Islamabad: India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to Japanese pharmaceutical company Takeda’s QDENGA (TAK-003), a major milestone in the country’s efforts to combat one of its fastest-growing mosquito-borne diseases.
The live attenuated tetravalent vaccine has been approved for people aged 4 to 60 years and is designed to protect against all four dengue virus serotypes. It will be administered in two subcutaneous doses, three months apart.
Unlike the earlier Dengvaxia vaccine, QDENGA does not require pre-vaccination blood testing or evidence of previous dengue infection, making it easier to incorporate into routine vaccination programmes.
The approval comes as dengue continues to pose a major public health challenge in India. The country reported more than 232,000 dengue cases in 2024, while the annual number of reported infections has increased around 11-fold over the past two decades, underscoring the need for additional preventive measures alongside mosquito control and disease surveillance.
According to Takeda, clinical trials showed QDENGA achieved 80.2 per cent efficacy against virologically confirmed dengue one year after completion of the two-dose schedule and 90.4pc efficacy against dengue-related hospitalisation after 18 months.
QDENGA has already been approved in more than 40 countries, including Indonesia, Brazil, Argentina, Thailand, the United Kingdom, the European Union, and several other dengue-endemic countries, making India one of the latest nations to authorise its use following evaluation of its safety and efficacy.
Health experts say vaccination should complement, rather than replace, established dengue control measures, including mosquito control, surveillance, early diagnosis and timely clinical management.
Takeda said it plans to launch QDENGA in India’s private healthcare sector during the first half of 2027 while continuing to expand its global manufacturing capacity to meet growing demand.
For Pakistan, where seasonal dengue outbreaks have caused thousands of infections and deaths over the past decade, India’s decision is expected to revive debate on the introduction of newer dengue vaccines as part of future dengue prevention and immunisation strategies.