Takeda announced that the European Commission granted marketing authorization for the company’s dengue vaccine QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) for the prevention of dengue in individuals from four years of age in the European Union. The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022. Experts advise that QDENGA should be used in accordance with official recommendations.
Commenting on the approval, Gary Dubin, President, Global Vaccine Business Unit, Takeda said, “With the increasing ease of travel today, our once expansive world has become that much smaller, increasing the risk of dengue disease for those living in dengue-endemic areas and for those travelling to these regions.” The worldwide incidence of dengue has risen eightfold in the past twenty years, and it continues to rise, fueled by climate change and urbanization. Today, dengue threatens about half the world’s population with a risk of infection in over 125 countries, and the disease is endemic in most of the European overseas countries, territories and departments located in tropical areas.
These factors have led to events of local transmission in non-endemic areas in continental Europe, including France, Italy, Germany and Spain. Dr Tomas Jelinek, Medical Director, Berlin Centre for Travel and Tropical Medicine, and Scientific Director, CRM Centrum für Reisemedizin Dusseldorf, said, “Effective dengue prevention requires a multi-faceted approach, and previous methods have been insufficient for a number of reasons. With the potential for dengue to cause local outbreaks as demonstrated in several European countries over recent years and the threat for European travellers visiting dengue-endemic countries, gaps exist that may put some people at risk. As a clinician, it is encouraging to have a new dengue vaccination tool available for a broad population of my patients.”
Approval from the EC was supported by results across 19 Phase one, two, and three trials with more than 28,000 children and adults, including four and a half years of follow-up data from the global, pivotal phase three Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The TIDES trial met its primary endpoint of overall vaccine efficacy (VE) by preventing 80.2 per cent of symptomatic dengue cases twelve months after vaccination. In addition, TAK-003 met its key secondary endpoint by preventing 90.4 per cent of hospitalizations 18 months after vaccination. Efficacy varied by serotype (DENV-1 – 4). The TIDES exploratory analyses showed that throughout the 4.5-year study follow-up, TAK-003 prevented 84 per cent of hospitalized dengue cases and 61 per cent of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.
TAK-003 has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients, and no important safety risks have been identified, to date. QDENGA is also approved in Indonesia for the prevention of dengue disease by any serotype in individuals six years to 45 years of age. Takeda continues to progress with regulatory filings in other dengue-endemic countries in Asia and Latin America.
.jpg)
