India is a significant step closer to the market introduction of its first tetravalent dengue vaccine after the Subject Expert Committee (SEC) under the Drugs Controller General of India (DCGI) recommended the approval of Takeda Biopharmaceuticals‘ Dengue Tetravalent Vaccine (TDV). The recommendation supports the import and use of the vaccine in individuals aged 4 to 60 years within India.
Job Overview
The recommendation by the SEC follows Takeda’s submission of a complete Phase III clinical study report for the Indian population, as required by the committee. The vaccine has already been approved in 41 countries and carries WHO pre-qualification status. Takeda’s global clinical program included twenty trials with over 28,000 subjects. The India-specific Phase III study was a randomised, double-blind, placebo-controlled trial across 480 healthy participants.
Important Dates
The Subject Expert Committee (SEC) held a hybrid meeting on March 19, 2026, where the recommendation was made.
Eligibility Criteria
The SEC has recommended approving the vaccine for use in individuals aged 4 to 60 years in India.
Selection Process
The committee’s recommendation was based on the submission and review of a complete Phase III clinical study report specifically for the Indian population, as well as robust efficacy datasets from global trials. The safety and immunogenicity results in the Indian study showed the vaccine was well tolerated, safe, and immunogenic across all age groups studied.
Important Instructions
Alongside the recommendation, the SEC stipulated a condition requiring Takeda to conduct a post-marketing safety and effectiveness study in the Indian population within six months of the vaccine’s introduction into the Indian market.
Conclusion
Dengue poses a high burden in India, and the availability of a licensed tetravalent vaccine targeting all four dengue serotypes could materially alter the public health calculus. With the SEC recommendation on record, the final approval decision now rests with the DCGI. If granted, Takeda’s TDV would become the first dengue vaccine cleared for widespread use across age groups in India.
