Takeda’s new dengue vaccine, TAK-003, has received prequalification from the World Health Organization (WHO).

TAK-003 is the second dengue vaccine to achieve this status.

WHO has recommended the use of the new vaccine for children aged six to 16 years in areas with a high burden of dengue and transmission.

A live-attenuated vaccine, TAK-003 includes weakened forms of all four serotypes of the dengue virus.

It is designed to be administered in a two-dose regimen with an interval of three months between doses.

Sanofi Pasteur’s CYD-TDV dengue vaccine had previously received the WHO prequalification.

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Dengue, a mosquito-borne disease, poses a significant health threat with an estimated 100 to 400 million cases annually.

The disease is prevalent in Asia, Africa and the Americas, with the WHO region of the Americas reporting 4.5 million cases and 2,300 deaths in 2023 alone.

WHO regulation and prequalification director Dr Rogerio Gaspar stated: “The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies including UNICEF and PAHO.  

“With only two dengue vaccines to date prequalified, we look forward to more vaccine developers coming forward for assessment so that we can ensure vaccines reach all communities who need it.”

Earlier this month, Takeda entered an exclusive worldwide option and licence agreement with AC Immune for an Alzheimer’s disease immunotherapy in a $2.2bn deal.