Immunization Safety Review Measles-Mumps-Rubella Vaccine and Autism (2001) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-12
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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 soci1
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In 1999, as a result of previous IOM work on vaccine safety and the Institute's access to independent scientific experts, CDC and NIH began a year of discussions with IOM to develop the Immunization Safety Review project to address existing and emerging vaccine-safety concerns. The Immunization Safety Review Committee, convened in the fall of 2000, comprises 15 members with expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, genetics, epidemiology, biostatistics, risk perception and communication, decision analysis, public health, nursing, and ethics.
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The significance assessment addresses such considerations as He burden of the adverse health event in question, the burden of disease Hat He vaccine prevents, and He level and potential consequences of public concern about He safety of vaccine use. The findings of the plausibility and significance assessments provide the basis for the committee's recommendations regarding public health response, immunization policy review, current and fixture research, and effective communication strategies for the specific immunization-safety questions.
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Current attention to the possible relationship between MMR and ASD stems primarily from a case series reported in 1998 (Wakefield et al., 1998~. Twelve children with a history of normal development followed by loss of acquired skills and gastrointestinal symptoms were referred to a London gastroenterology clinic that was interested in He connection between measles virus and bowel disease.
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is not possible to describe from this study the nature of any relationship among vaccinestrain measles virus infection, ASD, and bowel symptoms. In addition, case reports submitted to the Vaccine Adverse Event Reporting System, a national passive surveillance system in He United States, sometimes note a temporal association between MMR vaccination and the onset of symptoms, but these reports vary substantially in their level of detail and supporting medical documentation.
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Also, primate models which are effective for the study of vaccine safety and immunogenicity or He neurobehavioral aspects of ASD do not adequately represent any relationship between He MMR vaccine and ASD. Thus, the committee concludes that the evidence favors rejection of a causal relationship at the population level between MMR vaccine and autistic spectrum disorders (ASD)
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RECOMMENDATIONS Public Health Response Although the committee has concluded that He evidence favors rejection of the causal relationship at the population level between MMR vaccine and autist~c spectrum disorders, the committee nevertheless recommends that this issue receive continued attention. It does so in recognition Hat its conclusion does not exclude the possibility that MMR vaccine could contribute to ASD in a small number of children, as well as the following factors: the identified limitations of the evidence, He burden of ASD, the burden of the diseases prevented by the vaccine, the immense concern of parents, and He prominence of the issue in public debate.
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· Shady the possible effects of different immnn~don exposures for entangle, studying children whose families have chosen not to have them receive the MMR vaccine. · Conduct furler clinical and epidemiological studies of sufficie'It rigor to identify risk factors and biological markers of ASD in order to better UDderstand genetic or environmental causes.
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However, this conclusion does not exclude the possibility that MMR vaccine could contribute to ASD in a small number of children, because the epidemiological evidence lacks the precision to assess rare occurrences of a response to MMR vaccine leading to ASD and the proposed biological models linking MMR vaccine to ASD, although far from established are nevertheless not disproved. Because of the limitations of the evidence, the significant public concern surrounding the issue, the risk of disease outbreaks if immunization rates fall, and the seriousness of ASD, He committee recommends Hat continued attention be given to this issue.
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1996. Polymerase chain reaction detection of the hemagglutinin gene from an attenuated measles vaccine strain in the peripheral mononuclear cells of children with autoimmune hepatitis.
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1998. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.
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recognized the need for an independent, expert group to address vaccine-safety in a timely and objective manner. In 1999, as a result of lOM's previous work and its access to independent scientific experts, CDC arid NTH began a year of discussions with lOM to develop the Immunization Safety Review project to address vaccine-safety issues both existing and emerging.
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