Key Details
CDSCO has authorised Qdenga, India's first dengue vaccine, following evaluation of its quality, safety and efficacy.
Key Area | Main Update |
|---|---|
Approval significance | Qdenga is the first dengue vaccine authorised for use in India. |
Eligible population | Approved for individuals aged 4–60 years. |
Dosage | Two 0.5 ml subcutaneous doses administered three months apart. |
Vaccine type | Live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes. |
Evidence base | Approval supported by international clinical studies and a Phase III safety and immunogenicity study involving Indian participants. |
Global status | Approved in 42 countries, WHO prequalified, with more than 24 million doses distributed globally. |
CDSCO Authorises India's First Dengue Vaccine
The Ministry of Health and Family Welfare announced that CDSCO has granted marketing authorisation to Qdengaafter evaluating its quality, safety and efficacy under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
The approval makes Qdenga the first dengue vaccine authorised for use in India and expands the country's options for preventing a disease that continues to impose a significant seasonal public-health burden.
Vaccination Becomes a New Pillar of Dengue Prevention
The Ministry emphasised that vaccination is intended to complement—not replace—existing dengue-control measures under the National Vector Borne Disease Control Programme.
Vector control, disease surveillance, early diagnosis and appropriate clinical management will remain the foundation of dengue prevention, with vaccination adding an additional layer of protection for eligible populations.
Approval Is Backed by International and Indian Evidence
The regulatory evaluation drew on international clinical studies conducted across dengue-endemic and non-endemic settings, together with a pivotal Phase III study involving Indian participants aged 4–60 years.
The vaccine has also been approved in 42 countries, received WHO prequalification and has recorded the distribution of more than 24 million doses worldwide, providing an established evidence base for its safety and use.
What Is a Live-Attenuated Tetravalent Vaccine?
A live-attenuated vaccine uses weakened forms of a virus to stimulate immunity without causing the full disease. Tetravalent means the vaccine is designed to provide protection against all four dengue virus serotypes.
Policy Relevance
Integrated Dengue Control: Vaccination adds a new preventive tool alongside surveillance, vector control, early diagnosis and clinical management rather than replacing existing interventions.
Evidence-Based Regulation: Approval follows regulatory evaluation of quality, safety and efficacy, supported by international studies and clinical evidence from Indian participants.
Implementation Strategy: Public-health impact will depend on vaccination guidelines, prioritisation of eligible populations and integration with existing dengue-control programmes.
Access and Affordability: The effectiveness of vaccination will depend on availability, pricing, procurement and equitable access.
Future Immunisation Policy: The approval establishes the regulatory foundation for future decisions on whether and how dengue vaccination should be incorporated into broader public immunisation strategies.
Relevant Question for Policy Stakeholders: Which population groups should India prioritise if dengue vaccination is introduced more widely through public-health programmes?
Follow the Full News Here: CDSCO Approves India’s First Dengue Vaccine for Individuals Aged 4–60 Years