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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 Institute of Medicine Activities on Vaccines and Immunization by Kathleen R. Stratton, Ph.D. Associate Director, Division of Health Promotion and Disease Prevention, Institute of Medicine The Institute of Medicine (IOM) has a long history of involvement in important scientific and policy aspects of vaccine and immunization initiatives in this country and abroad. Studies have dealt with the vaccine research and development enterprise, assessments of vaccine safety, and immunization practices, and have taken the form of roundtables and forums, short letter reports, workshops, and full-length committee reports. These activities have been housed in various divisions of the IOM, but primarily in the Division of Health Promotion and Disease Prevention. Some studies were mandated by Congress, others were requested by federal agencies or private voluntary organizations, and still others were self-initiated. Many studies have had a concrete impact on vaccine and immunization policies and programs. A brief review of the origins, conclusions, and impact of these studies follows. VACCINE RESEARCH AND DEVELOPMENT The IOM has been involved in several projects that would fall under a vaccine research and development rubric. The Committee on Public –Private Sector Relations in Vaccine Innovation was convened in 1983 and, with broad-based financial support from government, industry, and internal Academy funds, was charged with analyzing and making recommendations about current institutional arrangements supporting the research, development, supply,
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 and promotion of vaccines. The committee's report, Vaccine Supply and Innovation (1985), contained recommendations that led, in part, to a pivotal Public Health Service (PHS) program, the National Vaccine Injury Compensation Program (discussed in detail in Adverse Events Associated with Childhood Vaccines ). The committee also recommended the creation of a National Vaccine Commission, which would be a nonprofit, congressionally chartered organization, and acknowledged that other loci for the organization, for example the IOM, the Office of Technology Assessment, or the Department of Health and Human Services, would not be incompatible with its mission. No such commission was established, but the National Childhood Vaccine Injury Act did establish the National Vaccine Program within the Office of the Assistant Secretary of Health of the Department of Health and Human Services. The mandate of the National Vaccine Program includes many of the responsibilities envisioned for the commission. The notion of central responsibility for vaccine issues was raised by the Children's Vaccine Initiative committee; this is described in a later section. The Committee on Issues and Priorities for New Vaccine Development was convened at the request of the National Institute for Allergy and Infectious Diseases (NIAID) to provide assistance in developing a more comprehensive approach to setting priorities for accelerated vaccine development. The committee developed an analytic framework to be used as an aid to decision-making. The framework took into consideration such factors as disease burden, costs to be saved by prevention of infectious diseases by vaccines, costs of the vaccine and vaccination programs, and technical feasibility of the candidate vaccines. The committee released a two-volume report: New Vaccine Development, Establishing Priorities. Volume I (1985) addressed diseases of importance in the United States, and volume II (1986) addressed diseases of importance to less technologically developed countries. The NIAID and private-sector vaccine manufacturers have used this framework to guide and support their research and development efforts. The New Vaccine Development project was considered so valuable that in 1994, NIAID asked the IOM to take a second look at prioritization issues. The Committee to Study Priorities for Vaccine Development was convened in early 1995 and will release its report in late 1996. This committee will focus exclusively on vaccines directed against conditions of importance to the United States, including contraception and chronic conditions such as cancer or autoimmune diseases; a vaccine directed against HIV/AIDS is excluded from consideration because it is already a high priority for the government.
