EU regulator recommends clearing Takeda's dengue vaccine
The European Medicines Agency is recommending that a dengue vaccine made by the Japanese pharmaceutical Takeda be authorized, in a move that could provide a new tool for millions worldwide against the potentially fatal disease
LONDON (AP) — The European Medicines Agency on Friday recommended the authorization of a dengue vaccine made by the Japanese pharmaceutical Takeda that could provide a new tool for millions worldwide against the potentially fatal disease.
The EU regulator said in a statement the vaccine should be cleared for anyone aged four and over, to prevent the four types of dengue. The viral disease causes more than 390 million infections globally every year, including up to 25,000 deaths, mostly in children.
“The benefits and safety of the current vaccine have been evaluated in 19 clinical trials that enrolled more than 27,000 people aged between 15 months and 60 years,” the EMA said. Studies showed Takeda's vaccine was about 84% effective in preventing people from being hospitalized with dengue and about 61% effective in stopping symptoms four years after getting immunized.
The most commonly reported side effects included headaches and muscle pain.
