NCHR joins Nonprofits in asking FDA to only allow Covid vaccine distribution after phase 3 trials completed

August 6, 2020


Stephen Hahn
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993


Dear Dr. Hahn:

We are experts in virology, epidemiology, vaccinology, infectious disease, clinical care and
public health. A vaccine(s) is needed to curtail the COVID-19 pandemic. We are committed to
promoting the broad uptake of safe and effective COVID-19 vaccines. The need is urgent but all
vaccines must be rigorously studied to determine whether their benefits exceed their risks.

For this reason, we urge that COVID-19 vaccines are made widely available only after the Food
and Drug Administration (FDA) has been able to evaluate safety and efficacy data from
completed Phase 3 clinical trials. The FDA’s review must be as thorough as has been the case for
previous vaccine candidates. As transparency will be critical for fostering public confidence and
maximizing vaccine use, the open meetings of the FDA’s Vaccines and Related Biologics
Product Approval (VRBPAC) Committee must be an essential part of the authorization and
approval processes.

Several COVID-19 vaccine candidates are now in Phase 3 trials. We hope one or more of them
will soon prove to be both safe and effective. The decisions to fund and produce many millions
of doses ahead of the trial results should save many months in providing approved vaccines to
the American public. In short, productive collaborations between scientists, the pharmaceutical
industry and the federal government may bring us to a remarkable and historic achievement – the
creation of a vaccine within a year after this pandemic virus was first identified.

But an effective vaccine will only be truly useful if a large proportion of the public is willing to
take it. Surveys have consistently shown that a significant fraction of Americans, from across the
political spectrum, is reluctant to accept a COVID-19 vaccine. Some long-standing concerns
about vaccine safety in general have no scientific foundation. However, more than 60% of US
voters prefer that a COVID-19 vaccine be thoroughly evaluated before it is made available, even
if doing so delays its roll-out. A particular concern applies to communities of color, where
historical medical inequities are also likely to reduce vaccine uptake. Actively involving these
and other communities that are at high risk of severe COVID-19 disease is essential to curtailing
the pandemic. Similar considerations apply to vaccine distribution, which must not be
determined by either an ability to pay or social influence.

The foundation of public confidence in vaccine safety has long been, and must remain, the well established and trusted FDA approval procedures. The public is typically and rightly able to comment on vaccine approval. It is important that investigators share Phase 3 trial design details. For example, Data Safety Monitoring Boards apply predetermined “stopping rules” to decide
whether a study should be terminated early based on the detection of early benefits, the
likelihood of no benefit, or the emergence of serious safety problems. These stopping rules
should be publicly available. There must also be continuous monitoring for unexpected severe
side effects that might only become apparent after large numbers of people are vaccinated.

To maximize the use of a COVID-19 vaccine(s) by the American people, it is therefore essential
that the science and public health communities work with the federal government to increase
public confidence in any approved or authorized product. However, we can only perform as
advocates if we ourselves are persuaded that the vaccine(s) truly is safe and effective. We must
be able to explain to the public what we know and what we don’t know about these vaccines. For
that to happen, we must be able to witness a transparent and rigorous FDA approval process that
is devoid of political considerations. We ask that company executives and government officials
take due note of these key points.

The COVID-19 virus has now killed more than 150,000 people in the USA alone. We need a
safe and effective vaccine urgently, but any lack of trust in its properties could significantly
compromise rollout. We look forward to the day when we can actively promote a safe and
effective COVID-19 vaccine to the American people, based on our full confidence in its public
health impact.

