New Delhi: In a major medical breakthrough, India has officially secured its first dengue vaccine. The Drug Controller General of India has granted market authorization to QDENGA, a dengue vaccine manufactured by Takeda Biopharmaceuticals India Private Limited, paving the way for widespread immunization against the deadly vector-borne disease.
The QDENGA vaccine is approved for individuals aged 4 to 60 years. According to a statement issued by the Japanese biopharmaceutical giant’s Indian branch, the vaccine can be administered regardless of a person’s previous dengue infection history. Crucially, this eliminates the need for mandatory pre-vaccination screening tests, streamlining the public rollout process. The two dose vaccine is administered subcutaneously, with a minimum gap of three months between the shots.
Highlighting the importance of the approval, Mahendra Nayak, Head of Intercontinental Markets at Takeda, stated, “Since its launch in 2022, the QDENGA vaccine has been approved in 43 countries, and more than 32 million doses have been distributed globally. This approval is a very important step towards strengthening dengue prevention in India.” He noted that seven years of clinical data show the vaccine offers sustained protection against all four serotypes of the dengue virus, significantly reducing the risk of severe infection and hospitalization.
The regulatory nod is backed by Takeda’s massive global clinical development program, which involved 19 trials across phases 1, 2, and 3, encompassing over 28,000 participants in both high and low endemic zones. Further validation came from a Phase 3 trial conducted specifically on the Indian population, which confirmed the safety and immunogenicity of the vaccine.
Dengue represents a colossal public health challenge in India. Goh Choo Beng, Head of Medical Affairs for Takeda’s Southeast Asia and India Cluster, emphasized that multiple serotypes of the virus frequently co-circulate in various regions across the country. The World Health Organization has strongly recommended the QDENGA vaccine for use in endemic areas, particularly advocating for its inclusion in public immunization programs to combat the disease effectively.
Currently, dengue affects over 125 countries globally. However, the burden is disproportionately high in India, which accounts for nearly one-third of the world’s total dengue cases. Rapid urbanization, large scale disease transmission, and shifting weather patterns consistently threaten millions of Indians, making this vaccine approval a long awaited milestone in the country’s public health defense system.
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