India is set to introduce its first approved dengue vaccine in the private market during the first half of 2027, marking a significant step in the country's efforts to prevent the mosquito-borne disease through vaccination.
Dr Reddy’s Laboratories and Japanese pharmaceutical company Takeda announced on Friday that they had entered into an agreement under which Dr Reddy’s will exclusively promote and distribute Takeda’s dengue vaccine, Qdenga, in India’s private pediatric and adult vaccination market. The launch remains subject to the completion of all regulatory and quality-related requirements.
The development follows the approval granted by the Central Drugs Standard Control Organisation (CDSCO) in July. The regulator authorized the marketing of Qdenga for individuals aged between four and 60 years, making it the first dengue vaccine approved for use in India.
Qdenga is a live-attenuated tetravalent vaccine designed to provide protection against all four dengue virus serotypes. The vaccine contains weakened dengue virus components and is administered in two doses of 0.5 ml each, with a three-month gap between doses.
A notable feature of the vaccine is that vaccination in India will not require prior testing to determine whether a person has previously been infected with dengue.
The vaccine's arrival comes at a time when dengue continues to pose a major public health challenge. According to the World Health Organization (WHO), more than 14.4 million dengue cases and 11,201 related deaths were reported globally in 2024. India alone accounted for 2,32,425 reported cases during the same period.
Indian regulatory approval was supported by evidence from global clinical studies as well as a Phase III trial, known as DEN-302, conducted among healthy Indian participants between the ages of four and 60 years.
According to CDSCO records, the Indian study evaluated both the safety of the vaccine and its immunogenicity, or ability to generate an immune response. In addition to Indian data, regulators also reviewed effectiveness evidence from Takeda’s global clinical development programme.
However, experts have noted certain limitations in the Indian study that may be relevant as the vaccine enters broader use. An assessment by the European Medicines Agency (EMA) found that 91.5 percent of participants in the DEN-302 study had already been exposed to dengue before receiving the vaccine. As a result, the number of participants with no prior dengue exposure was relatively small.
The EMA assessment cautioned that the limited number of seronegative participants made it difficult to draw firm conclusions regarding the vaccine's performance in individuals who had never previously contracted dengue. At the same time, the study reported that the vaccine generated an immune response against all four dengue virus serotypes regardless of participants’ prior exposure status.
These findings indicate that while the Indian study provides valuable information on safety and immune response, it offers limited evidence specifically relating to people in India who have never been infected by dengue.
The assessment did not identify any new safety concerns linked to the vaccine. However, it noted that the study population consisted largely of male participants who had previously been exposed to dengue, which may have influenced the frequency of vaccine-related reactions observed during the trial.
Qdenga is built on a DENV-2 backbone, with engineered surface proteins representing the other dengue virus serotypes, allowing it to target all four forms of the virus through a single vaccine platform.
The planned rollout is expected to bring vaccine-based dengue prevention to India for the first time and add a new tool in the fight against one of the country’s most widespread mosquito-borne diseases.