WHO prequalifies Japanese drug maker Takeda's dengue vaccine

New Delhi, May 15 The World Health Organisation (WHO) on Wednesday announced that it has prequalified Japanese drug maker Takeda's dengue vaccine.

The live-attenuated TAK-003 vaccine is the second dengue jab to be prequalified by the WHO.

It contains weakened versions of the four serotypes of the virus that cause dengue, the WHO said.

Previously, the WHO prequalified the CYD-TDV vaccine for dengue developed by Sanofi Pasteur.

The UN health body recommended the use of TAK-003 in children aged 6-16 years in areas with high dengue burden and transmission intensity. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses, it noted.

"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," said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification, in a statement. He called for more vaccine developers to come forward for assessment to “ensure vaccines reach all communities who need it”.

Earlier this year, Takeda partnered with Hyderabad-based Biological E to accelerate the manufacture of TAK-003 in India.

According to the companies, Biological E will scale up the production capacity to potentially reach 50 million doses annually. It will also accelerate Takeda's efforts to manufacture 100 million doses annually within the decade, they said.

As per Takeda's Phase 3 trial, published in The Lancet Global Health, TAK-003 continues protection against dengue fever through four and a half years (54 months) after vaccination.

Dengue is a vector-borne disease transmitted by the bite of an infected mosquito. Global estimates show that there are over 100-400 million cases of dengue each year and 3.8 billion people living in dengue-endemic countries, most of which are in Asia, Africa, and the Americas.

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