India has approved its first dengue vaccine, QDENGA (TAK-003), marking a significant milestone in the country's fight against one of its fastest-growing mosquito-borne diseases, NDTV reported. Approved by the Central Drugs Standard Control Organisation (CDSCO), the vaccine has been developed by Japanese pharmaceutical company Takeda and is designed to protect against all four dengue virus serotypes.
According to the report, the approval comes as India continues to shoulder one of the world's highest dengue burdens. Reported dengue cases have increased more than 11-fold over the past two decades, driven by rapid urbanisation, climate change, changing mosquito habitats and population growth.
QDENGA is a live, attenuated tetravalent vaccine that targets all four dengue virus serotypes—DENV-1, DENV-2, DENV-3 and DENV-4. Unlike Dengvaxia, another dengue vaccine that requires proof of previous infection before administration, QDENGA can be given regardless of whether a person has had dengue before. This eliminates the need for pre-vaccination blood tests, making it more suitable for large-scale immunisation programmes.
The vaccine is administered as two subcutaneous doses given three months apart. It has already received regulatory approval in more than 40 countries, including the European Union, the United Kingdom, Brazil, Indonesia and Argentina.
Who can receive the vaccine and how effective is it?
According to NDTV, the exact prescribing guidelines for India are expected to be announced by the CDSCO and Takeda closer to the vaccine's commercial launch.
Clinical trial data from the Phase III TIDES study, which enrolled more than 20,000 children and adolescents across eight dengue-endemic countries, showed encouraging long-term results. After 4.5 years of follow-up, QDENGA demonstrated 84% protection against dengue-related hospitalisation and approximately 61% protection against virologically confirmed dengue overall.
The vaccine also provided sustained protection against severe dengue in both individuals with and without prior dengue infection, although effectiveness varied across virus serotypes. These findings contributed to the vaccine's recommendation by the World Health Organization (WHO) and approvals in several countries.
Cost yet to be announced; vaccination alone not enough
NDTV reported that an official Indian price for QDENGA has not yet been announced. However, affordability could improve over time through Takeda's manufacturing partnership with Hyderabad-based Biological E, which plans to produce up to 50 million doses annually in India. Local manufacturing is expected to strengthen supply while reducing dependence on imports.
Experts have emphasised that vaccination should be viewed as one part of a broader dengue prevention strategy. The WHO recommends combining vaccination with mosquito control, elimination of breeding sites, public awareness campaigns, early diagnosis, surveillance and access to healthcare.
While the approval of QDENGA is expected to strengthen India's dengue response by reducing severe illness, hospital admissions and pressure on healthcare systems, experts caution that no vaccine can completely eliminate dengue because all four virus serotypes continue to circulate and mosquito-borne transmission persists. The vaccine, they say, should complement existing public health measures rather than replace them.
