kelty
Issac Guillermo Pena-Renteria
Dr. Jacqueline Leann Rohrer
Dr. Jack Alan Taylor
Center Number: 1007 Institution Name: Cincinnati Children's Hospital Medical Center
List of Investigator Names
Prof. Dr. Robert Wilson Frenck
Dr. David Isaac Bernstein
Dr. Rebecca Charlene Brady
Kristen N. Buschle
Michelle Dawn P. Dickey
Grant Christopher Paulsen
Dr. Felicia A. Scaggs Huang
Dr. Paul William Spearman
Eleanor A Widdice
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col Number: C4591001
Center Number: 1008 Institution Name: Clinical Research Professionals
List of Investigator Names
Timothy William Jennings
Tonya Clausen
Dr. Siddharth Kaul
Dr. Anthony J. Margherita
Stacey Miner
Brittany C. Nguyen
Ann M. Patek
Dr. Fredric A. Prater
Dawn M. Ringling
Richard A. Summa
Terry Joe Weis
Alaina Yarber
Center Number: 1009 Institution Name: J. Lewis Research, Inc. / Foothill Family Clinic South
List of Investigator Names
Dr. Shane Glade Christensen
Holly Marie Anderson
Emily Kathleen Bloomquist
Dr. Ross Anthony Brunetti
Dr. Thomas Kane Conner
Dr. Gina Marie Cox
Dr. Diana G. Grazulis
Dr. Wesley James Lewis
Dr. James P. Longe
Christopher Michael Matich
Dr. Bryan Lee Nelson
Emily Marie Raming
Dr. Sarah Jane Scott
Dr. John Edward Teddy Witbeck
Dr. Stephen Daniel Wood
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col Number: C4591001
Center Number: 1011 Institution Name: Clinical Research Consulting, LLC
List of Investigator Names
Dr. Susann Varano
Mandesha S. Bendolph
Joan Boyer
Lauren Calgreen
Adina Hodges
Gail R. Hopkins
Patrice Biana Lauture
Rachel J. Pierce
Holly A. Spain
Center Number: 1012 Institution Name: Hope Research Institute
List of Investigator Names
Dr. Med. Matthew W. Doust
Nathan L. Alderson
Jennifer Burgdorf
Stephanie A. Catanzaro
Sandra Parks Erickson
Shauna M. Harrell
Shana R. Harshell
Denise Sample
Dhwani Shah
Dr. Steven M. Siwek
Sahara Y. Vega
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col Number: C4591001
Center Number: 1013 Institution Name: Clinical Neuroscience Solutions, Inc
List of Investigator Names
Dr. med. Michael Edward Dever
Chanel Keari Adams
Dr. Patricia Ann W. Brown
Joan Elizabeth Cutillo
Ms. Letitia Mechelle Griffin
Dr. Linda Sue Harper
Rebecca Ann Klipper
Geraldine Marino
Dr. Robert Bond Molpus
Priya Moorhouse
Mrs. Penny Louise O'Neal
Ms. Deborah Ann Renner
Mr. William Trey Schesser
Felipe Porto de Souza Suplicy
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Proto
col Number: C4591001
Center Number: 1015 Institution Name: Boston Medical Center
List of Investigator Names
Dr. Elizabeth Day Barnett
Sacha Al Hassan
Deepa Anbumani
Kanika Bisht
Tori Blot
Assoc. Prof. Ellen Rae Cooper
Ridiane Denis
Ycar Devis
Faye Huang
Yuri Kim
Mona Lauture
Dayeun Lee
Debra McLaud
Carole Moloney
Casey Norton
Vishakha Sabharwal
Scarlett Salerno
Javier Sanchez
Mary Barbara Walsh
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col Number: C4591001
Center Number: 1016 Institution Name: Kentucky Pediatric/ Adult Research
List of Investigator Names
Dr. Daniel John Finn
Mrs. Ashley Danielle Bennett
Melanie Dawn Bishop
Lindsay B. Blackmon
Dr. Stanley Lawrence Block
Christal Gayle Denton
Lisa Michelle Dones
Whitney Chardae Downs
Dr. Rebecca Renee Findlay
Kayla Nicole Hamilton
Dr. James Allen Hedrick
Erica Michelle Koch
Kali Marie Lewis
Brittany Michelle Lisby
Wendy Marie Mattingly
Michelle Lynn Newton
Abby Gayle O'Bryan-Wimsett
Martha Renee Osbourn
Lea Faye Rust
Dr. Robert Alan Smith
Monica Boone Strenecky
Dr. Ronald Doyle Tyler
Shannon Michelle Woods
Andrea Yates
Tabitha Lorean Yates
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Proto
col Number: C4591001
Center Number: 1018 Institution Name: Texas Center For Drug Development, Inc.
List of Investigator Names
Dr. Veronica Garcia Fragoso
Shakira Laine Barr
Dr. Teresa M. Becker
Blanca Gomez
Lisa Robin Holloway
Odette Kourouma
Tracy Jean Kowalski
Dr. Cecilia L. McKeown-Biagas
Dr. Vicki E. Miller
Chen-Ho Yang
Center Number: 1019 Institution Name: Diagnostics Research Group
List of Investigator Names
Dr. Charles Porter Andrews
Dr. John Robert Holcomb
Center Number: 1021 Institution Name: Pmg Research Of Raleigh, LLC
List of Investigator Names
Dr. John Rubino
Dr. Warner Lee Wells Edmundson
Dr. Tina Griffin Harris
Dr. William Richard Jacobs
Dr. Douglas Brian Ellis Short
Adeel Mohammad Siddiqui
Stephanie Stoneback
Sarah M. Utech
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col Number: C4591001
Center Number: 1022 Institution Name: Wenatchee Valley Hospital
List of Investigator Names
Dr. Steven Richard Kaster
Ms. Diane M. Davis
Kathryn Eren
Linda Joanna Galvan
Patricia Ann Garland
Dr. Jason M. Lake
Jovana A. Munos
Ms. Cathy Jo Roozen
Lauryn Elise Wilson
Rebecca Ann Woolston
Eliza Del Rocio Zuniga
Center Number: 1024 Institution Name: South Jersey Infectious Disease
List of Investigator Names
Dr. Christopher John Lucasti
Dawn Marie Paone
Center Number: 1027 Institution Name: Pharmquest
List of Investigator Names
Dr. Alexander Vance Murray
Leanna Boles Cutchins
Dr. William Randall Harris
Ms. Susanne M. Stuckey
Dr. Richard Warren Tisovec
Dr. Randal Lee Von Seggern
Center Number: 1028 Institution Name: Lillestol Research LLC
List of Investigator Names
Dr. Michael John Lillestol
Jamie M. Brown
Karissa M. Emerson
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col Number: C4591001
Center Number: 1030 Institution Name: University Hospitals Cleveland Medical Center
List of Investigator Names
Prof. Dr. Robert Andrew Salata
Jalal-Deen Armiyaw
Reem Azem
James Capon
Alyssa Drosdak
Scott Alexander Fulton
Eduarda Grinsztejn Joao
Claire Irons
Bianca Islam
Matthew Mirsky
Dr. Elie Saade
Laura Schapiro
Christina Thoonkuzhy
George Ahmad Yendewa
Center Number: 1036 Institution Name: Trinity Clinical Research
List of Investigator Names
Dr. Marcus W. Lee
Dr. Robert Hiram Nichols
Diane L. Smith
Center Number: 1037 Institution Name: Clinical Neuroscience Solutions, Inc.
List of Investigator Names
Dr. Lisa Suzanne Usdan
Dr. Valerie Kaplan Arnold
Linda L. Byrd
Patricia Duffy Cunningham
Courtney S. Hale
Dr. Lora Jannette McGill
Carolyn J. Scatamacchia
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col Number: C4591001
Center Number: 1038 Institution Name: Holston Medical Group
List of Investigator Names
Dr. Rick James Whiles
Ms. Anna Renee Bays
Roger D. Begley
Dr. Andrew Peter Brockmyre
Robert B. Rutherford
Ashley E. Smith
Pamela C. Wright
Center Number: 1039 Institution Name: Arc Clinical Research At Wilson Parke
List of Investigator Names
Dr. Gretchen Crook
Jennifer Beanblossom
Dr. Kristen Jill Hansen-Peterman
Sarah Kay Higgs
Camille Horony
Linda Nguyen
Ana Paez
Bandana Risal
Amy Beth Siegel
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col Number: C4591001
Center Number: 1042 Institution Name: Texas Health Family Care
List of Investigator Names
Dr. William Michael Seger
Oluwatosin Oluwasina Akingbala
Mohammed S. Antwi
Elizabeth Diane Boydston
Tisha Q. Davis
Deborah Devlin
Melody Dawn Dufrene
Allison Elizabeth Green
Alma Guel
Dr. Anthony Sangyoon Kim
Samantha Loudermilk
Virginia Loudermilk
Alena Mitchell
Kimberly Diane Pullen
Abdur Rafay Qadri
Ben Seger
Maria Elizabeth Seger
Jean Lucger Seignon
Crystal Starr
Tasha Todd
John Daniel Villegas
Center Number: 1044 Institution Name: Virginia Research Center LLC
List of Investigator Names
Dr. Aaron N. Hartman
Raymond G. Decker
Rachel Stockstill Martin
Center Number: 1046 Institution Name: North Alabama Research Center, LLC
List of Investigator Names
Dr. Ernest Lee Hendrix
Maria Czarina Acelajado Onoya
Matthew Bragg Caldwell
Matthew David Hanserd
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ol Number: C4591001
Center Number: 1047 Institution Name: Medical Affiliated Research Center
List of Investigator Names
Dr. James Gordon McMurray
Dr. Michael Forrest Carter
Dr. Timothy Mitchell Howard
Tiffany Lozovsky
Center Number: 1048 Institution Name: Hope Research Institute
List of Investigator Names
Dr. Abram Hans Burgher
Nathan L. Alderson
Marybeth Barcome
Stephanie A. Catanzaro
Arthur Ken Cook
Bettie D'Nise Corcoran
Dr. Med. Matthew W. Doust
Norma E. Frederick
Scarlett Hammett
Shauna M. Harrell
Dr. Ramoun D. Jones
Ann Marie Mill ken
Center Number: 1052 Institution Name: Long Beach Clinical Trials Services Inc.
