The Children’s Vaccine Initiative: Continuing Activities

A Summary of Two Workshops Held September 12–13 and October 25–26, 1994

Greg W. Pearson, Editor

Steering Committee on the Children’s Vaccine Initiative: Continuing Activities

Division of Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1995



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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 The Children’s Vaccine Initiative: Continuing Activities A Summary of Two Workshops Held September 12–13 and October 25–26, 1994 Greg W. Pearson, Editor Steering Committee on the Children’s Vaccine Initiative: Continuing Activities Division of Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1995

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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 National Academy Press 2101 Constitution Avenue, N.W. Washington, D.C. 20418 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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the Agency for International Development. Additional copies of this report are available in limited quantities from: Division of Health Promotion and Disease Prevention Institute of Medicine 2101 Constitution Avenue, N.W. Washington, D.C. 20055 Copyright 1995 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 Staatlichemuseen in Berlin. COVER: Sonia Lubeck provided the drawing for the cover of this report.

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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 STEERING COMMITTEE ON THE CHILDREN’S VACCINE INITIATIVE: CONTINUING ACTIVITIES CAROLINE BREESE HALL (Chair), Professor of Pediatrics and Medicine in Infectious Disease, University of Rochester School of Medicine and Dentistry, Rochester, New York CIRO DE QUADROS, Senior Advisor on Immunization, Pan American Health Organization, Washington, D.C. R. GORDON DOUGLAS, President, Merck Vaccine Division, Whitehouse Station, New Jersey WILLIAM N. HUBBARD, President (Retired), Upjohn Co., Hickory Corners, Michigan SAMUEL L. KATZ, Wilburt C. Davison Professor of Pediatrics, Duke University Medical Center, Durham, North Carolina Staff GREG W. PEARSON, Project Director MICHAEL A. STOTO, Director, Division of Health Promotion and Disease Prevention KATHLEEN R. STRATTON, Deputy Director, Division of Health Promotion and Disease Prevention DEE SUTTON, Administrative Assistant DONNA D. THOMPSON, Division Assistant

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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 Preface The two workshops described in this report represent a continuation of Institute of Medicine (IOM) activities focusing on the Children ’s Vaccine Initiative (CVI). The CVI came into being at the World Summit for Children held in New York City in September 1990. Its goal then as now is to utilize our scientific and technologic capability to produce improved vaccines for the world’s children. Subsequent to the summit, the IOM conducted a study (funded in part by the U.S. Agency for International Development [USAID], the sponsor of these workshops) to evaluate the nontechnical impediments to the development of CVI-type vaccines. The involvement of the U.S. public and private sectors in this effort also was assessed. In July 1993, the IOM released a report resulting from this study, The Children’s Vaccine Initiative: Achieving the Vision. In March 1994, the newly formed IOM Steering Committee on the Children ’s Vaccine Initiative: Continuing Activities met for the first time. The panel was charged with overseeing the planning of these two workshops. With input from USAID, the committee decided that the first session should address impediments to the introduction in the developing world of new vaccines against acute respiratory infections (ARI). The USAID hoped the workshop would help inform its own program development as well as the activities of other players in this arena. To ensure that the broadest range of issues was considered, the committee decided the workshop should look at existing products that are at different stages of development. With this in mind, the panel selected three types of vaccines for discussion. Conjugate vaccine against Haemophilus influenzae b (Hib) represented a vaccine that is already widely used. Conjugate vaccine against

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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 Streptococcus pneumoniae was illustrative of a product still undergoing extensive development. The committee also chose to include conjugate vaccine against Neisseria meningitides. While not targeting an ARI pathogen, this vaccine was deemed suitable because its development falls midway between that of the other two. Although it selected only bacterial vaccines, the committee recognized the major role of viruses in causing ARI in the developing world. Some 70 people from around the world, including vaccine researchers, immunization program directors, and representatives of the vaccine industry, took part in the September workshop. One of the most successful aspects of the 1993 IOM study on the CVI was the convening of working groups comprised of representatives from universities, government agencies, biotechnology firms, large vaccine manufacturers, and multilateral agencies to discuss critical impediments to the development of new and improved vaccines. The interactions among these groups involved in the global vaccine enterprise were considered extremely useful—by the participants, the IOM, and the funders. This earlier success influenced the steering committee’s vision for the second workshop; the panel hoped this meeting would stimulate additional useful dialogue about the CVI between the public and private sectors. In particular, the committee wanted to focus attention on how the U.S vaccine and biotechnology industries may best contribute to meeting the needs of developing countries for new and improved vaccines. To increase the likelihood that participants would speak freely, the meeting was by invitation only and was held at a secluded site in rural Virginia. Because of the somewhat sensitive nature of the topics discussed, this Summary, unlike the one from the September workshop, does not identify participants by name. Thirty people took part in the October session. Speakers at the two workshops emphasized the unique vaccine needs and production capabilities of individual countries. Participants also noted the effect of U.S. economic and political pressures on the production of vaccines, both in the United States and in developing countries. One point repeatedly emphasized was that the economic health of vaccine manufacturers is essential if they are to participate in advancing immunization globally. The workshops also revealed the key role technology transfer will play in introducing and sustaining vaccine production capacity in the developing world. Evident was the strong desire of many countries around the world to be able to address their own infectious disease problems, either through direct purchase or indigenous manufacture of vaccines. This summary shows clearly that the barriers that currently prevent more effective childhood vaccines from reaching those in the developing world will not be removed by a single solution or quickly with multiple solutions. This does not mean the workshops were not a success. First, these meetings demonstrated a strong, multinational interest in improving immunization for

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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 children in all parts of the world and recognition that such actions will need to be tailored to the needs and realities of individual countries. Second, they provided the rare opportunity for close and congenial discussion of the range of issues relevant to the CVI. Third, the speakers and other participants generated a rich pool of ideas, and some potential solutions, to enhance a fully realized CVI. The accomplishments of these workshops, therefore, may be summarized as commitment, communication, and creativity. These were their goals. Caroline Breese Hall, Chair

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