Brasília – Brazil’s Health Minister Alexandre Padilha says Anvisa is expected to approve the Butantan Institute’s dengue vaccine by the end of 2025, enabling its inclusion in the National Immunization Program (PNI) in 2026. He emphasized that the vaccine, developed entirely in Brazil, marks a key milestone for the country’s technological independence in producing immunobiologicals.

Anvisa confirmed that the registration dossier was submitted on February 6, 2025, and that additional technical data are under evaluation. Once approved, the vaccine will become the first fully Brazilian dengue immunization, strengthening national capacity to respond to outbreaks and reducing dependence on imported formulations.

Source: O Globo