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 The Children's Vaccine Initiative (CVI) is both a concept and an organization, whose purpose is to harness new technologies to advance the immunization of children. Although the CVI's focus is international, the Agency for International Development (AID) and the PHS, responsible for formulating the U.S. response to the CVI, asked the IOM to identify and explore major economic, legal, regulatory, policy, and other factors that influence the development, introduction, and supply of vaccines, and to recommend ways to enhance cooperation and participation among relevant U.S. sectors in the realization of the CVI's goals. The Committee on the Children's Vaccine Initiative, operating under the auspices of the Division of International Health, released The Children's Vaccine Initiative: Achieving the Vision in 1993. The committee came to several conclusions regarding the problems of vaccine R&D but made only one recommendation: that an entity, which the committee tentatively referred to as the “National Vaccine Authority,” should be organized to advance the development, production, and procurement of new and improved vaccines of limited commercial potential but of important public health need. This recommendation and the findings of the report generated a lot of controversy among the public and private sectors. Although it is unlikely that an entity such as that proposed by the committee will be created, the report did galvanize many sectors in the vaccine community and has led to a new and important focus on the National Vaccine Program. The CVI is a long-term goal, and the 1993 report could not address all issues relevant to it. After the release of the Children's Vaccine Initiative, AID contracted with IOM to hold two follow-up workshops. These workshops addressed (1) the epidemiologic evidence regarding acute respiratory diseases and the need for vaccines directed against them, and (2)the economic, legal, and regulatory impediments to full participation in the CVI by U.S. vaccine manufacturers. The proceedings of those workshops were released in the summer of 1995. VACCINE SAFETY The Institute began addressing questions about the safety of specific vaccines (other than polio vaccine, which is discussed in a subsequent section) in 1987. At the request of the Centers for Disease Control (CDC; now the Centers for Disease Control and Prevention), IOM conducted a two-step assessment of a CDC-funded project related to a controversial aspect of vaccine safety. This pilot project, the Study of Neurologic Illness in Children (SONIC), was intended to address the putative role of vaccines, particularly DTP (diphtheria and tetanus toxoids and pertussis vaccine), in acute neurologic illness. The IOM committee was to review the study's protocol and make suggestions for changes, and then review the final report from this pilot project and make rec-
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 ommendations about the advisability of conducting a more definitive, large-scale study of neurologic illnesses and vaccination. The committee reviewed the protocol for the pilot study and recommended relatively minor changes. After reviewing the results of the pilot project, the committee recommended in a letter report that CDC not attempt a more definitive study, primarily for reasons of epidemiologic feasibility and the likelihood that even a large, expensive study would not be statistically powerful enough to detect the relatively rare neurologic events of interest. The CDC followed the advice of the committee and did not pursue the study. In addition to those activities, the SONIC Committee hosted a workshop to encourage discussion about the British National Childhood Encephalopathy Study (NCES). The NCES is the largest study ever undertaken regarding the role of vaccines in neurologic illness among children and provides the basis for most of what the research community knows about long-term sequelae from acute neurologic illness. This workshop helped inform CDC and the IOM committee's deliberations relative to the SONIC study. The IOM embarked on new activities related to vaccine safety in 1989. The National Childhood Vaccine Injury Act resulted from years of concern that fear of liability related to the rare but serious adverse effects of vaccines had decreased private investment in vaccine research and development. The act had a fairly wide impact, including the establishment of a no-fault compensation program for people injured by vaccines. The cornerstone of that program is a table of adverse health outcomes believed to be associated with administration of mandatory childhood vaccines, that is, those directed against diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio. This “Vaccine Injury Table” is written into law in the act and was created based on best-guess judgments—mostly by congressional staff—of which adverse reactions might be related causally to vaccine administration. Anyone who experiences an adverse event listed on the table within a specified time frame after vaccination is automatically compensated; thus, it has important fiscal and legal implications. Because no independent assessment of the scientific basis for the table had been undertaken, Congress mandated in the National Childhood Vaccine Injury Act that the IOM would conduct a review of the scientific and medical literature on the adverse consequences associated with vaccines. In a span of 5 years, the IOM convened three committees and published three reports on this topic: Adverse Effects of Pertussis and Rubella Vaccines (1991), Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (1994), and DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis (1994).
