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Original Investigation
March 9, 2020

Association Between Rotavirus Vaccination and Type 1 Diabetes in Children

Author Affiliations
  • 1Institute for Health Research, Kaiser Permanente Colorado, Aurora
  • 2Department of Epidemiology, Colorado School of Public Health, Aurora
  • 3Department of Endocrinology, Parkview Health and Parkview Physicians Group, Fort Wayne, Indiana
  • 4Kaiser Permanente Department of Research and Evaluation, Kaiser Permanente of Southern California, Pasadena
  • 5Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, Wisconsin
  • 6Division of Research, HealthPartners Institute, Minneapolis, Minnesota
  • 7Kaiser Permanente Division of Research, Kaiser Permanente of Northern California, Oakland
  • 8Immunization Safety Office, Vaccine Safety Datalink, Centers for Disease Control and Prevention, Atlanta, Georgia
JAMA Pediatr. Published online March 9, 2020. doi:10.1001/jamapediatrics.2019.6324
Key Points

Question  Is rotavirus vaccination associated with type 1 diabetes in children?

Findings  In this cohort study with a median follow-up of 5.4 years (interquartile range, 3.8-7.8 years), 360 169 children were exposed to the full series of rotavirus vaccination, 15 765 children were partially exposed to rotavirus vaccination, and 11 003 children were unexposed to rotavirus vaccination. The incidence of type 1 diabetes was not significantly different across the rotavirus vaccine exposure groups.

Meaning  Rotavirus vaccination does not appear to be associated with type 1 diabetes in children.

Abstract

Importance  Because rotavirus infection is a hypothesized risk factor for type 1 diabetes, live attenuated rotavirus vaccination could increase or decrease the risk of type 1 diabetes in children.

Objective  To examine whether there is an association between rotavirus vaccination and incidence of type 1 diabetes in children aged 8 months to 11 years.

Design, Setting, and Participants  A retrospective cohort study of 386 937 children born between January 1, 2006, and December 31, 2014, was conducted in 7 US health care organizations of the Vaccine Safety Datalink. Eligible children were followed up until a diagnosis of type 1 diabetes, disenrollment, or December 31, 2017.

Exposures  Rotavirus vaccination for children aged 2 to 8 months. Three exposure groups were created. The first group included children who received all recommended doses of rotavirus vaccine by 8 months of age (fully exposed to rotavirus vaccination). The second group had received some, but not all, recommended rotavirus vaccines (partially exposed to rotavirus vaccination). The third group did not receive any doses of rotavirus vaccines (unexposed to rotavirus vaccination).

Main Outcomes and Measures  Incidence of type 1 diabetes among children aged 8 months to 11 years. Type 1 diabetes was identified by International Classification of Diseases codes: 250.x1, 250.x3, or E10.xx in the outpatient setting. Cox proportional hazards regression models were used to analyze time to type 1 diabetes incidence from 8 months to 11 years. Hazard ratios and 95% CIs were calculated. Models were adjusted for sex, race/ethnicity, birth year, mother’s age, birth weight, gestational age, number of well-child visits, and Vaccine Safety Datalink site.

Results  In a cohort of 386 937 children (51.1% boys and 41.9% non-Hispanic white), 360 169 (93.1%) were fully exposed to rotavirus vaccination, 15 765 (4.1%) were partially exposed to rotavirus vaccination, and 11 003 (2.8%) were unexposed to rotavirus vaccination. Children were followed up a median of 5.4 years (interquartile range, 3.8-7.8 years). The total person-time follow-up in the cohort was 2 253 879 years. There were 464 cases of type 1 diabetes in the cohort, with an incidence rate of 20.6 cases per 100 000 person-years. Compared with children unexposed to rotavirus vaccination, the adjusted hazard ratio was 1.03 (95% CI, 0.62-1.72) for children fully exposed to rotavirus vaccination and 1.50 (95% CI, 0.81-2.77) for children partially exposed to rotavirus vaccination.

Conclusions and Relevance  The findings of this study suggest that rotavirus vaccination does not appear to be associated with type 1 diabetes in children.

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