Lilian Abbo, University of Miami
Jimi Adams, University of Colorado Denver
Terry Adirim, Schmidt College of Medicine at
Florida Atlantic University/Formerly
Department of Defense
Bisher Akil, Chelsea Village Medical, P.C.
Sandra Albrecht, Columbia University
G. Caleb Alexander, Johns Hopkins Bloomberg
School of Public Health
Matthew Aliota, University of Minnesota
Todd Allen, Ragon Institute of MGH, MIT and
Nelson Atehortua De la Pena, Jackson State
Su Aung, UCSF
Kathleen Bachynski, Muhlenberg College
Stefan Baral, Johns Hopkins School of Public
Joshua Barocas, Boston Medical Center
Peter Barr-Gillespie, Oregon Health & Science
Ingrid Bassett, Massachusetts General Hospital
Sanjay Basu, Harvard medical school
Robert Bazell, Yale School of Medicine
Robert Bednarczyk, Emory University Rollins
School of Public Health
Amy Bei, Yale School of Public Health
Kiran Belani, Children’s hospital of
Rachel Bender Ignacio, University of
Karen Benker, SUNY Downstate School of
Public Health
Wendy Berg, Children’s Minnesota
Michelle Berlin, OHSU
Stefano Bertozzi, UC Berkeley School of Public
Jovanna Bertran-Lopez, UMH
Marianne Berwick, University of New Mexico
Barbara Bierer, Brigham and Women’s Hospital
Silvia Bigatti, IU Fairbanks School of Public
Health at IUPUI
Bruce M Bissonnette, University of Chicago
Michela Blain, University of Washington
Jeffrey Blumberg, Tufts University
Joseph Bocchini, Jr., Willis-Knighton Health
Melissa Bondy, Stanford University
Luciana Borio, Former FDA, NSC
Ghada Bourjeily, The Miriam Hospital / Brown
Dan Burnett, USAF
Scott Burris, Temple University
Elaine Cabinum Foeller, ECU Brody School of
Carlos Camargo, Massachusetts General
Hospital / Harvard University
John Capitanio, University of California, Davis
Arthur Caplan, NYU Grossman School of
Farah Cassis-Ghavami, Children’s Minnesota
Kenneth Castro, Emory University
Jose Guillermo Castro, University of Miami
Connie Celum, University of Washington
Nisha Chandra-Strobos, johns hopkins Univ
school of Med
Eugene Chang, University of Chicago
Man Charurat, Institute of Human Virology,
University of Maryland School of Medicine
Erica Chavez Santos, University of Washington
Nancy Cheak-Zamora, self
Wilbur Chen, University of Maryland School of
Poyin Chen, MGH
Kata Chillag, Davidson College
John Chiosi, Massachusetts General Hospital
Stella Chou, Children’s hospital of
Carolyn Chu, UCSF
Lisa Cicutto, University of Colorado and
National Jewish Health
Robert Cohen, New York City Board of
Seth Cohen, University of Washington
Ted Cohen, Yale School of Public Health
Robert Coombs, University of Washington
Sara Cosgrove, Johns Hopkins University
School of Medicine
Patricia Cristofaro, Brown University
Leslie Curry, Yale University
Megan Rose Curtis, Mass General Brigham
Susan Cu-Uvin, Brown University
Marla Dalton, NFID
Richard J. David, University of Illinois at
Ian de Boer, University of Washington
Carlos del Rio, Emory University School of
Ronald Desrosiers, University of Miami Miller
School of Medicine
Kay Dickersin, Johns Hopkins
Gordon Dickinson, u of miami miller school of
Daniel DiMaio, Yale University
Kelly K. Dineen, Creighton University
Alexis Dinno, Harvard School of Public Health,
Yale School of Public Health, Yale School of
Forestry & Environmental Studies
Ana Djordjevic, PNHP-NY Metro
Betty Dong, University of California schools of
pharmacy and medicine
Gregory Downey, National Jewish Health
Joshua Dubansky, University of Nevada Reno
School of Medicine
Jeffrey Duchin, Public Health – Seattle & King
County and the University of Washington
Matthew Dudley, Johns Hopkins Institute for
Vaccine Safety
Michael Edzards, Children’s Minnesota
