Peer-reviewed article
Does an off-label two-dose RotaTeq vaccine schedule translate into a higher incidence of rotavirus hospital admissions compared to the approved three-dose RotaTeq schedule? A Canadian immunization research network study.
Élise Fortin, Éliane Miron, Ramandip Grewal, Sarah E Wilson, Naveed Z Janjua et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This Canadian study compared rotavirus hospital admissions in children aged 6-23 months between provinces using a standard three-dose RotaTeq vaccine schedule and Quebec, which switched to a two-dose schedule in 2018. The researchers found no statistically significant increase in rotavirus-related hospital admissions after Quebec's switch to the reduced schedule. Overall, rotavirus vaccination programs across Canada reduced hospital admissions for rotavirus-related gastroenteritis by 87% compared to the pre-vaccine period.
Key points
- Rotavirus vaccination programs reduced RV-associated gastroenteritis hospital admissions by 87% across all three provinces after vaccine introduction
- Quebec's two-dose RotaTeq schedule was not associated with a statistically significant increase in rotavirus hospital admissions (rate ratio = 2.32; 95% CI = 0.80-6.69)
- General acute gastroenteritis admissions showed no significant difference between Quebec's two-dose and other provinces' three-dose schedules (rate ratio = 1.02; 95% CI = 0.91-1.14)
- Only 19 rotavirus-related gastroenteritis hospital admissions were identified among the target age group across all three provinces during the 21-month period after Quebec's schedule change
- Study provides evidence supporting the use of a two-dose RotaTeq schedule in high-income settings with high vaccination coverage
Limitations
The study measures hospital admissions rather than all rotavirus disease cases, so milder infections treated in outpatient settings are not captured. The 95% confidence interval for the two-dose comparison includes the null value, meaning the study cannot definitively rule out a small increase in risk from the reduced schedule.
Abstract
BACKGROUND: Rotavirus (RV) vaccination programs were implemented between 2011 and 2012 in Canada and have considerably reduced the burden of RV disease. In September 2018, the province of Quebec implemented a reduced-dose RotaTeq vaccination schedule (two doses). Other provinces, such as British Columbia and Ontario, continued to use the approved three-dose schedule for this product. Our aim was to determine whether using a reduced-dose RotaTeq schedule was associated with an increased burden of RV disease. METHODS: This quasi-experimental study spanned from September 2006 to March 2023. The main analysis focused on children aged 6-23 months in Quebec, Ontario, and British Columbia. Data were retrieved from administrative databases using diagnosis-specific ICD-10 codes. A difference-in-differences approach using Poisson regression was used to compare admission rates for rotavirus-associated acute gastroenteritis (RV-AGE) and for any acute gastroenteritis (AGE) before and after the implementation of a reduced-dose RotaTeq vaccination schedule in Quebec. FINDINGS: A total of 3875 RV-AGE and 36,568 AGE hospital admissions were identified. Across the three provinces, the rates of admission for RV-AGE and AGE were 87% and 56% lower, respectively, after vaccine program introduction as compared to before. After the implementation of the reduced-dose RotaTeq vaccination schedule in Quebec, between September 2018 and August 2020, only 19 RV-AGE hospital admissions were identified among children between 6 and 23 months of age in the three provinces. In Quebec, the reduced schedule was not associated with a statistically significant increase in RV-AGE admissions (rate ratio = 2.32; 95%CI = 0.80-6.69), or for AGE admissions in general (rate ratio = 1.02; 95%CI = 0.91-1.14), compared to temporal trends in the other two provinces. INTERPRETATION: This study provides reassuring evidence regarding the use of a two-dose RotaTeq schedule in a high-income country with relatively high vaccination coverage and reaffirms the substantial impact of RV vaccination introduction at a population level.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
Problem
High incidence of rotavirus-related gastroenteritis and associated hospital admissions in children
- Intervention
- Reduced-dose (two-dose) RotaTeq vaccination schedule implemented in Quebec, compared to approved three-dose schedule in Ontario and British Columbia
- Population
- Children aged 6-23 months in three Canadian provinces (Quebec, Ontario, British Columbia) between September 2006 and March 2023
Key finding
Two-dose schedule not associated with statistically significant increase in rotavirus-associated gastroenteritis admissions (rate ratio = 2.32; 95% CI = 0.80-6.69)
Fortin et al. · PubMed (US National Library of Medicine) · 2 May 2026