List of Investigator Names
Dr. Suzanne Lorelei Fussell
Cynthia Chao
Alicia Delgado
Ms. Jessica Renata Fox
Viviana Gonzalez
Dr. Joseph O. Iwuajoku
Samir Mehta
Tamira Wade
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col Number: C4591001
Center Number: 1054 Institution Name: National Research Institute
List of Investigator Names
Dr. Mark Todd Leibowitz
Rea Elizabeth Cruz Abaniel
Dr. Juan Pablo Frias
Dr. Robert Allen Jenders
John Nelson
Dr. Parvin D. Syal
Center Number: 1055 Institution Name: Diablo Clinical Research, Inc.
List of Investigator Names
Dr. Helen Lee Stacey
Dr. Mark Peder Christiansen
Dr. Leonard H. S. Chuck
Stephanie J. Kim
Catherine Morimoto
Lana Norman
Meaghan Saint
Center Number: 1056 Institution Name: Indago Research & Health Center, Inc.
List of Investigator Names
Jose Francisco Cardona
Yisel Castro Someillan
Victoria Roque
Evelio Hiroel Sosa
Center Number: 1057 Institution Name: Clinical Neuroscience Solutions, Inc.
List of Investigator Names
Dr. Fadi Raji Chalhoub
Susan Pitts Angel
Sujeeta Dhakhwa
Brett Gellers
Dr. Nandita Joshi Jones
Dr. John Mark Joyce
Niketa Kamble
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col Number: C4591001
Center Number: 1066 Institution Name: Solaris Clinical Research
List of Investigator Names
Dr. David John Butuk
Janelle T. Barney
Mrs. Janaie Emily Bounsana
Erin M. Brennan
Melissa A. Conrad
Scott T. Frisby
Meredith K. Mangum
Paige McKenzie
Kaylee Christine Ruckrigl
Center Number: 1068 Institution Name: Bozeman Health Deaconess Hospital Dba Bozeman Health
Clini
cal ResearchList of Investigator Names
D
r. med. Andrew B. Gentry
David B. King
Christopher Lumsden
Susan Irene Meyer
Melissa Pew
Rebecca L. Rassi
Mark Winton
Center Number: 1071 Institution Name: Quality Clinical Research, Inc.
List of Investigator Names
Dr. Michael Joseph Dunn
Ronald Warren Anderson
John D. Hallgren
Brian Hollis
Dr. Rudolf J. Kotula
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col Number: C4591001
Center Number: 1072 Institution Name: Optimal Research, LLC
List of Investigator Names
Dr. Randle Thomas Middleton
Brittanie Alexander
Reba LuAnne Boggs
Courtney Carter
Misty E. Dixon
Charlotte Edmondson
Holly S. Gipson
Heather B. Mahoney
Dr. Nafisa U. Neighbors
Lauren S. Stiles
Joyce E. Todd
Terina Weir
Center Number: 1073 Institution Name: Alliance For Multispecialty Research, LLC
List of Investigator Names
Dr. Corey G. Anderson
Lisa M. Dean
Naomi Lescano Devine
Georgina Lopez-Wood
Tasha C. Marriott
Ashley Perez
James R.A. Ramsey
Dr. Victor Hugo Salazar-Calderon
Cecilia M. Tanori
David Tatelbaum
Nathan Tauta
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col Number: C4591001
Center Number: 1077 Institution Name: Meridian Clinical Research LLC
List of Investigator Names
Dr. Suchet R. Patel
Michael Todd Federico
Dr. Demetrios Gasparis
Dr. Lazarus Brent Christian Gehring
Dr. James Christopher Holler
Eric Joseph Lorraine
Katherine N. Macarak
Rekha S. Patel
John Simon Perry
Dr. Duncan Sze-Tu
Center Number: 1079 Institution Name: Pmg Research Of Charlotte LLC
List of Investigator Names
Dr. George Louis Raad
Laura Ashley Butler
Kameron Dugat
Robyn Johnson Glancy
Zachary Sean Larmore
Dr. Edward Roddy Mogabgab
Donald Dion Morrison
Dr. John William Sensenbrenner
Center Number: 1080 Institution Name: Pmg Research Of Raleigh, LLC D/b/a Pmg Research Of Cary
List of Investigator Names
D
r. Sylvia Piqueras Shoffner
Nicole Alexis Ando
Dr. Scott Carter Bilbro
Dr. Susan Lawrence Crittenden
Garett Randall Franklin
Samantha Kiker
Dr. Sujatha Raman
Amanda Reed
Dr. Derek Quentin Schroder
Savannah L. Shultz
Maurice Smith
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ol Number: C4591001
Center Number: 1081 Institution Name: Sterling Research Group, Ltd.
List of Investigator Names
Dr. Michael Bain Butcher
Diane B. Broadnax
Rachel Nicole Crabtree
Karen A. Freudemann
Julia T. Froschauer
James R. Fry
Gayle Diane Hennekes
Marcel Lanton
Ms. Donna J. Percy
Ms. Jeanne M Piccola
Christina M. Roedersheimer
Phillip Ross
Center Number: 1082 Institution Name: Alliance For Multispecialty Research, LLC.
List of Investigator Names
Dr. William Benjamin Smith
Ms. Katherine Buckner
Sarah Campbell
Dr. Richard Lee G bson
Savannah Kidd
Elizabeth Parker
Talya L. Thomas
Jennifer Allison Winbigler
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col Number: C4591001
Center Number: 1083 Institution Name: Benchmark Research
List of Investigator Names
Dr. Laurence Chu
Ms. Jennifer Bacchi
Maria Barrientes
Taylor Bartlett
Selena Bermudez
Lamar Box
Christian Casas
Dr. Ruth Michelle Chouteau
Lauren Christal
Martha Clark
Ms. Pamela B. Conley
Katherine Marie Davis
Ms. Tambra Layne Dora
Cindy Janette Duran
Pamela Fidler
Ruth Fitch
Brooke Asheley Harris
Mr. Isaiah Knight
Jennifer Leyva
Michelle R. Listz
Clara Loza
Jennifer R. Montes
Javier Perez
Marisol P. Ramos
Jessica Ruff
Dean Skiles
Sean Turnbow
Francesca Vigil
Breana Wade
Kelly Weber
Confidential P age 22 of 76
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FDA-CBER-2021-5683-0013793
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1084 Institution Name: Clinical Trials Of Texas, Inc.
List of Investigator Names
Dr. Douglas Scott Denham
Darlington Akahara
Muhammad Omair Ahsan Ata
Ayoade Oluwaseun Avworo
Stephen E Brick
Cathleen Chen
Maristelle Co
Graham Ellis
Kimberly R. Evans
Zachariah E Francois
Dr. Parke Joseph Hedges
Matthew Kenneth Korte
Anshumaan Maharaj
Mary Jo Perez-Jenkins
Cynthia A. Ramos
Clayton Alexander Stone
Dr. Thomas Roderick Weiss
Center Number: 1085 Institution Name: Ventavia Research Group, LLC
List of Investigator Names
Dr. Gregory Michael Fuller
Pamela B. Martin
Tracy Starnes
Center Number: 1087 Institution Name: Pmg Research Of Wilmington, LLC
List of Investigator Names
Dr. Kevin Dougherty Cannon
Dr. Mesha McKinney Chadwick
Confidential P age 23 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013794
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1088 Institution Name: Pmg Research Of Hickory, LLC
List of Investigator Names
Dr. John Keith Earl
Heather D. Barnett
Nicole Hope Everhart
Robert Eric Hart
Jennifer Sailors Lail
Ryan T. Parker
Shai C. Perry
Dr. Scott David Polster
Maranda Denise Rhudy
Kristen N. Sherrill
Heather Lynn Warta
Center Number: 1089 Institution Name: Pmg Research Of Salisbury, LLC
List of Investigator Names
Dr. Cecil Murray Farrington
Laura R. Kruchkow
Cortney B. Ledbetter
Kishan Rao Maramraj
Dr. Robert Eric McNeill
Jamie H. Myers
Kimberly H. Potts
Center Number: 1090 Institution Name: M3 Wake Research, Inc.
List of Investigator Names
Dr. Lisa Mauri Cohen
Dr. Wayne Lee Harper
Lori C. Bridges
James William Earnhardt
Ms. Lynn Gordon Eckert
Matthew Hanson Hong
Kendra Kristine Lisec
Dr. Adnan Nasir
Amanda Grace Olsen
Priti K. Patel
Douglas Allen Wadeson
Confidential P age 24 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013795
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1091 Institution Name: Aventiv Research Inc (Facility And Drug Shipment Address)
List of Investigator Names
D
r. Samir Arora
Rafe Bari
Brittany Biro
Brennan Brothers
Grazia Ann Cannon
Jordan Carpenter
Danijela Cvijetinovic
Jess J. DeMaria
Roger L. Faubel
Allison Forsythe
Sophia Gaines
Dr. Sridhar Guduri
Jessica Harpel
Chelsea Hughes
Layne Mikanik
Lindsay Newton
Grace Purkey
Jessica Spear
Dr. Roy C. St. John
Center Number: 1092 Institution Name: Sterling Research Group, Ltd.
List of Investigator Names
Dr. Rajesh Kumar Davit
James R. Fry
Dr. Bruce Cushman Gebhardt
Gayle Diane Hennekes
Victoria Hughes
Joanne Major
Dr. Padma N. Mangu
Debra Beck Schroeck
Ms. Cynthia Theresa Wright
Confidential P age 25 of 76
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FDA-CBER-2021-5683-0013796
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1093 Institution Name: Meridian Clinical Research, LLC
List of Investigator Names
Dr. David Jon Ensz
Taylor Alexandra Bergh
Ms. Tavane Elizabeth Harrison
Meagan Miller
Allie Jordan Oplinger
Center Number: 1094 Institution Name: Linq Research, LLC
List of Investigator Names
Dr. Murtaza Mussaji
Mohammad F. Siddiqui
Center Number: 1095 Institution Name: Tekton Research, Inc.