David Egilman, Alpert School of Medicine
Brown University
Joycelyn Elders, Former Surgeon General
Daniel Engel, University of Virginia School of
David Evans, University of Wisconsin-Madison
Michelle Finkel, Kaiser Permanente
Celia Fisher, Fordham University
Jay Fishman, Harvard Medical School,
Massachusetts General Hospital
Mike Fliss, University of North Carolina,
Chapel Hill
Cornelia Flora, ISU/Kansas State Univ
Howard Forman, Yale University
Donald Forthal, University of California, Irvine
Joel Frader, Feinberg School of Medicine,
Northwestern University
Adele Franks, Retired from Centers for Disease
Control and Prevention
Gary Freed, University of Michigan
Leonard Friedland, Pediatrics Philadelphia
Samuel R Friedman, New York University
Grossman School of Medicine
Thomas Friedrich, University of WisconsinMadison
Lance Gable, Wayne State University
David Galbraith, None, retired
Robert Gallo, Institute of Human Virology,
University of Maryland School of Medicine,
Baltimore, Md
Richard Garrad, Missouri State University
Laurie Garrett, No
Rebekah Gee, LSU
Jeffrey Gelfand, Harvard Medical School
Jeremiah Gelles, NYP- Brooklyn Methodist
Bruce Gellin, Sabin Vaccine Institute
Steve Georas, University of Rochester
George Gerton, University of Pennsylvania
Leonard Glantz, B.U. School of Public Health
Jeff Goad, Chapman University, National
Foundation for Infectious Diseases
Stephen Goff, Columbia University
Jay Gold, Retired (formerly MetaStar, Inc.)
Marcia Goldberg, Harvard Medical School and
Massachusetts General Hospital
Lynn R. Goldman, George Washington
University, Milken Institute School of Public
David F Goldsmith, George Washington
Andrew Goldstein, NYU School of Medicine
Cynthia Golembeski, Rutgers University
M Gomez, x
Gregg Gonsalves, Yale School of Public Health
Jessica Goodkind, University of New Mexico
Laura Gottlieb, UCSF
David Gozal, University of Missouri
Matthew Grady, Children’s hospital of
Ann Granchelli, National Jewish
Jean Grassman, CUNY Graduate School of
Public Health and Health Policy
Alice Gray, University of Colorado
Michael Grodin, Boston University School of
Public Health
Cary Gross, Yale School of Medicine
Cristina Gruta, UCSF
Jeanne Gullahorn, Harvard, Kansas, Michigan
Akash Gupta, Massachusetts General Hospital
Ashley Gyura, Children’s MN
Philip Gyura, Hazelden Betty Ford
Beatrice Hahn, University of Pennsylvania
Cheryl Hale, Children’s of Minnesota
Helge Hartung, The Children’s Hospital of
Philadelphia, U Penn
Dr. Peter Havel, University of California, Davis
Adam Hege, Appalachian State University
Robert Heimer, Yale University
Dominique Heinke, Massachusetts Department
of Public Health
Yaniv Heled, Georgia State University College
of Law
Wendy Hellerstedt, University of Minnesota
School and City University of New York
Alan Hinman, Task Force for Global Health
Kelly Hirko, Michigan State University College
of Human Medicine
Glenn Hirsch, National Jewish Health
Martin Hirsch, Harvard University and
Massachusetts General Hospital
Cynthia Ho, Loyola University of Chicago
Stephen Hoffman, Sanaria Inc.
Charles Holmes, Director, Georgetown
University Center for Innovation in Global
Kathleen Holton, American University
Nuria Homedes, Salud y Farmacos
Marc Horman, retired
Peter Hotez, Baylor College of Medicine
James Hoxie, University of Pennsylvania
Laura Hoyt, Children’s Minnesota
Deborah Huang, University of Washington
James Hughes, Emory University School of
Kristen Hysell, Massachusetts General Hospital
Peter Infante, Peter F Infante Consulting, L.L.C.
Sharon Inouye, Harvard Medical School
Ellen Isaacs, New York Medical College
Akiko Iwasaki, Yale University School of
Peter Jacobson, University of Michigan School
