Prime Highlights 

• India’s drug regulator approved Takeda’s Qdenga, making it the first dengue vaccine cleared for use in the country.  

• The two-dose vaccine protects against all four dengue virus types and can be given without prior dengue testing.  

Key Facts 

• Takeda Pharmaceutical is a Japan-based global pharmaceutical company, while Biological E is its Indian manufacturing partner for Qdenga.  

• Qdenga showed 80.2% efficacy against confirmed dengue cases and 90.4% efficacy against dengue-related hospitalisations in late-stage clinical trials.  

Background 

India’s medicines authority has approved Takeda Pharmaceutical’s Qdenga dengue vaccine, making it the nation’s first approved dengue vaccine. The Japanese drugmaker said the vaccine is expected to be available in India in the first half of next year after completing market authorization, with initial distribution through private healthcare facilities. 

Qdenga is designed to protect against all four dengue virus types and is approved for children and adults aged four to 60 years. The vaccine can be administered without first determining if a person has had dengue before. It is administered in two doses spaced three months apart. 

The approval comes as dengue cases continue to rise in India and across the world. According to the World Health Organization, the disease caused a record number of infections globally in the previous year, while India also reported thousands of cases and deaths. Takeda said reported dengue cases in India have increased sharply over the past two decades. 

The company said it remains on track to expand its global production capacity to 100 million doses annually by the end of the decade. It also reaffirmed its partnership with Indian vaccine maker Biological E to support manufacturing of up to 50 million doses each year. 

In a late-stage clinical trial, Qdenga showed 80.2% effectiveness against confirmed dengue cases one year after the second dose. It also demonstrated 90.4% effectiveness in reducing dengue-related hospitalizations after 18 months. 

Experts said the vaccine could reduce severe illness and hospital admissions but added that mosquito control will remain essential to limit future outbreaks.