Review of Adverse Effects of Vaccines

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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 pages · 6 x 9 · hardcover
ISBN Ebook: 0-309-21436-X
DOI: https://doi.org/10.17226/13164

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Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press.

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Ellen W. Clayton

Ellen Wright Clayton, J.D., M.D., is professor of genetics and health policy at Vanderbilt University, where she is a professor of law and of pediatrics. She is also the director of Vanderbilt’s Center for Biomedical Ethics and Society and is a general pediatrician at Vanderbilt Medical Center. Her research and teaching interests include pediatrics, medical and research ethics, legal and ethical issues in children’s and women’s health, and genetics and health policy. She has served as a member on numerous committees for the National Institutes of Health, including the Ethical, Legal, and Social Issues Working Group of the Newborn Screening Taskforce, Maternal and Child Health Bureau, Health Resources Services Administration. Dr. Clayton has served as a consultant to the Food and Drug Administration on the topic of clinical pharmacology during pregnancy. She is a member of the Institute of Medicine (IOM) and has served on several National Academies committees, as well as the IOM’s Health Sciences Policy Board. She has numerous publications in books, medical journals, interdisciplinary journals, and law journals on the intersection of law, medicine, and public health. Dr. Clayton received her M.D. from Harvard University in 1985 and her J.D. from Yale University in 1979.

Inmaculada B. Aban

Inmaculada B. Aban, M.S., Ph.D., is associate professor in the Department of Biostatistics at the University of Alabama, Birmingham (UAB). Dr. Aban’s current research interests are statistical methods in clinical trials, survival and reliability analysis, goodness-of-fit and model diagnostics, and inference for overdispersed count data and heavy tailed distribution. She has extensive experience in teaching statistics courses and in providing statistical consulting. Her current collaborative projects involve clinical trials in the areas of myasthenia gravis and heart failure. She is also a research faculty at the UAB Center for AIDS Research. Dr. Aban received her master’s degree in applied statistics and doctorate degree in mathematics with a concentration in statistics from Bowling Green State University, and completed her undergraduate degree in statistics at the University of the Philippines. Before she joined UAB in 2004, she was a faculty member of the Department of Mathematics and Statistics at the University of Nevada, Reno.

Douglas J. Barrett

Douglas J. Barrett, M.D., is senior vice president for health affairs at the University of Florida. In this position, he is responsible for maximizing the performance of the educational, research, and clinical programs in the six colleges of the University of Florida’s Health Sciences Center. Dr. Barrett is a practicing pediatrician and active in the American Academy of Pediatrics, American Board of Pediatrics, Association for Academic Health Centers, and the Society for Pediatric Research. He serves on the editorial board for Contemporary Pediatrics and is a reviewer for multiple journals. He is the author or co-author of three books, several book chapters, and more than 110 journal articles. Dr. Barrett’s research in childhood immune responses, immunodeficiency disease, and transplantation has been supported by grants from the National Institutes of Health, American Heart Association, and the American Cancer Society. Dr. Barrett received his M.D. in 1974 from the University of South Florida in Tampa and completed his pediatric internship training at Tampa General Hospital and All Children’s Hospital. After finishing a pediatric residency at SUNY/Upstate Medical Center in Syracuse, New York, he pursued his fellowship training in pediatric immunology in the Department of Pediatrics at the University of California, San Francisco.

Martina Bebin

Martina Bebin, M.D., M.P.A., is associate professor of neurology and pediatrics at the University of Alabama at Birmingham. She is a practicing child neurologist and her research interests include pediatric clinical drug development for epilepsy and outcomes research of epilepsy patients, with a focus on treatment of epilepsy in children. She has clinical responsibility for the care of children enrolled in a clinical trial supported by Novartis for treatment of tuberous sclerosis patients with subependymal giant cell tumors of the brain. She is currently working on the Tuberous Sclerosis Alliance Natural History Database Project, funded by the Tuberous Sclerosis Alliance and the Centers for Disease Control and Prevention. She is a former Robert Wood Johnson Foundation Health Policy fellow. Dr. Bebin received her M.D. from the University of Mississippi School of Medicine in 1986. She completed her pediatric and neurology training at the Mayo Clinic in Rochester, Minnesota and a fellowship in epilepsy at the University of Virginia. In 2005 she earned her M.P.A. from Harvard University-Kennedy School of Government.

