European regulator recommends clearing Takeda’s dengue vaccine

LONDON, Oct 17, (AP): The European Medicines Agency has 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.

There is no specific treatment for dengue, which is a leading cause of serious illness and death in roughly 120 Latin American and Asian countries. While about 80% of infections are mild, severe cases of the mosquito-spread disease can lead to internal bleeding, organ damage and death.

The green light for the Takeda vaccine comes after Sanofi Pasteur’s dengue vaccine triggered a public health crisis in the Philippines in 2017. The Dengvaxia shot was found to increase the risk of severe disease in people who had not previously been infected with dengue and was linked to the deaths of more than 100 children.