Brazil's Anvisa forms expert panel to assess safety of Butantan dengue vaccine

On 16 June 2026, Brazil's health regulator Anvisa issued Portaria 715/2026 establishing a specialist working group to deepen the safety evaluation of the Butantan‑DV dengue vaccine. The group will coordinate technical support for an external panel of experts tasked with reviewing clinical data on adverse events reported after immunisation.

Members of the group will come from Anvisa’s divisions for biological products, pharmacovigilance, product monitoring and sanitary inspection, with invited participation from the Ministry of Health’s National Immunisation Programme. The panel will be consultative, composed of qualified professionals without conflicts of interest. Its remit includes analysing supplemental information supplied by the Institute Butantan, consolidating all data, and reassessing the vaccine’s risk‑benefit profile.

The step follows a temporary suspension of the vaccine’s use in the public health system after 42 adverse‑event reports – three classified as serious and two resulting in deaths – among roughly 500,000 people who had received the dose. No causal link has been confirmed. The working group will remain in operation for an undefined period, providing technical reports that will guide the Anvisa Collegiate Board’s regulatory decisions.