TY - BOOK AU - Institute of Medicine AU - National Academy of Engineering A2 - Guruprasad Madhavan A2 - Charles Phelps A2 - Rino Rappuoli A2 - Rose Marie Martinez A2 - Lonnie King TI - Ranking Vaccines: Applications of a Prioritization Software Tool: Phase III: Use Case Studies and Data Framework SN - DO - 10.17226/18763 PY - 2015 UR - https://nap.nationalacademies.org/catalog/18763/ranking-vaccines-applications-of-a-prioritization-software-tool-phase-iii PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - SMART Vaccines - Strategic Multi-Attribute Ranking Tool for Vaccines - is a prioritization software tool developed by the Institute of Medicine that utilizes decision science and modeling to help inform choices among candidates for new vaccine development. A blueprint for this computer-based guide was presented in the 2012 report Ranking Vaccines: A Prioritization Framework: Phase I. The 2013 Phase II report refined a beta version of the model developed in the Phase I report. Ranking Vaccines: Applications of a Prioritization Software Tool: Phase III: Use Case Studies and Data Framework extends this project by demonstrating the practical applications of SMART Vaccines through use case scenarios in partnership with the Public Health Agency of Canada, New York State Department of Health, and the Serum Institute of India. This report also explores a novel application of SMART Vaccines in determining new vaccine product profiles, and offers practical strategies for data synthesis and estimation to encourage the broader use of the software. ER - TY - BOOK AU - Institute of Medicine A2 - Guruprasad Madhavan A2 - Kinpritma Sangha A2 - Charles Phelps A2 - Dennis Fryback A2 - Rino Rappuoli A2 - Rose Marie Martinez A2 - Lonnie King TI - Ranking Vaccines: A Prioritization Software Tool: Phase II: Prototype of a Decision-Support System SN - DO - 10.17226/13531 PY - 2013 UR - https://nap.nationalacademies.org/catalog/13531/ranking-vaccines-a-prioritization-software-tool-phase-ii-prototype-of PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - SMART Vaccines—Strategic Multi-Attribute Ranking Tool for Vaccines—is a prioritization software tool developed by the Institute of Medicine that utilizes decision science and modeling to help inform choices among candidates for new vaccine development. A blueprint for this computer-based guide was presented in the 2012 report Ranking Vaccines: A Prioritization Framework: Phase I. Ranking Vaccines: A Prioritization Software Tool,Phase II extends the proof-of-concept presented in the Phase I report, which was based on multi-attribute utility theory. This report refines a beta version of the model developed in the Phase I report and presents its next iteration, SMART Vaccines 1.0. Ranking Vaccines: Phase II discusses the methods underlying the development, validation, and evaluation of SMART Vaccines 1.0. It also discusses how SMART Vaccines should—and, just as importantly, should not—be used. The report also offers ideas for future enhancements for SMART Vaccines as well as for ideas for expanded uses and considerations and possibilities for the future. ER - TY - BOOK AU - Institute of Medicine A2 - Kathleen Stratton A2 - Alicia Gable A2 - Padma Shetty A2 - Marie McCormick TI - Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism SN - DO - 10.17226/10101 PY - 2001 UR - https://nap.nationalacademies.org/catalog/10101/immunization-safety-review-measles-mumps-rubella-vaccine-and-autism PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Immunization is widely regarded as one of the most effective and beneficial tools for protecting the public's health. In the United States, immunization programs have resulted in the eradication of smallpox, the elimination of polio, and the control and near elimination of once-common, often debilitating and potentially life-threatening diseases, including measles, mumps, rubella, diphtheria, pertussis, tetanus, and Haemophilus influenza type b. Along with the benefits of widespread immunization, however, have come concerns about the safety of vaccines. No vaccine is perfectly safe or effective, and vaccines may lead to serious adverse effects in some instances. Furthermore, if a serious illness is observed after vaccination, it is often unclear whether that sequence is coincidental or causal, and it can be difficult to determine the true nature of the relationship, if any, between the vaccination and the illness. Ironically, the successes of vaccine coverage in the United States have made it more difficult for the public to weigh the benefits and complications of vaccines because the now-controlled diseases and their often-serious risks are no longer familiar. However, because vaccines are so widely used-and because state laws require that children be vaccinated before entering daycare and school, in part to protect others-it is essential that safety concerns be fully and carefully studied. