Committee to Review Adverse Effects of Vaccines's Books

Adverse Effects of Vaccines

Evidence and Causality

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee to Review Adverse Effects of Vaccines

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Adverse Effects of Vaccines

Evidence and Causality

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee to Review Adverse Effects of Vaccines

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.

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894

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National Academies Press

Published Date

ISBN 10

0309214351

ISBN 13

9780309214353

Adverse Effects of Vaccines

Evidence and Causality

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee to Review Adverse Effects of Vaccines

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Adverse Effects of Vaccines

Evidence and Causality

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee to Review Adverse Effects of Vaccines

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894

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National Academies Press

Published Date

ISBN 10

0309214351

ISBN 13

9780309214353

Adverse Events Associated with Childhood Vaccines

Evidence Bearing on Causality

By: Institute of Medicine,Vaccine Safety Committee

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Adverse Events Associated with Childhood Vaccines

Evidence Bearing on Causality

By: Institute of Medicine,Vaccine Safety Committee

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.

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481

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National Academies Press

Published Date

ISBN 10

0309048958

ISBN 13

9780309048958

Adverse Effects of Pertussis and Rubella Vaccines

By: Institute of Medicine,Committee to Review the Adverse Consequences of Pertussis and RubellaVaccines

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Adverse Effects of Pertussis and Rubella Vaccines

By: Institute of Medicine,Committee to Review the Adverse Consequences of Pertussis and RubellaVaccines

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.

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382

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National Academies Press

Published Date

ISBN 10

0309103681

ISBN 13

9780309103688

Immunization Safety Review

Thimerosal-Containing Vaccines and Neurodevelopmental Disorders

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

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Immunization Safety Review

Thimerosal-Containing Vaccines and Neurodevelopmental Disorders

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

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.

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137

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National Academies Press

Published Date

ISBN 10

0309170370

ISBN 13

9780309170376

The Childhood Immunization Schedule and Safety

Stakeholder Concerns, Scientific Evidence, and Future Studies

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

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The Childhood Immunization Schedule and Safety

Stakeholder Concerns, Scientific Evidence, and Future Studies

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

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.

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237

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National Academies Press

Published Date

ISBN 10

0309267056

ISBN 13

9780309267052

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

By: Institute of Medicine,Medical Follow-up Agency,Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

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An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

By: Institute of Medicine,Medical Follow-up Agency,Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

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179

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National Academies Press

Published Date

ISBN 10

0309086264

ISBN 13

9780309086264

The Anthrax Vaccine

Is It Safe? Does It Work?

By: Institute of Medicine,Medical Follow-up Agency,Committee to Assess the Safety and Efficacy of the Anthrax Vaccine

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The Anthrax Vaccine

Is It Safe? Does It Work?

By: Institute of Medicine,Medical Follow-up Agency,Committee to Assess the Safety and Efficacy of the Anthrax Vaccine

The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

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288

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National Academies Press

Published Date

ISBN 10

0309182743

ISBN 13

9780309182744

Gulf War and Health

Volume 11: Generational Health Effects of Serving in the Gulf War

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Committee on Gulf War and Health, Volume 11: Generational Health Effects of Serving in the Gulf War

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Gulf War and Health

Volume 11: Generational Health Effects of Serving in the Gulf War

For the United States, the 1991 Persian Gulf War was a brief and successful military operation with few injuries and deaths. However, soon after returning from duty, a large number of veterans began reporting health problems they believed were associated with their service in the Gulf. At the request of Congress, the National Academies of Sciences, Engineering, and Medicine has been conducting an ongoing review of the evidence to determine veterans' long-term health problems and potential causes. Some of the health effects identified by past reports include post-traumatic stress disorders, other mental health disorders, Gulf War illness, respiratory effects, and self-reported sexual dysfunction. Veterans' concerns regarding the impacts of deployment-related exposures on their health have grown to include potential adverse effects on the health of their children and grandchildren. These concerns now increasingly involve female veterans, as more women join the military and are deployed to war zones and areas that pose potential hazards. Gulf War and Health: Volume 11 evaluates the scientific and medical literature on reproductive and developmental effects and health outcomes associated with Gulf War and Post-9/11 exposures, and designates research areas requiring further scientific study on potential health effects in the descendants of veterans of any era.

