Appendix I
Statement on Vaccine Development

Council of the Institute of Medicine November 5, 2001

The events following the tragedies of September 11, 2001, have reemphasized a serious defect in America’s capacity to deal with biological agents used in terrorist attacks. The capacity to develop, produce, and store vaccines to deal with these agents are inadequate to meet the nation’s needs. In 1993 the Institute of Medicine published The Children’s Vaccine Initiative: Achieving the Vision. In assessing the national and international situation, the committee said, “because the private sector alone cannot sustain the costs and risks associated with the development of most CVI vaccines, and because the successful development of vaccines requires an integrated process, the committee recommends that an entity, tentatively called the National Vaccine Authority (NVA), be organized to advance the development, production, and procurement of new and improved vaccines of limited commercial potential but of global public health need” [1].

In a 1992 report, Emerging Infections: Microbial Threats to Health in the United States, another IOM committee recommended the development of an integrated management structure within the federal government for acquiring vaccines, as well as a facility for developing and producing vaccines with government support [2].

Evidence for the inability of the private sector to meet the country’s needs for vaccines has accumulated substantially since the 1993 report. Fewer private companies are manufacturing vaccines. Continually needed vaccines such as the tetanus and influenza vaccines are in increasingly short supply. The availability of influenza vaccines has been delayed over the past several years and in 2000, one company stopped production. Pneumococcal conjugate vaccine is unavail-



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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Appendix I Statement on Vaccine Development Council of the Institute of Medicine November 5, 2001 The events following the tragedies of September 11, 2001, have reemphasized a serious defect in America’s capacity to deal with biological agents used in terrorist attacks. The capacity to develop, produce, and store vaccines to deal with these agents are inadequate to meet the nation’s needs. In 1993 the Institute of Medicine published The Children’s Vaccine Initiative: Achieving the Vision. In assessing the national and international situation, the committee said, “because the private sector alone cannot sustain the costs and risks associated with the development of most CVI vaccines, and because the successful development of vaccines requires an integrated process, the committee recommends that an entity, tentatively called the National Vaccine Authority (NVA), be organized to advance the development, production, and procurement of new and improved vaccines of limited commercial potential but of global public health need” [1]. In a 1992 report, Emerging Infections: Microbial Threats to Health in the United States, another IOM committee recommended the development of an integrated management structure within the federal government for acquiring vaccines, as well as a facility for developing and producing vaccines with government support [2]. Evidence for the inability of the private sector to meet the country’s needs for vaccines has accumulated substantially since the 1993 report. Fewer private companies are manufacturing vaccines. Continually needed vaccines such as the tetanus and influenza vaccines are in increasingly short supply. The availability of influenza vaccines has been delayed over the past several years and in 2000, one company stopped production. Pneumococcal conjugate vaccine is unavail-

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary able in several states because of the sole source manufacturer’s inability to meet demand. Only one source is currently available for meningococcal varicella and measles-mumps-rubella vaccines. There are just four major vaccine manufacturers in the world today, and only two in the United States [3]. There were four times that number only 20 years ago. There are many small new research and development companies backed by venture capital and devoted to vaccine development. Many are working on anticancer vaccines for which market forces may be enough to keep them in production. However, good products developed by these startups to combat infectious diseases often do not come to market because of the very large costs of testing in pilot studies and in manufacturing. Currently, the United States has a single licensed anthrax vaccine product, manufactured by a single plant. Because the Food and Drug Administration (FDA) had identified problems in the manufacturing process during regular inspections, the plant was closed for renovations in 1998, and to date, no new lots of anthrax vaccine have yet been cleared for release. Prior to the events of September 11, the delays and problems faced by both the Department of Health and Human Services and Department of Defense in developing and procuring a cell-culture smallpox vaccine provide convincing evidence that major changes are needed at the national level. With the government guaranteeing payment in this time of national need, several potential manufacturers have come forward. This is an ad hoc example of a larger national need for mechanisms to obtain other public-good vaccines on an ongoing basis, and not just under extenuating circumstances when there is a great deal of public awareness of the need for vaccines. The Children’s Vaccine Initiative committee listed the functions of a National Vaccine Authority as shown in Appendix 1. While these activities focused on the Children’s Vaccine Initiative, they now have a broader importance to America, as the potential need for vaccines required to meet biological threats increases. The IOM Council believes the Authority should focus its attention upon vaccines that will not be adequately produced by existing public or private entities. Important functions of the Authority would include: conducting inhouse vaccine-related research and development, assisting companies in the production of pilot lots of vaccines; and arranging and contributing to the procurement of National Vaccine Authority vaccines. An especially important function would be to provide opportunities for the production of pilot lots of vaccines developed by small biotechnology firms, and to produce vaccines when market forces are not sufficient to facilitate large-scale production. The IOM Council further believes the Authority should facilitate communications among relevant contributors to vaccine research and development, including academic research efforts, manufacturers, regulatory agencies, and the public. The Authority should not interfere in any way with public or private research or development efforts to create new vaccines. It should be available to

