Open Letter — 1 Day Sooner

Dr. Francis Collins, National Institutes of Health

Dear Dr. Collins,

The COVID-19 pandemic must be fought urgently on many fronts, but it is hard to picture robust economic and social recoveries in the absence of a vaccine. We are writing to underscore the vast importance of human challenge trials as a method to help develop vaccines. 

In April, thirty-five members of the US House of Representatives called upon U.S. regulators to consider allowing volunteers to be infected with the pandemic coronavirus to speed vaccine testing—in so-called human challenge or controlled infection trials.  In addition, over a hundred vaccine candidates are already under development around the world, at least ten of which have moved into the clinical trial phase. In May, the World Health Organization published guidance supporting trials of that form, if done ethically, and in June published a draft laying out a practical roadmap for their implementation.

The undersigned urge the U.S. government (including, but not limited to the Coronavirus Task Force, the Department of Health and Human Services, the Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health, and Congress), its allies, international funders, and world bodies (e.g. the World Health Organization), to undertake immediate preparations for human challenge trials, including supporting safe and reliable production of the virus and any biocontainment facilities necessary to house participants.

The rationale for human challenge trials is that they can greatly accelerate the development of a COVID-19 vaccine.

Human challenge trials can provide information much faster than conventional efficacy trials, which take months longer.  In such trials, volunteers still receive the vaccine candidate or a control.  Instead of resuming life as usual and waiting to “catch” a virus, volunteers are deliberately exposed to the pathogen under controlled conditions. Beyond being faster than conventional trials, a challenge test is likelier to conclude with interpretable results, e.g. should the presence of virus around the study site begin to fade over time.

If challenge trials can safely and effectively speed the vaccine development process, there is a formidable presumption in favor of their use, which would require a very compelling ethical justification to overcome. 

Human research demands caution and oversight. Crucial protections must be extended to protect the health and autonomy rights of volunteers. Guidance from the World Health Organization clarifies that human challenge trials are ethical when they meet certain criteria. The following are some protections that should clearly be in place. 

●    Trial participants should be relatively young and in good health.  The mortality risk of the coronavirus to 20-29 year-olds, healthy and unhealthy, is similar to that of living kidney donors , a relatively common procedure, similarly justified by the donor’s informed consent and the benefits to society. Excluding participants with preexisting conditions would lower the risk significantly.  

●      It is crucial that all trial participants be provided the highest quality medical care with frequent monitoring. A significant percentage of the population will likely become infected and their access to medical care may be limited.  As a result, the guarantee of excellent medical care in the study means that infection would be safer in the controlled, medically supervised, and isolated conditions of a challenge trial.

●      Ethical and scientific review must be of the highest quality. In the U.S., that would mean not only the usual FDA and IRB review but a vigorous public discussion and perhaps even an additional, independent ethics and science taskforce representing, among others, challenge volunteers.

●      The autonomy of the volunteers is of paramount concern. This means that the informed consent process must be robust (e.g. no children, no prisoners, multiple tests of comprehension). It also means that the wish of informed volunteers to participate in the trial ought to be given substantial weight. Providing some input over trial development and procedure to those interested in becoming volunteers (e.g. in the design of isolation conditions) could both enhance their agency and improve study design. Decades of psychological research on highly altruistic behaviors  has demonstrated that a large, and likely growing, fraction of the general population is willing to undergo meaningful risks to benefit others due to genuinely altruistic motivation rather than insensitivity to risk, psychopathology, or other ethically concerning motives.

If done properly, live Coronavirus human challenge trials can be an important way to accelerate vaccine development and, ideally, to save the lives of millions around the world as well as help rescue global economies. We strongly recommend that production of the unattenuated virus begin immediately consistent with good manufacturing practices for potential use in trials that balance risks and benefits and respect the safety and autonomy of volunteers. It is also vitally important that there is both full transparency on the vaccine development and trial process and a diverse group of trial participants necessary to provide a broadly effective and universally available vaccine.  We appeal to the government and foundation funders around the world to support this effort.

