@BOOK{NAP author = "Institute of Medicine", editor = "Kathleen Stratton and Andrew Ford and Erin Rusch and Ellen Wright Clayton", title = "Adverse Effects of Vaccines: Evidence and Causality", isbn = "978-0-309-21435-3", abstract = "In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children.\n\nAdverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma.\nAdverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.", url = "https://nap.nationalacademies.org/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Kathleen R. Stratton and Cynthia J. Howe and Richard B. Johnston, Jr.", title = "Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality", isbn = "978-0-309-07496-4", abstract = "Childhood immunization is one of the major public health measures of the 20th century and is now receiving special attention from the Clinton administration. At the same time, some parents and health professionals are questioning the safety of vaccines because of the occurrence of rare adverse events after immunization.\nThis volume provides the most thorough literature review available about links between common childhood vaccines\u2014tetanus, diphtheria, measles, mumps, polio, Haemophilus influenzae b, and hepatitis B\u2014and specific types of disorders or death.\nThe authors discuss approaches to evidence and causality and examine the consequences\u2014neurologic and immunologic disorders and death\u2014linked with immunization. Discussion also includes background information on the development of the vaccines and details about the case reports, clinical trials, and other evidence associating each vaccine with specific disorders.\nThis comprehensive volume will be an important resource to anyone concerned about the immunization controversy: public health officials, pediatricians, attorneys, researchers, and parents.", url = "https://nap.nationalacademies.org/catalog/2138/adverse-events-associated-with-childhood-vaccines-evidence-bearing-on-causality", year = 1994, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Violaine S. Mitchell and Nalini M. Philipose and Jay P. Sanford", title = "The Children's Vaccine Initiative: Achieving the Vision", isbn = "978-0-309-04940-5", abstract = "The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.", url = "https://nap.nationalacademies.org/catalog/2224/the-childrens-vaccine-initiative-achieving-the-vision", year = 1993, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis", url = "https://nap.nationalacademies.org/catalog/9814/dpt-vaccine-and-chronic-nervous-system-dysfunction-a-new-analysis", year = 1994, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Options for Poliomyelitis Vaccination in the United States: Workshop Summary", url = "https://nap.nationalacademies.org/catalog/9270/options-for-poliomyelitis-vaccination-in-the-united-states-workshop-summary", year = 1996, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Financing Vaccines in the 21st Century: Assuring Access and Availability", isbn = "978-0-309-08979-1", abstract = " The national immunization system has achieved high levels of immunization, particularly for children. However, this system faces difficult challenges for the future. Significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. These disparities result, in part, from fragmented public\u2013private financing in which a large number of children and adults face limited access to immunization services. Access for adults lags well behind that of children, and rates of immunizations for those who are especially vulnerable because of chronic health conditions such as diabetes or heart and lung disease, remain low.\n\nFinancing Vaccines in the 21st Century: Assuring Access and Availability addresses these challenges by proposing new strategies for assuring access to vaccines and sustaining the supply of current and future vaccines. The book recommends changes to the Advisory Committee on Immunization Practices (ACIP)-the entity that currently recommends vaccines-and calls for a series of public meetings, a post-implementation evaluation study, and development of a research agenda to facilitate implementation of the plan.\n\n\n", url = "https://nap.nationalacademies.org/catalog/10782/financing-vaccines-in-the-21st-century-assuring-access-and-availability", year = 2004, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Setting the Course: A Strategic Vision for Immunization: Part 2: Summary of the Austin Workshop", isbn = "978-0-309-08517-5", abstract = "Immunization is essential to disease prevention efforts in public health, but the U.S. health care system faces financial challenges that are affecting the delivery of immunization services. An earlier report from the Institute of Medicine (IOM), Calling the Shots: Immunization Finance Policies and Practices, pointed to the instability of the fundamental infrastructure that supports immunization programs throughout the United States, including growing financial burdens and operational complexities in immunization services, shortcomings in public- and private-sector investments in vaccine purchases and immunization programs, and fluctuations in insurance plans in the public and private health care sectors that create uncertainties regarding coverage of vaccine purchase and service delivery arrangements. In October 2001, a group of about 50 health officials, public health experts, health care providers, health plan representatives and purchasers, state legislative officials, and community leaders met at the Texas Medical Association in Austin to explore the implications of the IOM findings and recommendations for Texas. The 1-day workshop was the second in a series of four meetings organized by IOM with support from the Centers for Disease Control and Prevention to foster informed discussions about challenges for immunization finance and future strategies for strengthening immunization activities and the public health infrastructure that supports those activities.This report of the Austin workshop summarizes the findings of the previous IOM report and reviews continuing challenges in immunization finance for the nation and for individual states, with a particular focus on Texas. The report also highlights strategies proposed by individual workshop participants that can be used to address those challenges. Several presenters and discussants