Dengue vaccine approved in Indonesia regardless of prior exposure

pharmafile | August 23, 2022 | News story | Manufacturing and Production  

Takeda have announced the dengue vaccine, QDENGA®, was approved by the Indonesia National Agency for Drug and Food Control. Dengue is a mosquito-borne, viral disease that poses significant global public health threat, and is prevalent in over 125 countries.

The vaccine has been approved for the prevention of dengue disease caused by any serotype in patients aged six years to 45 years of age. 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.

In recent years, Indonesia has experienced almost half of the dengue disease burden within Southeast Asia. It continues to suffer one of the highest burdens of dengue in the world, while in the first half of 2022 alone, Indonesia reported over 63,000 dengue cases, and nearly 600 deaths. These were spread across 455 cities, in 34 provinces.

“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 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.

“As a doctor, I have seen firsthand the burden dengue disease places on the patients and communities I serve in Indonesia. There is an ongoing fear of an outbreak and contracting the disease, experiencing the physical setbacks dengue can cause as well as the potential financial impacts,” said Dr Anggraini Alam, paediatric infectious disease consultant. “Vaccination will offer health care providers in Indonesia a welcomed advancement in dengue prevention, along with vector control, allowing us to reduce the burden of dengue and protect the broader population.”

Ana Ovey

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