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Fiocruz submits formal request to manufacture dengue vaccine in Brazil

The vaccine will be produced in partnership with Japan's Takeda
Rafael Cardoso
Published on 17/10/2024 - 09:56
Agência Brasil - Rio de Janeiro
Dengue: a realidade de uma epidemia - Caminhos da Reportagem. O instituto Butantan está desenvolvendo a primeira vacina contra a dengue totalmente Brasileira. O Brasil já registrou mais de um milhão e meio de casos de dengue este ano e mais de mil óbitos até abril deste ano. Em 2024, bateremos o recorde de casos de dengue desde o início da série histórica, em 1990. Foto: Frame/TV Brasil
© Frame/TV Brasil

The Oswaldo Cruz Foundation (Fiocruz) has formally requested approval from the Ministry of Health to produce in Brazil the Qdenga vaccine, developed by Japan's Takeda, under a technology transfer agreement through a Productive Development Partnership (PDP).

Brazil’s national drug regulator Anvisa approved the registration of the Qdenga vaccine in March 2023, allowing it to be sold in Brazil under the approved conditions. In December last year,, the Ministry of Health announced the vaccine's inclusion in the country´s public healthcare system, the SUS.

The Ministry of Health reported purchasing four million doses of the vaccine from the Japanese laboratory in 2024, with a contract in place to distribute an additional nine million doses in 2025.

The vaccine began being administered through the public health sysem in February this year. Due to the limited supply from the manufacturer, it was prioritized for children and adolescents aged 10 to 14, the group with the highest hospitalization rates after the elderly. Individuals over 60 are not recommended to receive the vaccine, as there are no clinical studies supporting its use in this age group.

The World Health Organization (WHO) defines Qdenga as a live attenuated vaccine, containing weakened forms of all four dengue virus serotypes. WHO recommends the vaccine for children and adolescents aged 6 to 16 in regions with high dengue transmission. Qdenga is administered in two doses, spaced three months apart, following the vaccination schedule currently in place in Brazil.

The arbovirus monitoring panel reports 6,547,438 probable cases of dengue across Brazil in 2024, with 5,613 confirmed deaths and 1,499 still under investigation.

In addition to Qdenga, the Butantan Institute is also developing a dengue vaccine, with plans to submit the registration application to Anvisa later this year.