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Vaccine Supply and
Innovation
Division of Health Promotion and
Disease Prevention
Institute of Medicine
NATIONAL ACADEMY PRESS
Washington,D.C. 1985
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NATIONAL ACADEMY PRESS 2101 CONSTITUTION AVENUE, N.W. WASHINGTON, DC 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 competencies 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.
The study was supported under contracts with the Food and Drug Administration (223-83-1109), the
Department of the Army (DAMD17-83-G-9558), and the Centers for Disease Control (200-83-0609)
and grants from Lederle Laboratories, the Merieux Institute, Inc., and Merck Sharp & Dohme. Addition-
al support was provided by the National Research Council (NRC) Fund, a pool of private, discretionary
nonfederal funds that is used to support a program of Academy-initiated studies of national issues in
which science and technology figure significantly. The NRC Fund consists of contributions from a
consortium of private foundations including the Carnegie Corporation of New York, the Charles E.
Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T.
MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foundation, and the Alfred
P. Sloan Foundation; the Academy Industry Program, which seeks annual contributions from companies
that are concerned with the health of U.S. science and technology and with public policy issues with
technological content; and the National Academy of Sciences and the National Academy of Engineering
endowments.
Library of Congress Catalog Card Number 85-60772
International Standard Book Number 0-309-03544-9
Publication No. IOM 85-02
Printed in the United States of America
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Committee on Public-Pr~vate Sector Relations
in Vaccine Innovation
JAY P. SANFORD (ch~atr), School of Medicine, Uniformed Services University of the
Health Sciences
MARSHALL H. BECKER, Department of Health Behavior and Health Education,
University of Michigan, Ann Arbor
ROGER B. DWORKIN, School of Law, Indiana University, Bloomington
BERNARD N. FIELDS, Department of Microbiology and Molecular Genetics, Harvard
Medical School
JERK E. GOYAN, School of Pharmacy, University of California, San Francisco
HENRY G. GRAB OWSKI, Department of Economics, Duke University
SAMUEL L. KATZ, Department of Pediatrics, Duke University Medical Center
EDMUND KITCH, University of Virginia School of Law, Charlottesville
LOUIS LASAGNA, Sackler School of Graduate Biomedical Sciences, Tufts University
Medical School
MARTHA L. LEPOW, Department of Pediatrics, Albany Medical College
DAVID W. MARTIN, JR., Genentech, Incorporated, South San Francisco
DONALD N. MEDEARIS, JR., Department of Pediatrics, Harvard Medical School
THOMAS C. MERIGAN, JR., Division of Infectious Diseases, Stanford University School
of Medicine
EDWARD A. MORTIMER, JR., School of Medicine, Case Western Reserve University
JANE SISK, Office of Technology Assessment, United States Congress
GENE H. STOLLERMAN, School of Medicine, Boston University
THOMAS H. WELLER, Department of Tropical Public Health, Harvard School of Public
Health
See Appendix I for further information on committee members and consultants.
Consultant
LAWRENCE M. DeBROCK, Department of Economics, University of Illinois, Champaign
. . .
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Government-Tndustry Liaison Pane!
