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

Dear Dr. Hahn:

We are experts in , 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.

Signed,

Lilian Abbo, University of Miami Joshua Barocas, Boston Medical Center Jimi Adams, University of Colorado Denver Peter Barr-Gillespie, Oregon Health & Science University Terry Adirim, Schmidt College of Medicine at Florida Atlantic University/Formerly Ingrid Bassett, General Hospital Department of Defense Sanjay Basu, Bisher Akil, Chelsea Village Medical, P.C. Robert Bazell, Yale School of Medicine Sandra Albrecht, Columbia University Robert Bednarczyk, Emory University Rollins G. Caleb Alexander, Johns Hopkins Bloomberg School of Public Health School of Public Health Amy Bei, Yale School of Public Health Matthew Aliota, Kiran Belani, Children’s hospital of Todd Allen, Ragon Institute of MGH, MIT and Minnesota Harvard Rachel Bender Ignacio, University of Nelson Atehortua De la Pena, Jackson State Washington University Karen Benker, SUNY Downstate School of Su Aung, UCSF Public Health Kathleen Bachynski, Muhlenberg College Wendy Berg, Children's Minnesota Stefan Baral, Johns Hopkins School of Public Michelle Berlin, OHSU Health Stefano Bertozzi, UC Berkeley School of Public Man Charurat, Institute of Human Virology, Health University of School of Medicine Jovanna Bertran-Lopez, UMH Erica Chavez Santos, University of Washington Marianne Berwick, University of New Mexico Nancy Cheak-Zamora, self Barbara Bierer, Brigham and Women's Hospital Wilbur Chen, University of Maryland School of Medicine Silvia Bigatti, IU Fairbanks School of Public Health at IUPUI Poyin Chen, MGH Bruce M Bissonnette, University of Chicago Kata Chillag, Davidson College Michela Blain, University of Washington John Chiosi, Massachusetts General Hospital Jeffrey Blumberg, Tufts University Stella Chou, Children’s hospital of Philadelphia Joseph Bocchini, Jr., Willis-Knighton Health System Carolyn Chu, UCSF Melissa Bondy, Stanford University Lisa Cicutto, University of Colorado and National Jewish Health Luciana Borio, Former FDA, NSC Robert Cohen, New York City Board of Ghada Bourjeily, The Miriam Hospital / Brown Correction University Seth Cohen, University of Washington Dan Burnett, USAF Ted Cohen, Yale School of Public Health Scott Burris, Temple University Robert Coombs, University of Washington Elaine Cabinum Foeller, ECU Brody School of Medicine Sara Cosgrove, School of Medicine Carlos Camargo, Massachusetts General Hospital / Patricia Cristofaro, Brown University John Capitanio, University of California, Davis Leslie Curry, Yale University Arthur Caplan, NYU Grossman School of Megan Rose Curtis, Mass General Brigham Medicine Susan Cu-Uvin, Brown University Farah Cassis-Ghavami, Children's Minnesota Marla Dalton, NFID Kenneth Castro, Emory University Richard J. David, University of Illinois at Jose Guillermo Castro, University of Miami Chicago Connie Celum, University of Washington Ian de Boer, University of Washington Nisha Chandra-Strobos, johns hopkins Univ Carlos del Rio, Emory University School of school of Med Medicine Eugene Chang, University of Chicago Ronald Desrosiers, University of Miami Miller School of Medicine Kay Dickersin, Johns Hopkins Donald Forthal, University of California, Irvine Gordon Dickinson, u of miami miller school of Joel Frader, Feinberg School of Medicine, medicine Northwestern University Daniel DiMaio, Yale University Adele Franks, Retired from Centers for Disease Control and Prevention Kelly K. Dineen, Creighton University Gary Freed, University of Michigan Alexis Dinno, Harvard School of Public Health, Yale School of Public Health, Yale School of Leonard Friedland, Pediatrics Philadelphia Forestry & Environmental Studies Samuel R Friedman, New York University Ana Djordjevic, PNHP-NY Metro Grossman School of Medicine Betty Dong, University of California schools of Thomas Friedrich, University of Wisconsin- pharmacy and medicine Madison Gregory Downey, National Jewish Health Lance Gable, Wayne State University Joshua Dubansky, University of Nevada Reno David Galbraith, None, retired School of Medicine , Institute of Human Virology, Jeffrey Duchin, Public Health - Seattle & King University of Maryland School of Medicine, County and the University of Washington Baltimore, Md Matthew Dudley, Johns Hopkins Institute for Richard Garrad, Missouri State University Vaccine Safety Laurie Garrett, No Michael Edzards, Children's Minnesota Rebekah Gee, LSU David Egilman, Alpert School of Medicine Jeffrey Gelfand, Harvard Medical School Brown University Jeremiah Gelles, NYP- Brooklyn Methodist Joycelyn Elders, Former Surgeon General Hospital Brinda Emu, YALE UNIVERSITY Bruce Gellin, Sabin Vaccine Institute Daniel Engel, University of Virginia School of Steve Georas, University of Rochester Medicine George Gerton, University of Pennsylvania David Evans, University of Wisconsin-Madison Leonard Glantz, B.U. School of Public Health Michelle Finkel, Kaiser Permanente Jeff Goad, Chapman University, National Celia Fisher, Fordham University Foundation for Infectious Diseases Jay Fishman, Harvard Medical School, Stephen Goff, Columbia University Massachusetts General Hospital Jay Gold, Retired (formerly MetaStar, Inc.) Mike Fliss, University of North Carolina, Chapel Hill Marcia Goldberg, Harvard Medical School and Massachusetts General Hospital Cornelia Flora, ISU/Kansas State Univ Howard Forman, Yale University Lynn R. Goldman, George Washington Robert Heimer, Yale University University, Milken Institute School of Public Dominique Heinke, Massachusetts Department Health of Public Health David F Goldsmith, George Washington Yaniv Heled, Georgia State University College University of Law Andrew Goldstein, NYU School of Medicine Wendy Hellerstedt, University of Minnesota Cynthia Golembeski, Rutgers University DAVID HIMMELSTEIN, Harvard Medical M Gomez, x School and City University of New York Gregg Gonsalves, Yale School of Public Health Alan Hinman, Task Force for Global Health Jessica Goodkind, University of New Mexico Kelly Hirko, Michigan State University College of Human Medicine Laura Gottlieb, UCSF Glenn Hirsch, National Jewish Health David Gozal, University of Missouri Martin Hirsch, Harvard University and Matthew Grady, Children’s hospital of Massachusetts General Hospital Philadelphia Cynthia Ho, Loyola University of Chicago Ann Granchelli, National Jewish Stephen Hoffman, Sanaria Inc. Jean Grassman, CUNY Graduate School of Public Health and Health Policy Charles Holmes, Director, Georgetown University Center for Innovation in Global Alice Gray, University of Colorado Health Michael Grodin, Boston University School of Kathleen Holton, American University Public Health Nuria Homedes, Salud y Farmacos Cary Gross, Yale School of Medicine Marc Horman, retired Cristina Gruta, UCSF Peter Hotez, Baylor College of Medicine Jeanne Gullahorn, Harvard, Kansas, Michigan State James Hoxie, University of Pennsylvania Akash Gupta, Massachusetts General Hospital Laura Hoyt, Children's Minnesota Ashley Gyura, Children's MN Deborah Huang, University of Washington Philip Gyura, Hazelden Betty Ford James Hughes, Emory University School of Medicine Beatrice Hahn, University of Pennsylvania Kristen Hysell, Massachusetts General Hospital Cheryl Hale, Children's of Minnesota Peter Infante, Peter F Infante Consulting, L.L.C. Helge Hartung, The Children's Hospital of Philadelphia, U Penn Sharon Inouye, Harvard Medical School Dr. Peter Havel, University of California, Davis Ellen Isaacs, New York Medical College (retired) Adam Hege, Appalachian State University , Yale University School of Elizabeth Kern, National Jewish Health Medicine Jean Kerver, Michigan State University Peter Jacobson, University of Michigan School Joan King-Angell, Lifelong Medical Care of Public Health P. J. Klasse, Weill Cornell Medicine, Cornell Jana Jarolimova, Massachusetts General University Hospital Albert Ko, Yale School of Public Health Jacky Jennings, Johns Hopkins School of Medicine Roya Kohani, Harvard Medical Alumnae/ UCSD School of Medicine Prabhat Jha, University of Toronto Michael Kolber, University of Miami Miller Nikolaus Jilg, Massachusetts General Hospital School of Medicine Esther John, Stanford University School of Kristin Kranz, NA Medicine Nancy Krieger, Harvard T.H. Chan School of R. 