India approves first dengue vaccine as DCGI grants market authorization

India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to Takeda Biopharmaceuticals India's QDENGA, marking a significant milestone in the country's efforts to combat one of its most widespread mosquito-borne diseases, it was announced on Monday.

The vaccine has been approved for individuals aged between 4 and 60 years and can be administered irrespective of whether a person has previously been infected with dengue.

Unlike some earlier dengue vaccines, QDENGA does not require pre-vaccination screening, allowing eligible individuals to receive the vaccine without undergoing tests to determine prior dengue infection.

Takeda said the approval strengthens India's dengue prevention strategy at a time when the country continues to bear one of the world's highest disease burdens, with all four dengue virus serotypes circulating in several regions.

"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.

The company said the approval was supported by evidence from its global clinical development programme, comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic countries.

The Indian regulator also considered data from the Phase III DEN-302 clinical trial conducted in India, which evaluated the vaccine's safety and immune response among individuals aged 4 to 60 years.

According to Takeda, long-term follow-up data collected over seven years demonstrated that QDENGA continues to provide protection against dengue infection and dengue-related hospitalisation caused by all four virus serotypes.

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 the vaccine is designed to protect against all four dengue virus serotypes regardless of previous exposure.

"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," he said.

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