India Approves First Dengue Vaccine, Qdenga, for Ages 4-60

In a significant advancement for public health, India has officially approved its first dengue vaccine, Qdenga (TAK-003), developed by the Japanese pharmaceutical company Takeda Biopharmaceuticals. The Drug Controller General of India (DCGI), operating under the Central Drugs Standard Control Organisation (CDSCO), granted market authorization for the vaccine, making it a pivotal tool in the country's ongoing battle against dengue fever. The Qdenga vaccine has been approved for individuals aged 4 to 60 years and is designed to prevent dengue disease, which continues to pose a significant public health challenge in India. India carries one of the world's highest burdens of dengue, accounting for nearly one-third of global cases. Reported cases in the country have increased dramatically, experiencing an eleven-fold rise over the past two decades. Modelling studies suggest the actual number of infections is substantially higher than reported, likely reaching tens of millions annually. A key feature of Qdenga is its live-attenuated tetravalent nature, meaning it is engineered to provide protection against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). This is crucial as all four serotypes circulate simultaneously in various parts of India. The vaccine is administered as a two-dose regimen, with the second dose given three months after the first. A notable advantage of Qdenga, unlike some other dengue vaccines, is that it does not require pre-vaccination screening to determine prior dengue infection status. This simplifies its deployment and makes it suitable for large-scale public health programs. The approval in India is supported by extensive global clinical development programs, comprising 19 Phase I, II, and III trials that involved over 28,000 participants in both dengue-endemic and non-endemic regions. Takeda's pivotal Phase III TIDES (DEN-301) trial, which included more than 20,000 participants across eight dengue-endemic countries, demonstrated significant efficacy. The vaccine showed 80.2% efficacy against virologically confirmed dengue 12 months after the second dose and 90.4% efficacy against dengue-related hospitalization at 18 months. Follow-up data extending to 4.5 years indicated 84.1% efficacy against dengue-related hospitalization, with seven-year follow-up data confirming sustained protection across all four serotypes. Furthermore, a Phase III clinical trial (DEN-302) specifically conducted in India among participants aged 4 to 60 years corroborated the vaccine's safety, tolerability, and immunogenicity in the Indian population. Qdenga has already received regulatory approval in 43 countries across Asia, Latin America, and Europe since its global launch in 2022, with over 32 million doses distributed worldwide. It has also received prequalification from the World Health Organization (WHO), affirming its adherence to international standards for quality, safety, and effectiveness, making it eligible for procurement by global agencies. Takeda has established a manufacturing partnership with Hyderabad-based Biological E to produce up to 50 million doses annually, aiming to enhance the vaccine's accessibility. Commercial availability of Qdenga in India is anticipated by mid-2026 or the first half of 2027, initially through private healthcare settings. This approval is expected to significantly bolster India's comprehensive public health strategy against dengue, complementing existing measures such as vector control, surveillance, early diagnosis, and case management.

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