MercoPress. South Atlantic News Agency

Brazil approves locally produced dengue vaccine

Padilha said that the first doses could become available as early as next month

Brazil's National Health Surveillance Agency (Anvisa) has approved the final administrative step before the formal registration of the single-dose dengue vaccine developed by the São Paulo-based Butantan Institute for people aged 12 to 59, which protects against all four virus serotypes.

The announcement was made on Wednesday as the distribution strategy for the National Immunization Program (PNI) was unveiled. Health Minister Alexandre Padilha attended the occasion.

The drug, known as the Butantan-DV vaccine, is the first of its kind to be produced in Brazil, the result of a partnership among Brazil's Health Ministry, the Butantan Institute, and the Chinese laboratory WuXi.

The vaccine demonstrated 91.6% efficacy against severe dengue and 100% efficacy against hospitalizations in the 12-59 age group. General efficacy against symptomatic dengue episodes was 74.7% in phase 3 studies. An earlier phase 3 trial published in The Lancet Infectious Diseases reported 89% protection against severe episodes with warning signs.

The Butantan Institute has already produced 1 million doses for immediate delivery to the PNI and expects to have 100 million more doses available throughout 2026 and 2027.

Padilha underscored that the single-dose, quadrivalent vaccine was “100% Brazilian” and “more comprehensive in its protection capacity.” He announced that a committee of specialists would be convened to finalize the strategy for incorporating the vaccine into the PNI in early 2026, with the possibility of administering the first doses as early as December of this year.

Pan American Health Organization (PAHO) Director-General Jarbas Barbosa stressed the urgency, noting that dengue led to 13 million cases and 9,000 deaths across the Americas in 2024. Barbosa is a Brazilian national.

Despite the vaccine approval, Butantan Director Esper Kallás stressed that citizens must continue efforts to combat the Aedes aegypti mosquito, which also transmits Zika and Chikungunya. He suggested that professionals engaged in disease control, such as mosquito combat teams, could be prioritized for early doses due to their high exposure.

Currently, the only dengue vaccine available through Brazil's public health system is Qdenga (Takeda), which is limited to the population aged 10 to 14.