Initial Signatories in italics. Institutional affiliations for identification purposes only:

  • Scott Aaronson, David J. Bruton Centennial Professor of Computer Science, University of Texas at Austin

  • Amrita Ahuja, Director of the Douglas B. Marshall, Jr. Family Foundation

  • Chris Anderson, Head of TED

  • Alexander Berger, Managing Director at Open Philanthropy

  • Arthur Caplan, Drs. William F. and Virginia Connolly Mitty Professor of Bioethics, Department of Population Studies, NYU Langone Health

  • Nir Eyal, Henry Rutgers Professor of Bioethics and Director of the Center for Population-Level Bioethics (CPLB), Rutgers University

  • Ambassador James Glassman, Founding Executive Director at the George W. Bush Institute

  • Kim Krawiec, Kathrine Robinson Everett Professor of Law, Duke University School of Law

  • Marc Lipsitch, Professor of Epidemiology, Harvard University

  • Abigail Marsh, Professor of Psychology and Neuroscience, Georgetown University

  • Josh Morrison, Co-Founder and Executive Director at 1DaySooner

  • Stanley Plotkin, Emeritus Professor of Pediatrics, Perelman School of Medicine, University of Pennsylvania

  • Sophie Rose, Co-Founder and Director of Research at 1DaySooner

  • Nadine Rouphael, Associate Professor of Medicine and Acting Director, Hope Clinic, Emory Vaccine Center

  • Sally Satel, Resident Scholar at the American Enterprise Institute

  • Peter Singer, Ira W. DeCamp Professor of Bioethics in the University Center for Human Values, Princeton University

  • Kate Wharton, Senior Associate at CrossBoundary

  • Daniel Wikler, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard University

    Nobel Laureates

  • Mario Capecchi, Distinguished Professor in the Department of Human Genetics, University of Utah School of Medicine

  • Carol Greider, Professor of Molecular Biology and Genetics, Johns Hopkins University School of Medicine

  • Oliver Hart, Lewis P. and Linda L. Geyser University Professor, Harvard University

  • Lou Ignarro, Professor Emeritus, UCLA School of Medicine

  • William G. Kaelin, Jr., Professor of Medicine, Howard Hughes Medical Institute, Harvard Medical School

  • Barry Marshall, Clinical Professor and UWA Brand Ambassador, The University of Western Australia

  • Craig Mello, Distinguished Professor in RNA Therapeutics, University of Massachusetts Medical School

  • Paul Modrich, James B. Duke Professor of Biochemistry, Duke University

  • Edvard Moser, Professor of Neuroscience, Kavli Institute for Systems Neuroscience, Norwegian University of Technology and Science

  • May-Britt Moser, Professor of Neuroscience, Kavli Institute for Systems Neuroscience, Norwegian University of Technology and Science

  • Sir Richard Roberts, Chief Scientific Officer, New England Biolabs

  • Michael Rosbash, Professor of Biology and Investigator, Howard Hughes Medical Institute, Brandeis University

  • Alvin Roth, The Craig and Susan McCaw Professor of Economics, Stanford University

  • Jack Szostak, Alex Rich Distinguished Investigator, Massachusetts General Hospital

  • Arieh Warshel, Dana and David Dornsife Chair in Chemistry, Distinguished Professor of Chemistry and Biochemistry, University of Southern California

    Experts and Academics

  • Ralf Bader, Professor of Philosophy, University of Fribourg

  • Daniel Batson, Professor Emeritus of Psychology, University of Kansas

  • Karen Bennett, Professor of Philosophy and Department Chair, Rutgers University

  • Michael Bratman, Durfee Professor of Philosophy, Stanford University

  • John Broome, Emeritus White’s Professor of Moral Philosophy, University of Oxford

  • Allen Buchanan, Research Professor of Philosophy and Center for Philosophy of Freedom, University of Arizona; Emeritus Professor of Philosophy and Law, Duke University

  • Tyler Burge, Flint Professor of Philosophy, University of California, Los Angeles

  • Bryan Caplan, Professor of Economics, George Mason University

  • David Chalmers, University Professor of Philosophy, New York University

  • Carolyn Riley Chapman, Faculty Affiliate, NYU Division of Medical Ethics

  • Richard Chappell, Assistant Professor of Philosophy, University of Miami

  • Catherine Constable, Assistant Professor, Department of Medicine at NYU Grossman School of Medicine