List of Investigator Names
Paul Keith Pickrell
Andrew Bell
Brandi Chalman
Eileen Euperio
Lisa Johnson
Paige Kenny
Carol Ann Linebarger
John Luna
MD Hussain Malbari
Stefanie Mott
Dr. Eugene David Pampe
Dr. Melissa Guzman Winn
Center Number: 1096 Institution Name: Hany H. Ahmed, MD
List of Investigator Names
Van Quang Tran
Dr. Hany Hagag Ahmed
Dr. Homero Garza
Katherine Marie Lopez
Confidential P age 26 of 76
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FDA-CBER-2021-5683-0013797
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1097 Institution Name: Main Street Physician's Care
List of Investigator Names
Dr. Tom Allan Christensen
Dr. Stephen Dale Grubb
Dr. Steven O. Price
Center Number: 1098 Institution Name: Sms Clinical Research, LLC
List of Investigator Names
Dr. Salma Saiger
Amy Dunn
Kiery McMullen
Moiz Shafiq
Center Number: 1101 Institution Name: Methodist Physicians Clinic / Cct Research
List of Investigator Names
Dr. Thomas A. Wolf
Colleen Susanne Caliri
Heather J. Diederich
John Monaco Dobleman
Jessica Lee Francis
David Garcia
Renee Lynn Hochstein
Kylie M. Hutsell
Mrs. Stacie M. Jarzynka
Bridget Carisa Ladwig
Shirley McLaurine
Nathan Philip Neuberger
Christine Scheuring
Lynnda M. Schiermann
Brandi Schulz
Andrea VerMaas
Confidential P age 27 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013798
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1107 Institution Name: Alliance For Multispecialty Research, LLC
List of Investigator Names
Dr. med. Harry Earl Studdard
Carrie Allenbach
Dana Clark Bekurs
Katelyn Howard
Dr. Michael T. Ledet
Pamela Rowe Manley
Anna Brunson May
Confidential P age 28 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013799
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1109 Institution Name: Deland Clinical Research Unit
List of Investigator Names
Dr. Bruce Glenn Rankin
Fadhel Alyunis
Vienna Bauer
Tasha Brocato
Daniel T. Campbell
Jennifer Cline
Claxton Copeland
Paula Daniel
Jeanette De Leon
Dr. Craig Steven Dean
Jennifer Dittman
Szheckera Fearon
Shatonia Fields
Jessica C. Gilliam
Angela M. Hammerle
Assoc. Prof. Eva-Maria Heurich
Dr. John Michael Hill
Ryan Hobbick
Ms. Melissa Hodges
Ranie Hutchins
Christina Lynn Isbell
Taylor Martin
Clark Mason
Dhaneshwar Oomrow
Crystal A. Paccione
Vivek Rajasekhar
Antonio Rivera
Over Seijas
William Serrano
Steven Trai Shinn
Diana Toney
Thais Truffa
Michelle Tutt
Confidential P age 29 of 76
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FDA-CBER-2021-5683-0013800
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Ms. Amber Vasquez
Erika Wierzbicki
Center Number: 1110 Institution Name: Alliance For Multispecialty Research, LLC-Miami
List of Investigator Names
Dr. Jeffrey Bruce Rosen
Eric Gancedo
Monica Mauri
Jennifer S. Mokross
Jenny C. Montes De Oca Pineda
Tamara Richards
Assoc. Prof. Adam Michael Rosen
Center Number: 1111 Institution Name: Fleming Island Center For Clinical Research
List of Investigator Names
Dr. Michael Anthony Stephens
Dr. William J. Davila
Sarah C. Graham
Dr. Mitchell S Rothstein
Stephanie C. Wilder
Anne H. Witt
Confidential P age 30 of 76
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FDA-CBER-2021-5683-0013801
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1112 Institution Name: Clinical Research Atlanta
List of Investigator Names
Dr. Nathan Segall
Michelle Binns
Kimberly Cobb
Mustafa Elhallaoui
Jon Philip Finley
Tyra Gaines
Jeffrey Jones
Susan D. Jones
Ms. Jennifer LeBrun
Nancy Levine
William R. Osborne
Michelle Sowell
Cynthia Steele
Mildred Stull
Pamela Ta bott
Donna M. Toepfer
Kwannda Whatley
Karen Yangapatty
Confidential Pa ge 31 of 76
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FDA-CBER-2021-5683-0013802
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1114 Institution Name: Alliance For Multispecialty Research, LLC
List of Investigator Names
Dr. Richard M. Glover
Lindsey Brewer
Janelle L. Brown
Mrs. Melissa A. Burton
Jordan L. Danby
Sheri L. Duncan
Amber K. Grant
Dr. Robyn D. Hartvickson
Lisa R. Hemmelgarn
Dr. Troy A. Holdeman
Jeri L. King
Riley Gene King
Shannen Lassiter
Cayla E. Lawless
Jill D. Longstaff
Ragene Moore
Marissa K. Mueller
Aaron K. Nguyen
Justin R. Phillips
Katherine E. Saengerhausen
Dr. Stacy B. Slechta
Dylan L. Thomas
Shannon Lynn Thomas
Cindy N. Thome
Denae L. Villines
Eilleen D. Wi bert
Confidential Pa ge 32 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013803
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1116 Institution Name: Medpharmics, Limited Liability Company
List of Investigator Names
Dr. Paul G. Matherne
Melissa Benke
Nancy G. Bladsacker
Sarah Elizabeth Bowen
Amy Caldwell
Ashley Dean-Reaves
Donald K. Gaddy
Kathrine Gaddy
Ms. Nicole Daigle Guttierrez
Megan L. Hill
Lindsay T. Huckabee
Heather Lambert
Tiffany Payne
Connie Bagley Richardson
Laura Singley
Valerie Velasco
Dimitri A. Yanez
Center Number: 1117 Institution Name: Sundance Clinical Research, LLC
List of Investigator Names
Assoc. Prof. Larkin Tyler Wadsworth
Jennifer A. Berry
Lauren Clement
Lyly Dang
Horacio Domingo Antonio Marafioti
Center Number: 1118 Institution Name: Meridian Clinical Research, LLC
List of Investigator Names
Dr. Frank Steven Eder
Victoria Elizabeth Marie Engler
Ryan Daniel Little
Jennifer Lynn Molstead
Dr. Heather Thu Rattenbury-Shaw
John Tarbox
Confidential P age 33 of 76
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FDA-CBER-2021-5683-0013804
BLA BNT162b2 Sec tion 1.3.4 Financial Disclosure
T
HOSE LISTED BELOW HAV E DISCLOSED THAT THEY HAV E NO F INANC IAL INTERESTS IN THIS PRODUCT
Protocol Number: C4591001
Center Nu mber: 1120 Institution Name: Meridi an Clinical Research, LLC
List of Investig ator Names
Dr. Paul Simon Bradley
S
hanice L. Bennett
Jim Callis
A
nne Carson Crouch
Shannon Davis
Dr. Brandon James Essink
Brooke Bradley Halpern
A
manda Methe Lilienthal
Doungphon Nelson
Kay Lynn Olmsted
Center Nu mber: 1121 Institution Name: Optimal R esear ch, LLC
List of Investig ator Names
Dr. Daniel Herman Brune
J
essica Bonnette
Monica Brown
Shannon Carter
Jennifer Dixon
M
ichael J. Downey
Jennifer L. Hartley
J
ennifer Henz
R
achel Kilgus
Craig D. Koch
C
hristian Regalado-Mathews
D
anielle Scoles
J
ared Smith
Christina Troxell
S
idney Woll
Center Nu mber: 1122 Institution Name: Va North east Ohio H ealth care System
List of Investig ator Names
Federico Perez
Confidential Pag e 34 of 76Curtis Donskey
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FDA-CBER-2021-5683-0013805
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1123 Institution Name: Meridian Clinical Research
List of Investigator Names
Dr. Brandon James Essink
Jacob Arthur Bumsted
Laura McMullen Falcone
Roni S. Gray
Cassandra Heisey
Linda Jessie Layton
Jay Robert Meyer
Kimberly Dolan Mueller
Tiffany Nemecek
Frederick Conrad Raiser
Akossiwa Essi Yovogan
Center Number: 1124 Institution Name: Omega Medical Research
List of Investigator Names
Dr. David L. Fried
Amanda T. Cole
Jacqueline DiFazio
Patricia A. Feole
Helena Godley
Kristina M. Haughey
Lynne A. Haughey
Courtney Langlois
Amanda Z. O'Neill
Johnna A. Pezzullo
Lisa S. Rameaka
Molly J. Savitzky
Ariana C. Stanton
Confidential P age 35 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013806
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1125 Institution Name: Meridian Clinical Research, LLC
List of Investigator Names
Dr. Charles Harold Harper
Sally Eppenbach
Alisha Marie Kiepke
Cathy Jo Laflan
Wendell Eugene Lewis
Brett Milan Loseke
Chelsie Victoria Nutsch
Kari Kay Uhlir
Dr. Keith William Vrbicky
Confidential P age 36 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013807
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1126 Institution Name: Kaiser Permanente Santa Clara
List of Investigator Names
Rebecca B. Alexander
Janelle M. Baires
Jessica Margaux Barraza
Latisha Marie Burun
Christine Cash
Gail Larie Cook
David Cooper
Jolynne Gerardo Encarnacion
Douglas Ernst
Lauren Blair Fontenot
LaVonne Freed
Jeremy Giese
Julia R. Glanternik
Sarah Kang
Lisa Kennedy
Rebekah Danell Kotyk
Roma Kaur Kullar
Ludy Pasaoa Lemus
Ms. Eva S. Lowe
Lorrie Aileen Lowe
Nicole D. Makram
Ms. Shannon Mullen
Courtney Ann Oxandale
Ken Purdy
Sally Ann Upadhyaya
Dana Maria Weisshaar
Amy Wiesner
Confidential P age 37 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013808
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1127 Institution Name: Alliance For Multispecialty Research, LLC
List of Investigator Names
Dr. Tracy Ray Klein
Nathan P. Bergkamp
Sandra L. Blaylock
Olivia D. Eagleson
Gregory G. Greer
Lisa R. Hemmelgarn
Diandra M. Henriques
Ms. Jill Dion Hiebert
Denise R. Hole
Laura A. Holz
Dr. Terry D. Klein
Dr. Thomas C. Klein
Shannen Lassiter
Lynn A. Le
Jill D. Longstaff
Jessie R. Matthews
Meenakshi Kavya Natesan
Dr. Loan Minh Nguyen
Dr. Terry L. Poling
Christa B. Shue
Taylor M. Simmons
Brenna M. Sprout
Cindy N. Thome
Demetria N. Underwood
Ms. Ariel R. Wi ken
Gina M. Young
Center Number: 1128 Institution Name: Ventavia Research Group, LLC
