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Institute of Medicine (IOM) Reports


Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies

January 16, 2013

The Institute of Medicine (IOM) of the National Academies

This report is the most comprehensive examination of the immunization schedule to date. The IOM 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.



Adverse Effects of Vaccines: Evidence and Causality

August 25, 2011

The Institute of Medicine (IOM) of the National Academies

Using epidemiologic and mechanistic evidence, the committee developed 158 causality conclusions and assigned each relationship between a vaccine and an adverse health problem to one of four categories of causation:

  • Evidence convincingly supports a causal relationship
  • Evidence favors acceptance of a causal relationship
  • Evidence favors rejection of a causal relationship
  • Evidence is inadequate to accept or reject a causal relationship

The committee finds that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis. Additionally, evidence favors rejection of five vaccine-adverse event relationships, including MMR vaccine and autism and inactivated influenza vaccine and asthma episodes. However, for the majority of cases (135 vaccine-adverse event pairs), the evidence was inadequate to accept or reject a causal relationship. Overall, the committee concludes that few health problems are caused by or clearly associated with vaccines.



Immunization Safety Review: Vaccines and Autism

May 17, 2004

The Institute of Medicine (IOM) of the National Academies

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 The committee reviewed the extant published and unpublished epidemiological studies regarding causality and studies of potential biologic mechanisms by which these immunizations might cause autism.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: Influenza Vaccines and Neurological Complications

October 6, 2003

The Institute of Medicine (IOM) of the National Academies

The Immunization Safety Review committee reviewed the data on influenza vaccine and neurological conditions and concluded that the evidence favored acceptance of a causal relationship between the 1976 Swine Influenza vaccine and GBS in adults. The evidence about GBS for influenza vaccines of other years is not clear one way or the other (that is, the evidence is inadequate to accept or reject a causal relationship).



Immunization Safety Review: Multiple Immunizations and Immune Dysfunction

February 20, 2002

The Institute of Medicine (IOM) of the National Academies

The Immunization Safety Review committee reviewed the evidence regarding the hypothesis that multiple immunizations increase the risk for immune dysfunction, with a focus on evidence related to risk for infections, the autoimmune disease type I diabetes, and allergic disorders.

The committee found that evidence favors rejection of a causal relationship between multiple immunizations and increased risk for infections and for type I diabetes. They also found that epidemiological evidence regarding risk for allergic disease, particularly asthma, was inadequate to accept or reject a causal relationship. The committee recommended continued attention in the form of policy analysis, research, and communication strategy development to inform those concerned about these issues and to encourage parents to vaccinate their children.



Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders

October 1, 2001

The Institute of Medicine (IOM) of the National Academies

At the request of the Centers for Disease Control and Prevention and the National Institutes of Health, a committee was convened by the Institute of Medicine (IOM) of the National Academy of Sciences to examine whether or not the use of vaccines containing the preservative thimerosal can cause neurodevelopmental disorders. In Immunization Safety Review: Thimerosal Containing Vaccines and Neurodevelopmental Disorders, the IOM committee carefully examines this issue.



Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism

August 23, 2001

The Institute of Medicine (IOM) of the National Academies

The Centers for Disease Control and Prevention and the National Institutes of Health recognized the need for an independent group to carefully examine the hypothesized MMR-autism link and address other vaccine-safety issues as well, in order to give some guidance to themselves, health care providers, researchers, and a concerned public. These agencies engaged the Institute of Medicine, which in turn appointed the Immunization Safety Review Committee, a 15-member body of health professionals with wide-ranging expertise in areas relevant to the problem. The results of the committee’s assessment of the issue are described in this report titled Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism.



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