Study Finds No Evidence Linking Rotavirus Vaccine, T1D in Children


Investigators found no statistically significant evidence associating rotavirus vaccinations with type 1 diabetes (T1D) in children, according to results from a large cohort study published in JAMA Pediatrics.

Investigators found no statistically significant evidence associating rotavirus vaccinations with type 1 diabetes (T1D) in children, according to results from a large cohort study published in JAMA Pediatrics.

Rotavirus is most common in infants and young children, the CDC states. Symptoms can include vomiting, diarrhea, and dehydration. Currently, 2 rotavirus vaccines are licensed for use in infants in the United States. For each, multiple doses are administered orally over the course of 2 to 6 months. The CDC recommends “the first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old.”

“Concurrent increases in islet autoantibodies and rotavirus antibodies have been observed in children at risk for diabetes, and epidemiologic data suggest an association between gastrointestinal infection and incidence of T1D in children followed up from birth to 10 years of age,” the authors note. Because of this, some researchers hypothesize rotavirus infection could be a potential risk factor for T1D and that a live attenuated vaccination may increase or decrease the risk of T1D in children.

In a retrospective cohort study of 386,937 children, the investigators assessed the incidence of T1D among children aged 8 months to 11 years, with varying exposures to the vaccine. Children were followed for a median (interquartile range) 5.4 (3.8-7.8) years.

Three exposure groups were created. Children who received all recommended doses of a rotavirus vaccine by 8 months were considered fully exposed (n = 360,169). The second group was considered partially exposed, as children received some but not all recommended doses (n = 15,765). Unexposed children did not receive any rotavirus vaccines (n = 11,003).

Electronic health record data were collected from 7 integrated healthcare organizations participating in the Vaccine Safety Datalink (VSD), a research collaboration led by the CDC.

The researchers restricted the unexposed cohort to children “who had received all recommended vaccines except rotavirus vaccination to ensure that the association of rotavirus vaccination with the primary outcome could be isolated when comparing the incidence of T1D between the exposed and unexposed groups.” Additional adjustments were made for sex, race/ethnicity, birth year, mother’s age, birth weight, and gestational age. However, most cohort members were not followed through 10 to 14 years of age, when the incidence of T1D peaks, the authors noted.

Reported incidences of T1D included 415 cases in the fully exposed group, 32 cases in the partially exposed group, and 17 cases in the unexposed group. The total of 464 cases of T1D in the cohort represented an incidence rate of 20.6 cases per 100,000 person-years. Of the 464 children with diagnoses, 47.6% were female, and the majority (59.3%) were non-Hispanic white.

“Our findings do not show an association between rotavirus vaccination and T1D in children followed up for a median of 5.4 years,” the researchers concluded.

In the United States, from 2008 to 2013, “acute gastroenteritis-related hospitalization rates decreased between 31% and 55% during the postvaccination years…amounting to $1.2 billion in saved hospitalization costs.”

In addition, since their licensure, the 2 rotavirus vaccines have been associated with reduced rotavirus-related morbidity and mortality both in the United States and worldwide. Given the public health benefits and cost savings, continued used of the rotavirus vaccine is recommended.


Glanz JM, Clarke CL, Xu S, et al. Association between rotavirus vaccination and type 2 diabetes in children. JAMA Pediatr. 2020;174(5):455-462. doi: 10.1001/jamapediatrics.2019.6324

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