India has approved its first vaccine against dengue, with the Drug Controller General of India (DCGI) granting market authorisation to Takeda Biopharmaceuticals India’s QDENGA (TAK-003).

The vaccine is approved for the prevention of dengue in individuals aged 4 to 60 years, making it the first dengue vaccine to receive regulatory approval in the country.

QDENGA is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes. It is administered in two doses, given three months apart.

According to Takeda, the vaccine can be given regardless of whether a person has previously had dengue and does not require pre-vaccination screening, simplifying its use in dengue-endemic regions.

The approval comes as dengue remains a major public health concern in India, which accounts for nearly one-third of the global disease burden. Reported dengue cases in the country have increased almost 11-fold over the past two decades, although experts believe the actual number of infections is significantly higher.

The DCGI’s decision is based on Takeda’s global clinical development programme, which included 19 Phase I, II and III trials involving more than 28,000 participants in both dengue-endemic and non-endemic regions.

The company’s pivotal Phase III TIDES (DEN-301) study, which enrolled more than 20,000 participants across eight dengue-endemic countries, found the vaccine to be 80.2% effective against laboratory-confirmed dengue one year after the second dose. It also showed 90.4% efficacy in preventing dengue-related hospitalisation 18 months after vaccination.

Long-term follow-up data showed that protection remained durable, with 84.1% efficacy against dengue-related hospitalisation after 4.5 years, while seven-year data demonstrated sustained protection against dengue disease and severe outcomes.

The approval was also supported by a Phase III clinical trial conducted in India among participants aged 4 to 60 years. The company said the vaccine was found to be safe, well tolerated and capable of generating a strong immune response in children, adolescents and adults.

Takeda said QDENGA has already been approved in 43 countries across Asia, Latin America and Europe, with more than 32 million doses distributed through public and private immunisation programmes.

The vaccine has also been recommended by the World Health Organization (WHO) for use in dengue-endemic areas with high transmission and has received WHO prequalification. It is currently part of national immunisation programmes in countries including Brazil, and is also available through public vaccination programmes in Argentina, Colombia and Indonesia.

Takeda said it will work with Indian regulators, public health authorities and healthcare providers to support the rollout and availability of the vaccine in the country.