The World Health Organization (WHO) today announced that it has prequalified a second dengue vaccine, TAK-003, known as Qdenga and developed by Takeda.
Qdenga is a live-attenuated vaccine that contains weakened versions of all four dengue serotypes. The WHO recommends its use in children ages 6 to 16 years old in settings where the dengue burden and transmission intensity is high. It is given in two doses, 3 months apart.
Prequalification means the WHO has assessed the quality, safety, and efficacy, and the step paves the way for countries and groups to buy the vaccine for a broader rollout.
Step paves way for broader global access
Rogerio Gaspar, PhD, the WHO's director for regulation and prequalification, said Takeda's dengue vaccine is now eligible for procurement by United Nations agencies, including UNICEF and the Pan American Health Organization (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."
Brazil's drug regulators approved Qdenga in 2023, and, earlier this year, the first mass vaccination campaign launched in the city of Dourados in Brazil's Mato Grosso del Sul state.
The other prequalified dengue vaccine is Dengvaxia, made by Sanofi. It is given in a three-dose series, 6 months apart. It requires prevaccine screening and is given only to people who have had a previous dengue infection to avoid antibody-dependent enhancement, a phenomenon that makes repeat infections more severe and can cause severe illness after vaccination in those who haven't previously been exposed to the virus.