Appendix A

Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World

September 12–13, 1994

Foundry Building, Room 2004

1055 Thomas Jefferson Street, NW

Washington, D.C.

Room 2004

FINAL AGENDA

Day 1

8:30

Continental Breakfast

9:00

Welcome and Introduction

Caroline Hall, Steering Committee Chair

9:10

Overview

Floyd Denny, University of North Carolina



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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 Appendix A Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World September 12–13, 1994 Foundry Building, Room 2004 1055 Thomas Jefferson Street, NW Washington, D.C. Room 2004 FINAL AGENDA Day 1 8:30 Continental Breakfast 9:00 Welcome and Introduction Caroline Hall, Steering Committee Chair 9:10 Overview Floyd Denny, University of North Carolina

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 9:30 Determining Vaccine Need Moderator: Samuel Katz, Steering Committee Member Epidemiologic Data Gaps and Their Relevance to Vaccine Studies Mark Steinhoff, Johns Hopkins University The Situation in Nigeria and the United Arab Emirates Catherine Oyejide, College of Medicine, Ibadan, Nigeria Serotype Surprise: The Case of Haemophilus influenzae in Egypt Mona Assad, VACSERA, Cairo, Egypt The Global Burden of N. menigitidis-Caused Meningitis Jay Wenger, Centers for Disease Control and Prevention 10:30 Break 10:45 Discussion 11:45 Lunch 12:45 Overcoming Technologic Barriers Moderator: Emil Gotschlich, Rockefeller University Pneumococcal Conjugate Vaccines: Status and Prospects John La Montagne, National Institutes of Health The Limits of Conjugate Technology Philip Russell, Children’s Vaccine Initiative The Common-Antigen Approach to Vaccine Development David Briles, University of Alabama 1:30 Discussion 2:30 Break 2:45 A Meningococcal B Vaccine for Children Wendell Zollinger, Walter Reed Army Institute of Research

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994   One Approach to Constructing a Meningococcal A/B/C Vaccine Carl Frasch, Food and Drug Administration 3:15 Discussion 4:00 Break 4:15 Summary and Synthesis: Day 1 Moderators 4:45 Adjourn Day 2 8:30 Continental Breakfast 9:00 Proving Vaccine Efficacy: The Challenge of Developing-Country Field Trials Moderator: George Siber, Massachusetts Department of Health Pneumonia Diagnostics: The Achilles Heel of ARI Epidemiology Claire Broome, Centers for Disease Control and Prevention The Case-Control Method and Other Alternative Design Strategies Helena Makela, National Public Health Institute, Helsinki, Finland Report of a Post-Licensure Hib Efficacy Trial in Chile Myron Levine, University of Maryland 9:45 Discussion 10:45 Break 11:00 The Public-/Private-Sector Interface Moderator: William Hubbard, Steering Committee Member An Industry Perspective Peter Paradiso/Frank Malinoski, Lederle-Praxis Biologicals

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994   A Biotech Perspective Dale Spriggs, Virus Research Institute A Government Perspective George Curlin, National Institutes of Health 11:45 Discussion 12:30 Lunch 1:15 Introducing an Effective Vaccine Moderator: Donald Shepard, Brandeis University The Cost-Effectiveness of ARI Vaccines Benjamin Schwartz, Centers for Disease Control and Prevention The Purchase and Cost of New EPI Vaccines Maria Costales, Ministry of Health, Philippines Financing the use of Conjugate Hib Vaccine in Brazil Otavio Oliva, SIREVA, Rio de Janiero, Brazil 2:00 Break 2:15 Facilitating Vaccine Production Capability George Siber, Massachusetts Department of Health The Importance of Infrastructure and National Commitment: Lessons from the Polio Experience Ciro de Quadros, Steering Committee Member 2:45 Discussion 3:45 Break 4:00 Summary and Synthesis: Day 2 Moderators 4:30 Closing Comments Caroline Hall, Steering Committee Chair 4:45 Adjourn

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 WORKSHOP SPEAKERS Mona Asaad, M.D., Acting Director, The Egyptian Organization for Biological and Vaccine Production (VACSERA) David Briles, Ph.D., Professor, Division of Microbiology, University of Alabama at Birmingham, Birmingham, AL Claire Broome, M.D., Associate Director for Science, Centers for Disease Control and Prevention, Atlanta, GA Maria Otelia Costales, Officer in Charge, Maternal and Child Health Service, Department of Health, Manila, Philippines George Curlin, M.D., Deputy Director, Division of Microbiology and Infectious Disease, National Institute of Allergy, and Infectious Diseases, National Institutes of Health, Bethesda, MD Floyd Denny, M.D., Professor of Pediatrics, Division of Community Pediatrics, University of North Carolina, Chapel Hill, NC Ciro de Quadros, M.D, M.P.H., (IOM Steering Committee Member) Senior Advisor on Immunization, Pan American Health Organization, Washington, DC Carl Frasch, Ph.D., Chief, Bacterial Polysaccharides Laboratory Division of Bacterial Products, Food and Drug Administration, Rockville, MD Emil C. Gotschlich, M.D., Professor and Head, Bacterial, Pathogenesis and Immunology Laboratory, Rockefeller University, New York, NY Caroline Breese Hall, M.D. (IOM Steering Committee Chair) Professor of Pediatrics and Medicine in Infectious Disease, University of Rochester, Rochester, NY William N. Hubbard, Jr., M.D. (IOM Steering Committee Member) Hickory Corners, MI Samuel L. Katz, M.D. (IOM Steering Committee Member), Wilburt C. Davison Professor Department of Pediatrics, Duke University Medical Center, Durham, N.C. John La Montagne, Ph.D., Director, Division of Microbiology and Infectious Disease, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD Myron M. Levine, M.D., D.T.P.H., Professor and Director, Center for Vaccine Development, University of Maryland, Baltimore, MD Helena Makela, M.D., Ph.D., Director, Division of Infectious Diseases, National Public Health Institute, Helsinki, Finland Frank J. Malinoski, M.D., Ph.D., Director, Clinical Research, Lederle-Praxis Biologicals, West Henrietta, NY Otavio P. de Oliva, M.D., M.P.H., Coordinator Regional do SIREVA, Rio de Janeiro, Brazil Dr. Catherine Oyejide, Department of Public Health and Occupational Medicine, United Arab Emirates University, United Arab Emirates

