The two-dose live-attenuated vaccine has been authorised for dengue prevention in individuals aged 4 to 60 years, with an Indian post-marketing study required after its market introduction.
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Takeda’s tetravalent dengue vaccine Qdenga, making it the first dengue vaccine approved in India.
The vaccine has been authorised for the prevention of dengue disease in individuals aged 4 to 60 years, according to the Ministry of Health and Family Welfare. Takeda GmbH manufactures the vaccine in Germany, while Takeda Biopharmaceuticals India will import it into the country.
Qdenga, also known by its development code TAK-003, is a live-attenuated vaccine designed to provide protection against the four dengue virus serotypes. It uses dengue virus type 2 as its genomic backbone, with genetic components representing the other serotypes incorporated into the vaccine.
The vaccine is administered subcutaneously as two 0.5 ml doses, given three months apart.
CDSCO’s Subject Expert Committee on vaccines reviewed Takeda’s application and the supporting global and Indian clinical data in March 2026. The committee subsequently recommended permission to import the vaccine for the approved age group.
The recommendation included a condition requiring the company to conduct a post-marketing safety and effectiveness study in the Indian population within six months of introducing the vaccine in the country.
The Ministry said the regulatory assessment covered the vaccine’s quality, safety and efficacy, including data from an Indian Phase III safety and immunogenicity study involving participants aged 4 to 60 years.
Qdenga received World Health Organization (WHO) prequalification in May 2024. WHO prequalification enables eligible vaccines to be procured by United Nations agencies, but it is distinct from a recommendation for routine use across all authorised age groups.
WHO recommends programmatic use of TAK-003 primarily among children aged 6 to 16 years in locations with a high intensity of dengue transmission. It does not currently recommend routine programme use among children below six years because of lower observed efficacy in that age group. WHO also advises that dengue vaccination should form part of a broader prevention strategy that continues to include vector control, disease surveillance, case management and community engagement.
The Indian authorisation establishes the regulatory conditions under which the vaccine may be supplied in the country. Details concerning its commercial launch, price, availability and any potential use in government vaccination programmes have not yet been announced.
The approval comes as India continues to pursue multiple dengue-prevention approaches. Separately, an indigenous tetravalent vaccine developed by Panacea Biotec is undergoing a Phase III clinical trial in collaboration with the Indian Council of Medical Research (ICMR).
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