The European Commission has granted marketing authorisation for Sanofi’s dengue vaccine Dengvaxia (dengue tetravalent).
Dengvaxia will be available in Europe for individuals 9-45 years of age with a documented prior dengue infection, and who are living in endemic areas.
The authorisation comes after a study was conducted with vaccine involving more than 40,000 people from 15 countries. A Phase III trial showed a reduction in severe dengue of 93%, and of hospital admissions due to dengue of 82%.
However, the vaccine was not approved for use in children younger than nine due to insufficient levels of efficacy and safety; in particular, an increase in hospital admissions due to the infection among those aged two to five years.
Dengue is the most common mosquito-transmitted viral infectious disease. A 2016 study estimated nearly 60 million yearly symptomatic dengue cases worldwide, with estimates including asymptomatic cases at least six times higher, resulting in about 10, 000 deaths.
"In some of the European overseas territories where dengue recurs regularly, people who have had a dengue infection previously are at risk of being infected with the virus again," explains Dr. Su-Peing Ng, global medical head at Sanofi Pasteur, the vaccine unit of Sanofi.
"As the second infection with dengue tends to be more severe than the first, it is important to be able to offer these people a vaccine that could help protect them against subsequent dengue infections.”
Dengvaxia is already approved for use in several endemic countries in Latin America and Asia where reducing the human and economic burden of dengue is critical, due to the the global incidence of dengue having grown rapidly in recent decades.