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Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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Page 264
Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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Page 265
Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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Page 266
Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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Page 267
Suggested Citation:"Appendix I Statement on Vaccine Development." Institute of Medicine. 2002. Biological Threats and Terrorism: Assessing the Science and Response Capabilities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10290.
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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 reempha- sized 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, “be- cause 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 gov- ernment 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- 262

APPENDIX I: STATEMENT ON VACCINE DEVELOPMENT 263 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 prob- lems 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 govern- ment guaranteeing payment in this time of national need, several potential manufacturers have come forward. This is an ad hoc example of a larger na- tional 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 Na- tional 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 in- house vaccine-related research and development, assisting companies in the production of pilot lots of vaccines; and arranging and contributing to the pro- curement 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 communi- cations among relevant contributors to vaccine research and development, in- cluding academic research efforts, manufacturers, regulatory agencies, and the public. The Authority should not interfere in any way with public or private re- search or development efforts to create new vaccines. It should be available to

264 BIOLOGICAL THREATS AND TERRORISM 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 distri- bution of appropriate vaccines. It should identify mechanisms to expand current forms of liability protection for the adverse effects of vaccines, including expan- sion of federal efforts for indemnification of manufacturers. The Authority could become a source of appropriate reliable information to the media health care per- sonnel, 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 government- owned, contractor-operated national vaccine facility. The IOM Council believes this is one in a spectrum of public-private ventures by which a NVA could fa- cilitate development and production of needed vaccines. The conduct of re- search, 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 pri- vate 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 pro- duction 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 vac- cines. In other cases, a variety of public and private partnerships could be un- dertaken to produce needed vaccines [5]. The Council of the Institute of Medicine of the National Academies be- lieves that the development of a National Vaccine Authority is long overdue. It could be created within the Department of Health and Human Services, in col- laboration with the Department of Defense or as a joint effort of the two depart- ments. Moreover, the Council believes that establishment of a government- owned, 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.

APPENDIX I: STATEMENT ON VACCINE DEVELOPMENT 265 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 Clini- cal Research Center, University of Iowa Hospitals and Clinics, Iowa City Enriqueta C. Bond, Ph.D. President, Burroughs Wellcome Fund, Research Triangle Park, North Caro- lina 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 In- stitutes 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

266 BIOLOGICAL THREATS AND TERRORISM 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, Massa- chusetts 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

APPENDIX I: STATEMENT ON VACCINE DEVELOPMENT 267 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 Initia- tive: 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 manu- facturers • Train U.S. and overseas nationals in the principles of vaccine develop- ment, 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

268 BIOLOGICAL THREATS AND TERRORISM NOTE: Mitchell, V.S., Philipose, N.M., and Sanford, J.P., eds. The Chil- dren’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

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In the wake of September 11th and recent anthrax events, our nation's bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.

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