Brazil Suspends Butantan Single‑Dose Dengue Vaccine After Rare Severe Events

Overview

• The Ministry of Health and Anvisa announced the temporary suspension on Monday, June 8, after routine pharmacovigilance flagged 42 cases with warning signs among about 500,000 people who received Butantan‑DV.
• Officials say investigators have not found evidence of a causal link to the vaccine and describe the pause as a precaution to allow full review of clinical details and safety data.
• Qdenga, the two‑dose dengue vaccine from Takeda, remains available in public health posts and private clinics and is not affected by the Butantan suspension.
• Butantan‑DV is a single‑dose, tetravalent live‑attenuated vaccine that showed about 65% overall efficacy and roughly 80.5% protection against severe dengue in phase‑3 trials with five years of follow‑up.
• Lawmakers have demanded technical reports from Health Minister Alexandre Padilha and some municipalities are following federal guidance to halt local use, raising questions about transparency and short‑term impacts on vaccination campaigns and public confidence.