India has moved a step closer to introducing its first dengue vaccine after the Subject Expert Committee under the country’s central drug regulator gave a positive recommendation for Takeda’s Dengue Tetravalent Vaccine, Qdenga, for import approval. The panel’s nod, however, comes with a condition that the company must conduct a post-marketing safety and effectiveness study in the local population within six months of the vaccine’s introduction in the Indian market.
If cleared by the regulator, the vaccine would be recommended for use in people aged 4 to 60 years, a move that could widen prevention options in a country where dengue continues to strain hospitals during seasonal outbreaks. Takeda’s vaccine is already prequalified by the World Health Organization and has been positioned for broader use in endemic settings because it does not require prior dengue exposure before administration.
The recommendation is based on clinical and local data shared with the committee, including a global Phase 3 trial involving around 21,000 participants across more than eight countries and an Indian Phase 3 study that found the vaccine to be tolerated, safe and immunogenic in the target age group. The SEC also reviewed post-marketing data from global markets, which did not identify new significant safety signals beyond those already recognized in Takeda’s risk management plan.
The vaccine’s entry would be important for India because dengue control has largely depended on mosquito control, early diagnosis and supportive care. Public health experts have long viewed a vaccine as a potentially valuable additional tool in endemic regions, especially as cases rise in urban and semi-urban pockets each monsoon.
Takeda’s vaccine, marketed as Qdenga, has already been approved in 41 countries, and the company says about 24.4 million doses have been distributed globally since launch. The vaccine has also been studied extensively, with Takeda citing nine Phase 3 trials, six Phase 2 trials and five Phase 1 trials involving more than 28,000 subjects from both dengue-endemic and non-endemic regions.
In India, the vaccine will be manufactured by Biological-E, which is also working on the supply of single-dose and multi-use vials. The company has said the local partnership is intended to accelerate access through a Make in India manufacturing model. The partnership will substantially enhance manufacturing capabilities to ensure a sustainable global supply of the vaccine. Biological E will scale up its production capacity to potentially reach 50 million doses annually, accelerating Takeda’s efforts to manufacture 100 million doses annually within the decade.
The SEC’s recommendation marks a regulatory milestone, but final approval still rests with the national drug regulator. If granted, the vaccine could become the first widely available dengue vaccine for use across a broad age group in India, potentially changing how the country approaches prevention of the mosquito-borne disease.