List of Investigator Names
Mark Koch
Dr. Norma L. Escamilla
Patricia Dorothy Kaczmarski
Dr. Isaac Aaron Watemberg
James Russell Winn
Confidential Pa ge 38 of 76
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FDA-CBER-2021-5683-0013809
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1129 Institution Name: Jacksonville Center For Clinical Research
List of Investigator Names
Dr. Michael Jay Koren
Dr. Kenneth Aung-Din
Dr. Darlene Maria Bartilucci
Janet Ellen Garvey
Dr. Jeffry Alan Jacqmein
Dr. Alpa Mahendra Patel
Dr. Mitchell S Rothstein
Steven Toenjes
Dr. Carolyn Minh-Tram Tran
Center Number: 1130 Institution Name: Kaiser Permanente Northwest-Center For Health Research
List of Investigator Names
Dr. Stephen Paul Fortmann
Tara Beatty
Bryan David Kauffman
Dorothy K. Kurdyla
Dr. Richard Anthony Mularski
Katie Anne Sharff
Britta N Torgrimson-Ojerio
Eric C Walter
Center Number: 1131 Institution Name: Primed Clinical Research
List of Investigator Names
Dr. William John Randall
Melissa Jo Botts
Heather Lenee Goins
Zachariah Komon
Kimberly Lyons
Dr. Ann Trzaska Moell
Crystal Osman
Caitlyn Smith
Dr. Gilbert Walter Templeton
Confidential P age 39 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013810
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1133 Institution Name: Research Centers Of America
List of Investigator Names
Dr. Howard Israel Schwartz
Maria Companioni
Barbara G. Corral
Surisaday Mederos
Dr. Americo Francisco Padilla
Dr. Nelia Esther Sanchez-Crespo
Jennifer Haley Schwartz
Janet M. Sentil Tamayo
Dr Peter Paul Ventre
Center Number: 1134 Institution Name: Pmg Research Of Winston-Salem, LLC
List of Investigator Names
Dr. Jonathan Paul Wilson
Dr. Robert John Holmes
Josephine Blaire Purbrick
Ms. Danielle F. Reynolds
Ms. Ashley Nicole Schmidt
Dr. Brian Stanley Smith
Holly C. Smith
Andrew R. Stebich
Ms. Alissa Paige VanDyke
Center Number: 1135 Institution Name: Anaheim Clinical Trials, LLC
List of Investigator Names
Dr. Peter John Winkle
Riany Mirasol Valeriano Cadag
Dr. Amina Zakaria Haggag
Dr. Elizabeth Y. Lee
Confidential P age 40 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013811
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1136 Institution Name: Wake Research-Clinical Research Center Of Nevada, LLC
List of Investigator Names
Dr. Michael Lewis Levin
Dr. Melodie Ann Armstrong
Julie Hussey
Dr. Marcy A. Kulic
Dr. Judith L. Salz
Center Number: 1139 Institution Name: Accessioning Unit And Repository
List of Investigator Names
Dr. Emmanuel Benjamin Walter
Christopher Charles Clark
Jennifer Dougherty
Michael Joseph Smith
Geeta Krishna Swamy
Center Number: 1140 Institution Name: Suny Upstate Medical University
List of Investigator Names
Kathryn Anderson
Elizabeth Asiago-Reddy
Dr. Donald Clyde Blair
Ms. Rachael L. Cavelli
Dr. Joseph Bernard Domachowske
Timothy Endy
Sriharsha Gowtham
Elizabeth Harausz
Kristopher M. Paolino
Stephen James Thomas
Center Number: 1141 Institution Name: University Of Iowa Hospitals & Clinics Investigational Drug
Se
rvcesList of Investigator Names
Dr
. Patricia Lee Winokur
Assoc. Prof. Jeffery Linn Meier
Elizabeth Morgan
Debra Jane Pfab
Dr. Jack Thomas Stapleton
Laura Jean Stu ken
Confidential Pa ge 41 of 76
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FDA-CBER-2021-5683-0013812
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1142 Institution Name: University Of Texas Medical Branch
List of Investigator Names
Dr. Richard Earl Rupp
Megan Anne Berman
Cori Michelle Burkett
Elizabeth Ginn
Dr. Laura Porterfield
Center Number: 1145 Institution Name: Center For Immunization Research Inpatient Unit
List of Investigator Names
Kawsar R. Talaat
Brittany Marie Adjoodani
Rachel Lynette Adkinson
Kamal Dhanjani
Dr. Anna P. Durbin
Brittany Lanae Feijoo
Palmtama Grier
Noreen A. Hynes
Rachel Elizabeth Rokser
Beulah P. Sabundayo
Center Number: 1146 Institution Name: Amici Clinical Research
List of Investigator Names
Dr. med. Robert Stephen Falcone
Sonia Edwards
Dr. Anthony Frisoli
Christine Marie Hildebrand
Lisa Marie Malak
Confidential P age 42 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013813
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1147 Institution Name: Ochsner Clinic Foundation
List of Investigator Names
Assoc. Prof. Julia Betzabe Garcia-Diaz
Hailey Lynn Anderson
Melinda Benvenuti
Julie M. Castex
Freda C. Dunhurst
Lisa Anne Fredenburg
Jenna D. Griffin
Samuel Travis King
James McMullen
Center Number: 1149 Institution Name: Collaborative Neuroscience Research, LLC
List of Investigator Names
Dr. Steven H. Reynolds
Dr. Gregory Ralph Bonomo
Lee Jay Dolowich
Dr. Haig Armen Goenjian
Dr. Omid Omidvar
Lara Goenjian Shirikjian
Dr. Seanglong Te
Center Number: 1150 Institution Name: Senders Pediatrics
List of Investigator Names
Dr. Shelly David Senders
Sarah A. Ball
Dr. Elizabeth Zenowich Bucchieri
Dr. Laura A. Caserta
Dr. Allison B. Effron
Christopher Fackelmann
Caitlin Fillioe
Kelly M. Kelmes
Jennifer McKinnon
Keili A. Mistovich
Katie S. Passarell
Eliza K. Pereira
Confidential P age 43 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013814
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1152 Institution Name: California Research Foundation
List of Investigator Names
Dr. Donald Milan Brandon
Dr. William Burton Davis
Daniel Thomas Lawler
Center Number: 1156 Institution Name: Acevedo Clinical Research Associates
List of Investigator Names
Hector Antonio Rodriguez
Dr. Armando E. Acevedo
Dr. Armando Garcia
Yeniska Hall Nieves
Lizz L. Hernandez Diaz
Iris Izquierdo
Elaine Martinez
Alina Monteagudo Canto
Israel Zagales
Center Number: 1157 Institution Name: Paradigm Clinical Research Center
List of Investigator Names
Dr. Jamshid Saleh
Marisol Angel Corrales
Candice Cabading
Marla L. Clark
Stephanie J. Clayton
Emily P. Crews
Amber Dawn Falconer
Carmen Flores
Alisha Angel Garcia
Dr. Rafael Lupercio
Vicky A. Martin
Matthew Scott Miles
Matthew David Pohlmeyer
Sarah Ann Sandberg
Mohamed H Yassin
Ruba Zanaid
Confidential P age 44 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013815
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1161 Institution Name: Benchmark Research.
List of Investigator Names
Dr. Darrell T. Herrington
Cambree Allison
Dr. Warren Lee Conway
Ms. Dacia Corder
Krystal Shaunta Doucet
Cynthia M. Dukes
Priscilla R. Garcia
Kayla Joy Gibbs
Tina A. Goltl
Elyza A. Guerrero
Omega K. Hernandez
Mark Hinojos-Zamora
Jaime Hyatt
Priscilla Lozano
Pete Mendoza
Pricilla Percifield
Sierra Ramirez
Ivon Reveles
Jacquie Rincon
Vanessa Elvira Sanchez
Blanca Valdez
Melissa White
Shawnna White
Center Number: 1162 Institution Name: Atlanta Center For Medical Research
List of Investigator Names
Dr. med. Robert Alan Riesenberg
Maria E. Johnson
Dr. Mark N. Lerman
Dr. Stanford R. Plavin
Leana Laurencin Woodside
Confidential P age 45 of 76
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FDA-CBER-2021-5683-0013816
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1163 Institution Name: Benchmark Research
List of Investigator Names
Dr. George Harry Bauer
Edwin Dean Adamson
Julie Krutz Bilich
Michael J. Cotugno
Cynthia M. Dukes
Lois M. Eaglin
Kim M. Harper
Stacey Howard
Charie Michael Hynes
Brandon Joseph Illickal
Brenda Collins Lawson
Kyra Monchel Lawson
Jeffrey J. Segner
Center Number: 1166 Institution Name: Rapid Medical Research, Inc.
List of Investigator Names
Dr. Mary Beth Manning
Brianna Arman
Nicole Baitt
Dr. Toby Briskin
Sarah Dzigiel
Jennifer Gaston
Brooke Glivar
Lisa M. Hoagland
Briana Jackson
Emma Landskroner
Amy Maroun
Devan Patel
Denise Roadman
Joan Rothenberg
Brian Sharpe
Megan Sokolowski
Karly Tarase
Sharita Tedder-Edwards
Confidential P age 46 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013817
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1167 Institution Name: Holston Medical Group
List of Investigator Names
Dr. Emily Jane Morawski
Shane A. Daniell
Lisa D. Davis
Amanda G. Donoho
Ashley N. Helton
Dr. Curtis Matthew Jantzi
Anna M. Johnson
Dr. Joseph Anthony Ley
Dr. David J. Morin
Lori L. Ray
Emily B. Whitaker
Center Number: 1168 Institution Name: Lynn Institute Of Norman
List of Investigator Names
Dr. Steven Earl Cox
Brandy Ball
Lindsay M. Flaming
Angela Genovese
Aja George
Shanda Gower
Ms. Karen Hames
Avery Keller
Sharla Lister
Chalimar Rojo
Sharee Wright
Confidential P age 47 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013818
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1169 Institution Name: Lehigh Valley Health Network/network Office Of Research
And InnovationList of Investigator Names
Dr. Joseph Leo Yozviak
Kristen Cornell
Thomas Eames
Brian C. Friel
Dr. Timothy J. Friel
Dr. Marcelo G. Gareca
Dr. Margaret Linda Hoffman-Terry
Matthew Karpowicz
Terry Kloiber
Dr. Mark C. Knouse
Arun Mancheril
Hugh A. Marsh
Jean Novak
Andrew Orzel
Carla Rossi
Amy K. Slenker
Nicholas Trask
Center Number: 1170 Institution Name: North Texas Infectious Diseases Consultants, P.A.
