A Breakthrough in Public Health, ETPharma

New Delhi: Japanese biopharma 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-ever dengue vaccine approved for use in India and is recommended for the 4 - 60 age group. Takeda is required to conduct a "post marketing safety and effectiveness study in the local population within six months of introduction of the vaccine in 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 tetravalent vaccine has demonstrated (TIDES study) up to "seven years of protection" against all four dengue virus serotypes and is approved for use regardless of prior dengue exposure.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 from 1.5 to 60 years."Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally," said Dr. Mahender Nayak, Head of Intercontinental Markets, Takeda.The vaccine has also received prequalification from the World Health Organization (WHO), making it a preferred candidate for inclusion in public vaccination programmes.Unlike Sanofi's Dengvaxia (CYD-TDV), which is recommended only for individuals 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 late-stage 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 poses a significant global public health threat. India accounts for nearly one-third of the global dengue burden. Last year more than 1.1 lakh cases were reported across the country, an 11-fold increase over the past two decades."India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. Qdenga represents an important step in strengthening comprehensive approach to dengue prevention, alongside vector control, surveillance and other public health measures," said Dr Goh Choo Beng, Medical Affairs Head Southeast Asia and India Cluster, Takeda.