1. Introduction

This is the first dengue vaccine approved in India for the prevention of dengue disease.

The approval follows a comprehensive scientific evaluation of the vaccine’s quality, safety and efficacy under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. Dengue continues to be one of India’s most significant vector-borne diseases, causing seasonal outbreaks that put pressure on healthcare systems. The availability of a licensed vaccine provides an important addition to the country’s existing prevention and control measures.

2. Origin and Intent

Developed by Japanese pharmaceutical company Takeda, QDENGA is a live attenuated tetravalent vaccine designed to provide protection against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). It has been approved for individuals between 4 and 60 years of age and is administered in a two-dose schedule, with the second dose given three months after the first. One of its key advantages is that pre-vaccination dengue testing is not required, making vaccination easier to implement among eligible populations.

The Ministry of Health has clarified that the vaccine is intended to complement—not replace—existing dengue prevention measures under the National Vector Borne Disease Control Programme (NVBDCP). Vector control through mosquito breeding source reduction, disease surveillance, early diagnosis and timely clinical management will continue to remain the primary strategies for controlling dengue, while vaccination provides an additional layer of protection against the disease.

3. Key Amendments

The CDSCO has approved QDENGA for the prevention of dengue disease in individuals aged 4 to 60 years. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months). The vaccine’s approval is based on extensive evidence demonstrating its safety, immunogenicity and efficacy.

Clinical development included studies conducted across more than eight countries, including Brazil, Thailand and Sri Lanka, covering both dengue-endemic and non-endemic regions. The regulatory review also considered findings from a Phase III safety and immunogenicity study conducted in India, which evaluated the vaccine in individuals within the approved age group. These studies provided important evidence supporting its use in the Indian population.

Before receiving approval in India, QDENGA had already been authorised in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. The vaccine has also received World Health Organization (WHO) prequalification, enabling wider international use. Globally, more than 24 million doses have been distributed, and post-marketing surveillance has shown a favourable safety profile with no significant safety concerns reported.

4. Impact

The approval of India’s first dengue vaccine marks a significant milestone in the country’s public health response to a disease whose burden has increased considerably over the past decade. According to the National Centre for Vector Borne Diseases Control (NCVBDC), reported dengue cases remained below 30,000 annually until 2010, but infections have risen steadily since then, crossing one lakh cases in 2016 and reaching nearly three lakh reported cases in 2023.

The introduction of vaccination is expected to complement ongoing mosquito control programmes and help reduce severe illness, hospitalisations and the overall disease burden, particularly in dengue-endemic regions. At the same time, public health experts emphasise that vaccination alone cannot eliminate dengue. Continued community participation in eliminating mosquito breeding sites, maintaining sanitation, using personal protective measures and seeking early medical care will remain essential for effective disease control.

5. Conclusion

The CDSCO’s approval of QDENGA marks a major advancement in India’s efforts to prevent dengue and reduce its growing public health burden. As the country’s first approved dengue vaccine, it provides an important new preventive option backed by extensive global and Indian clinical evidence. While vaccination strengthens India’s dengue prevention strategy, its success will depend on being integrated with sustained vector control, disease surveillance, early diagnosis and effective clinical management. Together, these measures can significantly improve India’s preparedness against future dengue outbreaks.