  • Lewis Conway, Campaign Strategist, American Civil Liberties Union

  • Philip Cook, Sanford Professor Emeritus of Public Policy, Duke University

  • Stephen Darwall, Andrew Downey Orrick Professor of Philosophy, Yale University

  • Ara Darzi, Professor the Lord Darzi of Denham, OM, KBE, PC, FRS; Director of the Institute of Global Health Innovation, Imperial College London

  • Daniel Dennett, Austin B. Fletcher Professor of Philosophy, Tufts University

  • Pedro Rosa Dias, Associate Professor of Health Economics, Imperial College Business School, Imperial College London

  • Frances Egan, Professor of Philosophy, Rutgers University

  • Daniel Gilbert, Edgar Pierce Professor of Psychology, Harvard University

  • Rebecca Newberger Goldstein, Author; Research Associate, Harvard University

  • Lori Gruen, William Griffin Professor of Philosophy, Wesleyan University

  • Nita Farahany, Robinson O. Everett Professor of Law & Philosophy, Duke University School of Law

  • Kyle Ferguson, Postdoctoral Fellow, Division of Medical Ethics, NYU Grossman School of Medicine

  • Kit Fine, University Professor and Silver Professor of Philosophy and Mathematics, New York University

  • Stephen Finlay, Director and Professor of the Dianoia Institute of Philosophy, Australian Catholic University; Professor of Philosophy, University of Southern California

  • Stuart Firestein, Professor of Biological Sciences, Columbia University

  • Johann Frick, Assistant Professor of Philosophy and Human Values, Princeton University

  • Matteo M. Galizzi, Associate Professor of Behavioural Science, London School of Economics 

  • Daniel Garber, A. Watson J. Armour III University Professor of Philosophy, Princeton University

  • Tobias Gerhard, Associate Professor of Pharmacy and Epidemiology, Director, Center for Pharmacoepidemiology and Treatment Science, Rutgers Biomedical and Health Sciences

  • Kenneth Goodman, Professor of Medicine and Philosophy, University of Miami

  • Joshua Greene, Professor of Psychology, Harvard University

  • Alexander Guerrero, Associate Professor of Philosophy, Rutgers University

  • Saarthak Gupta, Research Fellow, Open Philanthropy

  • Jonathan Haidt, Professor of Ethical Leadership, New York University - Stern School of Business

  • Edward Hall, Norman E. Vuilleumier Professor of Philosophy, Harvard University

  • Hans Halvorson, Stuart Professor of Philosophy, Princeton University

  • Elizabeth Harman, Laurance S. Rockefeller Professor of Philosophy and Human Values, Princeton University

  • Dan Haybron, Theodore R. Vitali C.P. Chair in Philosophy, Saint Louis University

  • Adrian Hill, Lakshmi Mittal and Family Professor of Vaccinology & Director of the Jenner Institute, University of Oxford

  • Karla FC Holloway, James B. Duke Professor Emerita of English and Law, Duke University

  • Dale Jamieson, Professor of Environmental Studies and Philosophy, New York University

  • Robin Jeshion, Professor of Philosophy, University of Southern California

  • Justin Kalef, Director of Teaching Innovation, Department of Philosophy, Rutgers University

  • Gregory Keating, Maurice Jones, Jr. - Class of 1925 Professor of Law and Philosophy, Gould School of Law, University of Southern California

  • David Killoren, Research Fellow in Philosophy at the Dianoia Institute of Philosophy, Australian Catholic University

  • Philip Kitcher, John Dewey Professor of Philosophy, Emeritus, Columbia University

  • Christine M. Korsgaard, Arthur Kingsley Porter Professor of Philosophy, Harvard University

  • Colleen Kraft, Associate Professor of Pathology and Laboratory Medicine, Emory University

  • Zell Kravinsky, Investor and Philanthropist

  • Yamuna Krishnan, Professor of Chemistry, University of Chicago

  • Béatrice Longuenesse, Silver Professor & Professor of Philosophy, New York University

