Dengue Tetravalent Vaccine Approved in Indonesia | Takeda Philippines
Takeda’s Dengue Tetravalent Vaccine Approved in Indonesia for Use Regardless of Prior Dengue Exposure
Indonesia National Agency for Drug and Food Control, BPOM, Approved Takeda’s new dengue vaccine for Use in Individuals Six Years to 45 Years of Age1
Takeda’s Dengue Vaccine is the Only Dengue Vaccine Approved in Indonesia for Use in Individuals Without Need for Pre-vaccination Testing
Indonesia Approval Marks the First for Takeda’s First Marketed Vaccine Outside of Japan
Philippines – October 25, 2022 – Takeda (TSE:4502/NYSE:TAK) recently announced that their dengue 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 the vaccine should be in accordance with official recommendations. Takeda’s dengue vaccine 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.1
“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 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 125 countries.2
Dengue outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in the Philippines. The latest Epidemic-prone Disease Case Surveillance (ECDS) Report of the Department of Health (DOH) Epidemiology Bureau for Morbidity Week 38 (Jan 1 to Sep 24 2022) recorded a total of 172,985 dengue cases which is 197% higher compared to the same period last year. The number of cases detected is still expected to increase with the continuing monsoon season until the end of the year.
The approval of Takeda’s dengue vaccine 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. The vaccine demonstrated continued overall protection against dengue illness and hospitalization three years after vaccination, regardless of an individual’s previous dengue exposure.1 It has also been generally well tolerated, with no important safety risks identified in the TIDES trial, to date.<sup>3</sup> 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 committed to make their dengue vaccine available to healthcare providers and their eligible patients in Indonesia and to work with BPOM and local health experts to make the vaccine accessible in the coming months. Recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced a positive opinion, recommending approval of Takeda's dengue vaccine for the prevention of dengue disease caused by any serotype in individuals four years of age and older in Europe and in dengue-endemic countries who took part in the EU-Medicine for all or EU-M4all procedure.
“Having worked on vaccines and preventable diseases for more than four decades, we see that the addition of another public health intervention for Dengue, can be the cornerstone by which the Philippines can contribute to Sustainable Development Goal (SDG) 3 which aims to prevent needless suffering from preventable disease and premature death by focusing on key targets that boost the health of a country’s overall population,” said Executive Director of the Philippine Foundation for Vaccination (PFV) Dr. Lulu Bravo.
About Takeda
Takeda is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on four therapeutic areas - Oncology, Rare Diseases, Neuroscience and Gastroenterology - to develop highly innovative medicines that contribute to making a difference in people's lives.
About Takeda Philippines
Takeda Healthcare Philippines, Inc. (THPI) is a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited. Founded in 1968, THPI aims to broaden patient access to treatment across the country through sustainable access programs enabling affordable and integrated access solutions for disease areas such as oncology, gastroenterology, rare diseases & vaccines and by strengthening the healthcare system guided by our commitment to Patients, our People and the Planet.
References
Takeda. Summary of Product Characteristics. Retrieved August 2022.
World Health Organization. Fact Sheet. Dengue and Severe Dengue. January 2022. Retrieved August 2022.
Tricou, V. Efficacy and Safety of Takeda’s Tetravalent Dengue Vaccine Candidate (TAK-003) After 4.5 Years of Follow-Up. Presented at the 8th Northern European Conference of Travel Medicine; June 2022.