New Delhi: Japanese biopharmaceutical giant Takeda has secured approval to market its dengue prevention vaccine ‘Qdenga’ in India.
The approval granted last week is supported by a local Phase 3 study involving 480 healthy adults, where the vaccine was found to be “tolerated, safe and immunogenic” across the target age group.
This is the first dengue vaccine approved for use in India and is recommended for the age group of 4 to 60 years. Takeda must conduct a “post-marketing safety and efficacy study in the local population within six months of introducing the vaccine to the market.”
In India, the company had earlier announced a manufacturing partnership with Hyderabad-based Biological E to support Takeda’s goal of producing 100 million doses annually by the end of this decade.
Qdenga is designed to induce a strong immune response by generating detectable antibodies against all four dengue virus serotypes: DENV-1, DENV-2, DENV-3 and DENV-4.
The two-dose quadrivalent vaccine has been shown (TIDES study) up to “seven years of protection” against all four dengue virus serotypes and is approved for use regardless of prior exposure to dengue.
To establish its efficacy and safety, Takeda has conducted nine Phase 3 trials, six Phase 2 trials and five Phase 1 trials globally, with more than 28,000 volunteers from dengue-endemic and non-endemic regions, covering an age range of 1.5 to 60 years.
“Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed worldwide,” said Dr. Mahender Nayak, Head of Intercontinental Markets at Takeda.
The vaccine has also received prequalification from the World Health Organization (WHO), making it the preferred candidate for inclusion in public vaccination programs.
Unlike Sanofi’s Dengvaxia (CYD-TDV), which is recommended only for people with prior dengue infection, Qdenga can be administered without pre-vaccination testing, making it suitable for broad use in endemic regions.
The other rival TV003/TV005, developed by the US National Institutes of Health (NIH), is currently in an advanced stage of clinical development. Like Qdenga, the candidate is designed to provide protection against all four serotypes of the virus.
Dengue is a mosquito-borne viral disease that represents a major threat to global public health. India accounts for almost a third of the global dengue burden. More than 1.1 lakh cases were reported across the country last year, an 11-fold increase over the last two decades.
“India bears a substantial burden of dengue, and all four dengue virus serotypes have been documented circulating simultaneously in several regions. Qdenga represents an important step in strengthening a comprehensive approach to dengue prevention, along with vector control, surveillance and other public health measures,” said Dr. Goh Choo Beng, Head of Medical Affairs, Southeast Asia and India Group, Takeda.
