European Medicines Agency Recommends Approving Takeda’s Dengue Vaccine

ABOVE: A worker in Singapore fumigates a pathway to control mosquitoes carrying the dengue virus. © ISTOCK.COM, Kandl

Update (December 8): The European Commission has approved Takeda’s dengue vaccine, now known as QDENGA, for use against any of the four dengue serotypes in individuals aged four and older. It is the second approved vaccine for the virus and the first to be approved in Europe without the need for pre-vaccination testing.

The European Medicines Agency has announced today (October 14) its recommendation to approve a dengue vaccine manufactured by Japanese pharmaceutical company Takeda for people four years and older.

Dengue is a mosquito-borne disease that propagates in tropical and subtropical urban environments worldwide, according to the World Health Organization (WHO). The four closely related variants of the virus induce no or mild symptoms in more than 80 percent of those infected, but infections can develop into what is known as severe dengue in some cases. Severe dengue can cause organ impairment, bleeding, and vomiting and is a leading cause of illness and death in nearly 130 countries, with more than 70 percent of the cases located in Asia. The number of reported dengue cases has increased more than eightfold in the past twenty years; the WHO estimates there are nearly 400 million cases per year, of which around 100 million show symptoms. Severe dengue causes 25,000 deaths annually, mostly in young children, Reuters reports.

See “Bedeviled by Dengue”

The Takeda vaccine was tested in 19 clinical trials that included more than 27,000 participants between the ages of 15 months and 60 years, the EMA announcement states. It adds that the trials showed the vaccine prevented “fever, severe disease and hospitalization caused by any of the four serotypes of the dengue virus.”

The trials also found the new Takeda vaccine to be more protective for children and people aged 45 and older than the existing dengue vaccine, Dengvaxia, which was first approved, by Mexico's health ministry, in 2015. That vaccine, developed by Sanofi Pasteur, was found to increase disease severity in children who contracted dengue but hadn’t been previously infected. As a result, the vaccine’s rollout was halted in the Philippines in 2017; according to the Associated Press, the immunization was linked to the deaths of around 100 children.

See “Dengue Vaccine Trial Results Show Promise, with Caveats”

The most common side effects of the Takeda vaccine included injection site pain, headaches and muscle aches, and generally feeling unwell, the EMA announcement states. According to a statement from Takeda, Indonesia is the only country that has approved the vaccine so far, and it now expects the EMA to approve the vaccine in the coming months.