Takeda announced the company’s dengue vaccine, QDENGA (Dengue Tetravalent Vaccine, was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age.

The use of QDENGA should be in accordance with official recommendations. QDENGA is the only dengue vaccine approved in Indonesia for use in individuals regardless of previous dengue exposure and without the need for pre-vaccination testing.

“Dengue can affect anyone living in or traveling to endemic areas - regardless of age, health and socio-economic circumstances,” said Gary Dubin, President of Takeda’s Vaccine Business Unit. “Developing this innovative dengue vaccine has been an exciting challenge, and its approval in Indonesia is an important achievement for Takeda and for public health. We’re proud to introduce QDENGA as a new dengue prevention tool to the people of Indonesia, and we will continue to work with additional regulatory agencies to make QDENGA available globally.”

The approval of QDENGA is based on results through three years after vaccination from the ongoing Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial that enrolled over 20,000 healthy children and adolescents ages four to 16 years living in dengue-endemic areas in Asia and Latin America.