Patna: India has approved its first dengue vaccine after the Drug Controller General of India (DCGI) granted market authorisation to QDENGA, developed by Takeda Biopharmaceuticals India Private Limited. According to the company, the vaccine is approved for use in individuals aged 4 to 60 years.
The approval comes as India continues to face a significant dengue burden, with outbreaks reported across several states each year. Takeda said the vaccine can be administered to people regardless of whether they have previously been infected with dengue and does not require pre-vaccination screening.
What the Approval Means
According to Takeda, QDENGA is the first dengue vaccine to receive regulatory approval in India. The vaccine is indicated for people between the ages of 4 and 60 and is designed to protect against all four serotypes of the dengue virus.
The company said the vaccine can be given to both individuals who have never had dengue and those with a previous infection, eliminating the need for prior blood testing or screening before vaccination.
Clinical Evidence Behind the Decision
Takeda said the DCGI’s approval is based on findings from its global clinical development programme involving more than 28,000 participants across 19 Phase 1, Phase 2 and Phase 3 clinical trials.
According to the company, additional evidence from the Phase 3 DEN-302 clinical trial conducted in India demonstrated that the vaccine generated an immune response and had an acceptable safety profile among participants.
The vaccination schedule consists of two 0.5 ml doses, administered subcutaneously, with a minimum interval of three months between doses.
Already Approved in 43 Countries
Mahendra Nayak, Head of Intercontinental Markets at Takeda, said QDENGA has been approved in 43 countries since its global launch in 2022.
According to Nayak, more than 32 million doses have been distributed worldwide. He said seven years of clinical data indicate that the vaccine helps reduce the risk of symptomatic dengue and hospitalisation associated with severe disease.
WHO Recommendation
Takeda said the World Health Organization (WHO) recommends the use of QDENGA in regions where dengue is endemic.
According to the company, the WHO has stated that the vaccine can be incorporated into routine immunisation programmes in high-burden areas and does not require prior screening before administration.
Why Dengue Remains a Public Health Concern
Dengue is a mosquito-borne viral disease transmitted primarily by Aedes mosquitoes. It remains endemic in many parts of India, with seasonal outbreaks often intensifying during and after the monsoon.
According to Takeda, India accounts for nearly one-third of the world’s reported dengue cases. The company attributed the growing disease burden to factors including rapid urbanisation, climate change and expanding mosquito habitats.
Goh Chu Beng, Head of Medical Affairs for Takeda’s Southeast Asia and India Cluster, said all four dengue virus serotypes are circulating in several parts of India. He said vaccination could complement existing public health measures such as mosquito control, disease surveillance and public awareness campaigns.
What’s Next
While the DCGI’s approval allows QDENGA to be marketed in India, its inclusion in government immunisation programmes would require separate policy decisions by public health authorities.
Health experts continue to emphasise that vaccination, where available, should complement—not replace—vector control measures, including eliminating mosquito breeding sites, using protective clothing and repellents, and seeking early medical care if dengue symptoms develop.
