India Approves Takeda's 2-Dose QDENGA for Ages 4-60 as Dengue Cases Rose 11-Fold

3 articles · Updated · The Hindu · Jul 20

DCGI granted market authorization to Takeda's QDENGA, making it India's first approved dengue vaccine for people aged 4 to 60.
The live-attenuated tetravalent shot targets all four dengue serotypes, is given in 2 doses three months apart, and can be used without pre-vaccination screening or prior-infection checks.
Takeda said approval was backed by 19 Phase I-III trials involving more than 28,000 participants, including the 20,000-plus TIDES study across eight endemic countries.
Trial data showed 80.2% efficacy against confirmed dengue 12 months after dose two and 90.4% efficacy against dengue-related hospitalization at 18 months, with protection sustained through seven years.
The clearance comes as India bears nearly one-third of the global dengue burden and reported cases have climbed nearly 11-fold over the past two decades.

Sources

The Hindu1d ago

India's DCGI Approves Takeda's QDENGA, First Dengue Vaccine for Ages 4-60

The Times of India1d ago

India Approves First Dengue Vaccine, QDENGA (TAK-003), from Takeda for Ages 4-60

India Today1d ago

India approves first dengue vaccine, Japanese firm Qdenga formula will protect against all four virus subtypes - India Today

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Qdenga in India: The Strategic Rollout and Impact of the Nation’s First Dengue Vaccine (TAK-003) in 2026

Overview

India is on the verge of a major public health milestone with the anticipated introduction of its first dengue vaccine, Qdenga (TAK-003). Although the Central Drugs Standard Control Organisation has approved trials, the vaccine is not yet available for general use. Takeda, in partnership with Biological E, is preparing for a successful rollout by focusing on pricing, manufacturing readiness, and building trust with government stakeholders. The vaccine’s broad protection against all four dengue virus types and its integration into existing health strategies could significantly reduce dengue’s impact, provided equitable access and strong public education are ensured.

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