The World Health Organisation (WHO) said on May 15 that it had cleared Takeda Pharmaceuticals' dengue vaccine, giving international procurement agencies another option against the disease that affects millions of people each year.
The approval, called a prequalification, comes amid a surge in mosquito-borne viral infections across Asia, Africa, and the Americas, including new spread into previously unaffected areas.
In 2023, the United Nations agency reported an estimated five million cases and more than 5,000 deaths from the disease — the largest on record.
Takeda's vaccine, given in two doses over a three-month interval, protects against four serotypes of the dengue virus. It was cleared by WHO for use in children aged six to 16 in areas with high infection rates.
The prequalification makes it eligible for procurement by UN agencies such as Unicef and Pan American Health Organisation.
The shot, branded Qdenga, is already approved in countries such as Indonesia, Thailand, Argentina and Brazil, and was also authorised in the European Union in 2022.
The Japanese firm is in talks with the Indian drug regulator for approval in the dengue-endemic country. It signed a manufacturing pact with Indian vaccine maker Biological E in February to scale up production to 100 million doses annually by the decade's end.
French giant Sanofi's Dengvaxia is the other available dengue vaccine, having received approval in several countries in the Americas, the EU and Asia starting in 2015.
However, Dengvaxia's usage was considerably scaled after reports that it elevated the risk of severe disease in children without prior dengue exposure.
The vaccine had got WHO's prequalification in 2020 for use in people aged six to 45 years with a confirmed prior infection.
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