July 21, 2026
NEW DELHI – In a major breakthrough, India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to QDENGA from Takeda Biopharmaceuticals India.
The vaccine was approved for individuals aged between 4 and 60 years. It can be administered irrespective of whether a person has previously been infected with dengue, IANS reported.
Unlike some of the earlier dengue vaccines, pre-vaccination screening is not required for QDENGA. This allow all the eligible individuals to receive the vaccine without undergoing tests to determine prior dengue infection.
“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,” said Mahender Nayak, Head of Intercontinental Markets at Takeda.
Further, it informed that the approval from DCGI was supported by evidence from its global clinical development programme that comprises 19 Phase I, II and III clinical trials involving over 28,000 participants across dengue-endemic and non-endemic nations.
Morever, the Indian regulator considered data from the Phase III DEN-302 clinical trial conducted in India.
In the follow-up that was collected for over seven years, QDENGA continued to provide protection against dengue infection and dengue-related hospitalisation caused by all four virus serotypes, the company said.
As per the IANS report, the vaccine is administered as two subcutaneous injections of 0.5 ml each, given three months apart.
Goh Choo Beng, Medical Affairs Head for Takeda’s Southeast Asia and India Cluster, said “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”.
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