India’s drug regulator has granted market authorisation to Takeda’s QDENGA, making it the first dengue vaccine approved in the country, the Japanese pharmaceutical group said on Monday.

The live-attenuated tetravalent vaccine is authorised for prevention of dengue disease in individuals aged 4 to 60 years and is administered as a two-dose regimen three months apart. It can be given irrespective of prior infection and does not require pre-vaccination screening, Takeda said.

The approval comes as dengue continues to pose a significant public health challenge in India. India accounts for nearly one-third of the global dengue burden, and reported infections have risen almost 11-fold over the past two decades, though modelling studies suggest the true figure is substantially higher, as per a The Hindu report.

Takeda said the vaccine demonstrated 80.2 percent efficacy against virologically confirmed dengue 12 months after the second dose in its pivotal Phase III TIDES trial, which enrolled more than 20,000 participants across eight endemic countries. Efficacy against dengue-related hospitalisation reached 90.4 percent at 18 months, with follow-up data at 4.5 years showing 84.1 percent efficacy and seven-year results indicating sustained protection across all four virus serotypes.

The company said a Phase III trial conducted in India among participants aged 4 to 60 found the vaccine to be safe, well tolerated and immunogenic.

The approval was supported by a global clinical programme of 19 trials involving more than 28,000 participants. QDENGA has been authorised in 43 countries and more than 32 million doses have been distributed through public and private programmes.

The vaccine is recommended by the World Health Organization for use in high-transmission endemic settings and has received WHO prequalification. It is included in Brazil’s national immunisation programme and is available through public programmes in Argentina, Colombia and Indonesia.

Takeda said it would work with Indian regulatory authorities, public health stakeholders and healthcare providers to support planning and availability in the country.

The company said it expects Qdenga to become available in India in the first half of 2027, ​after market authorisation, with initial availability through private healthcare settings.