India approves first dengue vaccine QDENGA for people aged 4 to 60 years

India has approved its first dengue vaccine, QDENGA, for individuals aged 4 to 60 years. The DCGI clearance allows vaccination without pre-screening and marks a major step in strengthening dengue prevention alongside surveillance, vector control and public health measures.

New Delhi: Paving the way for the launch of the country’s first dengue vaccine, the central drug regulatory authority, the Drug Controller General of India (DCGI), has granted approval for Qdenga, a dengue vaccine for persons aged 4 to 60 years, manufactured by Japanese biopharma giant Takeda Biopharmaceuticals India Pvt Ltd.

In India, Takeda had earlier announced a manufacturing partnership with Hyderabad-based Biological E Limited to support its goal of producing 100 million doses annually, according to multiple reports.

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Qdenga is designed to induce a strong immune response by generating detectable antibodies against all four dengue virus serotypes, including DENV-1, DENV-2, DENV-3 and DENV-4.

The vaccine can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing, the vaccine maker said on Monday. Qdenga is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes. The vaccine is administered subcutaneously as a 0.5 ml two-dose regimen, with doses given three months apart.

Dr Mahender Nayak, Head of Intercontinental Markets, said, “The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalisation across all four dengue serotypes, an important milestone for communities and health systems.”

Peter Streibl, GM, Southeast Asia and India Cluster, said, “Takeda is committed to working with governments, public health authorities, healthcare professionals and partners across South and Southeast Asia.”

Dr Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster, said, “QDENGA is designed to protect against all four dengue serotypes, which are present in India.”

The approval in India is based on results from Takeda’s global clinical development programme involving 19 Phase 1, 2 and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions. The study demonstrated that QDENGA was well tolerated, safe and immunogenic in healthy adults, adolescents and children.y adults, adolescents and children.