of Public Health
Jana Jarolimova, Massachusetts General
Jacky Jennings, Johns Hopkins School of
Prabhat Jha, University of Toronto
Nikolaus Jilg, Massachusetts General Hospital
Esther John, Stanford University School of
R. Paul Johnson, Emory University
T Stephen Jones, Centers for Disease Control
and Prevention (retired)
Jeb Jones, Emory University
Catherine Jones, Tulane University School of
Brian Joyce, Northwestern University
James G Kahn, UCSF
Rizwan Kalani, University of Washington
Medical Center
Norty Kalishman, None
Jeremy Kamil, Louisiana State University
Health Sciences Center Shreveport
Amy Kapczynski, Yale Law School
Robert Kaplan, UCLA
Jonathan Karn, Case Western Reserve School of
Michael Katz, Columbia University, Stanford
Judith Katzburg, NA
Matthew Kavanagh, Georgetown University
Dean Kedes, University of Virginia
Elizabeth Kern, National Jewish Health
Jean Kerver, Michigan State University
Joan King-Angell, Lifelong Medical Care
P. J. Klasse, Weill Cornell Medicine, Cornell
Albert Ko, Yale School of Public Health
Roya Kohani, Harvard Medical Alumnae/
UCSD School of Medicine
Michael Kolber, University of Miami Miller
School of Medicine
Kristin Kranz, NA
Nancy Krieger, Harvard T.H. Chan School of
Public Health
James Krieger, University of Washington
Danuta Krotoski, Self-Employed
Allison Kuipers, University of Pittsburgh
Daniel Kuritzkes, Brigham and Women’s
Hospital/Harvard Medical School
Joseph Kurland, Children’s Minnesota
Jeanette LaBarre, Children’s Minnesota
Jess Ladd, Self-employed
Andrew Lai, UCSF Health
Lisa M Lee, Virginia Tech
Juan Leon, Emory University
Jeffrey Levi, George Washington University
George Lewis, Institute of Human Virology
Joel Lexchin, University Health Network
Renfeng Li, Virginia Commonwealth University
Tracy Lieu, Kaiser Permanente
W Liles, University of Washington
Brett Lindenbach, Yale University
Walter Ian Lipkin, Columbia University
Marc Lipsitch, Harvard Chan School of Public
Yang Liu, Institute of Human Virology,
University of Maryland Baltimore
Martha Livingston, SUNY Old Westbury
Bernard Lo, University of California San
Shahin Lockman, Brigham and Women’s
Johanna Lolax, The George Washington
University and Simmons University
Paul Luciw, University of California – Davis
Jing Luo, University of Pittsburgh
Mark Lurie, Brown Unviersity
Peter Lurie, Center for Science in the Public
Boris Lushniak, University of Maryland School
of Public Health
Katherine Luzuriaga, University of
Massachusetts Medical School
Jay Maddock, Texas A&M University
Lisa Maier, National Jewish Health
Barry Make, National Jewish Health
Lloyd Mancl, University of Washington
Mohan Manjegowda, University of Virginia
JoAnn Manson, Harvard Medical School and
Harvard T.H. Chan School of Public Health
Julia Marcus, Harvard Medical School
Edgar Marcuse, University of Washington
Serese Marotta, Families Fighting Flu
Duncan Maru, Mount Sinai School of Medicine
and NYC H&H / Elmhurst Hospital
Rani Marx, Initiative for Slow Medicine
Lawrence Mayer, private
Joseph (Mike) McCune, University of
California, San Francisco
Andrew Mehle, University of Wisconsin
Michelle Mello, Stanford University
Miriam Merad, Mount Sinai School Of
Cheryl Merzel, New York University School of
Global Public Health
Deborah K Mielke, Fairview- University of MN
Steven Miles, University of Minnesota
Suellen Miller, Ucsf
Supriya Misra, NYU School of Global Public
Dawn Misra, Michigan State University
John Modlin, Geisel School of Medicine at
Amir Mohareb, Massachusetts General Hospital
Supriya Mohile, University of Rochester
David Montefiori, Duke University Medical
John Moore, Weill Cornell Medicine, New York
