Published online September 1, 2004
PEDIATRICS Vol. 114 No. 3 September 2004, pp. 584-591 (doi:10.1542/10.1542/peds.2003-1177-L)
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Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association

Nick Andrews, MSc*, Elizabeth Miller, MBBS, FRCPath, FFPHM{ddagger}, Andrew Grant, PhD*, Julia Stowe, BA§, Velda Osborne, BSc|| and Brent Taylor, PhD, MBCHB§

* Statistics Unit
{ddagger} Immunisation Department, Health Protection Agency, Communicable Disease Surveillance Centre, London, United Kingdom
§ Centre for Community Child Health, Royal Free and University College Medical School, Royal Free Campus, London, United Kingdom
|| Morbidity and Health Care Team, Office for National Statistics, London, United Kingdom

Objective. After concerns about the possible toxicity of thimerosal-containing vaccines in the United States, this study was designed to investigate whether there is a relationship between the amount of thimerosal that an infant receives via diphtheria-tetanus-whole-cell pertussis (DTP) or diphtheria-tetanus (DT) vaccination at a young age and subsequent neurodevelopmental disorders.

Methods. A retrospective cohort study was performed using 109 863 children who were born from 1988 to 1997 and were registered in general practices in the United Kingdom that contributed to a research database. The disorders investigated were general developmental disorders, language or speech delay, tics, attention-deficit disorder, autism, unspecified developmental delays, behavior problems, encopresis, and enuresis. Exposure was defined according to the number of DTP/DT doses received by 3 and 4 months of age and also the cumulative age-specific DTP/DT exposure by 6 months. Each DTP/DT dose of vaccine contains 50 µg of thimerosal (25 µg of ethyl mercury). Hazard ratios (HRs) for the disorders were calculated per dose of DTP/DT vaccine or per unit of cumulative DTP/DT exposure.

Results. Only in 1 analysis for tics was there some evidence of a higher risk with increasing doses (Cox's HR: 1.50 per dose at 4 months; 95% confidence interval [CI]: 1.02–2.20). Statistically significant negative associations with increasing doses at 4 months were found for general developmental disorders (HR: 0.87; 95% CI: 0.81–0.93), unspecified developmental delay (HR: 0.80; 95% CI: 0.69–0.92), and attention-deficit disorder (HR: 0.79; 95% CI: 0.64–0.98). For the other disorders, there was no evidence of an association with thimerosal exposure.

Conclusions. With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.

Key Words: cohort study • neurodevelopment • safety • thimerosal • thiomersal • vaccines

Abbreviations: Hg, mercury • WHO, World Health Organization • VSD, Vaccine Safety Datalink • CDC, Centers for Disease Control and Prevention • HMO, health maintenance organization • ADD, attention-deficit disorder • GPRD, General Practice Research Database • ICD, International Classification of Diseases • DTP, diphtheria-tetanus-whole-cell pertussis • DT, diphtheria, tetanus • GP, general practitioner • HR, hazard ratio • CI, confidence interval

Accepted Mar 15, 2004.


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eLetters:

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THIMEROSAL DOES NOT BELONG IN VACCINES
Mark R. Geier,MD, Ph.D., et al.
Pediatrics Online, 8 Sep 2004 [Full text]
Re: THIMEROSAL DOES NOT BELONG IN VACCINES
Elizabeth Miller, et al.
Pediatrics Online, 10 Sep 2004 [Full text]
Does weight confound?
John P. Heptonstall
Pediatrics Online, 30 Oct 2004 [Full text]
Re: Does weight confound?
Nick J Andrews, et al.
Pediatrics Online, 10 Nov 2004 [Full text]
Re: Re: Does weight confound?
John P Heptonstall
Pediatrics Online, 24 Nov 2004 [Full text]
Puzzling Circumstances
John Stone
Pediatrics Online, 1 May 2005 [Full text]
Please can we have correct information about dosage?
John Stone
Pediatrics Online, 12 Jun 2005 [Full text]
Re: Please can we have correct information about dosage?
Elizabeth Miller, et al.
Pediatrics Online, 5 Sep 2005 [Full text]
Re: Re: Please can we have correct information about dosage?
John Stone
Pediatrics Online, 14 Sep 2005 [Full text]