For years, Takeda has been working hard to bring the first travel vaccine for dengue fever to the market. Now, the company can breathe a sigh of relief as the program snagged an approval from the Indonesia National Agency for Drug and Food Control—its first anywhere in the world.
The vaccine, called Qdenga, is approved in the country for use in people 6 to 45 years of age regardless of prior dengue exposure. The country's regulator granted the approval based on results from the company’s ongoing phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), which enrolled more than 20,000 healthy children aged 4 to 16 living in dengue-endemic areas in Asia and Latin America.
Three years after vaccination, the vaccine delivered efficacy of 62% and was “generally well tolerated,” Takeda said in a statement. The vaccine prevented hospitalization from dengue fever by 83.6%.
Four and a half years after the second dose, Qdenga showed efficacy of 61.2% against virologically confirmed dengue and 84.1% efficacy against hospitalization from dengue.
Qdenga is based on a live-attenuated dengue serotype 2 virus that “provides the genetic backbone” for all four dengue virus serotypes. It's designed to protect against any and all of the serotypes, Takeda says, and is a 0.5-mL dose in a two-dose series.
Dengue fever is a mosquito-borne viral disease that’s prevalent in over 125 countries. Recently, Indonesia has experienced “almost half” of the dengue disease burden in Southeast Asia and continues to suffer from one of the “highest burdens of dengue in the world,” the company said in a statement. In the first half of 2022, the country reported more than 63,000 dengue cases and nearly 600 deaths across 455 cities in 34 provinces.
Takeda said last December that the vaccine could reach up to $1.6 billion in peak sales.