OBJECTIVES: Dengue fever represents a significant burden for the Brazilian population. Between January and May 2024, more than 4.5 million cases and 2300 deaths related to dengue had been reported, three and two times increase compared to the same period in 2023. In the pivotal phase 3 trial (DEN-301), TAK-003 demonstrated efficacy against virologic confirmed dengue (VCD) and hospitalizations VCD up to 4.5 years. This study evaluates the public health impact and cost-effectiveness of vaccination strategies across different age groups, compared to non-vaccination.

METHODS: A static model with a dynamic component was developed to assess the impact of vaccination with TAK-003 on epidemiologic, economic and quality of life outcomes in Brazil, capturing both direct and indirect protections. Model inputs were derived from Brazil's official databases and the model was fitted to the country's dengue epidemiology. Vaccine efficacy was derived from DEN-301 study and extrapolated over 20 years to assess the outcomes over this period. Vaccination strategies were analyzed within each five-year age group across the age indication locally approved, assuming 90% coverage and an illustrative cost of US$25 per dose. Benefits were measured by quality-adjusted life years (QALY).

RESULTS: Modeling results revealed that implementing vaccination strategies with TAK-003 holds the potential to decrease by up to 26% and 29% symptomatic cases and hospitalizations, respectively, compared to non-vaccination, depending on the age strategy assessed. TAK-003 vaccination was dominant in most scenarios from a societal perspective, with up to 353,748 QALYs gained and savings of up to $260 million. From a payer’s perspective, TAK-003 was cost-effective across all evaluated scenarios, considering the US$8,264/QALY threshold set by the Brazilian HTA agency.

CONCLUSIONS: The TAK-003 vaccination program may lead to a significant reduction in disease burden and costs, regardless of the age group evaluated, and may serve as an additional effective dengue control measure for the Brazilian population.