Kirsten Bibbins-Domingo

Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., is associate professor of medicine and epidemiology and biostatistics at the University of California, San Francisco, and an attending physician at San Francisco General Hospital. Dr. Bibbins-Domingo is an active researcher in preventive cardiology, the epidemiology of cardiovascular disease in young adults, and race and gender health and healthcare disparities. Her research has examined the development of cardiovascular risk factors in young adults, the effectiveness of screening and diagnostic tests for cardiovascular disease, and computer-simulated projections of future cardiovascular disease trends and the impact of public health and clinical interventions on cardiovascular disease prevention. Dr. Bibbins-Domingo served on the IOM Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans from 2006 to 2007. She received her undergraduate degree in molecular biology and public policy from Princeton University and her medical degree, Ph.D. in biochemistry, and Masters of Clinical Research from the University of California, San Francisco.

Martha Constantine-Paton

Martha Constantine-Paton, Ph.D., is investigator at the McGovern Institute for Brain Research and Professor in the departments of Brain and Cognitive Sciences and Biology at the Massachusetts Institute of Technology (MIT). Previously, she was professor of biology at Yale University from 1985 until 1999, and a faculty member at Princeton University from 1976 through 1984, before joining MIT in 1999. Dr. Constantine-Paton studies activity-dependent brain development, glutamate receptor regulation, and physiology of the developing visual system in animal models. She is interested in the biochemical, structural, or genetic programs that cause the developing brain to lose its plasticity or to compensate for genetic mutations or trauma as the brain matures, possibly leading to loss of learning and memory or to neurological or neuropsychiatric disease. Dr. Constantine-Paton earned her Ph.D. in 1976 from Cornell University. She has received a number of honors and awards among them the Young Investigator Award from the Society of Neuroscience and a Merit Award from the National Eye Institute. She has served on numerous committees and councils. She has previously worked for the Institute of Medicine on panels that suggested new nutritional guidelines and explored the ethics and value of fetal tissue use. She has been a member of several grant review panels at the National Institutes of Health, including the National Advisory Eye Council and the Child Council Workgroup for the National Institute of Mental Health.

Deborah J. del Junco

Deborah J. del Junco, Ph.D., is the senior epidemiologist at the Center for Clinical and Translational Sciences at the University of Texas Health Science Center-Houston (UTHSC-H), and associate professor in the Department of Pediatrics (UTHSC-H School of Medicine) and the Division of Epidemiology and Disease Control (UTHSC-H School of Public Health). Her research and teaching have focused on epidemiology methods, gene-environment, and other complex interactions among etiologic factors in chronic disease, records linkage, meta-analysis, reproductive health, autoimmune disease, and Rett syndrome. She is an executive editor of Epidemiologic Perspectives and Innovations. She has many publications in peer-reviewed journals and has served on a large number of review panels and advisory committees for the National Institutes of Health, Centers for Disease Control and Prevention, and Department of Defense. Dr. del Junco completed a fellowship in the Department of Epidemiology and Biostatistics at the Mayo Clinic in Rochester, Minnesota in 1984 and received her Ph.D. in epidemiology from the University of Texas Houston Health Science Center in 1988.

Betty A. Diamond, M.D.

Betty A. Diamond, M.D., is head of the Center for Autoimmune and Musculoskeletal Disease at the Feinstein Institute for Medical Research. Her research has focused on the immune system and autoimmune diseases, with an interest in Systemic Lupus Erythematosus. Dr. Diamond is a practicing rheumatologist and has received many honors, including the Outstanding Investigator Award from the American College of Rheumatology, the Lee Howley Award from the Arthritis Foundation, the Recognition Award from the National Association of M.D.-Ph.D. Programs, and election to the Institute of Medicine. She is also on the Scientific Council of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Board of Directors of the American College of Rheumatology. She has a grant from Autism Speaks to study the effects of maternal autoantibodies on fetal development. Dr. Diamond earned her medical degree from Harvard Medical School in 1973, and then completed a residency in internal medicine at Columbia Presbyterian Medical Center and a post-doctoral fellowship in immunology at the Albert Einstein College of Medicine.

