JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH

Meeting Proceedings

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH Meeting Proceedings Board on Population Health and Public Health Practice INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This study was supported by Contract No. N01-OD-4-2139, Task Order No. 159 between the National Academy of Sciences and the National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museum in Berlin.

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings “Knowing is not enough; we must apply. Willing is not enough; we must do.” Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings PLANNING GROUP ON THE JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH RICHARD B. JOHNSTON, M.D., Professor of Pediatrics, Department of Pediatrics, University of Colorado School of Medicine, Denver, CO ANN ARVIN, M.D., Lucile Packard Professor of Pediatrics and Microbiology & Immunology, Stanford University, Stanford, CA CAROL CARDONA, D.V.M., PH.D., Veterinary Medicine Extension, University of California, Davis, Davis, CA PETER PALESE, PH.D., Professor & Chair, Department of Microbiology, Mount Sinai School of Medicine, New York, NY STAFF ROSE MARIE MARTINEZ, Sc.D., Director, Board on Population Health and Public Health Practice ALICE WEZI MUNTHALI, M.P.H. HOPE HARE, M.F.A., Administrative Assistant Consultant SANDRA HACKMAN, Copy Editor

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings JOHN R. LAMONTAGNE 1943-2004 This symposium is dedicated to the memory and legacy of John R. LaMontagne, Deputy Director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health. As a quiet but tireless champion, he helped to spearhead some of the most important recent global efforts to fight infectious diseases and to improve the health of children and adults everywhere. For nearly 30 years, John’s thoughtful demeanor and even-handed approach led the way in tackling some of nature’s greatest challenges to humankind. His influence has been incalculable on both national and international programs related to the development of vaccines for pertussis, rotavirus, AIDS, influenza, and malaria; new drugs for tuberculosis; and, more recently, biodefense research. In all of his work, John brought the human and public health dimensions to the efforts of laboratory research. He served the nation and the world immeasurably well, and we are better for it. For the leadership, wise counsel, humor, and friendship that he shared with us and so many others, we are deeply grateful.

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings Contents 1   INTRODUCTION   1      John R. La Montagne Memorial Symposium on Pandemic Influenza Research   1      Day 1- April 4, 2005   3      Day 2-April 5, 2005   4      Meeting Opening Remarks   5      Meeting Opening Remarks   5      Dr. Harvey Fineberg, President, Institute of Medicine   5 2   PLENARY SPEAKERS, DAY 1   7      Opening Remarks   7      The Honorable Michael Leavitt, Secretary of the Department of Health and Human Services   7      Meeting Objectives   10      Dr. Bruce Gellin, Director, National Vaccine Program Office   10      Current Status of Avian Influenza and Pandemic Threat   12      Dr. Julie Louise Gerberding, Director, Centers for Disease Control and Prevention   12      Plenary Presentation Slides-Dr. Julie Louise Gerberding   16      Meeting the Challenge of Pandemic Vaccine Preparedness: An FDA Perspective   19      Dr. Jesse Goodman, Director, Center for Biologics Evaluation and Review U.S. Food and Drug Administration   19      Plenary Presentation Slides-Dr. Jesse Goodman   25      Global Pandemic Preparedness Research Efforts   29      Dr. Klaus Stöhr, Project Leader, Global Influenza Programme, World Health Organization   29      Plenary Presentation Slides-Dr. Klaus Stöhr   35      The Role of NIH Research in Pandemic Influenza Preparedness   40      Dr. Anthony S. Fauci, Director, National Institute of Allergy and Infectious Disease, National Institutes of Health   40      Plenary Presentation Slides-Dr. Anthony S. Fauci   45 3   MORNING PLENARY DISCUSSION, DAY 1 (APRIL 4, 2004)   53      Moderator: Dr. Harvey Fineberg   53 4   WORKING GROUPS, DAY 1   59     Working Group 1  Influenza Virulence and Antigenic Change   59      Report to Plenary   59      Rapporteur—Dr. Robert Lamb   59      Working Group 1 Presentation Slides: Influenza Virulence and Antigenic Change-Dr. Lamb, Rapporteur   63      Working Group 1 Briefing Slides: Influenza Virulence and Antigenic Change-Dr. Palese, Briefer   65     Working Group 2  Controlling Animal Influenza and Decreasing Animal-to-Human Transmission   69      Report to Plenary Rapporteur: Dr. Bruce Innis   69

