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.
By two years of age, healthy infants in the United States can receive up to 20 vaccinations to protect against 11 diseases. Although most people know that vaccines effectively protect against serious infectious diseases, approximately one-quarter of parents in a recent survey believe that infants get more vaccines than are good for them, and that too many immunizations could overwhelm an infant's immune system. The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that multiple immunizations increase the risk for immune dysfunction. Specifically, the committee looked at evidence of potential biological mechanisms and at epidemiological evidence for or against causality related to risk for infections, the autoimmune disease type 1 diabetes, and allergic disorders.
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.
The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.
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. The 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.
The National Children's Study (NCS) was authorized by the Children's Health Act of 2000 and is being implemented by a dedicated Program Office in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The NCS is planned to be a longitudinal observational birth cohort study to evaluate the effects of chronic and intermittent exposures on child health and development in the U.S.. The NCS would be the first study to collect a broad range of environmental exposure measures for a national probability sample of about 100,000 children, followed from birth or before birth to age 21. Detailed plans for the NCS were developed by 2007 and reviewed by a National Research Council / Institute of Medicine panel. At that time, sample recruitment for the NCS Main Study was scheduled to begin in 2009 and to be completed within about 5 years. However, results from the initial seven pilot locations, which recruited sample cases in 2009-2010, indicated that the proposed household-based recruitment approach would be more costly and time consuming than planned. In response, the Program Office implemented a number of pilot tests in 2011 to evaluate alternative recruitment methods and pilot testing continues to date. At the request of Congress, The National Children's Study 2014 reviews the revised study design and proposed methodologies for the NCS Main Study. This report assesses the study's plan to determine whether it is likely to produce scientifically sound results that are generalizable to the United States population and appropriate subpopulations. The report makes recommendations about the overall study framework, sample design, timing, content and need for scientific expertise and oversight. The National Children's Study has the potential to add immeasurably to scientific knowledge about the impact of environmental exposures, broadly defined, on children\'s health and development in the United States. The recommendations of this report will help the NCS will achieve its intended objective to examine the effects of environmental influences on the health and development of American children.
The National Children's Study (NCS) is planned to be the largest long-term study of environmental and genetic effects on children's health ever conducted in the United States. It proposes to examine the effects of environmental influences on the health and development of approximately 100,000 children across the United States, following them from before birth until age 21. By archiving all of the data collected, the NCS is intended to provide a valuable resource for analyses conducted many years into the future. This book evaluates the research plan for the NCS, by assessing the scientific rigor of the study and the extent to which it is being carried out with methods, measures, and collection of data and specimens to maximize the scientific yield of the study. The book concludes that if the NCS is conducted as proposed, the database derived from the study should be valuable for investigating hypotheses described in the research plan as well as additional hypotheses that will evolve. Nevertheless, there are important weaknesses and shortcomings in the research plan that diminish the study's expected value below what it might be.
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.
Children's health has clearly improved over the past several decades. Significant and positive gains have been made in lowering rates of infant mortality and morbidity from infectious diseases and accidental causes, improved access to health care, and reduction in the effects of environmental contaminants such as lead. Yet major questions still remain about how to assess the status of children's health, what factors should be monitored, and the appropriate measurement tools that should be used. Children's Health, the Nation's Wealth: Assessing and Improving Child Health provides a detailed examination of the information about children's health that is needed to help policy makers and program providers at the federal, state, and local levels. In order to improve children's health-and, thus, the health of future generations-it is critical to have data that can be used to assess both current conditions and possible future threats to children's health. This compelling book describes what is known about the health of children and what is needed to expand the knowledge. By strategically improving the health of children, we ensure healthier future generations to come.
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.
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.
Increasing public investments in health care services for low-income and special needs children and adolescents in the United States have raised questions about whether these efforts improve their health outcomes. Yet it is difficult to assess the general health status and health care quality for younger populations, especially those at risk of poor health outcomes, because the United States has no national information system that can provide timely, comprehensive, and reliable indicators in these areas for children and adolescents. Without such a system in place, it is difficult to know whether and how selected health care initiatives and programs contribute to children's health status. Child and Adolescent Health and Health Care Quality identifies key advances in the development of pediatric health and health care quality measures, examines the capacity of existing federal data sets to support these measures, and considers related research activities focused on the development of new measures to address current gaps. This book posits the need for a comprehensive strategy to make better use of existing data, to integrate different data sources, and to develop new data sources and collection methods for unique populations. Child and Adolescent Health and Health Care Quality looks closely at three areas: the nature, scope, and quality of existing data sources; gaps in measurement areas; and methodological areas that deserve attention. Child and Adolescent Health and Health Care Quality makes recommendations for improving and strengthening the timeliness, quality, public transparency, and accessibility of information on child health and health care quality. This book will be a vital resource for health officials at the local, state, and national levels, as well as private and public health care organizations and researchers.
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.
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 vaccinesâ€"tetanus, diphtheria, measles, mumps, polio, Haemophilus influenzae b, and hepatitis Bâ€"and specific types of disorders or death. The authors discuss approaches to evidence and causality and examine the consequencesâ€"neurologic and immunologic disorders and deathâ€"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.
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.
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.
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. The 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.
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.
This eighth and final report of the Immunization Safety Review Committee examines the hypothesis that vaccines, specifically the measles-mumps-rubella (MMR) vaccine and thimerosal-containing vaccines, are causally associated with autism. The committee reviewed the extant published and unpublished epidemiological studies regarding causality and studies of potential biologic mechanisms by which these immunizations might cause autism. Immunization Safety Review: Vaccines and Autism finds that the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism. The book further finds that potential biological mechanisms for vaccine-induced autism that have been generated to date are only theoretical. It recommends a public health response that fully supports an array of vaccine safety activities and recommends that available funding for autism research be channeled to the most promising areas. The book makes additional recommendations regarding surveillance and epidemiological research, clinical studies, and communication related to these vaccine safety concerns.
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.
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 publicâ€"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.
In 2000, the Institute of Medicine (IOM) produced a report Calling the Shots: Immunization Finance Policies and Practices (IOM, 2000a) that illustrated the uncertainties and instability of the public health infrastructure that supports U.S. immunization programs. The IOM report proposed several strategies to address these concerns and to strengthen the immunization infrastructure. In March 2002, a group of 50 health officials, public health experts, health care providers, health plan representatives, health care purchasers, and community leaders met at The National Academies in Washington, DC to explore the implications of the IOM findings and recommendations for the federal and state governments. Private health plans and business sector representatives also participated in the meeting to discuss their role in fostering high levels of immunization coverage. The one-day workshop was the fourth and last in a series of meetings organized by IOM with support from the CDC to foster informed discussions about future financing strategies for immunization and the public health infrastructure. This report of the Washington, DC workshop summarizes the findings of the IOM study, reviews the implementation of the IOM recommendations, and highlights continuing immunization finance challenges for the nation as a whole as well as state and local health departments.
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.
The objective of the current literature review was to review, assess, and synthesize literature on influenza vaccination among children and adolescents 5 to 18 years of age to inform the Agency and the NACI Influenza Working Group (IWG) on the question of whether NACI should recommend the inclusion of healthy children 5-18 years of age in the list of intended recipients for the annual influenza vaccine."--P. 4.
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