Japan's Takeda Pharmaceutical said on Monday that India's drug regulator had approved its dengue vaccine, QDENGA, making it the first vaccine authorized in the country to help prevent the mosquito-borne disease.
The decision marks a significant step in India's efforts to curb dengue, which has become an increasingly serious public health challenge in recent years.
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Takeda said reported dengue cases in India have risen nearly elevenfold in the past two decades, highlighting the country's expanding struggle with the mosquito-borne disease and the need for stronger preventive measures.
QDENGA is a tetravalent live-attenuated vaccine designed to provide protection against all four dengue virus serotypes.
The vaccine can be administered irrespective of whether an individual has previously been infected with dengue and does not require pre-vaccination testing, simplifying its use in large-scale immunisation programmes, the company said.
India accounts for nearly one-third of the global dengue burden, making the country a key market for the vaccine.
Takeda said the approval comes at a critical time as health authorities continue to grapple with recurring outbreaks across several states.
To strengthen supply, Takeda entered into a partnership with Hyderabad-based vaccine manufacturer Biological E in 2024.
Under the agreement, Biological E plans to establish manufacturing capacity for up to 50 million doses annually, contributing to Takeda's target of producing 100 million doses globally each year by the end of the decade.
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Since its global launch in 2022, QDENGA has received approvals in 43 countries, with more than 32 million doses distributed worldwide.
Takeda said long-term clinical data has demonstrated sustained protection against symptomatic dengue and dengue-related hospitalisations.
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