LONDON –
The European Medicines Agency on Friday recommended approval of a dengue vaccine made by Japanese drugmaker Takeda that could provide millions of people around the world with a new tool against the potentially deadly disease.
The EU regulator said in a statement that the vaccine should be authorized for anyone aged four and over to prevent all four types of dengue. The viral disease causes more than 390 million infections worldwide each year, including up to 25,000 deaths, mostly in children.
“The benefits and safety of the current vaccine have been assessed in 19 clinical trials involving more than 27,000 people aged 15 months to 60 years,” the EMA said. Studies showed that Takeda’s vaccine was about 84 percent effective at preventing people from being hospitalized with dengue and about 61 percent effective at stopping symptoms four years after vaccination.
The most commonly reported side effects include headaches and muscle pain.
There is no specific treatment for dengue, which is a leading cause of serious illness and death in approximately 120 countries in Latin America and Asia. Although about 80 percent of infections are mild, severe cases of the mosquito-borne 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 vaccine was found to increase the risk of serious illness in people who were not they had previously been infected with dengue and was linked to the death of more than 100 children.
Critics charged that the Sanofi vaccine was prematurely rolled out to about 800,000 children in the Philippines. Numerous scientists and officials were indicted for introducing the vaccine “with undue haste,” which prosecutors said led to a homicide.
The World Health Organization had previously concluded that the Sanofi Pasteur vaccine was safe, but later said that children should only be immunized if they were first tested to make sure they had previously had dengue.
The EMA said its support for the Takeda vaccine means “an unmet global public health need is being addressed”, and explained that countries outside the EU should have confidence that the vaccine is safe and effective
After malaria, dengue is the most commonly diagnosed cause of fever among European travelers returning from developing countries.
In September, Indonesia became the first country to license the Takeda vaccine.