S. Claiborne Johnston

S. Claiborne Johnston, M.D., Ph.D., is associate vice chancellor of research, director of the Clinical and Translational Science Institute, professor of neurology and epidemiology, and director of the Neurovascular Disease and Stroke Center at the University of California, San Francisco. He is a practicing neurologist and his research has focused on stroke treatment and prevention. In the past, he has had funding from both Sanofi and Novartis to study drugs used in the treatment of stroke. Dr. Johnston has authored over 200 publications in scientific journals and has won several national awards for his research and teaching. He was a member of the California Health Disease and Stroke Prevention Advisory Council, which advises the Department of Health Services, and was co-director of Prevention Education Programs for the National Stroke Association. Dr. Johnston received his M.D. from Harvard Medical School and Ph.D. in epidemiology from the University of California, Berkeley School of Public Health.

Anthony L. Komaroff

Anthony L. Komaroff, M.D., is the Steven P. Simcox, Patrick A. Clifford, and James H. Higby Professor of Medicine at Harvard Medical School, senior physician at Brigham and Women's Hospital, and editor-in-chief of Harvard Health Publications. He was director of the Division of General Medicine and Primary Care at Brigham and Women's Hospital for 15 years and is the founding editor of Journal Watch, a summary medical information newsletter for physicians published by the Massachusetts Medical Society. Dr. Komaroff practices internal medicine (primary care and consultative medicine). For 25 years, he has conducted research on chronic fatigue syndrome, including studies of the prevalence of the illness, symptom presentation and functional capacity, as well as virologic, immunologic, and neurologic studies. He is the author of over 200 journal articles and book chapters and of one book, and is a fellow of the American College of Physicians and of the American Association for the Advancement of Science. Dr. Komaroff received his M.D. from the University of Washington.

B. P. Lawrence

B. Paige Lawrence, Ph.D., is associate professor of environmental medicine, and microbiology and immunology in the Molecular Toxicology and Environmental Medicine Cluster at the University of Rochester School of Medicine and Dentistry. Dr. Lawrence’s research is focused on defining the molecular mechanisms by which pollutants adversely affect the immune response to respiratory infection. This work includes the impact of acute exposure to environmental contaminants as well as the consequences of prenatal (maternal) exposures on immune function in the next generation. Her work has shown that aryl hydrocarbon receptor may have a complex mediating effect in the body and results have demonstrated impacts on immune system function, including inflammatory responses and fighting viral infections. Dr. Lawrence has numerous peer-reviewed publications and professional awards, and serves on the editorial board for several toxicology journals. She received her Ph.D. in cell biology from Cornell University in 1993, and post-doctoral training in immunology and toxicology at Oregon State University.

M. L. Markert

M. Louise Markert, M.D., Ph.D., is associate professor of pediatrics and immunology in the Division of Pediatric Allergy and Immunology at Duke University School of Medicine. Dr. Markert has pioneered the development of thymus transplantation for T cell reconstitution in infants born with complete DiGeorge anomaly. DiGeorge anomaly is a congenital disorder characterized by defects of the heart, parathyroid and thymus. Complete DiGeorge anomaly is fatal because of the absence of functional thymus leading to profound primary immunodeficiency. In research protocols to date, 59 infants with complete DiGeorge anomaly have been transplanted with postnatal cultured human thymic epithelial tissue. Over 70% of these infants survive and have developed functional T cells. Dr. Markert graduated from Smith College with a B.A. in biochemistry and then completed the M.D./Ph.D. program at Duke University. She received her Ph.D. in immunology, completed a two year pediatric residency at Duke, and then a three year fellowship in pediatric allergy and immunology. Dr. Markert joined the Duke faculty in 1987. She was program director of the Duke NIH-funded General Clinical Research Center from 1993 to 2004. From 1996 to 2004, she served on the American Board of Allergy and Immunology and was chair of the Board in 2002. Dr. Markert has published over 40 research articles plus invited chapters and reviews.

