Preserving the Scientific Integrity of Getting to COVID-19 Vaccines: From Clinical Trials to Public Allocation

 

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There are now more than 33 million confirmed COVID-19 cases worldwide and the death toll of the global pandemic has surpassed one million. The United States remains the most affected country, with more than seven million diagnosed COVID-19 infections and upwards of 200,000 deaths to date. The pandemic has also had enormous social and economic impacts globally, and continues to challenge families, communities, health systems, and virtually every aspect of society.

Efforts to develop COVID-19 vaccines are well underway, and protecting the scientific integrity of the process is paramount. The trials must be—and must be seen to be—free of political interference, carried out with the highest scientific and ethical rigor, and allowed to proceed until the safety and efficacy of each candidate vaccine has been thoroughly assessed. The ultimate goal is global distribution of and equitable access to effective vaccines that can help slow, and eventually end, the pandemic.

With this backdrop, Johns Hopkins University and the University of Washington brought together leading experts to explore these issues and put forward a concise plan for protecting the scientific integrity of these lifesaving efforts. “Preserving the Scientific Integrity of Getting to COVID-19 Vaccines: From Clinical Trials to Public Allocation” features insights from global leaders in vaccine science, health metrics, policy, regulation, and communications.

Speakers:

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Francis Collins	Anthony Fauci	Peter Marks	Moncef Slaoui
Michele Andrasik	Nancy Bennett	Chris Beyrer	Mike Bloomberg
Ana Mari Cauce	Larry Corey	Ronald J. Daniels	Ruth Faden
Helene Gayle	Scott Gottlieb	Tom Inglesby	Keith Jerome
Ruth Karron	Ellen MacKenzie	Apoorva Mandavilli	Bill Moss
Chris Murray	Kathleen Neuzil	Joshua Sharfstein	Will Stone
Sarah Zhang

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Opening Remarks:

• Michael R. Bloomberg,
  Founder, Bloomberg LP and Bloomberg Philanthropies, 108th Mayor of New York City

Welcome Remarks:

• Dr. Ana Mari Cauce, PhD,
  President, University of Washington
• Ronald J. Daniels, JD, LLM,
  President, Johns Hopkins University

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Session 1: The Science and Structure of the U.S. Government’s COVID-19 Vaccine Trial Program

Chairs

• Dr. Ana Mari Cauce, PhD,
  President, University of Washington
• Ronald J. Daniels, JD, LLM,
  President, Johns Hopkins University

Speakers

• Dr. Anthony S. Fauci, MD,
  Director, National Institute of Allergy and Infectious Diseases
• Dr. Moncef Slaoui, PhD,
  Chief Advisor, Operation Warp Speed

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Moderator Remarks

• Dr. Chris Beyrer, MD, MPH,
  Desmond M. Tutu Professor of Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health

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Session 2: Protecting Scientific Integrity in the Design and Conduct of COVID-19 Vaccine Efficacy Trials

Chairs

• Dr. Keith Jerome, MD, PhD,
  Professor and Head of Virology Division, University of Washington School of Medicine
• Dr. Ruth Karron, MD,
  Professor and Director, Johns Hopkins Vaccine Initiative, Johns Hopkins Bloomberg School of Public Health

Speaker

• Dr. Larry Corey, MD,
  Professor of Medicine and Laboratory Medicine, University of Washington School of Medicine

Panelists

• Dr. Michele Andrasik, PhD,
  Clinical Affiliate Professor, Departments of Global Health and Environmental and Occupational Health Sciences, University of Washington School of Public Health
• Dr. Larry Corey, MD,
  Professor of Medicine and Laboratory Medicine, University of Washington School of Medicine
• Dr. Joseph Millum, PhD,
  Bioethicist, Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health

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Moderator Remarks

• Dr. Chris Beyrer, MD, MPH,
  Desmond M. Tutu Professor of Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health

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Session 3: Regulatory Integrity and the Assessment of Vaccine Safety and Efficacy

Chairs

• Dr. Kathleen Neuzil, MD, MPH,
  Director, Center for Vaccine Development and Global Health, University of Maryland School of Medicine
• Dr. Joshua M. Sharfstein, MD,
  Vice Dean for Public Health Practice and Community Engagement, Johns Hopkins Bloomberg School of Public Health

Speaker

• Dr. Peter Marks, MD, PhD,
  Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Panelists

• Dr. Scott Gottlieb, MD,
  Former FDA Commissioner (2017 – 2019)
• Dr. Peter Marks, MD, PhD,
  Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

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Moderator Remarks

• Dr. Chris Beyrer, MD, MPH,
  Desmond M. Tutu Professor of Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health

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Session 4: Integrity in Communications: Trials Outcomes and the Public

Chair

• Dr. Tom Inglesby, MD,
  Director, Center for Health Security, Johns Hopkins Bloomberg School of Public Health

Panelists

• Apoorva Mandavilli,
  Journalist, The New York Times
• Will Stone,
  Journalist, NPR
• Sarah Zhang,
  Journalist, The Atlantic

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Moderator Remarks

• Dr. Chris Beyrer, MD, MPH,
  Desmond M. Tutu Professor of Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health

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Session 5: Integrity and Recommendations for Access, Allocation and Use

Chairs

• Dr. Ruth R. Faden, PhD, MPH,
  Founder, Johns Hopkins Berman Institute of Bioethics, Johns Hopkins Bloomberg School of Public Health
• Dr. Helene Gayle, MD, MPH,
  Co-Chair, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, The National Academies of Sciences, Engineering, and Medicine

Panelists

• Dr. Nancy M. Bennett, MD,
  Director, Center for Community Health and Prevention, University of Rochester School of Medicine and Dentistry
• Dr. William Moss, MD, MPH,
  Executive Director, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health


• Dr. Christopher Murray, MD,
  Director, Institute for Health Metrics and Evaluation and Chair, Dept. of Health Metrics Sciences, University of Washington and UW School of Medicine

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Introduction

• Dr. Ellen J. MacKenzie, PhD, ScM,
  Dean, Johns Hopkins Bloomberg School of Public Health

Symposium Summary

• Dr. Francis S. Collins, MD, PhD,
  Director, National Institutes of Health

Closing Remarks

• Dr. Ellen J. MacKenzie, PhD, ScM,
  Dean, Johns Hopkins Bloomberg School of Public Health

 

Johns Hopkins University’s clinicians and researchers specializing in global public health, infectious disease, and emergency preparedness have been at the forefront of the international response to the coronavirus outbreak by advancing the understanding of the virus, informing the public, and briefing policymakers to guide the response, improve care, and save lives. Stay up to date on the latest expert insights from the Johns Hopkins Bloomberg School of Public Health and get notified about future webcasts by subscribing to our Expert Insights Newsletter, delivered Mondays, Wednesdays, and Fridays.

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