Takeda's Qdenga becomes first dengue vaccine approved in India

India has approved its first dengue vaccine. The Drugs Controller General of India (DCGI) gave the green light to Japanese drugmaker Takeda's Qdenga for individuals aged four to 60 years.

The decision marks a significant step in the country's fight against a disease that hospitalises thousands every year. Qdenga is a live-attenuated vaccine that targets all four dengue virus serotypes.

Two-dose regimen

Qdenga is administered as a two-dose schedule, with the second shot given three months after the first. The vaccine has already been approved in several countries, including the European Union and Indonesia.

Takeda said clinical trials showed the vaccine reduced the risk of hospitalisation from dengue by 84% in the first 18 months after vaccination. The company has not yet revealed the price for the Indian market.

Dengue burden in India

Dengue is endemic in India. The country reported over 2.3 lakh cases and nearly 300 deaths in 2023, according to the National Vector Borne Disease Control Programme. The actual numbers are likely higher, as many cases go unreported.

The disease places a heavy burden on the healthcare system, particularly during the monsoon season when mosquito breeding peaks. Children and young adults are among the most affected groups.

What the approval means

Public health experts have welcomed the approval but caution that the vaccine should be part of a broader strategy. Vector control, early diagnosis, and proper case management remain critical.

The vaccine is not recommended for pregnant women, lactating mothers, or people with compromised immune systems. Takeda will need to conduct post-marketing surveillance to monitor long-term safety and effectiveness in the Indian population.

Rollout timeline

Takeda has not announced a specific launch date. The company is expected to work with state governments and private healthcare providers to roll out the vaccine across the country. Distribution will likely begin in high-burden states first.

The DCGI's approval is conditional. Takeda must submit periodic safety updates and efficacy data from ongoing studies.

The vaccine's arrival offers a new tool in the fight against dengue. Whether it becomes a game-changer will depend on affordability, public awareness, and how well it fits into India's existing immunisation programme. The coming months will reveal how quickly the vaccine reaches those who need it most.