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism, the first of a series from the Institute of Medicine (IOM) Immunization Safety Review Committee, presents an assessment of the evidence regarding a hypothesized causal association between the measles-mumps-rubella (MMR) vaccine and autism, an assessment of the broader significance for society of the issues surrounding the MMR-autism hypothesis, and the committee's conclusions and recommendations based on those assessments. ER - TY - BOOK AU - Institute of Medicine TI - Financing Vaccines in the 21st Century: Assuring Access and Availability SN - DO - 10.17226/10782 PY - 2004 UR - https://nap.nationalacademies.org/catalog/10782/financing-vaccines-in-the-21st-century-assuring-access-and-availability PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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–private 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. Financing 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. ER - TY - BOOK AU - Institute of Medicine A2 - Guruprasad Madharan A2 - Kinpritma Sangha A2 - Charles Phelps A2 - Dennis Fryback A2 - Tracy Lieu A2 - Rose Marie Martinez A2 - Lonnie King TI - Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint SN - DO - 10.17226/13382 PY - 2012 UR - https://nap.nationalacademies.org/catalog/13382/ranking-vaccines-a-prioritization-framework-phase-i-demonstration-of-concept PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - As a number of diseases emerge or reemerge thus stimulating new vaccine development opportunities to help prevent those diseases, it can be especially difficult for decision makers to know where to invest their limited resources. Therefore, it is increasingly important for decision makers to have the tools that can assist and inform their vaccine prioritization efforts. In this first phase report, the IOM offers a framework and proof of concept to account for various factors influencing vaccine prioritization-demographic, economic, health, scientific, business, programmatic, social, policy factors and public concerns. Ranking Vaccines: A Prioritization Framework describes a decision-support model and the blueprint of a software-called Strategic Multi-Attribute Ranking Tool for Vaccines or SMART Vaccines. SMART Vaccines should be of help to decision makers. SMART Vaccines Beta is not available for public use, but SMART Vaccines 1.0 is expected to be released at the end of the second phase of this study, when it will be fully operational and capable of guiding discussions about prioritizing the development and introduction of new vaccines. ER - TY - BOOK AU - Institute of Medicine A2 - Kathleen Stratton A2 - Alicia Gable A2 - Marie C. McCormick TI - Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders SN - DO - 10.17226/10208 PY - 2001 UR - https://nap.nationalacademies.org/catalog/10208/immunization-safety-review-thimerosal-containing-vaccines-and-neurodevelopmental-disorders PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. ER - TY - BOOK AU - Institute of Medicine TI - The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies SN - DO - 10.17226/13563 PY - 2013 UR - https://nap.nationalacademies.org/catalog/13563/the-childhood-immunization-schedule-and-safety-stakeholder-concerns-scientific-evidence PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. Driven 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. This 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. ER - TY - BOOK AU - Institute of Medicine A2 - Kathleen R. Stratton A2 - Cynthia J. Howe A2 - Richard B. Johnston, Jr. TI - Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality SN - DO - 10.17226/2138 PY - 1994 UR - https://nap.nationalacademies.org/catalog/2138/adverse-events-associated-with-childhood-vaccines-evidence-bearing-on-causality PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. This volume provides the most thorough literature review available about links between common childhood vaccines—tetanus, diphtheria, measles, mumps, polio, Haemophilus influenzae b, and hepatitis B—and specific types of disorders or death. The authors discuss approaches to evidence and causality and examine the consequences—neurologic and immunologic disorders and death—linked 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. This comprehensive volume will be an important resource to anyone concerned about the immunization controversy: public health officials, pediatricians, attorneys, researchers, and parents. ER - TY - BOOK AU - Institute of Medicine TI - Calling the Shots: Immunization Finance Policies and Practices SN - DO - 10.17226/9836 PY - 2000 UR - https://nap.nationalacademies.org/catalog/9836/calling-the-shots-immunization-finance-policies-and-practices PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Calling the Shots examines the basic strategies that finance the national immunization system in the current health care climate. It is a comprehensive volume, rich with data and highlighted examples, that explores: The evolution of the system in light of changing U.S. demographics, development of new vaccines, and other factors. The effectiveness of public health and health insurance strategies, with special emphasis on the performance of the "Section 317" program. The condition of the infrastructure for control and prevention of infectious disease, surveillance of vaccines rates and safety, and efforts to sustain high coverage. Calling the Shots will be an indispensable resource to those responsible for maintaining our nation's vaccine vigilance. ER - TY - BOOK AU - Institute of Medicine A2 - Christopher P. Howson A2 - Cynthia J. Howe A2 - Harvey V. Fineberg TI - Adverse Effects of Pertussis and Rubella Vaccines SN - DO - 10.17226/1815 PY - 1991 UR - https://nap.nationalacademies.org/catalog/1815/adverse-effects-of-pertussis-and-rubella-vaccines PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. This 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: 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. The relation of rubella vaccines to arthritis, various neuropathies, and thrombocytopenic purpura. The 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. ER - TY - BOOK AU - Institute of Medicine A2 - Kathleen Stratton A2 - Andrew Ford A2 - Erin Rusch A2 - Ellen Wright Clayton TI - Adverse Effects of Vaccines: Evidence and Causality SN - DO - 10.17226/13164 PY - 2012 UR - https://nap.nationalacademies.org/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. Adverse 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. Adverse 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. ER -