DCGI Clears India's First Dengue Vaccine For People Aged 4-60 Years, Offering New Tool Against Rising Disease Burden

India has approved its first vaccine against dengue, marking a significant step in the country's efforts to combat one of its fastest-growing vector-borne diseases.

The Drug Controller General of India (DCGI) granted marketing authorisation to Japanese drugmaker Takeda's tetravalent dengue vaccine, QDENGA.

The vaccine has been approved for people aged between four and 60 years and provides protection against all four dengue virus serotypes — DENV-1, DENV-2, DENV-3 and DENV-4 — which co-circulate in several parts of India.

The vaccine will be administered in two doses, three months apart. According to data submitted to the regulator, clinical trials involving more than 28,000 participants across multiple countries showed an efficacy of about 80% against laboratory-confirmed dengue one year after completion of the two-dose schedule.

The studies also demonstrated more than 90% protection against dengue-related hospitalisation during the initial follow-up period, with protection against severe disease sustained for several years.

Health experts said the vaccine could substantially help reduce hospital admissions during the annual dengue season, when hospitals often witness a surge in patients requiring intensive monitoring and supportive care.

Severe dengue remains one of the leading causes of hospitalisation among children and adults in endemic regions.

The experts also said that approval is also expected to strengthen India's dengue prevention strategy, which has so far relied primarily on vector control measures such as eliminating mosquito breeding sites, insecticide spraying, surveillance and public awareness campaigns. They, however, cautioned that vaccination should complement rather than replace mosquito control measures, as preventing mosquito breeding remains the most effective way to reduce transmission.

The vaccine's impact will depend largely on its affordability and accessibility. According to the sources, Takeda has partnered with Hyderabad-based Biological E to manufacture up to 50 million doses annually, a move expected to improve supply for the domestic market. However, pricing has not yet been announced, and its inclusion in the Universal Immunisation Programme or targeted vaccination campaigns will be decided by the government after further policy deliberations.

The approval is based on Takeda's global clinical development programme as well as a Phase III study conducted among Indian participants, which found the vaccine to be safe and immunogenic in children, adolescents and adults.

The health experts described the regulatory clearance as an important milestone but emphasised that dengue control would continue to require an integrated approach combining vaccination, early diagnosis, surveillance, effective case management and sustained community participation in eliminating mosquito breeding sites.

Reported infections have increased nearly eleven-fold over the past two decades, while India accounts for almost one-third of the global dengue burden. Public health experts believe the actual number of infections is considerably higher than reported because many cases remain undiagnosed or are not captured by surveillance systems.

Unlike earlier dengue vaccines, Qdenga can be administered without pre-vaccination screening to determine whether an individual has had a prior dengue infection.

With dengue expanding into newer geographical areas and climate change contributing to longer transmission seasons, the availability of a vaccine provides India with an additional preventive tool against a disease that continues to impose a significant health and economic burden every year.