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 These committees forged a new way of thinking and writing about causal inference related to vaccine injury. A hallmark of the approach used by the three committees is that they started with a position of neutrality and presumed that the evidence was neither for nor against a causal relation between a specific vaccine and a specific adverse health outcome. This is in contrast to a more typical approach that would assume there is no causal relation, putting the burden on the data to prove that there was a causal relation. The relation between DPT vaccine and encephalopathy, first studied by the IOM committee reviewing the SONIC protocol, was again studied by two of the above-mentioned adverse event committees. The committee studying pertussis and rubella vaccines concluded, primarily due to data from the NCES, that these data were insufficient to determine whether DPT could lead to chronic encephalopathy, although these data did support a causal relation between DPT and acute encephalopathy. During the final phases of the work conducted by the committee studying the other childhood vaccines, new, long-term followup data from the NCES were published. The PHS asked IOM to revisit the question. These new data allowed the Committee to Study New Research on Vaccines to conclude that the evidence favored acceptance of a causal relation between DPT vaccine and chronic nervous system damage as studied under the conditions of the NCES. The committee also concluded that the evidence was inadequate to accept or reject a causal relation between DPT vaccine and chronic nervous system dysfunction under any other conditions. Thus, three committees later, the question of DPT vaccine's relation with encephalopathy is still not answered fully, and it might never be. Hopefully, the new acellular pertussis vaccine, DTaP, will make the question less compelling. The findings of all three adverse event committees are to be considered by the secretary of the Department of Health and Human Services in future modifications of the table. That alone constitutes a significant and concrete impact. The reports also had a more intangible outcome —the IOM provided a neutral territory for discussions about vaccine safety. This issue had been emotionally charged for years. In 1994, the IOM convened a workshop to discuss general issues about methods to evaluate vaccine safety, and for the first time, parent's groups concerned about the safety of vaccines were equal players in a dialogue about scientific issues with vaccine manufacturers, the federal government, and academic researchers. As a result of the IOM activities in this area, the National Vaccine Program Office has funded IOM to establish a Vaccine Safety Forum. The forum consists of 22 representatives who are members of previous IOM vaccine safety committees, parent advocates, immunization advocates, or who represent academia, vaccine manufacturers, and
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 the federal government. The Forum's goal is to convene all interested parties in a neutral setting to promote informed discussions aimed at ensuring that the vaccines in use are the safest possible. The discussions will be informed by workshops that will most likely be open to a wide audience. IMMUNIZATION PRACTICES There are two main examples of IOM activities on immunization practices: (1) analyses of options regarding poliomyelitis vaccination strategies and (2) a workshop on barriers to immunization. The polio studies, released in 1977 and 1988, emerged from ongoing discussions about the U.S. policy, based on recommendations from the CDC's Advisory Committee on Immunization Practices and the American Academy of Pediatrics “red book” committee, that the oral polio vaccine (OPV, the Sabin vaccine) should be used for routine childhood immunizations. Many other countries use inactivated, or killed, polio vaccine (IPV, the Salk vaccine) or a mixed schedule of IPV followed by OPV. In these countries, OPV was also used during polio outbreaks. The OPV, but not IPV, carries a small but real risk of causing paralytic polio. Yet the debate is not straightforward, because IPV confers significantly less mucosal immunity than OPV, an important attribute when combating an enteric virus spread through the oral–fecal route, and might not confer lifelong immunity to wild-type polio infection. In 1977 and 1988, committees were convened to determine whether new data supported continued reliance on OPV or whether the decrease in natural polio infections and new data on the IPV were strong enough to suggest the need for a change in U.S. polio vaccine policy. The committees concluded that there was no compelling reason to change U.S. polio vaccination recommendations and suggested avenues for further research, which might possibly provide the information necessary for a further consideration of the appropriateness of this policy. The 1988 report stressed that a vaccine combining DPT and IPV in one injection might shift the debate, because use of IPV would then not require yet another injection. The large number of new