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519

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National Academies Press

Published Date

ISBN 10

0309478235

ISBN 13

9780309478236

Gulf War and Health

Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines

By: Committee on Health Effects Associated with Exposures During the Gulf War,Division of Health Promotion and Disease Prevention,Institute of Medicine

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Gulf War and Health

Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines

By: Committee on Health Effects Associated with Exposures During the Gulf War,Division of Health Promotion and Disease Prevention,Institute of Medicine

The men and women who served in the Gulf War theater were potentially exposed to a wide range of biological and chemical agents. Gulf War and Health: Volume 1 assesses the scientific literature concerning the association between these agents and the adverse health effects currently experienced by a large number of veterans.

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426

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National Academies Press

Published Date

ISBN 10

0309171628

ISBN 13

9780309171625

Canadian Immunization Guide

By: Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization

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Canadian Immunization Guide

By: Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization

The seventh edition of the Canadian Immunization Guide was developed by the National Advisory Committee on Immunization (NACI), with the support ofthe Immunization and Respiratory Infections Division, Public Health Agency of Canada, to provide updated information and recommendations on the use of vaccines in Canada. The Public Health Agency of Canada conducted a survey in 2004, which confi rmed that the Canadian Immunization Guide is a very useful and reliable resource of information on immunization.

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392

Published Date

ISBN 10

0660193922

ISBN 13

9780660193922

Adverse Effects of Pertussis and Rubella Vaccines

By: Institute of Medicine,Committee to Review the Adverse Consequences of Pertussis and RubellaVaccines

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Adverse Effects of Pertussis and Rubella Vaccines

By: Institute of Medicine,Committee to Review the Adverse Consequences of Pertussis and RubellaVaccines

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382

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National Academies Press

Published Date

ISBN 10

0309044995

ISBN 13

9780309044998

Immunization Safety Review

Vaccines and Autism

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

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Immunization Safety Review

Vaccines and Autism

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

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.

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214

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National Academies Press

Published Date

ISBN 10

030909237X

ISBN 13

9780309092371

Vaccine Safety Research, Data Access, and Public Trust

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program

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Vaccine Safety Research, Data Access, and Public Trust

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program

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.

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152

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National Academies Press

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ISBN 10

0309165245

ISBN 13

9780309165242

Immunization Safety Review

Influenza Vaccines and Neurological Complications

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

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Immunization Safety Review

Influenza Vaccines and Neurological Complications

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

Infection with the influenza virus can have a serious effect on the health of people of all ages, although it is particularly worrisome for infants, the elderly, and people with underlying heart or lung problems. A vaccine exists (the "flu" shot) that can greatly decrease the impact of influenza. Because the strains of virus that are expected to cause serious illness and death are slightly different every year, the vaccine is also slightly different every year and it must be given every year, unlike other vaccines. The Immunization Safety Review committee reviewed the data on influenza vaccine and neurological conditions and concluded that the evidence favored rejection of a causal relationship between influenza vaccines and exacerbation of multiple sclerosis. For the other neurological conditions studied, the committee concluded the evidence about the effects of influenza vaccine is inadequate to accept or reject a causal relationship. The committee also reviewed theories on how the influenza vaccine could damage the nervous system. The evidence was at most weak that the vaccine could act in humans in ways that could lead to these neurological problems.

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190

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National Academies Press

Published Date

ISBN 10

0309090865

ISBN 13

9780309090865

Immunization Safety Review

SV40 Contamination of Polio Vaccine and Cancer

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

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Immunization Safety Review

SV40 Contamination of Polio Vaccine and Cancer

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Immunization Safety Review Committee

The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the evidence on possible causal associations between immunizations and certain adverse outcomes, and to then present conclusions and recommendations. The committee's mandate also includes assessing the broader societal significance of these immunization safety issues. While all 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. The committee reviews three immunization safety review topics each year, addressing each one at a time. In this fifth report in a series, the committee examines the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40), a virus that causes inapparent infection in some monkeys, can cause certain types of cancer.

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