Japan-based Takeda Pharmaceutical’s dengue vaccine QDENGA has received approval from India’s drug regulator, becoming the first dengue vaccine authorized for use in the country. The approval marks a major development in India’s efforts to strengthen prevention against dengue, a mosquito-borne viral disease that has emerged as a growing public health concern.

Takeda announced that QDENGA is a tetravalent live-attenuated vaccine designed to protect against all four dengue virus serotypes. According to the company, the vaccine can be administered regardless of whether a person has previously been infected with dengue and does not require pre-vaccination testing, which could make it easier to include in large-scale immunisation efforts.

The approval comes as India continues to face recurring dengue outbreaks across several regions. Takeda said reported dengue cases in the country have increased nearly elevenfold over the past two decades, reflecting the expanding burden of the disease and the need for additional preventive strategies alongside existing mosquito-control measures.

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India represents a key market for dengue prevention efforts, as the country accounts for a significant share of the global dengue burden. Takeda said the vaccine’s approval arrives at a critical time for public health authorities managing rising cases and seasonal outbreaks, particularly in areas where dengue transmission remains persistent.

To support vaccine availability, Takeda entered into a partnership with Hyderabad-based Biological E in 2024. Under the agreement, Biological E is expected to develop manufacturing capacity capable of producing up to 50 million doses annually, supporting Takeda’s global goal of producing 100 million doses per year by the end of the decade.

Since its global launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed worldwide, according to Takeda. The company said long-term clinical data has shown continued protection against symptomatic dengue and dengue-related hospitalisations, supporting the vaccine’s role as a potential tool in reducing the impact of the disease.

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