EU approves Qdenga vaccine for dengue fever
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
Approval from the EC was supported by results across 19 Phase I, II and III trials with more than 28,000 children and adults, including four and a half years of follow-up data from the global, pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The TIDES trial met its primary endpoint of overall vaccine efficacy (VE) by preventing 80.2% of symptomatic dengue cases 12 months after vaccination. In addition, TAK 003 met its key secondary endpoint by preventing 90.4% 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% of hospitalized dengue cases and 61% 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 regulatory filings in other dengue-endemic countries in Asia and Latin America.
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