India clears first dengue vaccine for people aged 4 to 60
India has approved its first dengue vaccine, marking an important milestone in the country’s efforts to tackle the mosquito-borne disease. The Central Drugs Standard Control Organisation (CDSCO) has granted approval to Japanese pharmaceutical company Takeda’s dengue vaccine, QDENGA (TAK-003), for individuals between the ages of 4 and 60.
Takeda said the vaccine is now authorised in 43 countries and that more than 32 million doses have already been distributed through both government and private immunisation programmes worldwide.
The vaccine is designed to provide protection against all four dengue virus serotypes. It is administered as two injections given three months apart and does not require recipients to undergo prior dengue testing or prove previous exposure to the virus.
Health experts note that dengue cases in India have risen sharply over the past two decades, making prevention increasingly important. India accounts for a significant share of global dengue infections, with more than 1.13 lakh reported cases in 2025, although researchers believe the actual number of infections could be considerably higher.
QDENGA has also been recommended by the World Health Organization for use in regions where dengue is common and has received WHO prequalification.
Takeda officials described the approval as a major development for India’s public health efforts. They highlighted long-term clinical data showing sustained protection against dengue infection and hospitalisation across all four virus strains.
The approval is supported by an extensive global clinical programme involving over 28,000 participants across multiple Phase 1, 2 and 3 studies. One large international Phase III trial involving more than 20,000 participants demonstrated strong protection against laboratory-confirmed dengue after vaccination, while also significantly reducing the risk of dengue-related hospital admissions over several years.
Additional Phase III data collected in India found the vaccine to be safe, well tolerated and capable of generating a strong immune response in people aged 4 to 60.
The vaccine is already included in Brazil’s national immunisation programme and is also available through public vaccination initiatives in countries such as Argentina, Colombia and Indonesia. Takeda says it will now work with Indian authorities and healthcare providers to support the vaccine’s rollout.