Jason M Glanz1, Sophia R Newcomer2, Matthew F Daley3, David L McClure4, Roger P Baxter5, Michael L Jackson6, Allison L Naleway7, Marlene M Lugg8, Frank DeStefano9. 1. Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80218, United States; Department of Epidemiology, University of Colorado School of Public Health, 13001 E. 17th Place, Campus Box B119, Aurora, CO 80045, United States. Electronic address: jason.m.glanz@kp.org. 2. Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80218, United States. Electronic address: sophia.r.newcomer@kp.org. 3. Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80218, United States; Department of Pediatrics, University of Colorado School of Medicine, Children's Hospital CO, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States. Electronic address: matthew.f.daley@kp.org. 4. Marshfield Clinic Research Foundation, 1000 North Oak Avenue, Marshfield, WI 54449, United States. Electronic address: dave_epi@hotmail.com. 5. Kaiser Permanente Vaccine Study Center, Division of Research, Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612, United States. Electronic address: roger.baxter@kp.org. 6. Group Health Research Institute, 1730 Minor Ave #1600, Seattle, WA 98101, United States. Electronic address: jackson.ml@ghc.org. 7. Kaiser Permanente Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: allison.naleway@kpchr.org. 8. Kaiser Permanente Department of Research and Evaluation, 100 S. Los Robles Ave, Pasadena, CA 91101, United States. Electronic address: marlene.m.lugg@kp.org. 9. Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, United States. Electronic address: fxd1@cdc.gov.
Abstract
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.
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.
Authors: Stanley Xu; Sophia R Newcomer; Martin Kulldorff; Matthew F Daley; Bruce Fireman; Jason M Glanz Journal: Vaccine Date: 2019-01-29 Impact factor: 3.641