The European Commission (EC) approved Qdenga (TAK-003) for use in individuals aged four years and above, administered subcutaneously as a 0.5mL dose at a two-dose schedule, as per the official recommendations
EC approves Takeda’s Qdenga vaccine. (Credit: National Cancer Institute on Unsplash)
Japanese pharmaceutical company Takeda has secured the European Commission (EC) marketing authorisation for its tetravalent dengue vaccine candidate Qdenga (TAK-003).
Qdenga is developed using a live-attenuated dengue serotype 2 virus, which provides the genetic basis for all four dengue virus serotypes, to protect against the four serotypes.
The vaccine candidate is indicated for the prevention of dengue disease in individuals aged four years and above in the European Union (EU).
It should be administered subcutaneously as a 0.5mL dose at a two-dose schedule, in accordance with official recommendations.
The EC approval follows the positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in October 2022.
Takeda global vaccine business unit president Gary Dubin 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 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 travelling to endemic regions around the world.”
The EC approval is supported by results from 19 different Phase 1, Phase 2 and Phase 3 trials, enrolling more than 28,000 children and adults.
In addition, four and a half years of follow-up data from the Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial also supports the approval.
The TIDES trial met its primary endpoint of overall vaccine efficacy (VE) by preventing 80.2% of symptomatic dengue cases 12 months after vaccination.
TAK-003 has also met its key secondary endpoint of preventing 90.4% of hospitalisations 18 months after vaccination.
According to the TIDES exploratory analyses, the vaccine prevented 84% of hospitalised dengue cases and 61% of symptomatic dengue cases in the overall population.
Qdenga has been generally well tolerated in the clinical trials, with no disease enhancement or important safety risks identified in vaccine recipients, said the Japanese drugmaker.