India Approves Its First Dengue Vaccine
India Approves QDENGA as Its First Dengue Vaccine: India has approved QDENGA, the country’s first dengue vaccine, marking a significant milestone in the fight against one of the nation’s most widespread mosquito-borne diseases. The approval was granted by the Drug Controller General of India (DCGI) for use in individuals aged 4 to 60 years.
The vaccine offers protection against all four dengue virus serotypes and can be administered without pre-vaccination screening, making it easier to incorporate into public health programmes.
Static GK Fact: The Drug Controller General of India (DCGI) functions under the Central Drugs Standard Control Organisation (CDSCO) and is India’s national drug regulatory authority.
What is QDENGA?
QDENGA is a live attenuated dengue vaccine developed by Takeda Biopharmaceuticals of Japan.
It provides protection against all four dengue virus serotypes—DENV-1, DENV-2, DENV-3, and DENV-4. The vaccine is administered in a two-dose schedule and does not require prior testing to determine previous dengue infection.
Why is the Approval Significant?
India records a large number of dengue cases every year, and until now, disease control mainly relied on mosquito control, surveillance, public awareness, and supportive treatment.
The availability of QDENGA adds an important preventive tool to reduce dengue infections, severe disease, and hospitalisations. It is expected to strengthen India’s public health response alongside existing vector-control measures.
Static GK Tip: Dengue is caused by the dengue virus, which is transmitted mainly by the Aedes aegypti mosquito.
Clinical Trial Results
The approval is supported by Takeda’s extensive global clinical development programme involving over 28,000 participants across 19 Phase I, II, and III clinical trials, including studies conducted in India.
The international TIDES Phase III trial, involving more than 20,000 participants in eight countries, demonstrated 80.2% efficacy against laboratory-confirmed dengue one year after the second dose and 90.4% protection against dengue-related hospitalisation after 18 months. Protection against hospitalisation remained 84.1% for up to 4.5 years, with safety monitored for seven years.
WHO Recommendation and Global Use
The World Health Organization (WHO) recommends the use of QDENGA in countries where dengue is endemic without requiring pre-vaccination screening.
The vaccine has also received WHO prequalification, enabling procurement by international agencies such as UNICEF. Since its first approval in 2022, QDENGA has been approved in 43 countries, with over 32 million doses administered worldwide.
Availability in India
Although regulatory approval has been granted, Takeda has not yet announced the commercial launch date or pricing for India.
In several Asian markets, the vaccine costs approximately US$80–115 per dose, and a complete vaccination requires two doses.
Static GK Fact: WHO was established on 7 April 1948 and is headquartered in Geneva, Switzerland.
Static Usthadian Current Affairs Table
India Approves QDENGA as Its First Dengue Vaccine:
| Fact | Detail |
| Vaccine | QDENGA |
| Developer | Takeda Biopharmaceuticals (Japan) |
| Approved By | Drug Controller General of India (DCGI) |
| Significance | India’s first approved dengue vaccine |
| Eligible Age Group | 4–60 years |
| Vaccine Type | Live attenuated vaccine |
| Protection Against | DENV-1, DENV-2, DENV-3, DENV-4 |
| Doses Required | Two |
| Pre-vaccination Screening | Not required |
| WHO Status | Recommended and prequalified |
| First Global Approval | 2022 |
| Countries Approved | 43 |
| Doses Administered Globally | Over 32 million |
| Major Trial | TIDES Phase III Trial |
| Dengue Vector | Aedes aegypti mosquito |
