Japan's Takeda dengue vaccine gets second approval in EU

LONDON Reuters -- Japanese company Takeda Pharmaceuticals approved use of the dengue vaccine in the European Union on Thursday, making it the second approved vaccine for the mosquito-borne disease that causes millions of infections annually.

The vaccine, branded QDENGA, is designed for those 4 and older to prevent any of the four so-called serotypes of dengue.

There are no antivirals or specific treatments for the flu-like disease. Some people can develop life-threatening complications because of their illness, although it's mostly mild. Between 20,000 and 25,000 people, mostly children, die each year, according to the World Health Organization.

QDENGA was the first dengue vaccine approved by Sanofi in 2015 and secured its first approval in 2015.

The French drugmaker's vaccine was scaled back after the company disclosed in 2017 that it increased the risk of severe disease in seronegative children - those who had no prior dengue exposure when they got the shot.

Takeda's vaccine is based on a dengue 2 virus, with DNA from the other three serotypes added in. The vaccine can induce immune responses to a variety of different ways against all four dengue types, according to data from a pivotal trial.

In October, EU health regulators said in October that Takeda's vaccine showed wider protection for young children and people older than 45.

The Takeda vaccine has been approved in Indonesia, while the U.S. regulators are reviewing QDENGA on a priority basis.

Gary Dubin, president of Takeda's global vaccine business, told Reuters earlier this year that the vaccine will generate $700 million to $1.6 billion in sales over the course of several years.