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Developmental regression and autism reported to the Vaccine Adverse Event Reporting System

Center for Biologics Evaluation, Research, Food and Drug Administration, Maryland, USA,jane.woo{at}fda.hhs.gov

Robert Ball

Center for Biologics Evaluation and Research, Food and Drug Administration, Maryland, USA

Rebecca Landa

Kennedy Kriegar Institute, Johns Hopkins University, Maryland, USA

Andrew W. Zimmerman

Kennedy Krieger Institute, Johns Hopkins University, Maryland, USA

M. Miles Braun

Center for Biologics Evaluation and Research, Food and Drug Administration, Maryland, USA

VAERS Working Group, Center for Biologics Evaluation and Research, Food and Drug Administration, Maryland, USA

We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the child's developmental history. Medical record review indicated that 27 of 31 (87%) children had autism/ASD and 19 (61.3%) had evidence of developmental regression (loss of social, language, or motor skills). The proportion of VAERS cases of autism with regression was greater than that reported in population-based studies, based on the subset of VAERS cases with medical record confirmation. This difference may reflect preferential reporting to VAERS of autism with regression. In other respects, the children in this study appear to be similar to other children with autism. Further research might determine whether the pathogenesis of autism with developmental regression differs from that of autism without regression.

Key Words: adverse event • autism • regression • vaccine

Autism, Vol. 11, No. 4, 301-310 (2007)
DOI: 10.1177/1362361307078126


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