✓ verbatim from the press
Brazil's Health Ministry suspended on Monday (8) dengue vaccination with the immunizer developed by the Butantan Institute after registering 42 severe adverse reactions among about 500,000 vaccinated people, including three serious cases with two deaths under investigation. Health Minister Alexandre Padilha stated at a press conference that "there is insufficient data to establish causality between the vaccine and these serious cases, but it is an alert signal." ✓
Press quotes (2)
"O Ministério da Saúde anunciou, nesta segunda-feira (8), a suspensão temporária da imunização contra a dengue no país com a vacina desenvolvida pelo Instituto Butantan."
"não há dados para estabelecer a relação entre as mortes e a vacina diretamente. É um sinal de alerta para o sistema de vigilância"
The Butantan-DV vaccine — the first dengue vaccine developed entirely in the country and the world's first single-dose dengue vaccine — was being administered primarily to primary healthcare workers since January this year. According to National Immunization Program data, 417,432 healthcare professionals and 83,612 residents aged 15-59 in pilot cities Botucatu (SP), Nova Lima (MG), Maranguape (CE), and Araguaína region (TO) were vaccinated. ✓
Press quotes (1)
"A pasta afirma que 501.044 doses foram usadas no SUS, sendo que 417.432 vacinas foram aplicadas em profissionais de saúde de todo o país. Outras 83.612 doses serviram para estratégias de vacinação da população de 15 a 59 anos em Maranguape (CE), Nova Lima (MG), Botucatu (SP) e na região de Araguaína (TO)."
The three serious cases occurred among healthcare workers. A 39-year-old woman developed severe dengue with shock six days after vaccination, required ICU admission but was discharged. A 48-year-old woman developed meningoencephalitis 19 days after immunization and died. A 58-year-old man had fever five days after vaccination, progressing to refractory shock and death. The events were classified as "unexpected" for not appearing in clinical studies that tested the immunizer in 11,000 volunteers. ✓
Press quotes (1)
"O primeiro caso envolveu uma mulher de 39 anos que apresentou febre, dores musculares e náuseas seis dias após receber a vacina e evoluiu para sintomas de dengue grave, com choque e necessidade de internação em unidade terapia de intensiva (UTI). A paciente foi curada e recebeu alta. O segundo foi de uma mulher de 48 anos que desenvolveu sintomas de dengue grave com comprometimento neurológico, tendo recebido um diagnóstico de meningoencefalite 19 dias após a vacinação. A paciente morreu"
The suspension does not affect the Qdenga vaccine by pharmaceutical company Takeda, which continues to be administered to children and adolescents aged 10-14 in the Unified Health System. The Health Ministry advised people vaccinated with Butantan-DV in the last 21 days to seek medical follow-up if experiencing symptoms like fever, intense abdominal pain, persistent vomiting, bleeding, or warning signs. The Butantan Institute reported it will collaborate with investigations and hopes to resume vaccination "upon confirming its safety." ✓
Press quotes (2)
"A decisão não altera a aplicação da vacina Qdenga, já distribuída pelo Sistema Único de Saúde (SUS)."
"O Instituto Butantan informa que, seguindo orientação do Ministério da Saúde e da Anvisa, a vacinação contra a dengue será, de maneira preventiva, temporariamente interrompida para reavaliação da estratégia vacinal."
The suspension was recommended by the Interinstitutional Pharmacovigilance Committee (Cifavi) and Technical Advisory Chamber on Immunizations (Ctai)
Covered by only some sources, or where the accounts diverge.
Covered by only some sources (1)
The contract for purchasing the vaccine cost R$ 367.95 million for 3.9 million doses, at R$ 94.35 per dose
Conflicting versions (1)
-
What was the formal administrative act that determined the vaccination suspension?
Why it's still unknown: No official document (ordinance or resolution) published in the Official Gazette formalizing this administrative decision was found, only announcements at press conferences.
-
What is the expected timeline for completing investigations into adverse events?
Why it's still unknown: Minister Alexandre Padilha stated there is no defined deadline for concluding analyses of adverse effects.
-
What will be the epidemiological impact of the suspension in terms of compromised vaccination coverage?
Why it's still unknown: No data was released on interrupted vaccination targets or timeline for replacement with other available immunizers.
-
What specific technical characteristics of Butantan-DV might explain adverse events not observed with Qdenga?
Why it's still unknown: Technical differences between the two immunizers that would justify selective suspension only of the Butantan vaccine were not detailed.