Institute continues with 997 volunteers aged 60 to 79 in 4 centers in the south of the country, at the same time that application was suspended
The Butantan Institute continues to study the Butantan-DV dengue vaccine in people aged 60 or over. The research continues at the same time that the Ministry of Health temporarily applies the vaccine on Monday (June 8, 2026).
Clinical trials are ongoing in 4 centers in Rio Grande do Sul and 1 in Paraná. The study has 997 participants of both sexes.
Among the volunteers, 767 people aged 60 to 79 were selected by lottery. Of this group, 690 will receive the vaccine. Another 77 will receive a placebo. Additionally, 230 adults aged 40 to 59 will receive the vaccine. In this age group, there will be no placebo group.
In a note to Poder360the Institute reaffirmed that the suspension determined by the Ministry of Health does not affect ongoing clinical studies. “What was discontinued was the vaccination application strategy for health professionals and in the 3 municipalities where mass application was being carried out”said this Wednesday (June 10).
SUSPENSION AND HISTORY OF THE VACCINE
The suspension by the Ministry of Health took place after the identification of 42 severe cases. Of these, 3 cases were classified as serious. The agency reported that there were two deaths.
More than 500,000 doses were administered from January to May 30. Of the total, 3,703 people had symptoms similar to dengue.
The 42 vaccinated with alarm symptoms had abdominal pain, persistent vomiting or bleeding. According to the Ministry of Health, the events are rare and unexpected, as they were not reported during the study phase.
The government reported that, of the 42 people, 3 had serious symptoms and were hospitalized. Two died:
- case 1: 48-year-old woman developed symptoms of severe dengue with neurological impairment 19 days after immunization;
- case 2: 58-year-old man with fever 5 days after receiving the vaccine. It progressed to symptoms of severe dengue with refractory shock.
A 39-year-old woman, the 3rd patient admitted, had a fever and nausea 6 days after being vaccinated. The condition evolved into severe dengue, requiring an Intensive Care Unit. She was discharged.