List of Investigator Names
Dr. Mezgebe Berhe
Rahaf Al Masri
Christopher J. Bettacchi
Jessica Caldwell
Emma Dishner
Erin M. Duhaime
Kevin Golden
Dr. Clinton C. Haley
Bailey Isenberg
Misty Kell
Bryan King
Tammy Morgan
Dr. Uriel S. Sandkovsky
Confidential P age 48 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013819
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1171 Institution Name: Dm Clinical Research
List of Investigator Names
Dr. Earl Francis Martin
Carolina Deandres
Dr. Muhammad Irfan
Dr. Earl Edward Martin
Monica Christine Murray
Amy Christine Starr
Insiya Valika
Center Number: 1174 Institution Name: Infectious Diseases Physicians, LLC
List of Investigator Names
Dr. Donald Martin Poretz
Amber Edelman
Malika Welborn
Dr. David Allen Wheeler
Center Number: 1177 Institution Name: East-West Medical Research Institute
List of Investigator Names
Assoc. Prof. David Fitz-Patrick
Dr. Cindy H. T. Pau
Sian J. Smowton
Confidential P age 49 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013820
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1178 Institution Name: Clinical Research Associates, Inc.
List of Investigator Names
Dr. Stephan C. Sharp
Michael C. Caldwell
Stacy Lynn Cox
Michael J Hutson
Deborah S. Jamison
Deidre Lanier
Leanne J. Martin
Lois P. McClure
Kathryn Ann McNally
Audrey L. Quickel
Linda Moore Schipani
Allison G. Sochovka
Robert L. Stokes
Wendy M. Tidwell
Center Number: 1179 Institution Name: Michigan Center For Medical Research
List of Investigator Names
Dr. Steven Katzman
Dr. Michael Potes
Khalid Rao
Center Number: 1185 Institution Name: Universitätsklinikum Hamburg-Eppendorf
List of Investigator Names
Marylyn Addo
Kirsten A. Eberhardt
Tamara Nordmann
Michael Ramharter
Dr. Stefan Schmiedel
Parichehr Shamsrizi
Center Number: 1194 Institution Name: Ikf Pneumologie Gmbh & Co Kg
List of Investigator Names
Dr. med. Andreas Eich
Stefanie Franke
Dr. med. Marc Oliver Kornmann
Confidential P age 50 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013821
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1195 Institution Name: Medizentrum Essen Borbeck
List of Investigator Names
Dr. med. Axel Schaefer
Mazin Sanuri
Center Number: 1197 Institution Name: Studienzentrum Brinkum Dr. Lars Pohlmeier Und Torsten
DrescherList of Investigator Names
Dr. Med. Matthias Luttermann
Torsten Drescher
Dr. Lars Pohlmeier
Center Number: 1202 Institution Name: Crs Clinical Research Services Mannheim Gmbh
List of Investigator Names
Dr. med. Dr. rer nat. Armin Schultz
Dr. Friedeborg Seitz
Marina Streckebein
Center Number: 1203 Institution Name: Crs Clinical Research Services Berlin Gmbh
List of Investigator Names
Dr. Sybille Baumann
Matthias Berse
Manuela Casjens
Luca E bach
Jonas Fanomezana Eppel
Julian Hugo
Dr. Wilhelm Kai Peter Koch-Sembdner
Alexander Niewiadomski
Mares-Elaine Strempler
Confidential Pa ge 51 of 76
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FDA-CBER-2021-5683-0013822
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1204 Institution Name: Icahn School Of Medicine At Mount Sinai
List of Investigator Names
Dr. Judith Ann Aberg
Deena Altman
Tarashon Retima Broomes
Dr. Michelle S. Cespedes
Francesca Cossarini
Alina Jen
Sean T. Liu
Dana Suzanne Mazo
Sondra M. Middleton
Farah Rahman
Erika Maria Reategui Schwarz
Center Number: 1205 Institution Name: Hacettepe Universitesi Tip Fakultesi
List of Investigator Names
Prof. Dr. Serhat Unal
Dr. Murat Akova
Dr. Mine Durusu Tanriover
Ahmet Cagkan Inkaya
Center Number: 1207 Institution Name: Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi
List of Investigator Names
Ismail Bal k
Irem Akdemir Kalkan
Mehmet Serhat Birengel
Gule Cinar
Ezgi Gulten
Center Number: 1208 Institution Name: Acibadem Atakent Hastanesi
List of Investigator Names
Prof. Dr. Iftihar Koksal
Yildiz Okuturlar
Alpay Yesilaltay
Confidential Pa ge 52 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013823
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1209 Institution Name: Istanbul Yedikule Gogus Hastaliklari Ve Gogus Cerrahisi
Egitim Arastirma HastanesiList of Investigator Names
Prof. Dr. Sedat Altin
Gulsah Gunluoglu
Derya Hircin Cenger
Kerem Turkmen
Center Number: 1210 Institution Name: Medipol Mega Universite Hastanesi
List of Investigator Names
Prof. Ali Mert
Prof. Mesut Yilmaz
Center Number: 1212 Institution Name: Sakarya Universitesi Egitim Ve Arastirma Hastanesi
List of Investigator Names
Oguz Karabay
Abdulkadir Aydin
Ertugrul Guclu
Asli Vatan
Center Number: 1213 Institution Name: Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi
List of Investigator Names
Omer Fehmi Tabak
Hazal Erdem
Dr. Bilgul Mete
Center Number: 1214 Institution Name: Istanbul Universitesi Istanbul Tip Fakultesi
List of Investigator Names
Serap Simsek-Yavuz
Cagla Keskin Saritas
Center Number: 1217 Institution Name: Kocaeli Universitesi Tip Fakultesi
List of Investigator Names
Sila Akhan
Sonay Arslan
Confidential P age 53 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013824
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1218 Institution Name: Whiteriver Indian Hospital - Garrett Building
List of Investigator Names
Laura Hammitt
Laura B. Brown
James Joseph Campbell
Jane Lee Halpern
Nina Mayer Ritchie
Kristen Chimileski Roessler
Daniel John VandeRiet
Robert Weatherholtz
Center Number: 1219 Institution Name: Chinle Comprehensive Health Care Facility
List of Investigator Names
Laura Hammitt
Laura B. Brown
James Joseph Campbell
Jane Lee Halpern
Nina Mayer Ritchie
Kristen Chimileski Roessler
Daniel John VandeRiet
Robert Weatherholtz
Center Number: 1220 Institution Name: Northern Navajo Medical Center
List of Investigator Names
Laura Hammitt
Laura B. Brown
James Joseph Campbell
Jane Lee Halpern
Nina Mayer Ritchie
Kristen Chimileski Roessler
Daniel John VandeRiet
Robert Weatherholtz
Confidential P age 54 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013825
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1221 Institution Name: Johns Hopkins Center For American Indian Health
List of Investigator Names
Laura Hammitt
Laura B. Brown
James Joseph Campbell
Jane Lee Halpern
Nina Mayer Ritchie
Kristen Chimileski Roessler
Daniel John VandeRiet
Robert Weatherholtz
Center Number: 1223 Institution Name: Yale University
List of Investigator Names
Onyema E. Ogbuagu
Ms Laurie J. Andrews
Thilinie Bandaranayake
Melissa Campbell
Frances Santiago
Jessica Tuan
Center Number: 1224 Institution Name: Lynn Institute Of Denver
List of Investigator Names
Dr. Larry Lee Odekirk
Cherie D. Castro
Christina M. Gallegos
Veronica Gonzales
John D. McLaughlin
Mark H. Nathanson
Kelly Radin
Kristine Rausch
Confidential P age 55 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013826
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1226 Institution Name: Cepic - Centro Paulista De Investigacao Clinica E Servicos
Medicos Ltda (Casa Branca)List of Investigator Names
Prof. Cristiano Augusto de Freitas Zerbini
Breno Balabem Alves
Dr. Marta Eliane de Carvalho Bastos
MD Fernando Brunori
Sonia Yurico Omori Del Debbio
Dr. Emerson Alves Gimenez
Dr. Mariana Gioielli Waisberg
Dr. Raissa Gomes da Silva
Dr. Andrea Barranjard Vannucci Lomonte
Dr. Flora Maria D'Andrea Marcolino
Marcio Abreu Neis
Dr. Maria Jose Nunes
Valéria de Morais Silveira Telles
Center Number: 1229 Institution Name: Newtown Clinical Research Centre
List of Investigator Names
Dr. Essack Aziz Mitha
Salim Ahmed
Ilunga Felicien Kapanga
Naomie Kupangi Kapanga
Nokuthula Zinhle Khumalo
Fatima Sirkhotte
Center Number: 1230 Institution Name: Limpopo Clinical Research Initiative
List of Investigator Names
Dr. Leon Frederik Fouche
Michiel Andries Buys
Dr. Muhammed Ameen Fulat
Thinti Johanna Moreroa
Dr. Danellus Van der Watt
Pieter-Louis Vollgraaff
