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Ministry of Health has preemptively halted the application of Butantan-DV while investigating rare adverse events after about 500 thousand doses administered.
A decision with a strong impact on Brazilian public health put the Butantan dengue vaccine in the spotlight this Monday, June 8, 2026.
The Ministry of Health temporarily suspended the application of Butantan-DV after the registration of two suspected deaths and severe adverse events among vaccinated individuals.
The measure, according to the federal government, is preventive. Therefore, it does not confirm a direct relationship between the vaccine and the cases under investigation.
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By May 30, 2026, about 500 thousand doses had been administered in the country. Within this group, the Ministry of Health recorded 3,703 reports of adverse events, equivalent to 0.7% of those vaccinated.
Among these reports, 42 cases showed alarm signs compatible with severe dengue, such as abdominal pain, persistent vomiting, and bleeding. This group represents 0.008% of the total immunized.
Technical investigation examines severe cases after vaccination
The suspension was recommended by the National Pharmacovigilance Committee, after analyzing the reports made by municipal, state, and federal surveillance systems.
According to the Minister of Health, Alexandre Padilha, three cases were classified as severe. Of this total, two resulted in death.
The first severe case involved a woman of 39 years, who experienced fever, muscle pain, and nausea six days after vaccination. Subsequently, she developed severe dengue, required ICU care, but recovered.
Another case involved a woman of 48 years, who showed symptoms of severe dengue 19 days after receiving the vaccine. The condition included neurological impairment and meningoencephalitis.
The third case involved a man of 58 years, who had a fever five days after immunization. He then rapidly progressed to severe dengue with refractory shock.
So far, according to the Ministry of Health, there is not enough data to confirm a causal relationship between the vaccine and the deaths. Nonetheless, the interruption was adopted for safety.
Butantan-DV was administered in a single dose in Brazil
The Butantan-DV is the first dengue vaccine administered in a single dose and also the first entirely Brazilian.
At the beginning of 2026, the campaign prioritized healthcare professionals, who received about 417 thousand doses.
Another 83.6 thousand doses were administered to people aged 15 to 49 years in Botucatu (SP), Maranguape (CE), Nova Lima (MG), and the region of Araguaína (TO).
According to the Ministry of Health, these locations did not report significant adverse events among the vaccinated residents.
States and municipalities should pause new applications
States and municipalities should suspend new applications of the Butantan dengue vaccine while the investigation continues.
The Ministry of Health also informed that it will hold meetings with the cities to reinforce active search for possible adverse reactions.
People vaccinated in the last 21 days should watch for symptoms such as fever, intense abdominal pain, persistent vomiting, dizziness, and bleeding.
Also requiring attention are signs like intense drowsiness, irritability, dehydration, and worsening of general condition.
If these symptoms appear, the guidance is to seek assistance from the local health department.
Anvisa, PNI, and Butantan monitor the next steps
Anvisa notified the Butantan Institute and will convene a committee of experts to conduct the epidemiological investigation.
Meanwhile, the Butantan Institute will be responsible for analyzing the available data and presenting new information to the health authorities.
In a statement, the institute said it would follow the guidance of the Ministry of Health and Anvisa. It also reinforced its commitment to scientific rigor and the safety of the population.
According to Butantan, the vaccine showed a global efficacy of 79.6% and 89% protection against severe dengue in a study published in the scientific journal Nature.
Suspension does not interfere with the Qdenga vaccine
The measure does not affect the application of Qdenga, a vaccine developed by the pharmaceutical company Takeda and incorporated into the National Immunization Program at the end of 2023.
Currently, Qdenga remains available for free in the SUS for children and adolescents aged 10 to 14 years.
The suspension of Butantan-DV remains temporary and preventive. Now, the central question is knowing when the investigations will provide enough answers to determine the future of the first Brazilian vaccine against dengue, isn’t it?
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