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Published on: July 5, 2022
Paediatric rotavirus vaccination, coeliac disease and type 1 diabetes in children: a population-based cohort study
Thomas Inns1,2, Kate M Fleming3, Miren Iturriza-Gomara2,4,5
1St Helens and Knowsley Teaching Hospitals NHS Trust, Merseyside, UK.
Insights
UK rotavirus vaccination does not prevent coeliac disease (CD) or type 1 diabetes (T1D). This large study found no increased risk, confirming rotavirus vaccine safety for children.
Area of Science:
- Immunization
- Gastroenterology
- Endocrinology
Background:
- Rotavirus infection is a suspected risk factor for coeliac disease (CD) and type 1 diabetes (T1D).
- The UK introduced infant rotavirus vaccination in 2013.
- Previous research indicated potential beneficial off-target effects of rotavirus vaccination.
Purpose of the Study:
- To investigate if rotavirus vaccination prevents CD and T1D in the UK.
- To assess the association between rotavirus vaccination and the risk of developing CD and T1D.
- To provide further evidence on the safety profile of rotavirus vaccination.
Main Methods:
- A cohort study of 880,629 children born between 2010 and 2015 using UK primary care records.
- Follow-up from 6 months to 7 years, defining CD by diagnosis or gluten-free prescription and T1D by diagnosis.
- Mixed-effects Cox regression analysis adjusted for confounders to estimate hazard ratios (HRs).
Main Results:
- Rotavirus vaccination was not associated with a reduced risk of CD (adjusted HR = 1.05, 95% CI 0.86-1.28).
- No association was found between rotavirus vaccination and the risk of T1D (adjusted HR = 0.89, 95% CI 0.68-1.19).
- Females had a 40% higher hazard for CD compared to males.
Conclusions:
- This large cohort study found no evidence that rotavirus vaccination prevents CD or T1D.
- The findings support the safety of rotavirus vaccination, showing no increased risk for these conditions.
- Rotavirus vaccination has significantly reduced diarrheal disease globally.
Background:
Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK.
Methods:
A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices.
Results:
There were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86-1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68-1.19).
Conclusions:
Rotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.
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