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings      Working Group 2 Briefing Slides: Controlling animal Influenza and Decreasing Animal-to-Human Transmission-Dr. Swayne, Briefer   73     Working Group 3  Influenza Diagnostics for Surveillance   80      Report to Plenary Rapporteur-Dr. Alan Hay   80      Working Group 3 Briefing Slides: Challenges and Strategies for Detection and Characterization of Influenza Viruses: Surveillance and Diagnosis-Dr. Cox, Briefer   83     Working Group 4  Antivirals and Non-Specific Approaches, Treatments and Immunotherapies   88      Report to Plenary Rapporteur: Dr. Charles Hackett   88      Working Group 4 Presentation Slides: Antivirals and Non-Specific Approaches, Treatments and Immunotherapies-Dr. Hackett, Rapporteur   91      Working Group 4 Briefing Slides: Antivirals and Non-Specific Approaches, Treatments and Immunotherapies-Dr. Hayden, Briefer   93 5   AFTERNOON DISCUSSION: REACTION TO RAPPORTEURS, DAY 1   99 6   PLENARY SPEAKERS, DAY 2   103      Modeling and Pandemic Preparedness,   103      Professor Neil Ferguson, Professor of Mathematical Biology, Faculty of Medicine, Imperial College of London   103      Clinical Trials of Potential Pandemic Vaccines: Key Issues   110      Dr. John Treanor, Associate Professor of Medicine and Microbiology and Immunology, University of Rochester Medical Center   110      Plenary Presentation Slides-Dr. John Treanor   117      Research Issues in Animal Surveillance   124      Dr. Robert Webster, Professor and Chair, Department of Infectious Diseases, St. Jude’s Children’s Research Hospital   124      Plenary Presentation Slides-Dr. Webster   128 7   MORNING PLENARY DISCUSSION, DAY 2 (APRIL 5, 2005)   133      Moderator: Dr. Harvey Fineberg   133 8   WORKING GROUPS, DAY 2   137     WORKING GROUP 5:  Immunology, Assay Standardization, and Correlates of Protection   137      Rapporteur Report—Dr. Ann Arvin   137      Working Group 5 Presentation Slides: Immunology, Assay Standardization, and Correlates of Protection-Ann Arvin, Rapporteur   140      Working Group 5 Briefing Slides: Immunology, Assay Standardization, and Correlates of Protection-Dr. Brian Murphy, Briefer   141     WORKING GROUP 6:  Pandemic Vaccines—Assessment, Development and Production Strategies   142      Rapporteur Report-Dr. Regina Rabinovich   142      Working Group 6 Presentation: Pandemic Vaccines-Assessment, Development and Production Strategies, Dr. Rabinovitch, Rapporteur   145      TABLE 1 Research Priorities for Vaccine Assessment, Development, and Production   146

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings      Working Group 6 Briefing Slides: Pandemic Vaccines-Assessment, Development and Production Strategies-Dr. Harry Greenberg, Briefer   149     WORKING GROUP 7:  Strategies to Contain Outbreaks and Prevent Spread   150      Rapporteur Report—Dr. Nicole Lurie   150      Working Group 7 Presentation Slides: Strategies to Contain Outbreaks and Prevent Spread-Dr. Nicole Lurie, Rapporteur   153      Working Group 7 Briefing Slides: Strategies to Contain Outbreaks and Prevent Spread-Dr. Neil Ferguson, Briefer   154      Viral Transmission: Understanding and Predicting Pandemic Risk   158      Working Group 8   158      Rapporteur Report—Dr. Peter Palese   158      Working Group 8 Presentation Slides: Viral Transmission: Understanding and Predicting Pandemic Risk-Dr. Peter Palese, Rapporteur   161      Working Group 8 Briefing Slides: Viral Transmission: Understanding and Predicting Pandemic Risk-Dr. Daniel Perez, Briefer   162 9   PREPARATION FOR PANDEMIC INFLUENZA: FILLING THE GAPS IN KNOWLEDGE AND UNDERSTANDING   165 A   SPEAKER BIOGRAPHIES   179 B   PANDEMIC FLU WORKSHOP PARTICIPANTS   183     CONTENTS OF CD   203

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