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary assist such efforts when opportunities arise. It should interact with other public and private entities to assure a timely and effective system for storage and distribution of appropriate vaccines. It should identify mechanisms to expand current forms of liability protection for the adverse effects of vaccines, including expansion of federal efforts for indemnification of manufacturers. The Authority could become a source of appropriate reliable information to the media health care personnel, policy-makers, and the public. The FDA could work closely with such an Authority to oversee vaccine development and production as well as facilitate their oversight processes and reduce regulatory complexities. In some cases, it might find mechanisms to guarantee a price for vaccines to stimulate private sector production, as has occurred with smallpox vaccine in the current situation. Recently, proposals have been made for the creation of a governmentowned, contractor-operated national vaccine facility. The IOM Council believes this is one in a spectrum of public-private ventures by which a NVA could facilitate development and production of needed vaccines. The conduct of research, development, production, and distribution of vaccines in such a facility should be the responsibility of a private contractor selected by a competitive bidding process. This effort should not preclude other collaborations with private contractors in other public-private projects. Funding for such a facility will initially require a substantial financial investment [4]. While a major priority for this facility would be to develop vaccines necessary to protect American troops and for use against bioterrorism, the facility also should be charged with production of other vaccines that are in scarce supply and would not otherwise be provided in the public or private sectors. In some cases in which there are few private sector uses, the facility would become the principal source of such vaccines. In other cases, a variety of public and private partnerships could be undertaken to produce needed vaccines [5]. The Council of the Institute of Medicine of the National Academies believes that the development of a National Vaccine Authority is long overdue. It could be created within the Department of Health and Human Services, in collaboration with the Department of Defense or as a joint effort of the two departments. Moreover, the Council believes that establishment of a governmentowned, contractor-operated facility for research, development, and production of vaccines is essential to meeting the country’s public health needs, particularly those related to bioterrorism and protection of our armed forces. This facility also should play a role in development and production of other vaccines required for the public health that are not currently available on the open market. The Council encourages the president of the United States, the secretary of health and human services, secretary of defense, and the director of the Office of Homeland Security to evaluate these recommendations as critical elements for maintaining the country’s health.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary COUNCIL OF THE INSTITUTE OF MEDICINE Kenneth I. Shine, M.D. (Chairman) President, Institute of Medicine, Washington, D.C. Nancy C. Andreasen, M.D., Ph.D. Andrew H. Woods Chair of Psychiatry, and Director, Mental Health Clinical Research Center, University of Iowa Hospitals and Clinics, Iowa City Enriqueta C. Bond, Ph.D. President, Burroughs Wellcome Fund, Research Triangle Park, North Carolina Jo Ivey Boufford, M.D. Dean, Robert F. Wagner Graduate School of Public Service, New York University, New York City Harvey R. Colten, M.D. President and Chief Medical Officer, iMetrikus, Inc., Carlsbad, California Johanna T. Dwyer, D.Sc. Director, Frances Stern Nutrition Center, New England Medical Center, Boston, Massachusetts Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland James R. Gavin III, M.D., Ph.D. Senior Scientific Officer, Howard Hughes Medical Institute, Bethesda, Maryland Ada Sue Hinshaw, Ph.D. Dean, School of Nursing, University of Michigan, Ann Arbor Brigid L.M. Hogan, Ph.D. Investigator, Howard Hughes Medical Institute, and Hortense B. Ingram Professor, Department of Cell Biology, Vanderbilt University School of Medicine, Nashville, Tennessee Thomas S. Inui, M.D. President and Chief Executive Officer, The Fetzer Institute, Kalamazoo, Michigan

