Takeda’s dengue vaccine has received prequalification from the World Health Organization (WHO) and has been recommended for use in children aged six to 16 years in areas with high infection rates.
Qdenga (TAK-003) is now the second dengue vaccine to be prequalified by the organisation, following its prequalification of Sanofi’s Dengvaxia in 2020.
The global incidence of dengue has grown dramatically in recent decades, with about half of the world’s population now at risk of the mosquito-borne viral disease.
While many dengue infections are asymptomatic or produce only mild illness, the virus can occasionally cause more severe cases and death.
Takeda’s Qdenga, administered in two doses over a three-month interval, is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue.
The new prequalification status means United Nations agencies can procure Qdenga for eligible countries, enabling the global rollout of the vaccine.
Dr Rogerio Gaspar, WHO director for regulation and prequalification, said: “The prequalification of [Qdenga] 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.
“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.”
WHO’s latest decision comes seven months after the organisation’s Strategic Advisory Group of Experts on Immunization recommended Qdenga for use in children living in high dengue burden and transmission areas.
This was supported by data across 19 phase 1, 2 and 3 trials with more than 28,000 children and adults, including the pivotal phase 3 TIDES study.
TIDES met its primary endpoint of overall vaccine efficacy against virologically-confirmed dengue with 80.2% efficacy after 12 months, as well as all secondary endpoints after 18 months of follow up.
Already available in markets including Europe, Indonesia, Thailand and Brazil, Qdenga also received approval from the Medicines and Healthcare products Regulatory Agency last year.
The regulator’s decision gave individuals in the UK who are travelling to dengue-endemic countries the option of being vaccinated against infection for the first time.