Confidential P age 56 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013827
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1231 Institution Name: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
List of Investigator Names
Fernando Pedro Polack
Dr. Isabel Abramovich
Dr. Maria Natalia Accorinti
Dr. Solange Lara Marlene Acosta Altabe
Dr. Paula Andrea Agosti
Omar Ruben Aguayo
Dr. Gaston Agudo Franco
Dr. Caterina Lisette Aguilar Roman
Dr. Antonio Laureano Aguilera
Dr. Maria Florencia Aiccardi
Dr. Carla Antonela Airoldi
Dr. Maria Laura Airoldi
Dr. Mariano Aizpurua
Dr. Mariana Albarracin
Dr. Graciela Alegre
Dr. Julieta Alfonso
Dr. Maria Lorena Allende
Dr. Isabel Alvarez Burgos
Dr. Federico Abel Alvarez Loray
Dr. Anabella Alvarez Mandias
Dr. Maria Alejandra Andreau
Dr. Maria Mercedes Anoni
Dr. Daniel Elias Aput
Dr. Guillermo Luis Alberto Aquino
Dr. Esteban Araujo Ramos
Dr. Julieta Mabel Arredondo Martinez
Dr. Paula Leticia Asanovic
Dr. Maria Paula Ascarate
Victoria Auzmendi
Dr. Cristian Ruben Avellino
Dr. Maria Constanza Avena
Maria Cecilia Azpiroz
Dr. Maria Florencia Baccini
Confidential P age 57 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013828
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Dr. Maria Marcela Bachella
Laura Lorena Baffa
Dr. Lorena Alejandra Bajinay
Dr. Magdalena Bajo
Dr. Luis Leopoldo Balaguer
Dr. Carola Maria Baldoni
Dr. Lucrecia Noelia Bandeo
Dr. Alan Gonzalo Barrego
Dr. Sebastian Federico Batage j
Dr. Néstor Adrián Osvaldo Bautista Herrera
Dr. Mirta Susana Becerra Pons
Dr. Gabriela Luz Belachur
Dr. Sebastian Martin Tomas Belchior
Dr. Cynthia Gabriela Belo
Dr. María Guadalupe Bengoa
Dr. Maria Graciela Beretta
Dr. Antonella Berutti
Dr. Federico Daniel Bianco
Dr. Juan Manuel Bidegain
Dr. Favio Javier Bigas
Dr. Felipe Mariano Bilbao
Dr. Jessica Lorena Bilstein
Dr. Maria Cecilia Blanco
Dr. Ricardo Gaston Blanco
Dr. Lucia Bonfada
Dr. Maria Montserrat Borio
Dr. Monserrat Boroni
Dr. Maria Cecilia Bourgeois
Dr. Barbara Braun
Maria Emilia Breppe
Dr. Sergio Daniel Buscazzo
Benjamin Buteler
Dr. Guillermo Andres Calderon
Dr. Belen Camardelli
Dr. Maria Florencia Camean
Confidential Pa ge 58 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013829
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Jorgelina Lujan Candia
Alejandro Capdevilla
Dr. Angela Leonor Carbajal Maldonado
Dr. Maria Eliana Carballo Lencina
Dr. Federico Cardahi
Dr. Federico Daniel Cardozo
Dr. Josefina Carrano
Dr. Hugo Carranza
Dr. Barbara Carrizo
Dr. Gustavo Christian Casado
Dr. Lorena Alejandra Casal
Dr. Ana Maria Casalins
Dr. Analia Beatriz Castellano
Dr. Andrea Elizabeth Castelo
Dr. Maria Paula Castillo Areco
Dr. Cyntia Alejandra Castro
Dr. Romina Maricel Castro
Dr. Fabian Alberto Castro Barros
Dr. Francisco Castro Montiel
Viviana Elizabeth Cavenago
Dr. Maria Gabriela Cedron
Dr. Solana Ceretti
Dr. Marian Chacoff
Dr. Yolanda Isabel Chanampa
Dr. Agustina Chidichimo
Dr. Analía Christmann
Dr. Manuel Jose Clavijo
Dr. Ivana Carolina Cobos
Dr. Juan Ignacio Cocca Gioco
Dr. Paola Marina Codianni
Dr. Florencia Agostina Cogo Orellana
Dr. Luciana Compostela
Dr. Milena Fernanda Corengia
Dr. Santiago Corradetti
Dr. Sergio Javier Cortez
Confidential P age 59 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013830
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Sofia Costa
Dr. Gabriel Alejandro Cracovski
Dr. Mariano Emanuel Crespo
Dr. Ignacio Alberto Croci
Dr. Maria Teresa Cuervo
Dr. Evangelina Cueto
Dr. Jesica Barbara Cufre
Dr. Valeria Noemi Cugnu
Dr. Dolores Curubeto
Dr. Maria Florencia D`Ascoli Onel
Dr. Rafael Alejandro Dalpra
Dr. Maria Eugenia D'Angelo Exeni
Dr. Martin Claudio Darraidou
Dr. Florencia Gianina De Lafore
Dr. Valeria De Lassaletta
Dr. Barbara Paula De Nardo
Dr. Nicolas de Pro
Dr. Dario Javier Del Percio
Dr. Jimena Mariana Del Rincon
Dr. Micaela Delgado
Dr. Julia Daniela Delgado Riveros
Dr. Mariela Silvana Deraiopian
Dr. Alejandra Miriam Destito Soljan
Dr. Patricia Susana Devesa
Dr. Victoria Alejandra Di Nardo
Dr. Lucila Di Nunzio
Dr. Alejandro Fabian Diaz
Maria Florencia Diez
Melisa Dollanart
Dr. Lourdes Eugenia Dominguez Figueredo
Dr. Ana Soledad Donnari
Dr. Ana Belen Duarte
Dr. Belen Beatriz Duarte
Dr. Sabrina Beatriz Dulce
Mariana Dunaiewsky
Confidential P age 60 of 76
090177e196e4d4fd\Final\Final On: 29-Apr-2021 19:08 (GMT)
FDA-CBER-2021-5683-0013831
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Dr. Andrea del Socorro Duque Ramirez
Dr. Francisco Dusio
Dr. Pablo Augusto Echeverria
Dr. Maria Soledad Espinosa
Dr. Ignacio Esteban
Dr. Sara Carolina Esteche Roman
Dr. Samanta Claudia Estevez
Dr. Natali Denise Estrada
Dr. Tatiana Belen Estrada
Maria Candela Etchegaray
Dr. Vanesa Vanina Fainboim
Dr. Nicolas Ariel Fa k
Dr. Emanuel Fedun Rodriguez
Dr. Florencia Johanna Feldman
Dr. Martina Juliana Fernandez
Dr. Jose Hernan Fernandez Abuye
Dr. Lucia Maria Fernandez Abuye
Dr. Valentina Fernandez A berdi
Dr. Paula Ximena Fernández Estrella
Dr. Nicolas Ferrari
Dr. Juan Carlos Ferraris
Dr. Andres Ferreyra
Dr. Karen de Fatima Figueroa Bohorquez
Dr. Santiago Ignacio Foti
Dr. Jimena Paula Franco
Dr. Paula Franco
Dr. Hernan Cristian Freire
Dr. Jorge Leandro Fuentes
Dr. Maria Florencia Fulco
Dr. Agustina Furnari
Dr. Maria Victoria Eugenia Gaete Orueta
Dr. Agustin Leonardo Galarza
Dr. Juan Ignacio Galeano
Dr. Carmen Gallastegui
Dr. Mariano Ernesto Garabito
Confidential Pa ge 61 of 76
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FDA-CBER-2021-5683-0013832
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Belkys Iris Garcia
Dr. Victoria Garcia
Dr. Emiliano Garcia Coloccini
Dr. Natalia Soledad Garcia Escude
Dr. Tomas Garcia Solchaga
Dr. Ezequiel Gayer
Dr. Julieta Gelardi
Dr. Sergio Edario Gelman
Maria Jose Ghiberti
Dr. Eduardo Juan Gimenez
Dr. Maria Silvina Gimenez
Dr. Laura Ines Giovanetti
Dr. Virginia Godoy
Dr. Barbara Constanza Gomez
Dr. Adriana Goncalves de Almeida
Dr. Facundo Gonzalez
Dr. Jose Luis Gonzalez
Dr. Liliana Beatriz Gonzalez
Dr. Maria Laura Gonzalez
Dr. Adolfo Felipe Gonzalez Osorio
Dr. Ezequiel Alejandro Graziano
Dr. Julia Grigioni
Sebastian Federico Grinstein
Dr. Jhonatan Guerrero Gallego
Dr. Marina Guglielmino
Dr. Maria Emilia Gutierrez Meyer
Dr. Johana Katherine Gutierrez Perez
Dr. Leandro Alfredo Heffner
Dr. Ruth Patricia Henquin
Dr. Luis Ramiro Heredia
Dr. Milagros Heredia
Dr. Rocío Heredia
Dr. Luciana Hernandez
Dr. Maria Alejandra Herrera Jure
Dr. Maria Gabriela Herrera Ledesma
Confidential P age 62 of 76
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FDA-CBER-2021-5683-0013833
BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Alejandra Hintze
Dr. Pablo Simon Hurevich
Dr. Macarena Ilarregui
Dr. Noelia Leonor Iraizos Zegarra
Dr. Maria Belen Marisol Irigoyen
Dr. Nicolas Itcovici
Dr. Hernán Ariel Jamui
Dr. Maria Viviana Elizabeth Jelovina
Dr. Yadira Magdalia Jimenez Garcia
Dr. Ximena Soledad Juarez
Veronica Maria Junyent Berrotaran
Dr. Valeria Dina Kes
Dr. Andres Kogan
Dr. Paola Teresa Koslowski
Dr. Jose Francisco Labella
Dr. Eduardo Bernardo Landa
Dr. Fernando Landreau
Dr. Fernando Mariano Lanzilotti
Dr. Lorena Larroude
Dr. Carolina Maria Mascarenhas Laurence
Dr. Irina Nataly Aznaryn Leon Romero
Dr. Martina Leonard
Dr. Romina L bster
Dr. Juan Pablo Lopez
Juan Manuel Lopez
Dr. Jimena Fernanda Lopez Arroyo
Dr. Rocio Lopez Castelo
Dr. Agustin Mario Losinno
Dr. Juan Martin Lourenco da Cunha
Natalia Andrea Lozano
Dr. Gabriela Yesica Lucero
Dr. Federico Alfredo Luna
Dr. Flavia Alejandra Luna Matheu
Clarice Arianne Madureira Cena
Dr. Julieta Alejandra Maffia
Confidential Pa ge 63 of 76
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FDA-CBER-2021-5683-0013834
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Carolina Monica Magadan
Miguel Orlando Magallanes Quijandria
Dr. Fernando Andres Magdalena
Dr. Ezequiel Horacio Maldonado
