Takeda’s dengue vaccine has been pre-qualified by the World Health Organization (WHO), making it the second such vaccine to do so.

Developed by Japan’s Takeda, TAK-003 is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue. A WHO pre-qualification paves the way for easier adoption of the vaccine in countries, including those without strong regulatory systems.

WHO recommends the use of TAK-003 in children aged 6–16 years in settings with high dengue burden and transmission intensity. The vaccine is administered in a two -dose schedule with a three-month interval between doses.

Earlier this year, Japan’s Takeda had inked a partnership with Biological E, involving its dengue vaccine QDENGA (TAK-003) and this formed a critical part of the company’s strategy to ramp up supplies in India and globally, Gary Dubin, Takeda’s President of the Global Vaccine Business Unit had told businessline.

Company top-brass had also said then, that they were working with the Indian regulatory authority towards licensure.

Climate change impact

Prequalification of this vaccine is important, as it expands global access by making it eligible for procurement by UN agencies including UNICEF and PAHO, said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. “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,” Gaspar said. The prequalification list also includes Sanofi Pasteur’s CYD-TDV vaccine against dengue.

Dengue is a vector-borne disease transmitted by the bite of an infected mosquito and cases are expected to increase and expand geographically due to climate change and urbanization, the WHO said.

Over 100-400 million cases of dengue are estimated worldwide each year and 3.8 billion people live in dengue-endemic countries, mostly in Asia, Africa and the Americas. The largest number of dengue cases reported was in 2023 with the WHO Region of the Americas reporting 4.5 million cases and 2,300 deaths.

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