Julie Morita, Chicago Department of Public
Michele Morris, University of Miami Miller
School of Medicine
Anne Moscona, Columbia University
Walther Mothes, Yale University
Herb Myers, Retired
K M Venkat Narayan, Emory University
Sandra Nelson, Massachusetts General Hospital
Lorene Nelson, Stanford University School of
Bud Nicola, University of Washington School of
Public Health
Douglas Nixon, Weill Cornell Medicine
Robert Noble, retired Professor of Medicine,
Division of Infectious Diseases
Ali Nouri, Federation of American Scientists
Dave O’Connor, University of WisconsinMadison
Shelby O’Connor, University of WisconsinMadison
Paul Offit, Children’s Hospital of
Bisola O. Ojikutu, Brigham and Women’s
Douglas Opel, University of Washington School
of Medicine
Walter Orenstein, Emory University School of
Karin Pacheco, National Jewish Health, and
University of Colorado School of Public Health
Alisa Padon, Public Health Institute
Kimberly Page, University of New Mexico
Health Sciences Center
Sunil Parikh, Yale School of Public Health
Tyan Parker Dominguez, USC Suzanne
Dworak-Peck School of Social Work
Wendy Parmet, Northeastern Univ.
Adina Parsley, retired
Deborah Passey, University of Utah
Rena Patel, University of Washington
Kavita Patel, Brookings Institution
Sonali Paul, University of Chicago Medicine
Cynthia Pearson, National Women’s Health
Steven Pergam, University of Washington
janet perlman, UCSF
Dennis M. Perrotta, Texas Department of State
Health Services
Sue Peschin, Alliance for Aging Research
Gerald Pier, Brigham and Women’s Hospital
Kent Pinkerton, University of California, Davis
Amy Pisani, Vaccinate Your Family
Stephen Plank, Ex Harvard School of Public
Health faculty; Rockefeller Foundation
Rebeca Plank, Brigham and Women’s Hospital
Travis Porco, UCSF
Tonia Poteat, University of North Carolina
School of Medicine
John Potter, Fred Hutchinson Cancer Research
Enrique Pouget, CUNY
Alexis Powell, Universityof Miami Miller
Schoolof Medicine
Mark C. Poznansky, Massaschusetts General
Hospital and Harvard Medical School
Lou Priem, Bassett Healthcare
Mary Procidano, Fordham University
Selvi Rajagopal, Johns Hopkins University
School of Medicine
Delbert Raymond III, Eastern Michigan
Mathew Reeves, Michigan Sttate University
Dorit Reiss, University of California, Hastings
College of the Law
Matt Reynolds, University of WisconsinMadison
Beth Rezet, CHOP
Josiah Rich, Brown University
Douglas Richman, University of California San
Josh Rising, Rising Health Strategies
Stefano Rivella, CHOP-UPenn
Anthony Robbins, National Vaccine Program
Gregory Robbins, MGH
Christopher Robertson, Boston University
Saul Rodriguez, Syneos Health
Charles Rosen, University of California, Irvine,
School of Medicine
Jacob Rosenberg, MGH
Joseph Ross, Yale University
Heather Ross, Arizona State University
Mitchel Rothholz, American Pharmacists
Emily Rugel, University of Sydney
H. Earl Ruley, Vanderbilt University School of
Tamara Rushovich, Harvard T.H. Chan School
of Public Health
Dave Ruud, Retired
Sarah Rybicki, University of Minnesota, School
of Public Health
Parya Saberi, University of California, San
Mohammad Sajadi, Institute of Human Virology
at the University of Maryland School of
Tony Salloum, University of Miami Miller
school of medicine
Daniel Salmon, Institute for Vaccine Safety,
Johns Hopkins University Bloomberg School of
Public Health
Mario Santiago, University of Colorado
Ana Santos Rutschman, Saint Louis University
School of Law
Paul Sax, Brigham and Women’s Hospital,
Harvard Medical School
Charles Schade, Retired
William Schaffner, Vanderbilt University
Medical Center
Laura Schmidt, School of Medicine, University
of California at San Francisco
