The vaccine is the first in the world applied in a single dose and the first entirely Brazilian. According to the federal government, the suspension is temporary for the investigation of the cases.
Government announces suspension of dengue vaccination
After the suspension of immunization against dengue with the vaccine from the Butantan Institute on Monday (8), the Ministry of Health must continue investigating the deaths and adverse cases recorded after the application of the vaccine.
The use of the national vaccine was temporarily discontinued after 42 cases of severe reactions were recorded – including two deaths – that could be linked to the vaccine.
According to the agency, the next steps following the announcement are:
- Discontinuation of application by states and municipalities
The Minister of Health, Alexandre Padilha, stated that the states and municipalities will be informed about the ministry’s decision for the use of the Butantan vaccine to be suspended.
“We will reinforce at this meeting [after the collective with the municipal surveillance networks] the technical note to temporarily discontinue Butantan’s current dengue vaccine strategy,” said Padilha.
He also reinforced that, as this is a temporary suspension, the vaccines must be kept in the municipalities’ refrigerated networks, even without the use of the vaccine.
- Tracking new cases of adverse effects
Another step signaled by the Ministry of Health is the tracking of possible new cases of adverse reactions related to the application of the vaccine.
The department will have meetings with the municipalities where the vaccine was administered to actively search for new complaints. In other words, cities will be instructed to analyze local cases to understand whether there is a possible relationship with the vaccine and notify them.
In addition, the ministry will begin to guide the active monitoring of cases in the hospital network of:
- Dengue in people with recent vaccination;
- Cases with alarm signals; and
- Deaths
The recommendation is to monitor by lot, unit or territory.
- Investigation of deaths and adverse effects
Finally, the ministry will continue the investigation into the serious adverse effects observed, including the two deaths. This is because, despite the announcement of the temporary discontinuation of the use of the vaccine, it is still not possible to establish a causal relationship between the application of the vaccine and deaths.
The National Health Surveillance Agency (Anvisa) notified the Butantan Institute and must convene a committee of experts to conduct the epidemiological investigation of the cases.
In an interview with GloboNews, the infectious disease specialist and director of the Immunization Committee of the Brazilian Society of Infectious Diseases, Rosana Richtmann, stated that, in this aspect, it is essential to try to understand from an epidemiological point of view who are the people who have had adverse events.
“They will analyze all the people who had these signs, even those who were not serious, to see if they have any characteristics in common,” he said.
And whoever has had the vaccine, what should they do?
For those who have already taken the vaccine, the next steps recommended by the Ministry of Health are to pay extra attention to possible adverse effects.
The folder recommends that anyone who was immunized in the last 21 days should be followed up at a local health unit to observe whether or not there will be adverse reactions.
In this scenario, the warning symptoms are:
- Fever
- Severe and continuous abdominal pain
- Persistent vomiting
- Dizziness
- Bleeding
- Intense drowsiness
- Irritability
- Signs of dehydration
- Worsening general condition
What was recorded by pharmacovigilance
In the period from January to May 30, 2026, 3,703 notifications of unexpected events with symptoms similar to dengue were recorded, equivalent to 0.7% of the total number of people vaccinated.
Among these records, 42 cases showed alarm signals. In these, patients presented conditions such as abdominal pain, persistent vomiting and bleeding. These episodes corresponded to 0.008% of the total number of people vaccinated and were classified as very rare events, although not predicted in clinical studies or described in the leaflet.
Among the cases, three were considered serious and, among them, two deaths. The first serious case involves a 39-year-old woman who developed fever, muscle pain and nausea six days after vaccination. According to the federal government, she developed severe dengue fever with shock and had to be admitted to the ICU, but recovered.
The cases of deaths are:
- A 48-year-old woman who developed severe dengue symptoms 19 days after receiving the vaccine. The condition included neurological impairment, with meningoencephalitis, and the patient died.
- A 58-year-old man who developed a fever five days after vaccination and quickly progressed to severe dengue fever with refractory shock. He also died.
As next steps, the National Health Surveillance Agency (Anvisa) reported that it has notified the Butantan Institute and must convene a committee of experts to conduct the epidemiological investigation of the cases.
Butantan will be responsible for analyzing the available information and presenting new data to the authorities. The research work will be conducted jointly by Anvisa, the Ministry of Health, through the PNI, and the Butantan Institute.
Measure does not affect Qdenga
Incorporated into the National Immunization Program (PNI) at the end of 2023, the Qdenga vaccine, developed by the pharmaceutical company Takeda, is available in the SUS (free of charge) for children and adolescents aged 10 to 14 years, the age group that concentrates the highest number of hospitalizations for dengue after the elderly (the vaccine was not released by Anvisa for people over 60 years of age).
