Brazil's drug regulatory agency has approved Japan-based Takeda's four-strain vaccine against dengue virus for use in people ages 4 to 60 years old, the company announced yesterday.
Takeda's vaccine can be used regardless of earlier dengue infection and doesn't require testing for prior infection before use. Brazil is the first country in Latin America to approve the vaccine, called Qdenga, to combat the mosquito-borne disease.
The company's vaccine is a live attenuated product built on a serotype 2 backbone and includes all four dengue serotypes. It is given subcutaneously in two doses, 3 months apart.
Brazilian officials based their approval on clinical studies that included more than 28,000 children and adults. Efficacy varied by dengue serotype, and over the 4.5-year study period, the vaccine prevented 84% of hospitalized cases and 61% of symptomatic cases.
Vivian Kiran Lee, MD, Takeda's medical affairs director in Brazil, said dengue outbreaks and hospitalizations strain Brazil's health system. In 2022, the country saw a huge spike in activity, resulting in more than 1.4 million cases and more than 1,000 deaths. She said the company's vaccine reduces barriers to vaccination and has the potential, when combined with vector control programs, to reduce the burden of the disease on health systems.