WHO clears Takeda's dengue vaccine

(Reuters) -The World Health Organization (WHO) said on Wednesday 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 amidst a surge in mosquito-borne viral infections across Asia, Africa, and the Americas, including new spread into previously unaffected areas.

Last year, the UN agency reported an estimated 5 million cases and over 5000 deaths due to 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 6 to 16 in areas with high infection rates.

The prequalification makes it eligible for procurement by United Nations agencies like UNICEF and Pan American Health Organization.

The shot, branded Qdenga, is already approved in countries like Indonesia, Thailand, Argentina and Brazil, and was also authorized 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 6 to 45 years with a confirmed prior infection.

(Reporting by Christy Santhosh; Editing by Tasim Zahid)