  • Sayantan Banerjee, Assistant Professor in Operations Management & Quantitative Techniques at the Indian Institute of Management Indore

  • Mario Macis, Associate Professor of Economics, Johns Hopkins University

  • Todd May, Class of 1941 Memorial Professor of the Humanities, Clemson University

  • Trip McCrossin, Assistant Teaching Professor, Department of Philosophy, Rutgers University

  • Victoria McGeer, Professor of Philosophy at Australian National University; Senior Research Scholar at the University Center for Human Values, Princeton University

  • Jeff McMahan, White’s Professor of Moral Philosophy, University of Oxford

  • Aneesh Mehta, Associate Professor of Medicine, Emory University

  • Marisa Miraldo, Associate Professor in Health Economics, Imperial College London

  • Richard Nisbett, Theodore M. Newcomb Distinguished University Professor Emeritus of Psychology, University of Michigan

  • Akinlolu Ojo, Professor of Medicine and Population Health, University of Kansas School of Medicine

  • Bishr Omary, Senior Vice Chancellor for Academic Affairs and Research, Henry Rutgers Professor of Biomedical Sciences, Robert Wood Johnson Medical School, Rutgers University

  • Peter Openshaw, Professor of Experimental Medicine, Imperial College London

  • Steven Pinker, Johnstone Family Professor of Psychology, Harvard University

  • Philip Pettit, Laurance S. Rockefeller University Professor of University Center for Human Values, Princeton University; Distinguished Professor of Philosophy, Australian National University

  • Janet Radcliffe-Richards, Professor of Practical Philosophy & Distinguished Research Fellow, Oxford Uehiro Centre for Practical Ethics, University of Oxford

  • Zachary Robinson, Research Fellow, Open Philanthropy

  • Sherrilyn Roush, Professor of Philosophy, University of California, Los Angeles

  • Julian Savulescu, Uehiro Chair in Practical Ethics, University of Oxford

  • Thomas M. Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Emeritus, Harvard University

  • Jonathan Schaffer, Distinguished Professor of Philosophy, Rutgers University

  • Susanna Schellenberg, Distinguished Professor of Philosophy and Cognitive Science, Rutgers University

  • Gina Schouten, Assistant Professor of Philosophy, Harvard University

  • Michael Schur, Screenwriter and Television Producer, Creator of The Good Place

  • Andrew Sepielli, Associate Professor of Philosophy, University of Toronto

  • Michael Smith, McCosh Professor of Philosophy, Princeton University

  • Peter Smith, Professor of Tropical Epidemiology, London School of Hygiene & Tropical Medicine

  • Scott Soames, Distinguished Professor of Philosophy, University of Southern California

  • Jeff Sebo, Clinical Assistant Professor of Environmental Studies, Affiliated Professor of Bioethics, Medical Ethics, and Philosophy, New York University

  • Ernest Sosa, Board of Governors Professor of Philosophy, Rutgers University

  • Christopher Snyder, Joel and Susan Hyatt Professor of Economics, Dartmouth College

  • Stephen Stich, Distinguished Professor of Philosophy and Cognitive Science, Rutgers University

  • Brian L. Strom, Chancellor, Rutgers Biomedical & Health Sciences; Executive Vice President for Health Affairs; University Professor, Rutgers University

  • Alex Tabarrok, Bartley J. Madden Chair in Economics and Professor of Economics, George Mason University

  • Larry Temkin, Distinguished Professor of Moral Philosophy, Rutgers University

  • Lorna E. Thorpe, Professor and Director in the Division of Epidemiology, NYU Grossman School of Medicine, NYU Langone Health

  • Deborah VandenBroek, Principal Consultant, VandenBroek LLC

  • Dominic Wilkinson, Consultant Neonatologist, John Radcliffe Hospital Oxford; Professor of Medical Ethics, Oxford Uehiro Centre for Practical Ethics, University of Oxford

  • Ramnik Xavier, Core Institute Member of the Broad Institute & Professor of Medicine, Massachusetts General Hospital & Harvard Medical School

  • David Zuckerman, Professor of Computer Science, University of Texas at Austin

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