Anvisa will establish a panel of experts to deepen the epidemiological investigation about the Butantan-DV vaccine

Picture: Butantan Institute

The Brazilian Health Regulatory Agency (Anvisa) announced it will establish a panel of experts, with representatives from academia and the scientific community, to expand the epidemiological investigation related to the manufacture of the dengue vaccine by the Butantan Institute (Butantan-DV).

The decision was made during a press conference of the Ministry of Health (June 8th), which announced the Butantan-DV vaccination strategy against dengue will be temporary discontinued as a preventive measure after some rare, unexpected events have been observed. Those events raised warning concerns related to the vaccine.

The panel of experts will deepen the analyses and will guide Anvisa's review of the vaccine profile. To advance the studies, the Agency has already requested new data from Butantan Institute, which will be evaluated jointly with the Ministry of Health National Immunization Program. Such procedure is initiated whenever new information is collected that may change the risk-benefit balance of an immunizing agent.

The Butantan-DV vaccine was approved in Brazil in December 2025 based on 16 phase 1 clinical studies, in addition to phase 2 and 3 studies. Those studies evaluated more than 11,000 people, following international regulatory practices and the World Health Organization (WHO) guidelines.

The measures adopted do not affect other dengue vaccines registered in Brazil.