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Dengue Fever: WHO Prequalifies ‘TAK-003’ as Second Vaccine

The World Health Organisation (WHO) has prequalified the second dengue vaccine, TAK-003 as a new weapon in the fight against the mosquito-borne illness prevalent in tropical and subtropical regions.

The new vaccine for dengue received prequalification on May 10, 2024, according to a press statement released by the WHO on Wednesday, on its website.

According to WHO, dengue is a vector-borne disease transmitted by the bite of an infected mosquito. Severe dengue fever is a potentially lethal complication that can develop from dengue infections.

Annually, an estimated 100-400 million dengue cases occur worldwide, affecting 3.8 billion people across endemic regions primarily in Asia, Africa, and the Americas.

The record for the highest number of cases was set in 2023 when the WHO region of the Americas reported approximately 4.5 million cases and 2,300 deaths.

The global health body in a statement on Wednesday, however, said TAK-003, developed by Takeda, is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that causes dengue fever.

It recommends using TAK-003 in children aged 6-16 years in settings with high dengue burden and transmission intensity, adding that the vaccine should be administered in a 2-dose schedule with a 3-month interval between doses.

WHO Director for Regulation and Prequalification, Dr Rogerio Gaspar, said, “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.”

The WHO official said it is estimated that there are over 100 to 400 million cases of dengue worldwide each year and that 3.8 billion people live in dengue-endemic countries, most of which are in Asia, Africa, and the Americas.

“The largest number of dengue cases reported was in 1023 with the WHO Region of the Americas reporting 4.5 million cases and 2300 deaths. Dengue cases are likely to increase and expand geographically due to climate change and urbanization,” Gasper said.

The pre-qualification of TAK-003 comes alongside the existing WHO-approved CYD-TDV vaccine developed by Sanofi Pasteur.