Marc C. Patterson

Marc C. Patterson, M.D., is chair of the Division of Child and Adolescent Neurology and professor of neurology, pediatrics, and medical genetics at Mayo Clinic. Dr. Patterson is a child neurologist with special expertise in neurometabolic and neurogenetic disorders. His research has focused on neurometabolic disorders, with a particular focus on Niemann-Pick disease, Type C, Gaucher disease, and Congenital Disorders of Glycosylation. Dr. Patterson was born and educated in Australia, where he graduated from the University of Queensland, before training in medicine, pediatrics, and neurology at the Royal Brisbane, Royal Children’s and Royal Women’s Hospitals in Brisbane. He competed further training in pediatrics and child neurology at Mayo Graduate School of Medicine, and a fellowship in neurometabolic diseases with Roscoe Brady at the National Institutes of Health. On completion of training, Dr. Patterson joined the staff of Mayo Clinic and faculty of Mayo Medical School, where he was associate professor in the Departments of Neurology, Pediatric and Adolescent Medicine, and Medical Genetics. In 2001, he moved to New York and was professor of clinical neurology and pediatrics at Columbia University and director of pediatric neurology at The Neurologic Institute of New York and Children’s Hospital of New York – Presbyterian. In 2007, he returned to Mayo Clinic.

Hugh A. Sampson

Hugh A. Sampson, M.D., is professor of pediatrics and immunology at the Mount Sinai School of Medicine. He is also director of the Jaffe Food Allergy Institute, dean for Translational Biomedical Sciences at the Mount Sinai Medical Center, and a practicing pediatric allergist. Dr. Sampson’s research has focused on food allergic disorders, including work on the immuno-pathogenic role of food hypersensitivity in atopic dermatitis, the pathogenesis of food-induced anaphylaxis, characterization of food-induced gastrointestinal hypersensitivities, and immunotherapeutic strategies for treating food allergies. He holds a patent for a potential treatment vaccine for peanut allergy. Dr. Sampson is the past-president of the American Academy of Allergy, Asthma, and Immunology and a member of the Institute of Medicine. He is a co-editor of Pediatric Allergy and Immunology and has served on the editorial board of the Journal of Allergy and Clinical Immunology, and Clinical and Experimental Allergy. Dr. Sampson received his medical degree from the State University of New York, then finished a residency in pediatrics at the Children’s Memorial Hospital, and completed a fellowship in allergy and immunology at Duke University.

Pauline A. Thomas

Pauline A. Thomas, M.D. is associate professor in the Department of Preventive Medicine and Community Health, with joint appointments in OB/GYN/Women’s Health and Pediatrics at New Jersey Medical School, and in the School of Public Health, Newark Campus-University of Medicine and Dentistry of New Jersey. She is also a practicing pediatrician. Her research interests include pediatric HIV, public health practice and surveillance methodology, and health care delivery. She served as assistant commissioner for surveillance in the Division of Epidemiology at the New York City Department of Health and Mental Hygiene and director of the Health Department’s Office of AIDS Surveillance. Dr. Thomas received her medical degree from Yale University School of Medicine in 1977 and completed her residency in pediatrics at Strong Memorial Hospital of the University of Rochester, New York.

Leslie P. Weiner

Leslie P. Weiner, M.D., is professor of neurology and molecular microbiology and immunology and holds the Richard Angus Grant, Sr. Chair in Neurology at the Keck School of Medicine of the University of Southern California (USC). Dr. Weiner earned his medical degree from the University of Cincinnati and completed his neurology residency at the Johns Hopkins Hospital. At Johns Hopkins, he also pursued a fellowship in neurology and epidemiology, focusing on viruses of the nervous system. He then completed a fellowship at the National Institutes of Health Laboratory of Slow Virus Infections. Dr. Weiner served as chair of the USC Department of Neurology for 25 years and he remains a practicing neurologist. Dr. Weiner’s research interests include a human T cell vaccine for the treatment of secondary progressive multiple sclerosis (MS), gene therapy for MS, molecular mimicry, and more recently, neural stem cells. He has written more than 200 papers and has received numerous honors. He served as an expert witness for a federal judge in cases regarding adverse effects of the swine flu vaccine in the 1970’s.

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Review of Adverse Effects of Vaccines

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Review of Adverse Effects of Vaccines

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Featured publication

Adverse Effects of Vaccines: Evidence and Causality

Description

Collaborators

Committee

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Staff

Major units and sub-units

Contact

Provide feedback

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More like this

Modernizing Mathematics Education for Grades 9-14

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