TY - BOOK AU - Institute of Medicine TI - Priorities for the National Vaccine Plan SN - DO - 10.17226/12796 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12796/priorities-for-the-national-vaccine-plan PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health. ER - TY - BOOK AU - Institute of Medicine TI - Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office SN - DO - 10.17226/12257 PY - 2008 UR - https://nap.nationalacademies.org/catalog/12257/initial-guidance-for-an-update-of-the-national-vaccine-plan PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - This book is the Institute of Medicine's response to the first part of the statement of task asking for a review of the 1994 National Vaccine Plan. The Committee on the Review of Priorities in the National Vaccine Plan reviewed the goals, objectives, strategies, and anticipated outcomes presented in the plan; their findings are contained in this book. In the first section of the book, the committee examines what has changed in the broader social, policy, and economic context of vaccine development and immunization, and highlights several areas where noteworthy progress has been made, particularly by federal agencies. The committee acknowledges that progress in developing and delivering vaccines has benefited from essential contributions by other stakeholders, including researchers, manufacturers, state and local public health agencies, and health care providers. In the second section of the book, the committee uses what it learned from reviewing the 1994 plan and the process of preparing it to distill key elements. Based on these elements, the committee offers guidance to NVPO and its partners on developing the update to the national vaccine plan. 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 - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Helene Gayle A2 - William Foege A2 - Lisa Brown A2 - Benjamin Kahn TI - Framework for Equitable Allocation of COVID-19 Vaccine SN - DO - 10.17226/25917 PY - 2020 UR - https://nap.nationalacademies.org/catalog/25917/framework-for-equitable-allocation-of-covid-19-vaccine PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine. ER - TY - BOOK TI - PY - UR - PB - The National Academies Press CY - Washington, DC LA - English ER - TY - BOOK AU - Institute of Medicine A2 - Violaine S. Mitchell A2 - Nalini M. Philipose A2 - Jay P. Sanford TI - The Children's Vaccine Initiative: Achieving the Vision SN - DO - 10.17226/2224 PY - 1993 UR - https://nap.nationalacademies.org/catalog/2224/the-childrens-vaccine-initiative-achieving-the-vision PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. ER - TY - BOOK AU - Institute of Medicine A2 - Geoffrey Evans A2 - Ann Bostrom A2 - Richard B. Johnston A2 - Barbara Loe Fisher A2 - Michael A. Stoto TI - Risk Communication and Vaccination: Workshop Summary SN - DO - 10.17226/5861 PY - 1997 UR - https://nap.nationalacademies.org/catalog/5861/risk-communication-and-vaccination-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - Institute of Medicine TI - Vaccine Safety Forum: Summaries of Two Workshops SN - DO - 10.17226/5881 PY - 1997 UR - https://nap.nationalacademies.org/catalog/5881/vaccine-safety-forum-summaries-of-two-workshops PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. 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 TI - Overcoming Barriers to Immunization: A Workshop Summary DO - 10.17226/9113 PY - 1994 UR - https://nap.nationalacademies.org/catalog/9113/overcoming-barriers-to-immunization-a-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - 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 TI - Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary DO - 10.17226/9269 PY - 1994 UR - https://nap.nationalacademies.org/catalog/9269/research-strategies-for-assessing-adverse-events-associated-with-vaccines-a PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine 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 TI - Options for Poliomyelitis Vaccination in the United States: Workshop Summary DO - 10.17226/9270 PY - 1996 UR - https://nap.nationalacademies.org/catalog/9270/options-for-poliomyelitis-vaccination-in-the-united-states-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Optimizing the Process for Establishing the Dietary Guidelines for Americans: The Selection Process SN - DO - 10.17226/24637 PY - 2017 UR - https://nap.nationalacademies.org/catalog/24637/optimizing-the-process-for-establishing-the-dietary-guidelines-for-americans PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition AB - Federal guidance on nutrition and diet is intended to reflect the state of the science and deliver the most reliable recommendations possible according to the best available evidence. This guidance, updated and presented every 5 years in the Dietary Guidelines for Americans (DGA), serves as the basis for all federal nutrition policies and nutrition assistance programs, as well as nutrition education programs. Despite the use of the guidelines over the past 30 years, recent challenges prompted Congress to question the process by which food and nutrition guidance is developed. This report assesses the process used to develop the guidelines; it does not evaluate the substance or use of the guidelines. As part of an overall, comprehensive review of the process to update the DGA, this first report seeks to discover how the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints for the purpose of informing the 2020 cycle. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Erin Hammers Forstag TI - Research with Pregnant and Lactating Persons: Mitigating Risk and Liability: Proceedings of a Workshop–in Brief DO - 10.17226/27142 PY - 2023 UR - https://nap.nationalacademies.org/catalog/27142/research-with-pregnant-and-lactating-persons-mitigating-risk-and-liability PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Pregnant and lactating persons are frequently excluded from clinical research, and often have to make treatment decisions without an adequate understanding of the benefits and risks to themselves and their developing or newborn baby. The National Academies Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a workshop in March 2023 as part of a consensus study to discuss how institutions and organizations make risk-benefit decisions regarding the inclusion and exclusion of pregnant and lactating persons in clinical research, and the role of real and perceived liability considerations, health equity, risk management, and trial insurance in those decisions. The workshop reviewed existing approaches to manage and mitigate risks relevant to the inclusion of pregnant and lactating persons in clinical research. This Proceedings of a Workshop-in Brief summarizes the discussions held during the workshop. ER - TY - BOOK AU - Institute of Medicine AU - Institute of Medicine TI - Informing the Future: Critical Issues in Health, Fifth Edition DO - 10.17226/12709 PY - 2009 UR - https://nap.nationalacademies.org/catalog/12709/informing-the-future-critical-issues-in-health-fifth-edition PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Today, perhaps more than ever, health care is a key item on the nation's agenda. Government policy makers, health professionals, scientists, industrial and civic leaders, patient advocates, and private citizens across the social spectrum are focusing on how best to obtain a high-quality health system that is efficient and affordable in its operation and that functions well for everyone. The Institute of Medicine (IOM) regularly considers this challenge from a variety of perspectives. Recent efforts have focused on improving the organization and operation of the nation's largest health agency; working to assess what diagnostic, therapeutic, and preventive services work best; gauging the overall health of the nation's population; and identifying ways to build an even stronger foundation of evidence-based medicine that effectively captures the promise of scientific discovery and technological innovation and enables doctors, nurses, and other health professionals to provide the right care for the right patient at the right time. The body of this book illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007. ER - TY - BOOK AU - Institute of Medicine TI - The Children's Vaccine Initiative: Continuing Activities DO - 10.17226/9103 PY - 1995 UR - https://nap.nationalacademies.org/catalog/9103/the-childrens-vaccine-initiative-continuing-activities PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - Institute of Medicine AU - National Research Council TI - Vaccine Supply and Innovation SN - DO - 10.17226/599 PY - 1985 UR - https://nap.nationalacademies.org/catalog/599/vaccine-supply-and-innovation PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - 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. ER -