India Approves First Dengue Vaccine Qdenga for Ages 4 to 60
India's Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Qdenga, a recombinant live attenuated dengue vaccine developed by Takeda GmbH, making it the first dengue vaccine approved in the country. The vaccine is indicated for individuals aged 4 to 60 years and is administered as two subcutaneous doses of 0.5 ml each, three months apart. The Union Health Ministry stated the approval followed a comprehensive scientific evaluation of quality, safety, and efficacy under the Drugs and Cosmetics Act. Clinical studies included a pivotal Phase III trial in India and trials across eight countries. Qdenga has already received regulatory approval in 42 nations and WHO prequalification. Over 24 million doses have been distributed globally with a favourable safety profile. The approval is expected to complement India's existing vector control and disease management efforts under the National Vector Borne Disease Control Programme.
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