Key Highlights:
- Takeda’s Qdenga has received approval from India’s drug regulator, becoming the first dengue vaccine cleared in the country. Designed to protect against all four dengue virus serotypes, the vaccine is indicated for individuals aged 4–60 years and is expected to launch in India in H1’27, initially through private healthcare settings.
- Qdenga is administered in two 0.5 mL doses three months apart and does not require pre-vaccination testing. In a late-stage trial, the vaccine demonstrated 80.2% efficacy against confirmed dengue cases one year after the second dose and 90.4% efficacy against dengue-related hospitalizations after 18 months.
- Takeda is partnering with Biological E to expand Qdenga’s manufacturing in India, with the collaboration targeting production capacity of up to 50 million doses annually. The approval comes as dengue cases in India have increased significantly over the past two decades, highlighting the need for preventive interventions.
Implications:
Qdenga’s approval as India’s first dengue vaccine creates a new prevention market in a country where reported cases have risen about 11‑fold in two decades, and positions Takeda (with Biological E) to build a large, private‑sector vaccine franchise ahead of any public programme by offering a two‑dose, no‑testing‑required product for ages 4–60 with strong efficacy against disease and hospitalisation and manufacturing capacity targeting tens of millions of doses per year.
Source: Reuters
