India Approves First Dengue Vaccine; Launch Expected in First Half of 2027
India has approved its first dengue vaccine, the Drug Controller General of India (DCGI) announced on Monday. The vaccine, QDENGA, developed by Takeda, received market authorisation under Form CT-20 of the New Drugs and Clinical Trials Rules, 2019. It is cleared for individuals aged 4 to 60 years.
The vaccine is administered in two doses, given three months apart, and is designed to protect against all four dengue virus serotypes. Unlike some earlier dengue vaccines, QDENGA can be given regardless of prior dengue infection and does not require pre-vaccination screening.
According to Takeda, the vaccine is expected to be launched in the first half of 2027. The company is working closely with regulators and other stakeholders ahead of the launch. Pricing has not yet been finalised.
The approval is based on a Phase III clinical trial involving Indian participants aged 4 to 60 years, which found the vaccine to be safe, well-tolerated and immunogenic. QDENGA has also received WHO prequalification and is recommended by the World Health Organisation for use in dengue-endemic settings without pre-vaccination screening.
Dengue remains a significant public health challenge in India. According to a modelling study published in Nature, India accounts for nearly 34 per cent of the global dengue burden, the highest for any country. Reported dengue cases in India have increased 11-fold over the past two decades, with over 1.13 lakh cases reported in 2025 alone.
Spread by Aedes mosquitoes, dengue has no specific antiviral treatment and can progress rapidly to severe disease requiring hospitalisation. All four dengue virus serotypes circulate in India, contributing to recurrent outbreaks, said Dr Goh Choo Beng, medical affairs head for Southeast Asia and India at Takeda.
Takeda said QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally through public and private immunisation programmes. The company will work with Indian regulatory authorities and healthcare stakeholders to support the vaccine's rollout.
