India Approves First Dengue Vaccine QDENGA: Major Relief as DCGI Grants Approval for Ages 4 to 60

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New Delhi : With the onset of the monsoon season every year, dengue cases witness a sharp surge across the nation, impacting millions of people. Overcrowded hospitals and severe complications have become increasingly common as dengue instances rise annually. In a significant breakthrough for public health, India has approved its first-ever dengue vaccine, QDENGA. Developed by the Japanese pharmaceutical company Takeda, the vaccine has been granted approval by the Drugs Controller General of India (DCGI) for individuals aged between 4 and 60 years.

QDENGA marks a pivotal advancement as the first approved dengue vaccine in India that does not require prior dengue screening, making it suitable for both previously infected individuals and those who have never had dengue before. Administered in two doses spaced three months apart, this approval comes at a critical juncture for India, which accounts for nearly one-third of the global dengue burden. According to company reports, reported dengue cases in India have surged roughly 11-fold over the last two decades, with over 1.13 lakh cases registered in 2025 alone, though experts believe the actual number of cases could be significantly higher.

Extensive research and clinical trials involving over 28,000 individuals have demonstrated the high efficacy and safety profile of QDENGA. Clinical trial results indicated that 12 months following the second dose, the vaccine demonstrated an efficacy rate of 80.2% in preventing dengue illness and reduced the risk of dengue-related hospitalizations by 90.4%. Long-term follow-up studies further revealed that even after 4.5 years, the vaccine maintained an 84.1% efficacy rate in preventing hospitalizations, with sustained safety and efficacy proven over a seven-year period.

Recognizing its safety, quality, and effectiveness, the World Health Organization (WHO) has recommended QDENGA for inclusion in public immunization programs in regions with high dengue transmission rates. Having achieved WHO prequalification, the vaccine meets international standards, offering a promising tool in India’s ongoing battle against seasonal dengue outbreaks.