New Delhi: India has achieved a major milestone in the fight against dengue after the Drugs Controller General of India (DCGI) granted marketing approval to QDENGA, the anti-dengue vaccine developed by Japanese pharmaceutical company Takeda Biopharmaceuticals. With this approval, QDENGA becomes the first dengue vaccine authorized for use in India.

In a statement issued on Monday, Takeda Biopharmaceuticals India announced that the DCGI has granted market authorization to QDENGA under the New Drugs and Clinical Trials (NDCT) Rules, 2019 for the prevention of dengue in individuals aged 4 to 60 years.

No Prior Dengue Infection Test Required

One of QDENGA’s key advantages is that it can be administered regardless of whether a person has previously been infected with dengue. The company stated that recipients do not need to undergo any serological testing before vaccination, making the vaccine easier to deploy in large-scale immunization programs.

Dengue Remains a Major Public Health Challenge

Dengue continues to pose a significant public health threat in India. According to data from the National Vector Borne Disease Control Programme, the country reported 6,927 dengue cases and 10 deaths by February this year.

Health experts estimate that nearly one-third of the world’s dengue cases occur in India, with the virus remaining endemic across most parts of the country.

Effective Against All Four Dengue Serotypes

Takeda said that QDENGA provides protection against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4).

Mahendra Nayak, Head of Intercontinental Markets at Takeda, said that seven-year follow-up data demonstrate sustained protection against dengue infection and hospitalization caused by all four serotypes, calling the vaccine a significant advancement for both communities and healthcare systems.

Approved in 43 Countries

Since its global launch in 2022, QDENGA has received regulatory approval in 43 countries, with more than 32 million doses distributed worldwide.

A Major Step Forward for India

Go Choo Beng, Head of Medical Affairs for Southeast Asia and India Cluster at Takeda, noted that India bears a high dengue burden, with all four virus serotypes circulating simultaneously in several regions.

He said the approval of QDENGA strengthens India’s comprehensive dengue prevention strategy, complementing vector control, disease surveillance, public awareness campaigns, and other public health interventions.

Approval Backed by Extensive Clinical Research

The approval is based on Takeda’s extensive global clinical development program, which included 19 Phase I, II, and III clinical trials involving more than 28,000 participants from dengue-endemic and non-endemic regions.

A key part of the program was the Phase III TIDES (DEN-301) trial, which enrolled over 20,000 participants across eight countries to evaluate the vaccine’s long-term safety and efficacy.

Key Clinical Findings

• 80.2% overall efficacy against virologically confirmed dengue 12 months after the second dose.
• 90.4% protection against dengue-related hospitalization 18 months after vaccination.
• 84.1% protection against hospitalization 4.5 years after the two-dose regimen.
• Sustained protection for seven years against all four dengue virus serotypes.

A New Chapter in Dengue Prevention

Public health experts believe that the approval of QDENGA marks a significant breakthrough in India’s efforts to combat dengue. Until now, there has been no specific antiviral treatment for dengue, and severe forms of the disease, including dengue hemorrhagic fever, can be life-threatening.

The availability of India’s first approved dengue vaccine is expected to strengthen disease prevention efforts and reduce the burden of dengue-related illness and hospitalization in the years ahead.