The United Nations’ health agency will consider the SAGE’s recommendation and revise its position paper on dengue vaccines to include final guidance on Qdenga’s use in public vaccination campaigns
Takeda’s Qdenga (dengue tetravalent vaccine [live, attenuated]) (TAK-003) has been recommended by the World Health Organisation’s (WHO) Strategic Advisory Group of Experts (SAGE) for high dengue burden and transmission areas.
Qdenga is based on a live-attenuated dengue serotype 2 virus. It is indicated in the European Union (EU) to protect against dengue virus serotypes.
The WHO will consider the recommendation of SAGE and revise its position paper on dengue vaccines in the upcoming months. The final guidance on Qdenga’s use will be implemented in the public vaccination campaigns.
According to Takeda, SAGE’s recommendation to include the vaccine in settings with high dengue disease burden and high transmission intensity is intended to boost the public health impact and reduce any possible risk in seronegative individuals.
The advisory group has also recommended the use of the vaccine in children between the ages of six to 16, but one to two years before the age-specific peak incidence of hospitalisations related to dengue.
For this age group, Qdenga should be given in a two-dose schedule with a three-month gap between doses.
Additionally, SAGE’s recommendations include a well-designed communication strategy and community engagement during the vaccine introduction.
Takeda global vaccine business unit president Gary Dubin said: “The global impact of dengue cannot be overlooked as the incidence continues to rise. This week, the World Health Organisation’s (WHO) Strategic Advisory Group of Experts (SAGE) provided important recommendations for the use of Qdenga in preventing dengue.
“We’re encouraged by their feedback and look forward to the final position from the WHO in the coming months.”
The advisory group’s recommendations were based on the data from 19 Phase 1, 2, and 3 trials involving more than 28,000 children and adults.
SAGE also reviewed the Phase 3 Tetravalent Immunisation against Dengue Efficacy Study (TIDES) study, which was created as per WHO’s guidance for a second-generation dengue vaccine.
The trial achieved its primary endpoint of overall vaccine efficacy (VE) with an efficacy of 80.2% against virologically confirmed dengue (VCD) at the end of 12 months. The late-stage study also met all its secondary endpoints at 18 months follow-up.
Currently, the dengue vaccine is available for adults and children in the private market in countries in Europe, Brazil, and Indonesia. It is expected to be available soon in Argentina and Thailand.