Immunization Safety Review

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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 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-09086-5
ISBN Ebook: 0-309-52781-3
DOI: https://doi.org/10.17226/10822

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Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press.

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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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118 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-08610-8
ISBN Ebook: 0-309-56638-X
DOI: https://doi.org/10.17226/10534

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Institute of Medicine. 2003. Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer. Washington, DC: The National Academies Press.

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Immunization to protect infants and children from vaccine-preventable diseases is one of the greatest achievements of public health. Immunization is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio.

The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the available evidence on a series of immunization safety concerns. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001- 2003). While all of 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. In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis (MS) and Guillain-Barré syndrome (GBS).

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120 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-08469-5
ISBN Ebook: 0-309-56610-X
DOI: https://doi.org/10.17226/10393

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Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press.

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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.

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152 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-08328-1
ISBN Ebook: 0-309-50866-5
DOI: https://doi.org/10.17226/10306

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Institute of Medicine. 2002. Immunization Safety Review: Multiple Immunizations and Immune Dysfunction. Washington, DC: The National Academies Press.

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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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136 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-07636-6
ISBN Ebook: 0-309-56573-1
DOI: https://doi.org/10.17226/10208

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Institute of Medicine. 2001. Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. Washington, DC: The National Academies Press.

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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.

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102 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-07447-9
ISBN Ebook: 0-309-55787-9
DOI: https://doi.org/10.17226/10101

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Institute of Medicine. 2001. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism. Washington, DC: The National Academies Press.

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