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Michael M.E. Johns, M.D. Executive Vice President for Health Affairs, Director, Robert W. Woodruff Health Science Center, Emory University, Atlanta, Georgia Mary-Claire King, Ph.D. American Cancer Society Professor of Medicine and Genetics, University of Washington, Seattle Lawrence S. Lewin, M.B.A. Executive Consultant, Washington, D.C. Joseph B. Martin, M.D., Ph.D. Dean of the Faculty of Medicine, Harvard Medical School, Boston, Massachusetts William L. Roper, M.D. Dean, School of Public Health, University of North Carolina, Chapel Hill Stephen M. Shortell, Ph.D. Blue Cross of California Distinguished Professor of Health Policy and Management, Professor of Organization Behavior, School of Public Health, University of California, Berkeley Edward H. Shortliffe, M.D., Ph.D. Professor and Chair, Department of Medical Informatics Columbia Presbyterian Medical Center, Columbia University, New York City Kenneth E. Warner, Ph.D. Avedis Donabedian Distinguished University Professor of Public Health Department of Health Management & Policy School of Public Health, University of Michigan, Ann Arbor Gail R. Wilensky, Ph.D. John M. Olin Senior Fellow, Project HOPE, Bethesda, Maryland Ex Officio Members (non-voting): David R. Challoner, M.D. IOM Foreign Secretary Director, Institute for Science and Health Policy, University of Florida, Gainesville

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Harold J. Fallon, M.D. IOM Home Secretary Dean Emeritus, School of Medicine, University of Alabama, Birmingham REFERENCES 1. Mitchell, V.S., Philipose, N.M., and Sanford, J.P., eds. The Children’s Vaccine Initiative: Achieving the Vision. Washington, D.C.: National Academy Press, 1993. 2. Lederberg, J., Shope, R.E., and Oaks, S.C., Jr., eds. Emerging Infections: Microbial Threats to Health in the United States. Washington, D.C.: National Academy Press, 1992. 3. Merck Vaccine Division (parent company is Merck Pharmaceuticals) and Wyeth-Lederle Vaccines (parent company is American Home Products Corporation) are U.S.-based companies. Aventis Pasteur and GlaxoSmithKline operate within the United States and have products licensed by the FDA for use in the United States, but they are companies based in other countries. 4. Department of Defense. Report on Biological Warfare Defense Vaccine Research and Development Programs. July 2001. 5. Pearson, G.W. The Children’s Vaccine Initiative: Continuing Activities. Washington, D.C.: National Academy Press, 1995. APPENDIX 1: Function of a National Vaccine Authority Define the need Assess the market Establish priorities for U.S. CVI vaccine development in conjunction with the global CVI Characterize desired vaccine products Assemble intellectual property rights Advance CVI product development through the private sector Conduct in-house vaccine-related research and development Assist companies in the production of pilot lots of vaccine Support clinical testing and field trials of candidate vaccines Transfer CVI-related vaccine technology to developing country manufacturers Train U.S. and overseas nationals in the principles of vaccine development, pilot manufacture, and quality control Arrange and contribute to the procurement of NVA vaccines Evaluate and redefine needs Represent the United States in international CVI forums, such as the Consultative Group

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary NOTE: Mitchell, V.S., Philipose, N.M., and Sanford, J.P., eds. The Children’s Vaccine Initiative: Achieving the Vision. Washington, D.C.: National Academy Press, 1993, p. 133. In addition to these functions, the need for vaccines to fulfill anti-terrorist and military requirements should be included. SOURCE: http://www.iom.edu/IOM/IOMHome.nsf/Pages/Vaccine+Development