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Dengue vaccine from Japan's Takeda wins EU approval

QDENGA protects against 4 types of the disease, becomes 2nd inoculation in bloc

Takeda's dengue vaccine was authorized for use in the European Union on Dec. 8. Nearly 25,000 people worldwide, mostly children, die annually from the mosquito-borne disease.   © Reuters

LONDON (Reuters) -- Japanese company Takeda Pharmaceutical's dengue vaccine was authorized for use 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 use 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 viral disease. While the illness is mostly mild, some people can develop life-threatening complications. Between 20,000 and 25,000 people, mostly children, die each year, according to the World Health Organization.

QDENGA follows Sanofi's Dengvaxia, which was the world's first dengue vaccine and which secured its first approval in 2015.

The use of the French drugmaker's vaccine was scaled back considerably 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. Data from a pivotal trial has shown the vaccine can induce immune responses to a varied degree against all four dengue types.

Compared to Dengvaxia, Takeda's vaccine shows wider protection for young children and people older than 45, EU health regulators said in October when they recommended authorizing QDENGA.

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

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

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