On Monday, Takeda, a Japanese multinational pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of dengue vaccine candidate TAK-003. The vaccine candidate is for the prevention of dengue disease caused by any serotype in individuals of 4 years of age and older in Europe and dengue-endemic countries. According to experts, dengue cases have grown dramatically around the world in recent decades, causing an estimated 390 million infections and 500,000 hospitalizations annually.

The company released a statement stating that the committee’s positive opinion was based on the results from five different clinical trials, which included more than 28,000 children and adults. The results also included the data from four and a half years of follow-up from the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, which was consistent with the World Health Organization’s (WHO) recommendation.

The study showed that TAK-003 decreased the risk of hospitalization due to dengue by 84%. It also showed that the vaccine reduced the risk of symptomatic dengue by 61% in the overall population, including both seropositive and seronegative individuals. In August, TAK-003 was approved by the National Agency for Drug and Food Control of Indonesia for the prevention of dengue disease by any serotype in individuals aged between 6 and 45 years of age.