1st dengue vaccine gets DCGI nod, set to hit market next year

NEW DELHI: India Monday approved its first dengue vaccine, marking a significant milestone in the country’s fight against one of its fastest-growing vector-borne diseases. The Drug Controller General of India (DCGI) granted market authorisation under Form CT-20 of New Drugs and Clinical Trials Rules, 2019, to QDENGA, Takeda’s dengue vaccine, for individuals aged 4 to 60 years.The vaccine requires two doses, given three months apart. It is designed to protect against all four dengue virus serotypes.Unlike an earlier dengue vaccine available internationally, QDENGA can be administered regardless of previous dengue infection and does not require pre-vaccination screening.According to Dr Mahender Nayak, head of Intercontinental Markets at Takeda, the vaccine is expected to be launched in the first half of 2027. The company is working closely with the regulator and other stakeholders ahead of the launch, he added. The pricing has not yet been finalised.The approval in India was supported by a Phase III clinical trial in Indian participants aged 4 to 60 years, which found the vaccine to be safe, well tolerated and immunogenic. According to the company, the vaccine has also received WHO prequalification and is recommended by World Health Organisation for use in dengue-endemic settings without pre-vaccination screening.The approval comes at a time when dengue continues to pose a public health challenge. According to Takeda, reported dengue cases in India have increased 11-fold over the past two decades.A landmark modelling study published in Nature estimated that India accounts for nearly 34% of global dengue burden, the highest for any country.According to the company, more than 1.13 lakh dengue cases were reported in India in 2025. Spread by Aedes mosquitoes, dengue has no specific antiviral treatment and can rapidly progress 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, Southeast Asia & India Cluster.Takeda said QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally through public and private immunisation programmes. Company said it will work with Indian regulatory authorities and healthcare stakeholders to support the vaccine’s rollout.Get the latest India News and Live updates. Download the TOI app.