In a landmark move for public health, the Drug Controller General of India (DCGI) has granted market authorization to Takeda Biopharmaceuticals India Pvt. Ltd. for QDENGA (TAK-003), making it the first dengue vaccine approved in the country. The vaccine is indicated for individuals aged 4 to 60 years and can be used regardless of previous dengue exposure, eliminating the need for pre-vaccination testing. This approval comes as India battles a significant dengue burden, accounting for nearly one-third of global cases.
QDENGA’s approval is backed by an extensive clinical development program involving over 28,000 participants across 19 trials. The pivotal Phase III TIDES trial enrolled more than 20,000 participants in eight countries and demonstrated 80.2% efficacy against virologically confirmed dengue at 12 months post-second dose. Additionally, the vaccine showed 90.4% efficacy against dengue-related hospitalization at 18 months, underscoring its potential to reduce severe outcomes.
Dr. Mahender Nayak, Head of Intercontinental Markets at Takeda, emphasized the vaccine’s role in evidence-based prevention. ‘Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalization across all four serotypes,’ he said. Since its global launch in 2022, QDENGA has been approved in 43 countries and over 32 million doses have been distributed.
The approval marks a significant step forward in dengue prevention in India, offering a new tool to combat a disease that causes widespread illness and puts pressure on healthcare systems. Takeda has committed to working with public health authorities and partners to ensure equitable access to the vaccine across the country.
Article and image source: covaipost.com
