On May 15, the World Health Organization (WHO) granted prequalification to Takeda Pharmaceuticals’ dengue vaccine, Qdenga®, marking a significant step in the fight against dengue fever. This approval allows international procurement agencies to consider Qdenga® as a viable option to combat this mosquito-borne viral disease, which impacts millions globally.
Dengue fever, notably on the rise across Asia, Africa, and the Americas, saw an estimated five million cases and over 5,000 deaths in 2023, as reported by the WHO. This represents the highest annual figures to date.
Takeda’s Qdenga® is administered in two doses over a three-month period and offers protection against all four serotypes of the dengue virus. The WHO’s clearance specifies its use for children aged 6 to 16 in regions with high dengue infection rates. With this prequalification, the vaccine is now eligible for procurement by UN agencies such as UNICEF and the Pan American Health Organization.
Previously, Qdenga® received approvals in several countries, including Indonesia, Thailand, Argentina, and Brazil, and it was authorized in the European Union in 2022. Additionally, Takeda is currently negotiating with the Indian drug regulator for approval in India, a country heavily affected by dengue.
To support large-scale production, Takeda signed a manufacturing agreement with Indian vaccine producer Biological E in February, aiming to produce 100 million doses annually by the end of the decade.
With this clearance, Qdenga® joins Dengvaxia®, developed by French pharmaceutical company Sanofi, as the available vaccines for dengue. Dengvaxia®, approved in various countries since 2015, had its usage restricted after it was found to increase the risk of severe disease in children without prior dengue exposure. In 2020, Dengvaxia® received WHO prequalification for use in individuals aged 6 to 45 years with confirmed previous dengue infection.
This new approval of Takeda’s Qdenga® provides a crucial additional tool in the global effort to control dengue fever and reduce its significant health burden.
WHO: World Health Organization; UN: United Nations; UNICEF: United Nations International Children’s Emergency Fund
Adapted from: https://www.straitstimes.com/world/who-clears-takedas-dengue-vaccine
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