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Takeda’s dengue vaccine receives MHRA approval for those aged four years and older

Around 3.9 billion people globally are currently at risk of dengue, a mosquito-borne viral disease


Takeda’s dengue vaccine, Qdenga (TAK-003), has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for those aged four years and older, the company announced.

The decision enables eligible individuals from the UK travelling to dengue endemic regions to receive the vaccine, regardless of previous dengue exposure, for the first time.

The worldwide incidence of dengue, a mosquito-borne viral disease, has grown dramatically in recent decades and was recognised by the World Health Organization in 2019 as one of the top ten threats to global health.

An estimated 3.9 billion people globally – 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 European Centre for Disease Prevention and Control, with all reported cases imported from endemic territories... Dengue symptoms usually last for up to seven days, so the impact for those who contract the infection while travelling abroad can be substantial.”

The MHRA’s decision, which follows the European Commission’s approval of Qdenga in December 2022, is supported by results from the ongoing phase 3 TIDES trial.

The study met its primary endpoint, demonstrating overall vaccine efficacy against the virus after 12 months, as well as all secondary endpoints at 18 months, including vaccine efficacy for hospitalised dengue cases.

A recent three-year follow-up analysis of data from the study also confirmed the vaccine’s cumulative efficacy of 83.6% for dengue and hospitalised cases.

While vaccine efficacy was shown to decline during the third year, the company said it remained ‘robust’ for hospitalised cases.

Simon Meadowcroft, medical director, Takeda UK and Ireland, said: “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.”

The company said it expects to make the vaccine available in the UK in spring/summer 2023.

Article by
Emily Kimber

7th February 2023

From: Regulatory



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