India Gets Its First Approved Dengue Vaccine; Qdenga Cleared for Individuals Aged 4-60
India has approved the use of Qdenga, a dengue vaccine developed by Takeda, for individuals aged 4 to 60. The vaccine has already been cleared in 42 countries and is supported by extensive global clinical trials.
Why it matters
The introduction of a vaccine in a high-burden country like India is a major public health milestone for tropical disease management.
In a significant step towards strengthening India’s fight against dengue, the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation to the country’s first dengue vaccine, Qdenga®, for the prevention of dengue disease in individuals aged 4 to 60 years.
The vaccine, developed by Takeda GmbH, Germany, will be imported and marketed in India by Takeda Biopharmaceuticals India Pvt. Ltd. The approval has been granted by the CDSCO under the Ministry of Health and Family Welfare following a comprehensive scientific evaluation of its quality, safety and efficacy in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Qdenga is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is manufactured in Vero cells using a dengue virus type-2 backbone engineered with serotype-specific surface proteins. The vaccine is supplied as a freeze-dried powder for reconstitution and is administered through a subcutaneous injection.
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