Victor Schoenbach, UNC Gillings School of
Global Public Health
Robert Schooley, University of California San
Pamela Schreiner, University of Minnesota
John Scott, University of Washington
Grace Sembajwe, Northwell Health
Ellen Shaffer, UCSF; CPATH (Center for Policy
Analysis on Trade & Health)
Angela Shen, CHOP
Michael Siegel, Retired. Formerly at Children’s
Hospital of Los Angeles
Lynn Silver, Public Health Institute
Ross Silverman, Indiana University Fairbanks
School of Public Health
Michael Silverstein, retired
Robin Simon, Wake Forest University
Geoffrey Smith, Albion College (AB),
University of Vermont College of Medicine
(MD), Harvard School of Public Health (MPH)
Martin Spencer, University of British Columbia
Natalie Spicyn, Park West Health System
Shaefer Spires, Duke University School of
Michael Steinman, University of California, San
MARIO STEVENSON, University of Miami
Frances Stewart, Walter Reed National Military
Medical Center
Patsy Stinchfield, Children’s Minnesota
Nicholas Stine, CommonSpirit Health
Alexis Strongin, Retired
John Sullivan, University of Massachusetts
Medical School
John Swartzberg, UC Berkeley
David Taryle, NJH
Gloria Tavera, Case Western Reserve University
david tayloe, Goldsboro Pediatrics, PA
Douglas Taylor, Southeast Community Research
AJ te Velthuis, Princeton University
Lydia Temoshok, University of Maryland
School of Medicine
Ba-Bie Teng, UTHealth
Larisa Tereshchenko, Oregon Health & Science
Dennis Thombs, University of North Texas
Health Science Center School of Public Health
Adriene Thornton, Children’s Minnesota
Scott Tibbetts, University of Florida
Karen Todd, WakeMed Health and Hospitals
Tlaloc Tokuda, San Jose State CA, UofHawaii,
Australian Catholic Uni – Sydney
Madris Tomes, Device Events
Tarlise Townsend, NYU Grossman School of
Indi Trehan, University of Washington
Virginia Triant, MGH
Alexander Tsai, Massachusetts General Hospital
Athe Tsibris, Brigham and Women’s Hospital,
Harvard Medical School
Allan Tunkel, Warren Alpert Medical School
Anna Turabelidze, Gf
Yoram Unguru, The Herman & Walter
Samuelson Children’s Hospital at Sinai and
Johns Hopkins Berman Institute of Bioethics
Anna Valdez, Sonoma State University
Sten Vermund, Yale School of Public Heatlh
Liza Vertinsky, Emory Law School
Rochelle Walensky, Massachusetts General
Hospital, Harvard Medical School
Andrew Ward, Scripps Research Institute
Deanna Wathington, Former Dean, College of
Health Sciences, Bethune-Cookman University
Sidney Watson, Saint Louis University
Donald Weinbaum, New Jersey Public Health
David Weinstock, Harvard Medical School
Jason Weisfeld, Harvard T.H. Chan School of
Public Health
Matthew Weitzman, University of Pennsylvania
& Children’s Hospital of Philadelphia
Leana Wen, George Washington University
Michael Wessels, Boston Children’s Hospital
and Harvard Medical School
Deborah Wexler, Immunization Action
Judith White, Unoversity of Virginia
Cynthia Whitney, Emory University
Robin Wilson, Temple University
Gabriel Wilson, Woodland Heights Medical
Elizabeth Wonderlich, Southern Research
Susan Wood, George Washington University,
Milken Institute School of Public Health
Matthew Wynia, University of Colorado School
of Medicine and Colorado School of Public
Jiayi Xu, Mount Sinai
Reza Yaesoubi, Yale School of Public Health
Kimon Zachary, Massachusetts General Hospital
and Harvard Medical School
Stephanie Zaza, American College of Preventive
Steven Zeichner, University of Virginia
Nicole Zeisig, Memorial Hermann
Patricia Zettler, The Ohio State University
Moritz College of Law
Pan Zheng, Institute of Human Virology,
University of Maryland Baltimore
Diana Zuckerman, National Center for Health