Integrating the Rabies Vaccine RabiVax-S and VaxiRab-N into Tanzania's Routine Immunization Schedule for the exposed population: A Recommendation from the Tanzania Immunization Technical Advisory Group

Background: Rabies, a fatal zoonotic disease, is still an important public health challenge in Tanzania and has been causing an estimated 350-800 human deaths annually, with children under 15 years of age accounting for over half of the cases. This document reviews evidence data to guide the introduction of pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) using cell-culture or embryonated egg-based rabies vaccines (CCEEVs), precisely RabiVax-S® and VaxiRab-N®, into Tanzania’s routine immunization program. Methods: The Tanzania Immunization Technical Advisory Group (TITAG) met from August to September 2024 to discuss the evidence supporting the introduction of a two-site intradermal (ID) schedule (0, 3 and 7 days) (RabiVax-S®/VaxiRab-N®). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) method was used to assess the quality of available evidence for vaccine efficacy, effectiveness, safety, cost-effectiveness, and programmatic feasibility. Data were obtained from randomized controlled trials, systematic reviews, WHO position papers, GAVI recommendations, and operational research. Results: RabiVax-S® and VaxiRab-N® are highly immunogenic CCEEVs with a clinical efficacy of nearly 100% for both PrEP and PEP. These vaccines induce durable immunological memory. Safety profiles are excellent, with only mild, transient side effects; contraindications include a history of allergic reactions to previous doses. From a cost perspective, the intradermal schedule was more affordable than intramuscular IM schedules. Integration of the program through established health information systems would be possible but needs strategically focused effort in regions with low coverage and healthcare worker training and a robust One Health approach. Recommendation: TITAG recommended the integration of RabiVax-S®/VaxiRab-N® (2-site ID on days 0, 3, and 7) vaccine into the routine vaccination schedule for exposed populations in addition to the recommended standard wound management.