Takeda Received Expert Committee Nod for Dengue Vaccine Import

Takeda Pharmaceutical Company is a step closer to dengue vaccine Import approval in India after receiving a positive recommendation from the Subject Expert Committee, marking a major development in the country’s fight against mosquito-borne diseases.

The dengue vaccine import approval process now awaits final clearance from the national drug regulator, which could pave the way for the first widely accessible dengue vaccine in India.

The vaccine, Qdenga, is designed to protect against all four dengue virus strains and can be administered to individuals aged 4 to 60 years, regardless of prior infection.

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This makes it a broader solution compared to earlier options that had limitations. The company presented data from global clinical trials involving more than 20,000 participants, showing strong immune response and consistent safety outcomes.

The expert panel has asked Takeda to conduct a post-marketing safety study in India within six months of rollout to ensure the vaccine performs effectively in local conditions. This step aligns with India’s cautious approach to new vaccine approvals.

Takeda has also partnered with Biological E to support large-scale manufacturing, with plans to produce up to 100 million doses over time. This could improve affordability and accessibility if the vaccine is approved.

The dengue vaccine import approval could mark a shift from reactive treatment to preventive care in India, where dengue cases continue to rise each year. With final approval pending, the vaccine may soon become a key tool in reducing disease burden nationwide.c