The World Health Organisation’s (WHO) Strategic Advisory Group of Experts (SAGE) has recommended Takeda’s QDENGA (dengue tetravalent vaccine [live, attenuated]) for use in high dengue burden and transmission areas.
The SAGE recommendation will be considered by the WHO in the coming months. It will update the position paper on dengue vaccines to include final guidance on QDENGA’s use in public vaccination programmes.
SAGE recommendations include the introduction of the vaccine in settings with high dengue disease burden and high transmission intensity to increase the public health impact and lower any potential risk in seronegative populations.
It has also recommended the usage of QDENGA for children aged between six and 16 years. For this age group, the vaccine should be introduced one to two years before the age-specific peak incidence of hospitalisations due to dengue.
The vaccine must be given in a two-dose schedule with a three-month interval between doses.
Introduction of the vaccine requires a well-designed communication strategy and community engagement.
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SAGE assessed data across 19 Phase I, II and III studies of more than 28,000 adults and children, including the pivotal Phase III Tetravalent Immunisation against Dengue Efficacy Study (TIDES) trial. This study was in line with WHO guidance for a second-generation dengue vaccine.
The trial attained its primary endpoint of overall vaccine efficacy against virologically confirmed dengue with an efficacy of 80.2% for 12 months. It achieved all secondary endpoints during an 18-month follow-up period.
Takeda Global Vaccine Business Unit president Gary Dubin stated: “The global impact of dengue cannot be overlooked as the incidence continues to rise. This week, the World Health Organisation’s SAGE provided important recommendations for the use of QDENGA in preventing dengue.”