Key Highlights:
- Takeda has received a positive recommendation from the Subject Expert Committee (SEC) under Central Drugs Standard Control Organization for import approval of its dengue tetravalent vaccine Qdenga, subject to a post-marketing safety and effectiveness study within six months of launch
- Qdenga, prequalified by the World Health Organization, is indicated for individuals aged 4–60 years and demonstrated strong efficacy against all four dengue serotypes in global and local Phase 3 trials, while being suitable regardless of prior dengue exposure
- Takeda has partnered with Biological E Limited for local manufacturing targeting ~100M doses annually, with plans to pursue public procurement alongside private market sales; the vaccine is already approved in 41 countries with ~24.4M doses distributed
Implications:
Qdenga’s positive SEC opinion moves India close to its first widely available dengue vaccine, with import approval tied to a rapid post‑marketing safety and effectiveness study in local populations.
Because Qdenga is WHO-prequalified, effective against all four dengue serotypes in large Phase 3 programmes, and usable regardless of prior dengue status, it can be deployed at scale across 4–60-year-olds—critical in hyper‑endemic urban India.
Takeda’s tie-up with Biological E to build capacity toward roughly 100 million doses per year (via multi-dose vials for endemic markets) under a Make-in-India model should support both government procurement and private sales, using Qdenga’s track record of 24.4 million doses in 41 countries to underpin confidence on safety and supply.
Source: CDSCO I Image: Takeda
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