Safety of Thimerosal-Containing Vaccines

A Two-Phased Study of Computerized Health Maintenance Organization Databases

Thomas Verstraeten, Robert Davis, Frank DeStefano, Tracy A. Lieu, Philip H. Rhodes, Steven B. Black, Henry Shinefield, Robert T. Chen

Research output: Contribution to journalArticle

193 Citations (Scopus)

Abstract

Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 μg of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.

Original languageEnglish (US)
Pages (from-to)1039-1048
Number of pages10
JournalPediatrics
Volume112
Issue number5
StatePublished - Nov 1 2003
Externally publishedYes

Fingerprint

Thimerosal
Health Maintenance Organizations
Vaccines
Databases
Safety
Confidence Intervals
Language Development Disorders
Tics
Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Mercury
Cohort Studies
Retrospective Studies

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Verstraeten, T., Davis, R., DeStefano, F., Lieu, T. A., Rhodes, P. H., Black, S. B., ... Chen, R. T. (2003). Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases. Pediatrics, 112(5), 1039-1048.

Safety of Thimerosal-Containing Vaccines : A Two-Phased Study of Computerized Health Maintenance Organization Databases. / Verstraeten, Thomas; Davis, Robert; DeStefano, Frank; Lieu, Tracy A.; Rhodes, Philip H.; Black, Steven B.; Shinefield, Henry; Chen, Robert T.

In: Pediatrics, Vol. 112, No. 5, 01.11.2003, p. 1039-1048.

Research output: Contribution to journalArticle

Verstraeten, T, Davis, R, DeStefano, F, Lieu, TA, Rhodes, PH, Black, SB, Shinefield, H & Chen, RT 2003, 'Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases', Pediatrics, vol. 112, no. 5, pp. 1039-1048.
Verstraeten T, Davis R, DeStefano F, Lieu TA, Rhodes PH, Black SB et al. Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases. Pediatrics. 2003 Nov 1;112(5):1039-1048.
Verstraeten, Thomas ; Davis, Robert ; DeStefano, Frank ; Lieu, Tracy A. ; Rhodes, Philip H. ; Black, Steven B. ; Shinefield, Henry ; Chen, Robert T. / Safety of Thimerosal-Containing Vaccines : A Two-Phased Study of Computerized Health Maintenance Organization Databases. In: Pediatrics. 2003 ; Vol. 112, No. 5. pp. 1039-1048.
@article{cdf9195ccdeb4aa7acb7d1f1ae9aede0,
title = "Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases",
abstract = "Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 μg of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95{\%} confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95{\%} CI: 1.01-1.27) and 7 months (RR: 1.07; 95{\%} CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.",
author = "Thomas Verstraeten and Robert Davis and Frank DeStefano and Lieu, {Tracy A.} and Rhodes, {Philip H.} and Black, {Steven B.} and Henry Shinefield and Chen, {Robert T.}",
year = "2003",
month = "11",
day = "1",
language = "English (US)",
volume = "112",
pages = "1039--1048",
journal = "Pediatrics",
issn = "0031-4005",
publisher = "American Academy of Pediatrics",
number = "5",

}

TY - JOUR

T1 - Safety of Thimerosal-Containing Vaccines

T2 - A Two-Phased Study of Computerized Health Maintenance Organization Databases

AU - Verstraeten, Thomas

AU - Davis, Robert

AU - DeStefano, Frank

AU - Lieu, Tracy A.

AU - Rhodes, Philip H.

AU - Black, Steven B.

AU - Shinefield, Henry

AU - Chen, Robert T.

PY - 2003/11/1

Y1 - 2003/11/1

N2 - Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 μg of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.

AB - Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 μg of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.

UR - http://www.scopus.com/inward/record.url?scp=0242300675&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0242300675&partnerID=8YFLogxK

M3 - Article

VL - 112

SP - 1039

EP - 1048

JO - Pediatrics

JF - Pediatrics

SN - 0031-4005

IS - 5

ER -