India clears first dengue vaccine for people aged 4 to 60

The Drug Controller General of India (DCGI) has approved Takeda Biopharmaceuticals India’s QDENGA (TAK-003) for marketing, marking the first time a dengue vaccine has been authorised in the country, the company said in a press statement.

The vaccine is indicated for the prevention of dengue in individuals between 4 and 60 years of age. QDENGA is a live-attenuated tetravalent vaccine developed to guard against all four dengue virus serotypes. It is administered in two doses given three months apart.

According to Takeda, the vaccine may be administered regardless of prior dengue infection and does not require screening before vaccination. The decision comes as dengue remains a major public health concern in India, where reported cases have risen nearly elevenfold over the past 20 years. The country accounts for close to one-third of the global dengue burden, although modelling analyses indicate that the true number of infections is likely far higher than official figures suggest.

The authorisation is supported by Takeda’s global clinical development programme, which includes 19 Phase I, II and III trials with more than 28,000 participants in both endemic and non-endemic regions.

The key Phase III TIDES (DEN-301) study enrolled over 20,000 participants in eight dengue-endemic countries. Takeda reported that the vaccine achieved 80.2% efficacy against virologically confirmed dengue one year after the second dose and 90.4% efficacy in preventing dengue-related hospitalisation at 18 months. Data collected at 4.5 years indicated 84.1% efficacy against hospitalisation, while seven-year follow-up results showed continued protection against dengue illness and related hospitalisations across all four serotypes.

Regulatory approval in India was further supported by a Phase III trial conducted in participants aged 4 to 60 years. The company stated that the findings demonstrated the vaccine to be safe, well tolerated and capable of generating an immune response in children, adolescents and adults.

Takeda noted that QDENGA has received approval in 43 countries across Asia, Latin America and Europe, with more than 32 million doses supplied through public and private immunisation initiatives. The World Health Organization recommends its use in high-transmission dengue-endemic settings, and the vaccine has obtained WHO prequalification. It has been incorporated into Brazil’s National Immunization Program and is also available through public programmes in Argentina, Colombia and Indonesia.

The company added that it plans to collaborate with Indian regulators, public health authorities and healthcare professionals to facilitate rollout and access to the vaccine across the country.