India Approves First Dengue Vaccine

India's drug regulator has granted market authorisation to Takeda Biopharmaceuticals' QDENGA, the country's first-ever approved dengue vaccine. This significant development allows for the use of QDENGA in individuals aged 4 to 60, irrespective of their previous dengue exposure or the need for pre-vaccination testing.

Dengue remains a major public health challenge in India, with thousands of cases reported annually. QDENGA's approval offers a new preventive tool, complementing existing vector control and surveillance measures. The vaccine has demonstrated effectiveness against all four circulating dengue virus serotypes.

Clinical trials involving over 28,000 participants supported the approval, showing significant efficacy in preventing dengue and hospitalisation. Specifically, efficacy against virologically confirmed dengue was 80.2% at 12 months post-second dose, and 90.4% against hospitalisation at 18 months. Long-term data indicates 84.1% efficacy in preventing dengue-related hospitalisations after 4.5 years.

The vaccine is administered as a two-dose regimen, three months apart. It has received World Health Organization recommendations for dengue-endemic settings and prequalification, further bolstering its standing as a vital public health intervention.