ROBERT F. ACKER, National Foundation for Infectious Diseases
DAVID W. BARRY, Burroughs Wellcome Company
A. JOHN BEALE, Wellcome Research Laboratories, United Kingdom
JOHN H. BRYANT, National Institutes of Health
FRANCIS R. CANO, Lederle Laboratories
JAMES P. CARLOS, National Institutes of Health
PINYA COHEN, Merieux Institute
CIRO C.A. de QUADROS, Pan American Health Organization
DAVID A. ESPESETH, United States Department of Agriculture
LEONARD D. FENNINGER, American Medical Association
JEROME GOLD, Wyeth Laboratories
GEORGE F. GRADY, Massachusetts Public Health Biologics Laboratories
MAURICE R. HILLEMAN, Merck Sharp & Dohme Research Laboratories
ALAN HINMAN, Centers for Disease Control
NEIL HOLLANDER, Blue Cross/Blue Shield Association
DAVID L. HUXSOLL, United States Army Medical Research Institute of Infectious Diseases
DONALD R. JAtEk;E, Parke-Davis
WILLIAM S. JORDAN, National Institutes of Health
JOEL KAVET, Department of Health and Human Services
JEFFREY P. KOPLAN, Centers for Disease Control
ROBERT E. LOUIE, Cutter Laboratories
SUSAN H. MATHER, Veterans Administration
DONALD P. METZGAR, Connaught Laboratories, Limited, Canada
JOHN R. MITCHELL, Michigan Department of Public Health
GARY NOBLE, Centers for Disease Control
PAUL D. PARKMAN, Food and Drug Administration
CORNELIUS W. PETTINGA, Eli Lilly and Company
M. SUSAN UEBER RAYMOND, Center for Public Resources
MICHAEL A. RIDDIOUGH, Springfield, Virginia
DAVID ROBINSON, United States Army Medical Research and Development Command
JOHN ROBBINS, National Institutes of Health
PHILIP K. RUSSELL, Fitzsimons Army Medical Center
MARTIN H. SMITH, American Academy of Pediatncs
GASTON S. TAWIL, Pan American Health Organization
KENNETH S. WARREN, The Rockefeller Foundation
DONALD A. YOUNG, Health Care Financing Administration
Institute of Me~dicine ,StaJ77
ROY WIDDUS, Study Director
ENRIQUETA C. BOND, Director, Division of Health Promotion and Disease Prevention
CYNTHIA HOWE, Research Assistant
EVE K. NICHOLS, Editor
JUDE C. PAYNE, Research Assistant
GAIL E. SPEARS, Administrative Secretary
1V
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Preface
Vaccines are an elegant solution to one of the perennial problems of the human race infectious
disease. The body's own protective mechanisms are primed by specific interventions to thwart the
invasion or multiplication of pathogens. Lewis Thomas has described this immunization process as
one of the genuinely decisive technologies of modern medicine it is effective, relatively in-
expensive, relatively simple, and relatively easy to deliver.
In the United States, the contribution of vaccines to improved public health has been recognized
by all 50 states in laws requiring preschool immunization. In addition, many studies have affirmed
the benefits and cost-effectiveness of immunization programs for adults (Office of Technology
Assessment 1979, 1980, Pneumococcal and Influenza Evaluations).
Today's vaccines protect millions of people from the ravages of disease, and new developments
offer the possibility of widening their scope even further. It is unlikely, however, that any existing
vaccine will soon repeat the feat of the smallpox vaccine total worldwide eradication of a
disease although this ultimately may be possible for diseases such as measles, polio, and rubella.
For many other diseases, continuing immunization programs will be required because the pathogens
occur in reservoirs from which they are difficult to eliminate, e.g., the environment or other
animals. Also, no existing vaccine is universally effective or risk free; hence, research efforts must
continue to further minimize undesirable side effects. Finally, vaccines are not available for some
major diseases; extending the benefits of immunization will require efforts to encourage the
development of new vaccines.
The process of vaccine innovation in this country, including basic research' development, testing,
production, and marketing, involves numerous organizations in both the public and private sectors.
In general, however, the availability of vaccines for public use depends entirely on the willingness of
commercial manufacturers to undertake production. Numerous studies over the past two decades
have raised the concern that our reliance on market incentives to ensure vaccine availability may lead
to a failure to meet public health needs. Also, these incentives may not result in optimal levels of
vaccine innovation (National Immunization Work Groups, 19771.
These concerns and others involving the application of advances in biotechnology to vaccine
production led the Institute of Medicine to establish the Committee on Public-Pr~vate Sector
Relations in Vaccine Innovation.* The committee, convened in May 1983, was charged with
*The activities of this committee complemented the work of the Institute of Medicine's Committee on Issues and
Priorities for New Vaccine Development. The latter's charge was to design a comprehensive approach to setting priorities
for accelerated vaccine development. Its first report, New Vaccine Development: Establishing Priorities, Volume 1
(1985), describes application of the committee's model to diseases of importance in the United States; Volume 2 will
evaluate the usefulness of the model in setting priorities for vaccines needed by technologically less developed nations.
v
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analyzing and making recommendations about current institutional arrangements supporting the
research, development, supply, and promotion of vaccines. Specifically, the committee was asked
to
suggest ways of improving interactions among federal agencies involved in vaccine research,
regulation, and utilization; the pharmaceutical industry; and other interested parties, such as medical
specialty organizations and the Advisory Committee on Immunization Practices
· define measures for fostering a more active exchange between the public and nriv~. ~.~.tr~r~ in
development of vaccines for the United States and foreign markets
~; 1 ~ ~ ~ ~ _ ~.4 ~ _ _ 1 _ _ ~ ~. - . · ~ · . ~
~^ v ^~^
`;ons~aer means for reversing tne Become in the domestic capability for vaccine production,
including evaluation of the practicability and desirability of federally supported production facilities
· explore ways of encouraging the development of vaccines of low commercial potential and of
. . . . .