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Perrotta, Texas Department of State Division of Infectious Diseases Health Services Ali Nouri, Federation of American Scientists Sue Peschin, Alliance for Aging Research Dave O'Connor, University of Wisconsin- Gerald Pier, Brigham and Women's Hospital Madison Kent Pinkerton, University of California, Davis Shelby O'Connor, University of Wisconsin- Madison Amy Pisani, Vaccinate Your Family Paul Offit, Children’s Hospital of Stephen Plank, Ex Harvard School of Public Philadelphia Health faculty; Rockefeller Foundation Bisola O. Ojikutu, Brigham and Women's Rebeca Plank, Brigham and Women's Hospital Hospital Travis Porco, UCSF Douglas Opel, University of Washington School of Medicine Tonia Poteat, University of North Carolina School of Medicine Walter Orenstein, Emory University School of Medicine John Potter, Fred Hutchinson Cancer Research Center Karin Pacheco, National Jewish Health, and University of Colorado School of Public Health Enrique Pouget, CUNY Alisa Padon, Public Health Institute Alexis Powell, Universityof Miami Miller Schoolof Medicine Kimberly Page, University of New Mexico Health Sciences Center Mark C. Poznansky, Massaschusetts General Hospital and Harvard Medical School Sunil Parikh, Yale School of Public Health Lou Priem, Bassett Healthcare Tyan Parker Dominguez, USC Suzanne Dworak-Peck School of Social Work Mary Procidano, Fordham University Wendy Parmet, Northeastern Univ. 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Earl Ruley, Vanderbilt University School of Saate Shakil, UNIVERSITY OF Medicine WASHINGTON DIVISION OF CARD Tamara Rushovich, Harvard T.H. Chan School Angela Shen, CHOP of Public Health Michael Siegel, Retired. Formerly at Children's Dave Ruud, Retired Hospital of Los Angeles Sarah Rybicki, University of Minnesota, School Lynn Silver, Public Health Institute of Public Health Ross Silverman, Indiana University Fairbanks Parya Saberi, University of California, San School of Public Health Francisco Michael Silverstein, retired Mohammad Sajadi, Institute of Human Virology at the University of Maryland School of Robin Simon, Wake Forest University Medicine Geoffrey Smith, Albion College (AB), Tony Salloum, University of Miami Miller University of Vermont College of Medicine school of medicine (MD), Harvard School of Public Health (MPH) Martin Spencer, University of British Columbia Madris Tomes, Device Events Natalie Spicyn, Park West Health System Tarlise Townsend, NYU Grossman School of Medicine Shaefer Spires, Duke University School of Medicine Indi Trehan, University of Washington Michael Steinman, University of California, San Virginia Triant, MGH Francisco Alexander Tsai, Massachusetts General Hospital MARIO STEVENSON, University of Miami Athe Tsibris, Brigham and Women's Hospital, Frances Stewart, Walter Reed National Military Harvard Medical School Medical Center Allan Tunkel, Warren Alpert Medical School Patsy Stinchfield, Children's Minnesota Anna Turabelidze, Gf Nicholas Stine, CommonSpirit Health Yoram Unguru, The Herman & Walter Alexis Strongin, Retired Samuelson Children's Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics John Sullivan, University of Massachusetts Medical School Anna Valdez, Sonoma State University John Swartzberg, UC Berkeley Sten Vermund, Yale School of Public Heatlh David Taryle, NJH Liza Vertinsky, Emory Law School Gloria Tavera, Case Western Reserve University DENNIS VOELKER, NATIONAL JEWISH HEALTH, DENVER, CO david tayloe, Goldsboro Pediatrics, PA Rochelle Walensky, Massachusetts General Douglas Taylor, Southeast Community Research Hospital, Harvard Medical School Center Andrew Ward, Scripps Research Institute AJ te Velthuis, Princeton University Deanna Wathington, Former Dean, College of Lydia Temoshok, University of Maryland Health Sciences, Bethune-Cookman University School of Medicine Sidney Watson, Saint Louis University Ba-Bie Teng, UTHealth Donald Weinbaum, New Jersey Public Health Larisa Tereshchenko, Oregon Health & Science Association University David Weinstock, Harvard Medical School Dennis Thombs, University of North Texas Health Science Center School of Public Health Jason Weisfeld, Harvard T.H. 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