India clears first dengue vaccine, QDENGA, for people aged 4 to 60

New Delhi: The Drug Controller General of India (DCGI) has granted market authorisation to Takeda Biopharmaceuticals India's QDENGA (TAK-003), making it the first dengue vaccine to be approved in the country, according to a press release issued by the company.

The vaccine has been approved for the prevention of dengue disease in individuals aged 4 to 60 years.

QDENGA is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes, DENV-1, DENV-2, DENV-3 and DENV-4, and is administered as a two-dose regimen of 0.5 ml each, given three months apart.

According to the company, the vaccine can be administered irrespective of whether an individual has had a previous dengue infection and does not require pre-vaccination screening, unlike Sanofi's Dengvaxia, which is recommended only for those with prior infection exposure.

The approval comes as dengue continues to pose a significant public health challenge in India, where reported cases have increased nearly 11-fold over the past two decades. India accounts for nearly one-third of the global dengue burden, though modelling studies suggest actual infections are substantially higher than reported.

The approval is based on Takeda's global clinical development programme comprising 19 Phase I, II and III trials involving more than 28,000 participants across dengue-endemic and non-endemic regions.

The pivotal Phase III TIDES (DEN-301) trial enrolled more than 20,000 participants across eight dengue-endemic countries.

According to Takeda, the vaccine demonstrated 80.2 per cent efficacy against virologically confirmed dengue 12 months after the second dose, and 90.4 per cent efficacy against dengue-related hospitalisation at 18 months. Follow-up data at 4.5 years showed 84.1 per cent efficacy against dengue-related hospitalisation, rising to 90.6 per cent after a booster dose administered at that stage.

Seven-year follow-up data showed sustained protection against dengue disease and related hospitalisation across all four serotypes.

The approval in India was also supported by a separate Phase III trial among participants aged 4 to 60 years, which the company said found the vaccine safe, well tolerated and immunogenic in children, adolescents and adults.

Takeda said QDENGA has been approved in 43 countries across Asia, Latin America and Europe since its launch in 2022, with more than 32 million doses distributed through public and private immunisation programmes.