Takeda’s QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved for Use in European Union

• The European Commission Approved QDENGA (TAK-003) for Use in Individuals Four Years of Age and Olderⁱ
• QDENGA Becomes the Only Dengue Vaccine Approved in the EU for Use in Individuals Regardless of Previous Dengue Exposureⁱ

Today announced that the European Commission (EC) granted marketing authorization for the company’s dengue vaccine QDENGA^® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) for the prevention of dengue disease in individuals from four years of age in the European Union (EU).ⁱ  QDENGA should be used in accordance with official recommendations. The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022.

“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 traveling to these regions,” said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda. “The European Commission’s approval marks an important turning point for QDENGA as we are one step closer to achieving our aspiration to help reduce the global burden of dengue. We are proud to introduce QDENGA in many parts of the EU, offering healthcare providers a new tool in dengue prevention for their patients living in the EU and traveling to endemic regions around the world.”

The worldwide incidence of dengue has risen eight-fold in the past 20 years, and it continues to rise, fueled by climate change and urbanization.ⁱⁱ 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.^ii,iii  These factors have led to local transmission in non-endemic areas in continental Europe, including France, Italy, Germany, and Spain.^iv Dengue is a leading cause of fever in travelers returning to Europe from endemic countries, and the incidence of dengue among European travelers is generally underestimated.^v,vi  The threat of disease is present for more than 26 million people from Europe who typically travel to endemic regions each year for holidays and visiting friends and family.^vii

“Effective dengue prevention requires a multi-faceted approach, and previous methods have been insufficient for several reasons. With the potential for dengue to cause local outbreaks as demonstrated in several European countries over recent years, and the threat for European travelers visiting dengue-endemic countries, gaps exist that may put some people at risk,” said Dr. Tomas Jelinek, Medical Director of the Berlin Centre for Travel and Tropical Medicine and Scientific Director of the CRM Centrum für Reisemedizin Dusseldorf. “As a clinician, having a new dengue vaccination tool available for a broad population of my patients is encouraging.”

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