NEW DELHI, July 20 (Alliance News): India’s drug regulator has approved Japanese pharmaceutical company Takeda’s dengue vaccine, QDENGA, making it the first dengue vaccine to receive regulatory approval in the country.
Takeda Pharmaceutical’s India unit announced that the vaccine is designed to protect against all four dengue virus serotypes and is approved for use in children and adults aged four to 60 years.
According to the company, QDENGA has already been approved in 43 countries and demonstrated an efficacy of 80.2% against confirmed dengue cases one year after the second dose. The vaccine also showed 90.4% effectiveness in preventing dengue-related hospitalisations after 18 months during late-stage clinical trials.
The vaccine is administered in two 0.5 ml doses, given three months apart, and can be used regardless of whether an individual has previously been infected with dengue, eliminating the need for pre-vaccination screening.
The World Health Organization (WHO) reported a record 14.4 million dengue cases and 11,201 deaths worldwide in 2024, including 232,425 cases and 233 deaths in India. Reported dengue infections in India have increased significantly over the past two decades.
Takeda partnered with Indian vaccine manufacturer Biological E in 2024 to expand production of QDENGA in India.
Health experts welcomed the approval, saying the vaccine is expected to reduce severe illness and hospitalisations, although continued mosquito control measures will remain essential to prevent outbreaks.
Meanwhile, Hyderabad-based Indian Immunologicals Limited is also developing a dengue vaccine candidate and plans to begin mid-stage clinical trials.
