- India approves QDENGA, its first dengue vaccine.
- Vaccine for ages 4-60, no prior screening needed.
- WHO recommended; Takeda partners Biological E for production.
India has officially approved its first dengue vaccine after the Drug Controller of India (DCGI) granted market authorisation to Takeda Biopharmaceuticals India Pvt Ltd's QDENGA. The vaccine has been approved for people aged between 4 and 60 years and can be administered regardless of whether a person has earlier been infected or not. Additionally, the QDENGA would not require pre-vaccination screening, allowing eligible individuals to receive the vaccine without first being tested for past dengue infection, making it easier to use in dengue-endemic regions.
Mahender Nayak, Head of Intercontinental Markets at Takeda, said that the launch of the QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. The permission marks a significant step towards strengthening dengue prevention in India.
Covers All Four Dengue Virus Serotypes
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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 a significant milestone for communities and public health systems.
India's 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 backed 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.
What Did WHO Say?
According to Takeda, QDENGA is recommended by the World Health Organisation (WHO) to use in dengue- endemic settings and supports its introduction into public immunisation programmes in areas with high transmission wi thout requiring pre-vaccination screening.
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WHO certified the vaccine as it meets international standards for quality, safety and efficacy. It is also eligible for procurement through global agencies such as UNICEF and the Pan American Health Organization (PAHO), the company claimed.
Reuters claimed Takeda has partnered with Indian vaccine manufacturer Biological E to expand production of QDENGA.
Declared in 2024, the collaboration aims to establish a manufacturing capacity of 50 million doses annually at Ni 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, outlining the urgency of strengthening prevention efforts.