The European Union on Thursday authorized the use of the Japanese company Takeda’s dengue vaccine, making it the second approved against the mosquito-borne disease that causes millions of infections a year.
The vaccine, brand QDENGA, is designed for use from 4 years of age to prevent any of the four dengue serotypes.
There are no antivirals or specific treatments for this flu-like viral illness. Although the disease is usually mild, some people can develop life-threatening complications.
According to the World Health Organization, each year between 20,000 and 25,000 people die, mostly children.
QDENGA succeeds Sanofi’s Dengvaxia, which was the world’s first dengue vaccine, gaining its first approval in 2015.
Use of the French drugmaker’s vaccine fell sharply after the company revealed in 2017 that it increased the risk of severe disease in “seronegative” children, meaning those who had not been exposed to dengue before receiving the shot.
Takeda’s vaccine is based on the dengue 2 virus, to which DNA from the other three serotypes is added. Data from a trial have shown that the vaccine can induce varying degrees of immune responses against all four types of dengue.
Compared with Dengvaxia, Takeda’s vaccine shows greater protection for young children and people over 45, EU health regulators said in October when recommending authorization of QDENGA.
Takeda’s vaccine has also been approved in Indonesia, while US regulators are reviewing it on a priority basis.