India Approves And Gets Its First Dengue Vaccine

India-West News Desk

NEW DELHI- India has approved its first dengue vaccine, with the Drug Controller General of India granting market authorization to Takeda Biopharmaceuticals India’s QDENGA (TAK-003), the company announced in a press release.

The approval comes against the backdrop of a rising dengue burden in the country. Reported cases have increased nearly 11-fold over the past two decades, and India accounts for almost one-third of the global dengue burden, although modelling studies suggest the actual number of infections is significantly higher than official estimates.

Authorized for people aged 4 to 60 years, QDENGA is a live-attenuated tetravalent vaccine developed to protect against all four dengue virus serotypes. It is given in two doses, three months apart. Takeda said the vaccine can be administered irrespective of a person’s previous dengue infection and does not require pre-vaccination screening.

Data submitted to the Indian regulator included findings from a Phase III clinical study conducted in India involving children, adolescents and adults between the ages of 4 and 60 years. According to the company, the vaccine was found to be safe, well tolerated and immunogenic in all three age groups.

The approval was also supported by Takeda’s broader clinical development program, which comprised studies involving more than 28,000 participants from both dengue-endemic and non-endemic regions.

Takeda said the vaccine recorded 80.2 per cent efficacy against virologically confirmed dengue one year after the second dose and 90.4 per cent efficacy against dengue-related hospitalization after 18 months. Follow-up data collected over the next several years showed continued protection, including 84.1 per cent efficacy against dengue-related hospitalization at 4.5 years and sustained protection against dengue disease and hospitalization through seven years across all four virus serotypes.

The company said QDENGA has already been authorized in 43 countries across Asia, Latin America and Europe. More than 32 million doses have been distributed through public and private immunization programs. The vaccine has also received World Health Organization prequalification and is recommended by the WHO for use in dengue-endemic settings with high transmission.

Takeda said it will now work with Indian regulatory authorities, healthcare providers and public health stakeholders to support the vaccine’s availability in the country.