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Takeda’s Tetravalent Dengue Vaccine (Tak-003) Receives First Global Approval for Use in Indonesia Without Need for Pre-vaccination Testing

The approval of TAK-003 indicates a new era in the fight against dengue in Indonesia, which faces one of the world’s highest burdens of the disease.

Takeda announced in August that its live attenuated dengue vaccine (TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM). Indonesia is the first country globally to approve TAK-003 for the prevention of dengue disease in individuals six to 45 years of age, regardless of previous dengue exposure and without the need for pre-vaccination testing.

“We are thrilled to announce the approval of our dengue vaccine in Indonesia, signifying a new era in the management of dengue. This milestone is critical as Indonesia suffers from a high burden of dengue in the region, causing severe impacts on the health and welfare of the people,” said Dr. Mahender Nayak, Asia Pacific Area Head, Takeda. “Our extensive clinical data demonstrates that our dengue vaccine provides protection for children and adults across all four dengue serotypes, preventing serious illness and hospitalization for those living in Indonesia. Years of steadfast dedication and cumulative efforts have brought us here today, and we remain committed to protect[ing] those at risk of contracting dengue in endemic communities, many of which are located in this part of the world.”

Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 100 countries. In the first half of 2022 alone, Indonesia reported over 63,000 dengue cases and nearly 600 deaths spread across 455 cities in 34 provinces.

“Indonesia is a dengue-endemic country where cases increase at the start of [the] rainy season and put everyone at risk, both children and adults who may experience mild to severe symptoms of dengue,” said Prof. Dr. Sri Rezeki Hadinegoro Sp.A(K), Professor of Paediatric Infectious Disease. “The approval of the new tetravalent dengue vaccine is an option for dengue prevention, particularly for the population at the age group of 6-45 years old, regardless of their previous dengue exposure, and with no pre-vaccination screening required.”

“We are delighted with the approval of the dengue tetravalent vaccine for adults, where this population has an equal risk of contracting dengue with younger populations regardless of their lifestyle and where they live. This indication means we can protect more people in the family against dengue,” said Dr. Sukamto Koesnoe, SpPD KAI, Head of Adult Immunization Task Force, PB PAPDI (The Indonesian Society of Internal Medicine).

The approval of the tetravalent dengue vaccine is based on data from the 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. Takeda’s tetravalent dengue vaccine demonstrated continued overall protection against dengue illness and hospitalisation three years after vaccination, regardless of an individual’s previous dengue exposure.

The vaccine has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients, and no important safety risks have been identified in the TIDES tria, to date. Takeda recently presented long-term safety and efficacy results from the TIDES trial through 54 months of follow-up, which further validated the vaccine’s efficacy and safety profile.

Takeda is proud to make its tetravalent dengue vaccine available to health care providers and their eligible patients in Indonesia. Takeda is also committed to increasing accessibility of the vaccine in collaboration with BPOM and local health experts.

TAK-003 is currently undergoing regulatory review for the prevention of dengue in children and adults in the European Union (EU) and in dengue-endemic countries outside the EU through the EU-M4all (previously Article 58) procedure. It is not yet approved for use in other countries. [APBN]

Source: Takeda