Cumulative and episodic vaccine aluminum exposure in a population-based cohort of young children

Jason M. Glanz, Sophia R. Newcomer, Matthew F. Daley, David L. McClure, Roger P. Baxter, Michael L. Jackson, Allison L. Naleway, Marlene M. Lugg, Frank DeStefano

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Background: In addition to antigens, vaccines contain small amounts of preservatives, adjuvants, and residual substances from the manufacturing process. Some parents have concerns about the safety of these ingredients, yet no large epidemiological studies have specifically examined associations between health outcomes and vaccine ingredients, other than thimerosal. This study examined the extent to which the Vaccine Safety Datalink (VSD) could be used to study vaccine ingredient safety in children. Methods: Children born 2004-2011 were identified in VSD data. Using immunization records, two cohorts were identified: children who were up-to-date and children who were undervaccinated before age 2 years. A database was also created linking vaccine type and manufacturer with ingredient amounts documented in vaccine package inserts. Thirty-four ingredients in two or more infant vaccines were identified. However, only amounts (in mg) for aluminum were consistently documented and commonly contained in infant vaccines. Analyses compared vaccine aluminum exposure across cohorts and determined the statistical power for studying associations between aluminum exposure and hypothetical vaccine adverse events. Results: Among 408,608 children, mean cumulative vaccine aluminum exposure increased from 1.11 to 4.00. mg between ages 92-730 days. Up-to-date children were exposed to 11-26% more aluminum from vaccines than undervaccinated children. Power analyses demonstrated that safety studies of aluminum could detect relative risks ranging from 1.1 to 5.8 for a range of adverse event incidence. Conclusions: The safety of vaccine aluminum exposure can be feasibly studied in the VSD. However, possible biological mechanisms and confounding variables would need to be considered before conducting any studies.

Original languageEnglish
Pages (from-to)6736-6744
Number of pages9
Issue number48
StatePublished - Nov 27 2015


Funding source: The work was funded by contract 200-2012-53582 from the Centers for Disease Control and Prevention Vaccine Safety Datalink infrastructure task order. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of CDC .

FundersFunder number
Centers for Disease Control and Prevention


    • Aluminum
    • Immunizations


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