Rotavirus vaccination does not appear to increase or decrease the risk of developing  type 1 diabetes, according to the findings of a recently published retrospective cohort study.

To investigate the association between receipt of the live attenuated rotavirus vaccine and the risk of type 1 diabetes, researchers analyzed data from the Vaccine Safety Datalink that included 386,937 children 8 months to 11 years of age. The main outcome of the study was the incidence of type 1 diabetes, controlling for other risk factors including sex, race/ethnicity, birth year of child, season of child’s birth, mother’s age, weight at birth, gestational age, and number of well-child visits between 30 days and 2 years. 

During the analysis, children were divided into 3 exposure groups. The “fully exposed” group included children who received all recommended doses of the rotavirus vaccine by 8 months old (93.1%). The “partially exposed” group included children who received some of the recommended doses of the vaccine (4.1%). The “unexposed” group included children who did not receive any doses of the vaccine (2.8%). All patients included in the study were followed until a diagnosis of type 1 diabetes was made, disenrollment of the patient, or December 31, 2017. 

The study authors reported a median follow-up period of 5.4 years (interquartile range, 3.8-7.8 years) and a person-time follow-up of 2,253,879 years. A total of 464 cases of type 1 diabetes were identified during the analysis, equating to an incidence rate of 20.6 cases per 100,000 person-years. The authors reported adjusted hazard ratios of 1.03 (95% CI, 0.62-1.72) for children fully exposed to the vaccine and 1.50 (95% CI, 0.81-2.77) for children partially exposed compared with children not exposed to the vaccine at all. 

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“In this large cohort study, we did not find evidence that rotavirus vaccination was associated with an increased or decreased incidence of type 1 diabetes in children,” the authors concluded. They added, “Although rotavirus vaccination may not prevent type 1 diabetes, these results should provide additional reassurance to the public that rotavirus vaccination can be safely administered to infants.”


Glanz JM, Clarke CL, Xu S, et al. Association Between Rotavirus Vaccination and Type 1 Diabetes in Children. JAMA Pediatr. Published online March 09, 2020. doi:10.1001/jamapediatrics.2019.6324