emphasized that adequate funding is necessary for immunization programs but that financial resources alone are not sufficient to guarantee success. Similarly, they indicated that no single agency or group in the public or the private sector should expect, or should be expected, to solve immunization problems. Speakers from both public and private health agencies observed that collaboration, consultation, and partnership efforts across levels of government and between the public and private sectors are essential.", url = "https://nap.nationalacademies.org/catalog/10495/setting-the-course-a-strategic-vision-for-immunization-part-2", year = 2002, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and National Research Council", title = "Vaccine Supply and Innovation", isbn = "978-0-309-03544-6", abstract = "The United States is facing a vaccine shortage that may threaten public health. This book examines vaccine research and development, production and supply, and utilization and offers recommendations aimed at ensuring vaccine supply and promoting innovation. In addition, this comprehensive volume provides information on the adverse reactions associated with the range of vaccines used in the United States and contains the most thorough analysis ever published on the state of the law regarding vaccine-related injury and compensation for vaccine injury.", url = "https://nap.nationalacademies.org/catalog/599/vaccine-supply-and-innovation", year = 1985, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Kathleen Stratton and Donna A. Almario and Theresa M. Wizemann and Marie C. McCormick", title = "Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy", isbn = "978-0-309-08886-2", abstract = "With current recommendations calling for infants to receive multiple doses of vaccines during their first year of life and with sudden infant death syndrome (SIDS) the most frequent cause of death during the postneonatal period, it is important to respond to concerns that vaccination might play a role in sudden unexpected infant death. \n\nThe committee reviewed epidemiologic evidence focusing on three outcomes: SIDS, all SUDI (sudden unexpected death in infancy), and neonatal death (infant death, whether sudden or not, during the first 4 weeks of life). Based on this review, the committee concluded that the evidence favors rejection of a causal relationship between some vaccines and SIDS; and that the evidence is inadequate to accept or reject a causal relationship between other vaccines and SIDS, SUDI, or neonatal death. The evidence regarding biological mechanisms is essentially theoretical, reflecting in large measure the lack of knowledge concerning the pathogenesis of SIDS. ", url = "https://nap.nationalacademies.org/catalog/10649/immunization-safety-review-vaccinations-and-sudden-unexpected-death-in-infancy", year = 2003, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "The Children's Vaccine Initiative: Continuing Activities", url = "https://nap.nationalacademies.org/catalog/9103/the-childrens-vaccine-initiative-continuing-activities", year = 1995, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Christopher P. Howson and Cynthia J. Howe and Harvey V. Fineberg", title = "Adverse Effects of Pertussis and Rubella Vaccines", isbn = "978-0-309-10368-8", abstract = "Parents have come to depend on vaccines to protect their children from a variety of diseases. Some evidence suggests, however, that vaccination against pertussis (whooping cough) and rubella (German measles) is, in a small number of cases, associated with increased risk of serious illness.\nThis book examines the controversy over the evidence and offers a comprehensively documented assessment of the risk of illness following immunization with vaccines against pertussis and rubella. Based on extensive review of the evidence from epidemiologic studies, case histories, studies in animals, and other sources of information, the book examines:\n\n The relation of pertussis vaccines to a number of serious adverse events, including encephalopathy and other central nervous system disorders, sudden infant death syndrome, autism, Guillain-Barre syndrome, learning disabilities, and Reye syndrome.\n The relation of rubella vaccines to arthritis, various neuropathies, and thrombocytopenic purpura.\n\nThe volume, which includes a description of the committee's methods for evaluating evidence and directions for future research, will be important reading for public health officials, pediatricians, researchers, and concerned parents.", url = "https://nap.nationalacademies.org/catalog/1815/adverse-effects-of-pertussis-and-rubella-vaccines", year = 1991, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary", url = "https://nap.nationalacademies.org/catalog/9269/research-strategies-for-assessing-adverse-events-associated-with-vaccines-a", year = 1994, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies", isbn = "978-0-309-26702-1", abstract = "Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk.\nDriven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule.\nThis report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.", url = "https://nap.nationalacademies.org/catalog/13563/the-childhood-immunization-schedule-and-safety-stakeholder-concerns-scientific-evidence", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Setting the Course: A Strategic Vision for Immunization: Part 3: Summary of the Los Angeles Workshop", isbn = "978-0-309-08712-4", abstract = "Immunization is essential to disease prevention efforts in public health, but the nation's immunization system faces financing challenges that are affecting the delivery of services. A 2000 report from the Institute of Medicine (IOM), Calling the Shots: Immunization Finance Policies and Practices (IOM, 2000), pointed to the instability of the fundamental infrastructure that supports immunization programs throughout the United States, including unpredictable federal funding levels, growing financial burdens and operational complexities in immunization services, shortcomings in public- and private-sector investments in vaccine purchases and immunization programs, and fluctuations in coverage plans in the public and private health care sectors that create uncertainties regarding vaccine purchase and service delivery arrangements. In January 2002, health