Dr. Maria Aldana Malvicino
Dr. Natalia Silvia Florencia Mammana
Dr. Janet del Valle Manrique Lopez
Dr. Ana Laura Mansilla
Natalia Soledad Mansilla Irusta
Dr. Valeria Maria Manzanares
Dr. Felix Waldemar Marasco
Dr. Carla Graciela Marchionatti
Dr. Leticia Veronica Marcos
Dr. Daniela Fernanda Marino
Maria Fernanda Martí
Dr. Betiana Gabriela Martin
Dr. Paola Soledad Martin
Dr. Claudia Fabiana Martinez
Dr. Maximiliano Ezequiel Martinez
Dr. Macarena Martinez Crespo
Dr. Ines Martinez Romero
Dr. Maria Fernanda Martino
Dr. Maria Florencia Marugo
Dr. Gisela Maspero
Dr. Ines Maria Mattausch
Dr. Anabella Soledad Mazzeo
Dr. Maria Florencia Mazzeo
Dr. Jose Francisco Meana Gonzalez
Dr. Tomas Meglia
Dr. Maria Carolina Melito
Dr. Soledad Mendoza
Dr. Geraldo Antonio Meza Santiago
Dr. Luis Eduardo Molinari
Dr. Maria Claudia Molise
Leandro Montaña Espindola
Confidential P age 64 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Graciela Victoria Montaner
Dr. Cintia Marina Morales
Dr. Marco Antonio Morales Morales
Dr. Ileana Cristina Moreira Varanese
Dr. Samanta Moroni
Dr. Amalia Beatriz Moschen
Dr. Josefina Mosteirin
Dr. Natalia Beatriz Mozeluk
Gisela Alejandra Muller
Dr. Alan Ariel Mysler
Dr. Dalila Maria Nafeh Ronquillo
Dr. Maria Ivonne Name
Dr. Lucia Maria Narvaez
Dr. Rocio Mariel Navarro
Dr. Pablo Hernan Naveira
Dr. Luis Juan Neira
Dr. Maria Alejandra Neira
Dr. Cinthia Mariel Nenninger
Dr. Marco Antonio Augusto Nogara
Dr. Gabriela Beatriz Norese
Dr. Gabriela Edith Novoa
Dr. Sabrina Yael Nowicky
Juan Pablo Nuñez
Dr. Natalia Elizabeth Nuñez
Dr. Jimena Ochoa
Dr. Sabrina Odriozola
Gaston Ofman
Dr. Maria Pia Olivera Abdala
Dr. Emilio Augusto Ominetti
Dr. Agustina Gimena Ordoñez
Dr. Melisa Lucia Orrego
Dr. Lucila Soledad Orsomarso
Dr. Graciela Belen Ortiz
Dr. Eliana Ortiz Tolaba
Dr. Marco Flavio Ottino
Confidential P age 65 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Maria Laura Oyarvide
Dr. Salome Denise Pagni
Dr. Maria Mercedes Paladino
Dr. Florencia Ivana Palmieri
Dr. Mariana Ines Palopoli
Dr. Mariela del Carmen Elizabeth Panichella
Dr. Maria Teresa Panighetti
Dr. Maria Laura Pattin
Dr. Anabella Yael Pecheny
Dr. Constanza Peire
Dr. Fernando Maximiliano Peralta Luna
Dr. Maria Clara Perez
Dr. Maria Florencia Perez Latessa
Dr. Gonzalo Pérez Marc
Dr. Rafael Perez Vidal
Dr. Carlos Martin Pessolani
Dr. Andres Petrocelli
Dr. Diana Ruth Pieniazek
Dr. Maria Agustina Pirker Asategui
Dr. Maria Lucila Pitocco
Dr. Sebastian Ignacio Pogliani
Dr. Silvina Micaela Polacov
Dr. Felipe Pomes
Evangelina Soledad Pujadas
Dr. Florencia Quadrana
Dr. Agustin Quiñones Maffassanti
Dr. Alejo Quiñones Maffassanti
Dr. Valeria Cristina Quinteros Caceres
Dr. Manuel Lautaro Quiroz
Dr. Noelia Alexandra Quispe
Dr. Valeria Maria de Lujan Quispe
Dr. Maria Victoria Rajuan
Dr. Maria Victoria Ramon
Dr. Pablo Andres Ramondelli
Paula Micaela Ramos
Confidential P age 66 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Mariel Rando
Dr. Cecilia Ray
Micaela Re Furci
Dr. Luciana Elena Real
Dr. Patricia Alejandra Rearte Carvalho
Dr. Valeria Lorena Regairaz
Dr. Carlos Cesar Reguera
Dr. Debora Sandra Reichbach
Romina Mariana Renner
Dr. Maria Alejandra Retrivi
Dr. Maria Laura Rey
Dr. Yanina Rivera
Dr. Micaela Paz Rivero
Dr. Ana Carolina Riveros
Dr. Flor Maria Robalino Muñiz
Dr. Cecilia Ana Mercedes Robledo
Dr. Paula Robredo
Dr. Sergio Rodrigo Rodas
Dr. Lucia Maria Rodriguez
Dr. Romina Belen Rodriguez Coria
Dr. Cintia Marina Romanelli
Dr. Romina Noelia Romero
Dr. Maria Ines Roque
Dr. Silvia Rossi
Dr. Guillermina Maria Roveda Verges
Dr. Maria Florencia Ruffa
Dr. Maria Paula Ruiz Cobos
Dr. Betiana Sabbattini
Dr. Florencia Maria Salani
Dr. Sofia Alexia Salvia
Dr. Myriam Susana Sanchez
Dr. Martha Gabriela Sanchez Navarro
Dr. Tatiana Mariela Sanchez Quiroga
Dr. Maria Macarena Sandoval
Dr. Gaspar Mariano Sanfilippo
Confidential P age 67 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Ignacio Martin Santarelli
Dr. Agustina Santoni
Dr. Francisco Antonio Santucho Saravia
Dr. Daniel Esteban Sartorelli
Dr. Johanna Elizabeth Sas
Dr. Agustina del Rosario Sbruzzi
Dr. Judith Ines Scherman
Dr. Micaela Belen Schiavi
Dr. Ana Schindler
Dr. Laura Maria Schiró
Violeta Schneider
Lionel Emiliano Schuster
Dr. Tamara Schvarstein
Dr. Georgina Paola Sciancalepore
Dr. Agostina Sdrigotti
Dr. Fernando Daniel Sebastiani
Dr. Armando Carlos Segret
Dr. Virginia Antonella Seguel Jabat
Dr. Franco Walter Hernan Servat
Dr. Jose Alberto Shiraishi Ferreyra
Dr. Lucinardo Soares Belarmino
Dr. Barbara Carina Soberon
Dr. Gonzalo Daniel Sola
Dr. Martin Emilio Soria
Dr. Eleonora Irene Sorin
Dr. Barbara Sparrow
Dr. Giuliana Sposito
Dr. Patricia Stach
Dr. Diego Fernando Staffieri
Dr. Esteban Jose Suarez
Dr. Analia Beatriz Suarez Pulido
Dr. Lila Elisabeth Sueldo
Dr. Valeria Luciana Svartman Menezes
Daniela Lucia Szlaen
Dr. Martin Ignacio Taboada
Confidential P age 68 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Raul Cesareo Taboada
Natali Melisa Tanel
Dr. Maria Florencia Tarrazo Barranco
Dr. Florencia Melina Tedeschi
Dr. Luciana Laura Terracina
Dr. Mariana Soledad Thuns
Dr. Sebastian Jose Tisman
Dr. Laura Mariana Tisser
Dr. Juan Manuel Torres Moirano
Dr. Diego Andres Tourn
Dr. Elda Rossella Tralice
Dr. Virginia Macarena Trias Uriarte
Dr. Ignacio Leandro Uriarte
Dr. Nancy Alejandra Urquiza
Dr. Anabel Silvina Vaca Lizzi
Dr. Rita Maria Valdez
Dr. Paula Maria Valdez Tappata
Dr. Antonela Nale Valente
Dr. Leandro Ariel Vallejos Insegna
Dr. Emmanuel Ezequiel Valls
Dr. Mercedes Guadalupe Vazquez
Dr. Federico Vecchietti
Dr. Gabriela Vecchio
Dr. Juan Jose Vega
Dr. Elizabeth Ana Ventrice
Dr. Maria Florencia Vera Morandini
Dr. Victoria Verga
Dr. Ana Liss Vergez
Dr. Javier Miguel Veron
Dr. Sebastian Manuel Vidaurreta
Dr. Patricia Eliana Vides De la Hoz
Dr. Alejandra de Lourdes Vigliano
Dr. Vanina Vilaseca
Dr. Florencia Elizabeth Villegas Herbas
Dr. Dayler Hernan Virgo Zambrana
Confidential P age 69 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Dr. Florencia Virili
Dr. Virginia Esther Visco
Dr. Juan Tomas Voievdca
Dr. Marino Volpe
Dr. Santiago Javier Vommaro
Dr. Veronica Wahren
Dr. Diego Emanuel Waserman
Dr. Giselle Maria Wehit
Dr. Maria Jorgelina Werbach
Dr. Cristian Jorge Wood
Dr. Anastasiya Yashnyk
Dr. Romina Zadoff
Dr. Agustina Zavaleta
Marisa Beatriz Zocca
Dr. Joaquin Vicente Zunzuneguy
Center Number: 1232 Institution Name: Iact Health
List of Investigator Names
Dr. Jeffrey Kenneth Kingsley
April Pixler
Center Number: 1235 Institution Name: Lsuhsc-Shreveport Clinical Trials Office
List of Investigator Names
Prof. Dr. John Anthony Vanchiere
Pat F. Bass
Dr. Paul D. Cooper
Louis Keith Scott
Confidential P age 70 of 76
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FDA-CBER-2021-5683-0013841
BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1241 Institution Name: Hospital Santo Antonio/ Associacao Obras Sociais Irma
DulceList of Investigator Names
Edson Duarte Moreira
Lais Almeida Silva
Dr. Carolina Oliveira Barbosa
Dominique Kalinne Bahiense da Silva
Gracimara De Jesus Santos
Rafaela Machado Leal Borges
Marcus Paulo Pagani Passos
Beatriz Pereira dos Santos
João Paulo Soares Costa
Rafael Solla Galvão
Yuri Boa Sorte de Oliveira
Center Number: 1246 Institution Name: Jongaie Research
List of Investigator Names
Dr. med. Dany Badibanga Musungaie
Charlotte De Jong
Dr. Douwe M. de Jong
Center Number: 1247 Institution Name: Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
List of Investigator Names
Dr. Haylene Nell
Dr. Matthys Michiel De Vries Basson
Precious Nomcebo Garnett
Dr. Rehana Loghdey
Zarinah Mohamed
Dr. Catharina Elizabeth Pretorius
Dr. Maria Magdalena Pretorius
Dr. Mirna Catharina Siebert
Confidential P age 71 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1248 Institution Name: Pharmaron Cpc, Inc.
