DCGI approves India’s first dengue vaccine—QDENGA

India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to the vaccine QDENGA, developed by Takeda Biopharmaceuticals India.

The vaccine is approved for people aged 4 to 60 years and can be given regardless of whether a person has previously been infected with dengue.

Unlike the older dengue vaccine, Dengvaxia, QDENGA does not require people to undergo blood testing to determine whether they have previously had dengue, a significant advantage for large-scale public health programmes.

“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, Takeda.

The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalisation across all four serotypes, an important milestone for communities and health systems, he added.

The vaccine has already been approved in more than 40 countries, including the European Union, the United Kingdom, Brazil, Indonesia and Argentina. India now joins that list at a time when dengue is emerging as one of the country’s biggest seasonal public health threats.

The approval in India is based on results from Takeda’s global clinical development programme, involving 19 Phase 1, 2 and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions, the company said.

It is also supported by data from a Phase III clinical trial (DEN-302) conducted in Indian participants, which evaluated the safety and immunogenicity of the vaccine in individuals aged 4-60 years, it added.

The vaccine is administered subcutaneously, 0.5 ml as a two-dose regimen, with doses given three months apart.

India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions, said Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster, Takeda.

“QDENGA is designed to protect against all four serotypes, regardless of prior 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,” Beng added.

The company added that the World Health Organisation (WHO) recommends QDENGA for use in dengue-endemic regions and supports its inclusion in public immunisation programmes in high-transmission areas without requiring pre-vaccination screening.

QDENGA has also received WHO prequalification, confirming that it meets international standards for quality, safety and effectiveness. This also makes the vaccine eligible for procurement by global agencies such as UNICEF and the Pan American Health Organisation (PAHO).

Dengue, a mosquito-borne viral disease, poses a significant global public health threat, with prevalence in over 125 countries. India accounts for nearly one-third of the global dengue burden, the company said.

Millions of Indians remain at risk each year due to widespread endemicity, rapid urbanisation and climate-related factors that drive mosquito proliferation, it added.