officials, public health experts, health care providers, health plan representatives, health care purchasers, and community leaders met at the University of California at Los Angeles to explore the implications of the IOM findings and recommendations for California in general and for Los Angeles and San Diego County in particular. The one-day workshop was the third in a series of four meetings organized by IOM with support from the Centers for Disease Control and Prevention to foster informed discussions about challenges for immunization finance and future financing strategies for immunization activities and the public health infrastructure that supports those activities.This report of the Los Angeles workshop summarizes the findings of the IOM study, reviews progress in responding to the IOM recommendations at the federal level, and highlights continuing challenges in immunization finance for the nation and at the state and local levels in California.", url = "https://nap.nationalacademies.org/catalog/10607/setting-the-course-a-strategic-vision-for-immunization-part-3", year = 2003, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Vaccine Safety Forum: Summaries of Two Workshops", isbn = "978-0-309-05791-2", abstract = "On November 6, 1995, the Institute of Medicine's Vaccine Safety Forum convened a workshop on detecting and responding to adverse events following vaccination. Workshop speakers and participants discussed the difficulties in detecting adverse events, current adverse events detection and response methods and procedures, suggestions for improving the means of detecting and responding to adverse events following vaccination, and future areas of research. This document represents a summary of that workshop.", url = "https://nap.nationalacademies.org/catalog/5881/vaccine-safety-forum-summaries-of-two-workshops", year = 1997, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Kathleen Stratton and Alicia Gable and Marie C. McCormick", title = "Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders", isbn = "978-0-309-07636-4", abstract = "In this report, the Immunization Safety Review committee examines the hypothesis of whether or not the use of vaccines containing the preservative thimerosal can cause neurodevelopmental disorders (NDDs), specifically autism, attention deficit\/hyperactivity disorder (ADHD), and speech or language delay.", url = "https://nap.nationalacademies.org/catalog/10208/immunization-safety-review-thimerosal-containing-vaccines-and-neurodevelopmental-disorders", year = 2001, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Geoffrey Evans and Ann Bostrom and Richard B. Johnston and Barbara Loe Fisher and Michael A. Stoto", title = "Risk Communication and Vaccination: Workshop Summary", isbn = "978-0-309-05790-5", url = "https://nap.nationalacademies.org/catalog/5861/risk-communication-and-vaccination-workshop-summary", year = 1997, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Kathleen Stratton and Donna A. Almario and Marie C. McCormick", title = "Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders", isbn = "978-0-309-08469-7", abstract = "Immunization to protect infants and children from vaccine-preventable diseases is one of the greatest achievements of public health. Immunization is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio.The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the available evidence on a series of immunization safety concerns. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001- 2003). While all of the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis (MS) and Guillain-Barré syndrome (GBS).", url = "https://nap.nationalacademies.org/catalog/10393/immunization-safety-review-hepatitis-b-vaccine-and-demyelinating-neurological-disorders", year = 2002, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Patricia M. Graves and Myron M. Levine", title = "Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program", isbn = "978-0-309-10168-4", abstract = "Malaria is an infectious disease common to several parts of the world, including Africa, northern South America, and Asia. During their service in the military, U.S. active members may be sent to any part of the world, including parts of the world where Malaria is an issue. In Liberia in 2003, for example, there was a 28 percent attack rate in Marines who spent a short time ashore, and half of the 80 Marines affected needed to be evacuated to Germany. This was not only costly to the U.S. military but dangerous as well. To fight against this disease, there exists a Malaria Vaccine program in the U.S. military. However, there exists a variety of potential vaccine targets for the most severe and important form of malaria; malaria from the species Plasmodium falciparum. Issues also arise with the fact that there are three possible stages to create vaccines against\u2014preerythrocytic, blood, or transmission. \n \nThe Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested that the Institute of Medicine (IOM) conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. There was to be a focus on vaccine against the preerythrocytic and blood stages. The IOM formed a committee of 11 experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health. \n \nThe committee focused different tasks including determining whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines, recommending how to overcome significant, identified barriers, and identifying major strategic goals and timelines based on the material received and presentations made by the DoD's program representatives. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program presents the committee's findings, current malaria vaccines, and recommendations for the development of the U.S. Military vaccine research. \n ", url = "https://nap.nationalacademies.org/catalog/11656/battling-malaria-strengthening-the-us-military-malaria-vaccine-program", year = 2006, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Robert G. Petersdorf and William F. Page and Susan Thaul", title = "Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces", isbn = "978-0-309-05593-2", url = "https://nap.nationalacademies.org/catalog/5515/interactions-of-drugs-biologics-and-chemicals-in-us-military-forces", year = 1996, publisher = "The National Academies Press", address = "Washington, DC" }