New Delhi: India is set to get its first dengue vaccine in the private market in the first half of 2027, marking the country’s first availability of a vaccine-based prevention option against the mosquito-borne disease.
Dr Reddy’s Laboratories and Japanese pharmaceutical company Takeda on Friday announced an agreement under which Dr Reddy’s will exclusively promote and distribute Qdenga in India’s private paediatric and adult vaccination market. The rollout remains subject to completion of regulatory and quality-related processes.
Qdenga Is India’s First Approved Dengue Vaccine
The Central Drugs Standard Control Organisation (CDSCO) granted Qdenga marketing authorisation in July for people aged 4 to 60 years, making it the first dengue vaccine approved for use in India.
Qdenga is a live-attenuated tetravalent vaccine, designed to generate protection against all four dengue virus serotypes. It is administered as two 0.5 ml doses given three months apart.
Unlike some dengue vaccination approaches, vaccination with Qdenga in India does not require prior testing to determine whether a person has previously been infected with dengue.
Why Is The Dengue Vaccine Significant For India?
The vaccine arrives amid a substantial dengue burden in India and globally.
The World Health Organisation reported more than 14.4 million dengue cases and 11,201 deaths worldwide in 2024, while India reported 2,32,425 cases during the year.
Dengue is transmitted primarily by infected Aedes mosquitoes and can cause symptoms including high fever, severe headache, muscle and joint pain and, in some cases, serious complications.
The availability of a vaccine could therefore add another tool to dengue prevention alongside mosquito-control measures and efforts to reduce breeding sites.
What Did The Indian Clinical Trial Show?
The Indian approval was supported by global clinical evidence as well as a Phase III study, DEN-302, involving healthy Indian participants aged 4 to 60.
According to CDSCO records, the Indian study assessed the vaccine’s safety and immunogenicity, or its ability to trigger an immune response. The regulator also considered efficacy data from Takeda’s wider global clinical programme.
However, there are limitations to the Indian data.
An assessment by the European Medicines Agency found that 91.5 per cent of participants in DEN-302 already had evidence of previous dengue exposure. This meant the number of participants who had never previously encountered dengue was relatively small.
The EMA assessment said the limited number of dengue-naive participants prevented firm conclusions about the vaccine’s performance in that group.
The study nevertheless found an immune response against all four dengue serotypes regardless of participants’ baseline dengue exposure.
How Does Qdenga Work?
Qdenga is a tetravalent vaccine, meaning it is designed to provide protection against all four dengue virus serotypes.
The vaccine uses a DENV-2 backbone, with surface proteins corresponding to the other dengue serotypes engineered into the vaccine.
Its two-dose schedule involves an initial dose followed by a second dose three months later.
Will Qdenga Be Available To Everyone In India?
The initial rollout is planned for the private vaccination market, covering both paediatric and adult vaccination.
However, availability will depend on completion of the required regulatory and quality-related processes before the planned 2027 launch.
The vaccine’s introduction does not replace other dengue-control measures. Preventing mosquito breeding, reducing exposure to mosquito bites and early medical attention for suspected dengue will continue to remain important.
For individuals considering vaccination, eligibility and vaccination decisions should be discussed with a qualified healthcare professional, particularly for children and people with specific medical circumstances.