Improving existing vaccines
· address the legal issues involved in the testing, manufacture, and marketing of vaccines for
domestic and foreign markets including antitrust matters, Dronosed changes in the. Art hews
and liability for vaccine-related injuries
~r ---- ~AN Add_ t~~~
· examine the process used in developing recommendations for vaccine use and for national
deployment strategies
Careful selection of members produced a committee with collective expertise in infectious
disease, internal medicine, pediatrics, epidemiology, public health, vaccine development, sociolo-
gy, ethics, economics, law, and public policy. A government-industry liaison pane! was established
to assist the committee, and additional comments were invited from other individuals on specific
topics. The committee also reviewed the extensive testimony given before congressional hearings
on proposals for the establishment of a vaccine injury compensation system.
In November 1983, the committee sponsored a conference on garners to Vaccine Innovation,
attended by more than 80 participants from the United States and abroad. A range of vaccine
development case histories and position papers were prepared for the conference. During the
meeting, working groups identified and discussed means of reducing barriers and disincentives to
vaccine research and development, production and supply, and utilization. As a result of the
conference, our study committee defined two goals that became the framework for its recommenda-
tions: (1) to facilitate the control of infectious diseases by ensuring the continued innovation,
production, and use of vaccines and (2) to ensure that this goal is achieved in a socially responsible
and just manner.
All of the commiKee's discussions were based on the premise that a domestic vaccine industry is
essential to ensure vaccine innovation and availability in the United States. This assumption derived from
an understanding of the unique features of vaccine production: the difficulty of quality control for
biological products, the length of the production cycle, and specific problems that would be created by
sole reliance on foreign manufacturers.
The committee believes that the information and approaches suggested in this report may contribute to
the solution of problems that it could not address because of time and resource constraints. The economic
analysis presented in Chapter 4, for example, should provide useful background information for a
conference planned in 1986 on Preventive Biomedical Technologies (a symposium to be convened by the
National Academy of Engineering). In addition, the national vaccine commission proposed in this report
would be an appropriate body to deal with some of the issues presented in Chapter 7, including the special
problems surrounding the development of vaccines for use in less developed countries, and the possible
need for government facilities for vaccine production.
Many of the issues on which the committee sought information or data to use as a basis for policy
vat
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recommendations touched areas of commercial sensitivity. The committee is grateful to manufacturers
for providing information that is not usually made public. This is presented in an aggregate form in the
report.
Not all of the information sought by the committee could be obtained, however. The conclusions
presented in this document represent a synthesis of data, subjective information, and interpretation. The
committee has tried to characterize the current environment surrounding vaccine innovation and
production as objectively and honestly as possible.
The Committee on Public-Private Sector Relations in Vaccine Innovation would like to take particular
note of support provided by the Institute of Medicine staff and study director Roy Widdus. The support of
the study's sponsors also is gratefully acknowledged.
JAY P. SANFORD
Chairman
. .
V11
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Contents
1 Summary .......................................................
2 Vaccines: Past, Present, and Future ..................................
3 Vaccine Availability: Concerns, Barriers, and Impediments
4 Economic Aspects of Vaccine Innovation and Manufacturing
Vaccine Tniurv ...................................................
s
6 Liability for the Production and Sale of Vaccines ......................
7 An Approach to Problems of Communication, Coordination,
and Collaboration in Vaccine Policy ...............................
8 Vaccine Injury Compensation and Liability Remedies
APPENDIXES
A Product License Holders
B ~~
C
D Injury Compensation Systems in the United States
E Vaccine-Injury Compensation in Other Countries
F Proposed Vaccine-Injury Compensation Systems .......................
G Mechanisms Used in Other Countries to Ensure Vaccine Supply ..........
H Background Papers
Biographical Notes on Committee Members and Consultants
Recommendations for the Proposed Vaccine Commission
A Vaccine Supply Public insurance Option
No-Fault Vaccine Injury Insurance ..................................
Index
14
27
45
65
85
123
136
1X
161
164
166
171
176
183
192
194
196
201
205
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Vaccine Supply and
Innovabon
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