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 Peter Paradiso, Ph.D., Senior Director of Scientific Affairs, Lederle-Praxis Biologicals, West Henrietta, NY Philip Russell, M.D., Special Advisor to the CVI, Center for Immunization Research, Johns Hopkins University, Baltimore, MD Benjamin Schwartz, M.D., Chief, Childhood and Vaccine-Preventable Diseases, Epidemiology Section, Centers for Disease Control and Prevention, Atlanta, GA Donald S. Shephard, Ph.D., Institute for Health Policy, Brandeis University, Waltham, MA George Siber, M.D., Director, Biologics Laboratory, Massachusetts Department of Health, Jamaica Plain, MA Dale Spriggs, Ph.D., Director, Clinical Research and Development, Virus Research Institute, Cambridge, MA Mark Steinhoff, M.D., Associate Professor, Center for Immunization Research, Department of International Health, Johns Hopkins University, Baltimore, MD Jay Wenger, M.D., Chief, Childhood and Respiratory Diseases Branch, Centers for Disease Control and Prevention, Atlanta, GA Wendell Zollinger, Ph.D., Research Biologist, Department of Bacterial Diseases, Walter Reed Army Institute of Research, Washington, DC WORKSHOP PARTICIPANTS Judith R. Bale, Ph.D., Program Officer, Board on Science and Technology for International Development, Washington, DC Kenneth Bart, M.D., Associate Director for Medical and Scientific Affairs, Office of International Health, U.S. Public Health Service, Rockville, MD Alfred Bartlett, M.D., M.P.H., Acting Chief, Child Survival Division, Office of Health and Nutrition, Agency for International Development, Washington, DC Ruth Brenner, M.D., Senior Staff Fellow, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD Robert Clay, M.P.H., Acting Deputy Director, Office of Health and Nutrition, Agency for International Development, Washington, DC John Clemens, M.D., Chief, Epidemiology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD Jose Luis Di Fabio, Advisor on Vaccines, Pan American Health Organization, Washington, DC Gerald W. Fischer, M.D., President, Virion, Rockville, MD James Froeschle, M.D., Director, Clinical Research, Connaught Laboratories, Swiftwater, PA

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 Joan Fusco, North American Vaccine Inc., Beltsville, MD Bruce G. Gellin, M.D., Assistant Professor, Department of International Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD Dan Granoff, M.D., Executive Director, Clinical Research, The Biocine Company, Emeryville, CA William Hausdorff, Ph.D., Project Officer, Children’s Vaccine Initiative Project, Agency for International Development, Office of Health and Nutrition, Washington, DC Carole Heilman, Ph.D., Chief, Respiratory Diseases Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD Akira Homma, Ph.D., Regional Advisor on Biologics, Pan American Health Organization, Washington, DC David L. Klein, Ph.D., Bacterial Respiratory Disease Program Officer, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD Kaimi Lin, M.D., Medical Research Officer, National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD Sharon Mates, Ph.D., President, North American Vaccine Inc., Beltsville, MD Paul M. Mendelman, Merck Research Laboratories, West Point, PA Molly Mort, Ph.D., AAAS Fellow, Office of Health and Nutrition, Agency for International Development, Washington, DC Trudy Murphy, M.D., Associate Professor of Pediatrics, University of Texas, Southwestern Medical Center/Dallas, Dallas, TX David Oot, M.P.H., Director, Office of Health and Nutrition, Agency for International Development, Washington, DC Jan T. Poolman, M.D., Head, Laboratory of Vaccine Development and Immune Mechanisms, National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands Regina Rabinovich, M.D., Assistant Director, Division of Microbiology and Infectious Disease, National Institute of Allergy and Infectious Diseases, Rockville, MD Malla Rao, Visiting Scientist, National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD Anthony Robbins, M.D., Office of the Assistant Secretary for Health, National Vaccine Program Office, Rockville, MD John B. Robbins, M.D., Chief, Laboratory of Development and Molecular Immunology, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD Murray Trostle, Dr.P.H., Public Health Advisor, Office of Health and Nutrition, Agency for International Development, Washington, DC

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The Children’s Vaccine Initiative: Continuing Activities: A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 Ronnie Waldman, M.D., M.P.H., Deputy Director/Technical, BASICS, Agency for International Development, Washington, DC Joel I. Ward, M.D., Chief, Pediatric Infectious Diseases, Harbor-University of California/LA, Torrance, CA Roy Widdus, Ph.D., Office of the Assistant Secretary for Health, National Vaccine Program Office, Rockville, MD James Young, Ph.D., Vice President, Research and Development, MedImmune, Gaithersburg, MD Paul Zeitz, D.O., M.P.H., Child Survival Fellow, Agency for International Development, Office of Health and Nutrition, Washington, DC Beatrice Zurita, London School of Hygiene and Tropical Medicine, University of London, London, England Staff Greg Pearson, Project Director Dee Sutton, Administrative Assistant