ROTAVAC 5D® Vaccine: Recommendations of the Tanzania Immunization Technical Advisory Group

Abstract

Background:  Rotavirus gastroenteritis causes most diarrheal deaths, with 95% of cases occurring in low-income countries. The implementation of Rotarix™ vaccine in 2013 in Tanzania, resulted in a significant decrease of Rotavirus positivity and hospitalization among children under 5 years of age. Due to a decrease in the supply of  Rotarix™, it was necessary to switch to ROTAVAC 5D® vaccine to ensure a sustained vaccination supply and  avoid associated morbidity and mortality as result of the shortage.

Methods: The Tanzania Immunization Technical Advisory Group (TITAG) held its 5th meeting from 21st to 25th February 2022 in Dodoma, during which it reviewed the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to assess the potential switch from Rotarix^TM to ROTAVAC 5D®.

Results: ROTAVAC 5D® was found to be safe and efficacious with similar margins to other WHO prequalified Rotavirus vaccines including Rotarix™. Although ROTAVAC 5D® is based on human G9P [11] Rotavirus 116E strain, the vaccine offers heterotypic (cross) protection against multiple Rotavirus strains. Taking into consideration of other factors, the costs benefit analysis for the Rotavirus Vaccines (Rotarix™ and ROTAVAC 5D®) proved to be  cost-effective relative to no vaccination. The total incremental economic costs per child for Rotarix™ was found to be the least costly and cost-effective compared to ROTAVAC 5D®, but the differences were small and subject to change with minor adjustments to uncertain input variables.

Conclusions and Recommendations: The high-quality evidence available has clearly demonstrated that ROTAVAC 5D® (liquid, 5 doses vial) was comparable to ROTARIX™ in terms of safety, efficacy, cross-protection to wild Rotavirus, and cost-effectiveness. Hence, the TITAG recommended the use of ROTAVAC 5D® a five-dose vial (liquid) in Tanzania. Continuous surveillance is crucial for obtaining data on vaccine effectiveness, Adverse Events Following Immunization (AEFIs) including intussusception rates, as recommended by WHO, to make timely decisions regarding ROTAVAC 5D® vaccine use.