Dengue vaccine, QDENGA, Approved for Use in European Union


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Takeda announced Thursday that the European Commission (EC) has granted marketing authorization for its QDENGA® (tetravalent dengue vaccine) vaccine. [Live, Attenuated]) (TAK-003) for the prevention of dengue disease in individuals from four years of age in the European Union (EU).

Aedes aegypti

The positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has been approved. in October 2022.

said Gary Dubin, managing director, corporate president of Takeda’s global vaccine business unit. “The European Commission approval marks an important turning point for QDENGA as we move 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 European Union, offering healthcare providers a new tool in dengue prevention For their patients who live in the European Union and travel to endemic areas around the world.”

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The worldwide incidence of dengue has increased eightfold in the past 20 years, and is still rising, due to climate change and urbanization. Today, dengue threatens about half of the world’s population at risk of infection in more than 125 countries, and the disease is endemic in most European countries, territories and sections located in the tropics. These factors have led to local transmission events in non-endemic areas of mainland Europe, including France, Italy, Germany and Spain. Dengue is a major cause of fever in travelers returning to Europe from endemic countries, and the incidence of dengue among European travelers is generally not insignificant. The threat of the disease is present in more than 26 million people from Europe who usually travel to endemic areas each year to spend holidays and visit friends and family.

Effective prevention of dengue fever requires a multifaceted approach, and previous methods were inadequate for a number of reasons. With the potential for dengue to cause local outbreaks as shown in several European countries in recent years, and the threat to European travelers visiting dengue-endemic countries, there are gaps that may put some people at risk,” said Dr. Thomas Jelinek, Medical Director. from the Berlin Center for Travel and Tropical Medicine and Scientific Director of the CRM Centrum für Reisemedizin Dusseldorf “As a physician, it is encouraging that a new dengue vaccination tool is available to a wide range of my patients.”

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The approval from the European Commission was supported by results across 19 Phase 1, 2, and 3 trials with more than 28,000 children and adults, including four and a half years of follow-up data from the pivotal global Phase III quadrivalent dengue immunization (IV) efficacy study ( TIDES) for trial. The TIDES trial achieved the primary endpoint of total vaccine efficacy (VE) by preventing 80.2% of symptomatic dengue cases 12 months after vaccination. In addition, TAK-003 achieved its primary secondary endpoint by preventing 90.4% of hospital admissions 18 months after vaccination. Efficacy varied by serotype (DENV-1-4). TIDES exploratory analyzes showed that throughout the study’s 4.5-year follow-up period, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the general population, including seropositive and seronegative individuals. TAK-003 has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients, and no significant safety risks identified, to date.

QDENGA (TAK-003) is a dengue vaccine based on live attenuated dengue virus serotype 2, which provides the genetic backbone for all four dengue virus serotypes and is designed to protect against any of these serotypes.

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