India has approved its first dengue vaccine after the Drug Controller General of India (DCGI) granted market authorisation to Takeda Biopharmaceuticals India Pvt Ltd’s QDENGA, a major step in the country’s
efforts to combat one of its most widespread mosquito-borne diseases.
QDENGA has been approved for the prevention of dengue in individuals aged 4 to 60 years.
The vaccine can be administered regardless of whether a person has previously been infected with dengue and does not require pre-vaccination testing, making it easier to deploy in dengue-endemic regions.
“Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India,” Mahender Nayak, Head of Intercontinental Markets at Takeda, said in a statement, as quoted by Moneycontrol.
He added that the latest seven-year data for QDENGA demonstrated continued protection against dengue infection and dengue-related hospitalisation across all four dengue virus serotypes, calling it an important milestone for communities and public health systems.
Approval Backed By Global, Indian Clinical Trials
The Indian approval is based on evidence from Takeda’s extensive global clinical development programme, comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants across both dengue-endemic and non-endemic regions.
The approval is also supported by findings from the Phase III DEN-302 clinical trial conducted in India, which evaluated the vaccine’s safety and immunogenicity in participants between the ages of 4 and 60 years.
WHO Recommendation Strengthens Case
Takeda said QDENGA is recommended by the World Health Organisation (WHO) for use in dengue-endemic settings and supports its introduction into public immunisation programmes in areas with high transmission, without requiring pre-vaccination screening.
The vaccine has also received WHO prequalification, certifying that it meets international standards for quality, safety and efficacy. This makes it eligible for procurement through global agencies such as UNICEF and the Pan American Health Organisation (PAHO), according to the company.
Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster at Takeda, said all four dengue virus serotypes have been documented as circulating simultaneously in multiple regions across the country.
“QDENGA is designed to protect against all four serotypes, regardless of prior exposure. Its approval represents an important step in strengthening India’s comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures,” Beng said, according to Moneycontrol.
Manufacturing Expansion Planned In India
In a development reported by Reuters, Takeda has partnered with Indian vaccine manufacturer Biological E to expand production of QDENGA.
The collaboration, announced in 2024, aims to establish a manufacturing capacity of 50 million doses annually at Biological E, contributing to Takeda’s global target of producing 100 million doses every year by the end of the decade, the report mentioned.
It also cited the company as saying that reported dengue cases in India have increased 11-fold over the past two decades, underscoring the urgency of strengthening prevention efforts.