List of Investigator Names
Prof. Mohamed S. Al-Ibrahim
Rebecca Coppola
Dr. Paolo B. DePetrillo
Katarzyna Maria Fraczek
Albert Yuriy Fuzayl
Michael Neil Morgan
Dana Rasmussen
Lisa Thompson
Center Number: 1251 Institution Name: Birmingham Clinical Research Unit
List of Investigator Names
Dr. Hayes Taylor Williams
Dr. Gary Louis Boyd
LaShondra Cade
Aileen Cunningham
Connie Moya
Sita Patel
Ms. Mitzi L. Roberts
Center Number: 1252 Institution Name: Main Street Physician's Care
List of Investigator Names
Dr. Stephen Dale Grubb
Dr. Tom Allan Christensen
Krystal S. Hill
Dr. Steven O. Price
Center Number: 1254 Institution Name: Bayview Research Group
List of Investigator Names
Dr. Monica Lee
Dr. Michael N. Pakdaman
Confidential P age 72 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1258 Institution Name: Dayton Clinical Research
List of Investigator Names
Dr. Martin John Schear
Missy L. Chapman
Amy A. Hitchler
Tammy Jo Lilly
Center Number: 1260 Institution Name: Umass Memorial Medical Center - University Campus
List of Investigator Names
Dr. Robert William Finberg
Ms. Carol A. Ciccarelli
Mary Dawn Co
Amanda Davies
Kaethe R. Giaquinto
Dr. John P. Haran
Danielle Kokoski
Jaclyn Karen Longtine
Ms. Karen Longtine
Juan Perez Velazquez
Bethany P. Trainor
Jennifer Po-wen Wang
Dr. Mireya A. Wessolossky
Center Number: 1261 Institution Name: Benaroya Research Institute At Virginia Mason
List of Investigator Names
Dr. Carla Joy Greenbaum
Sandra Marian Lord
Michael Richter
Dana Elizabeth VanBuecken
Confidential P age 73 of 76
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Protoc
ol Number: C4591001
Center Number: 1264 Institution Name: Uc Davis Medical Center
List of Investigator Names
Dr. Timothy Albertson
Dr. Roblee Peter Allen
Dr. Stuart Harvey Cohen
Angela Haczku
Richart Harper
Dr. Nicholas James Kenyon
Brian Michael Morrissey
Dr. Susan (Nmi) Murin
Justin Michael Oldham
Dr. Christian Erik Sandrock
Dr. Namita Sood
Dr. Ken Y. Yoneda
Center Number: 1265 Institution Name: Kaiser Permanente Los Angeles Medical Center
List of Investigator Names
Dr. William James Towner
Jennifer J. Chang
Celia M. Garza-Halstead
V kas K. Jayadeva
Dr. Marc Joseph La Riviere
Yu Fon Lee
Center Number: 1269 Institution Name: Providence Clinical Research
List of Investigator Names
Dr. Teresa Sheahan Sligh
Dr. Parul M. Desai
Scott Preston Sligh
Confidential Pa ge 74 of 76
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BLA BNT162b2 S ection 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Proto
col Number: C4591001
Center Number: 1270 Institution Name: Kaiser Permanente Santa Clara
List of Investigator Names
Rebecca B. Alexander
Janelle M. Baires
Jessica Margaux Barraza
Latisha Marie Burun
Christine Cash
Gail Larie Cook
David Cooper
Jolynne Gerardo Encarnacion
Douglas Ernst
Lauren Blair Fontenot
LaVonne Freed
Jeremy Giese
Sarah Kang
Lisa Kennedy
Roma Kaur Kullar
Ludy Pasaoa Lemus
Ms. Eva S. Lowe
Lorrie Aileen Lowe
Nicole D. Makram
Ms. Shannon Mullen
Courtney Ann Oxandale
Ken Purdy
Sally Ann Upadhyaya
Dana Maria Weisshaar
Amy Wiesner
Confidential P age 75 of 76
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BLA BNT162b2 Se ction 1.3.4 Financial Disclosure
Protocol Number: C4591001DU
E DILIGENCE WAS PERFORMED TO OBTAIN DISCLOSURES FROM THESE INVESTIGATORS**
Center Number: 1042 Institution Name: Texas Health Family Care
List of Investigator Names
Katherine Hollie
Ce
nter Number: 1116 Institution Name: Medpharmics, Limited Liability Company
List of Investigator Names
Wendy Shaw
Jessica Stahl
Ce
nter Number: 1247 Institution Name: Tiervlei Trial Centre, Basement Level, Karl Bremer
HospitalList of Investigator Names
Dr Corli Marx
**Pfizer was unable to obtain a completed Financial Disclosure Form for the Clinical Investigator(s) listed above, despite acting
wi
th Due Diligence to obtain the required financial information. If no response was received from the initial request to the clinical
investigator(s), additional attempts were performed (via mail, phone, fax, and/ or e-mail) in order to meet the recommendations
mentioned within the FDA’s Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical
Investigators for certifying Due Diligence (B.7.Q&A). For those investigators no longer at the institution where the study was
conducted - Pfizer made reasonable attempts to research and request the clinical investigator’s new contact information.
By declaring Due Diligence Pfizer is certifying that it has conducted reasonable efforts to contact the Clinical Investigator(s) above
to obtain disclosable financial information.
Confidential Pa ge 76 of 76
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FDA-CBER-2021-5683-0013847
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Form Approved: OMB No. 0910-0396 Food and Drug Administration
Report Date: 03/30/2021
BLA
CERTIFIC ATION: FINANCIAL INTERESTS AND
ARRANGEMENTS OF CLINICAL INVESTIGATORS
TO BE COMPLETED BY APPLICANT
With respect to all covered clinical studies (or specific clinical studies listed below (if appropriate)) submitted
in support of this application , I certify to one of the statements below as appropriate. I understand that this
certification is made in compliance with 21 CFR part 54 and that for the purposes of this statement, a clinical
investigator includes the $pouse and each dependent child of the as defined in 21 CFR 54.2(d).
Please mark the applicable check box.
0 (1) As the sponsor of the submitted studies , I certify that I have not entered into any financial
arrangement with the listed clinical investigators (enter names of clinical investigators below or
attach list of names to this form) whereby the value of compensation to the investigator could be
affected by the outcome of the study as defined in 21 CFR 54.2(a). I also certify that each listed
clinical investigator required to disclose to the sponsor whether the investigator had a proprietary
interest in this product or a significant equity in the sponsor as defined in 21 CFR 54.2(b) did not
disclose any such interests. I further certify that no listed
investigator was the recipient of significant
payments of other sorts as defined in 21 CFR 54.2(f).
D (2) As the applicant who is submitting a study or studies sponsored by a firm or party other than
the applicant, I certify that based on information obtained from the sponsor or from participating
clinical investigators, the listed clinical investigators (attach list of names to this form) did not
participate in any financial arrangement with the sponsor of a covered study whereby the value of
compensation to the investigator for conducting the study could be affected by the outcome of the
study (as defined in 21 CFR 54.2 (a)); had no proprietary interest in this product or significant
equity interest in the sponsor of the covered study (as defined in 21 CFR 54.2(b)); and was not the
recipient of significant payments of other sorts (as defined in 21 CFR 54.2(f)).
0 (3) As the applicant who is submitting a study or studies sponsored by a firm or party other than
the applicant, I certify that I have acted with due diligence to obtain from the listed clinical
investigators (attach list of names) or from the sponsor the information required under 54.4 and it
was not possible to do so. The reason why this information could not be obtained is attached.
'.C1;f,;Ciii;fiVeSti9ators (See attaCh8dJ :
. - -- - ---- ---- -- ----- ---- - - -- --
NAME TITLE
Dr. Christopher Marshallsay Head of Scientific/Medical Writing & Trial Transparency
FIRM/ORGANIZATION
BioNTech SE
SIGNATURE
This section applies only to the requirements of pe ork Reduction Act of 1995. Do NOT send your completed form to
An agency may not conduct or sponsor, and a person is required to respond to, a collection of the PRA Staff email address below.
information unless it displays a currently valid OMB control number. Public reporting burden for this Department of Health and Human Services
collection of information is estimated to average 1 hour per response, including time for reviewing Food and Drug Administration
instructions, searching existing data sources, gathering and maintaining the necessary data, and Office of Operations
complet ing and reviewing the collection of information. Send comments regarding this burden PRAStaff@fda .hhs.gov
estimate or any other aspect of this collection of information to the address to the right:
#An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Number."
FORM FDA 3454 PSC Publishing Services (301) 443-6740 EF
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FDA-CBER-2021-5683-0013848
BNT162b2 Section 1.3.4 Financial Disclosure
Product’s Established Name:
Protocol Number:
Study Name:BNT162b2
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
Disclosure Cut-off Date:Disclosure Start Date: 04/22/2020
10/23/2020
Confidential Page 1 of 3
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BNT162b2 Section 1.3.4 Financial Disclosure
THOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Institution Name: CRS Clinical Research Services Mannheim GmbHProtocol Number: BNT162-01
Center Number: 276-01
List of Investigator Names
Armin Schultz
Friedeborg Seitz
Helen Basse
Isabel Botz
Yvonne Kondella
Sven Kolitsch
Kai Mehltretter
Brigitte Kalsch
Ewald Schrader
Brigitte Schneiderheinze
Marina Streckebein
Thomas Stolte
Uwe Theiß
Volker Urban
Jolanta Wierdak
Institution Name: CRS Clinical Research Services Berlin GmbHCenter Number: 276-02
List of Investigator Names
Sybille Baumann
Matthias Berse
Manuela Casjens
Luca E bach
Jonas Fanomezana Eppel
Julian Hugo
Wilhelm Koch-Sembdner
Alexander Niewidakowski
Matthias Norden
Britta Schrödel
Mares-Eliane Strempler
Confidential Page 2 of 3
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BNT162b2 Section 1.3.4 Financial Disclosure
T
HOSE LISTED BELOW HAVE DISCLOSED THAT THEY HAVE NO FINANCIAL INTERESTS IN THIS PRODUCT
Institution Name: CRS Clinical Research Services Kiel GmbH Protocol Number: BNT162-01
Center Number: 276-03
List of Investigator Names
Atef Halabi
Bettine Steinmann
Haidar Maatouk
Abir Alatrach
Yamina Stumpf-Niggemach Marc
Petersen-Sylla
Confidential Page 3 of 3Center Number: 276-04
List of Investigator Names
Antje Blank
Walter E. Haefeli
Felicitas Stoll
David Czock
Amin Muhareb
Katja Gümüs
Evelyn KrohmerInstitution Name: Medizinische Universitätsklinik Heidelberg
Institution Name: Universitätsklinikum Frankfurt Center Number: 276-05
List of Investigator Names
Maria Vehreschild
Christoph Stephan
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