The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda’s vaccine candidate Qdenga for active immunisation against dengue infection from four years of age.
Dengue is the fastest spreading mosquito-borne virus and was recognised by the World Health Organization (WHO) in 2019 as one of the top ten threats to global health.
An estimated 3.9 billion people around the globe – about half of the world’s population – are currently at risk of dengue and it is now endemic in more than 125 countries, causing an estimated 390 million infections and 500,000 hospitalisations each year.
Dr George Kassianos, a specialist in immunisations, said, “Although the UK is not an endemic country, more than 800 UK holidaymakers had their trips ruined by dengue before the pandemic, according to the ECDC, with all reported cases imported from endemic territories. With this in mind, a pre-travel vaccination that provides an additional precautionary option to most travellers, in addition to following effective mosquito bite prevention, should be welcomed.”
Dengue is predominantly spread to people through the bites of infected Aedes aegypti and Aedes albopictus mosquitoes. These mosquitoes are mostly found in urban and semi-urban areas in tropical and sub-tropical climates.
Phase III trial results
The decision adopted by the MHRA follows key results from the ongoing Phase III, double-blind, randomised, placebo-controlled TIDES trial, which evaluated the efficacy, safety and immunogenicity of the dengue tetravalent vaccine.
TIDES met its primary endpoint of overall vaccine efficacy (VE) against virologically confirmed dengue (VCD) at 12-months follow-up and all secondary endpoints at 18-months follow-up, including VE against hospitalised dengue and VE in baseline seropositive and baseline seronegative individuals.
Simon Meadowcroft, Medical Director, Takeda UK & Ireland, commented, “Dengue is a complex and widespread disease with half the world’s population living in endemic areas. The launch of Qdenga means that for the first time those living in the UK and travelling to dengue-endemic countries, have the option of being vaccinated against infection”
Takeda expects to make Qdenga available in the UK in spring/summer 2023.