combination vaccines currently being developed will most likely change many aspects of immunization. The debate continues over polio vaccination, however. The World Health Organization has declared that wild-type polio has been eradicated from the Western Hemisphere. Public health officials envision worldwide eradication of the disease. Thus, it seems time, once again, to evaluate whether or not an immunization policy should include the use of a vaccine directed against a very, very rare infection that carries a risk of causing a serious disease when an alternative vaccine that carries no such risk exists. The IOM's Vaccine Safety Forum held a workshop in the spring of 1995 on safety issues related to polio vaccines and current immunization practices. This workshop informed the
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 CDC's Advisory Commission on Immunization Practices discussion of this issue. A different type of workshop related to immunization policies was held in early 1994. The late 1980s and early 1990s brought forth much compelling evidence that domestic immunization efforts were failing—for example, 89 people died from measles in 1990. In addition, although domestic immunization rates for 5-year-olds were fairly high, since immunization is a requirement for entry into kindergarten, the number of 2-year-olds with up-to-date immunizations was embarrassingly low. A common explanation offered for these data was that vaccines were too expensive. Policymakers, however, suspected that more was at issue than cost. In anticipation of heath care reform during the early stages of the Clinton administration, the IOM convened a workshop on vaccination rates. The workshop did much to stress that financial factors were not a major barrier to vaccination. Rather, the committee concluded that efforts to improve immunization rates among preschool children should focus on leadership for action on immunization; accountability, and responsibility for providing immunizations; support for improving provider practices; effective communication with families and communities; and development of better information and more effective information tools to support each of the other efforts. A workshop summary, OvercomingBarriers to Immunization (1994), was disseminated widely and used by many vaccine advocates to bolster programs to increase immunization rates and decrease vaccine-preventable illness. OTHER WORKSHOP ACTIVITIES The IOM has held other workshops related to vaccines. Projects related to vaccines against HIV/AIDS are covered in the chapter on AIDS policy-making by Leslie Hardy, later in this volume. Other issues addressed through workshops were the need for temperature-stable vaccines for use in developing countries and an upcoming workshop on new developments in malaria vaccines and their implications for control and eradication programs. SUMMARY The Institute has a long, productive history of helping scientists and policymakers think about vaccine development, vaccine safety, and immunization
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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 practices. Some of the activities have had concrete consequences, such as changes to the Vaccine Injury Table; others have contributed to a groundswell leading to important changes, such as the need for vaccine compensation reform or better understanding of why the United States has failed to immunize its children. The potential for further developments and progress is enormous, as would be the resulting benefits. BIBLIOGRAPHY Adverse Effects of Pertussis and Rubella Vaccines , Christopher P. Howson, Cynthia J. Howe, and Harvey V. Fineberg, eds., 1991. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality, Kathleen R. Stratton, Cynthia J. Howe, and Richard B. Johnston, Jr., eds., 1994. The Children's Vaccine Initiative: Achieving the Vision, Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, eds., 1993. The Children's Vaccine Initiative: Continuing Activities. A Summary of Two Workshops, Greg W. Pearson, ed., 1995. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis Kathleen R. Stratton, Cynthia J. Howe, and Richard B. Johnston, Jr. eds., 1994. Evaluation of Poliomyelitis Vaccines, 1977. An Evaluation of Poliomyelitis Vaccine Policy Options, 1988. New Vaccine Development: Establishing Priorities, Volume I. Diseases of Importance in the United States, 1985. New Vaccine Development: Establishing Priorities, Volume II Diseases of Importance in Developing Countries, 1986. Overcoming Barriers to Immunization: A Workshop Summary, Jane S. Durch, ed., 1994. Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary, Kathleen R. Stratton, Cynthia J. Howe, and Richard B. Johnston, Jr., eds., 1994. Review of an Epidemiologic Study of Neurologic Illness and Vaccination in Children. Letter report to the Centers for Disease Control, October 1990. Review of a Protocol for an Epidemiologic Study of Neurologic Illness and Vaccination in Children. Letter report to the Centers for Disease Control, September 1987. Vaccine Supply and Innovation, 1985.
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