India Approves First Dengue Vaccine Qdenga® to Combat Disease
In a groundbreaking move to enhance India’s fight against dengue, the Central Drugs Standard Control Organisation (CDSCO), part of the Ministry of Health and Family Welfare, has approved the marketing authorization for Qdenga®, a live, attenuated tetravalent dengue vaccine developed by Takeda GmbH, Germany. This marks the first dengue vaccine to gain approval in India, aimed at preventing the infectious disease that poses a significant health risk in tropical regions.
The approval was based on a thorough evaluation of the vaccine’s quality, safety, and efficacy, adhering to the standards set by the Drugs and Cosmetics Act of 1940 and related rules. Qdenga® has been developed using cutting-edge recombinant DNA technology and produced in Vero cells, incorporating engineered genes from the dengue virus type-2 to create a robust immunization solution.
Immunization Schedule and Clinical Success
Qdenga® is intended for individuals aged between 4 to 60 years. The vaccination protocol consists of two doses of 0.5 ml administered at intervals of three months. Comprehensive clinical trials conducted in over eight countries, including Brazil, Thailand, and Sri Lanka, have established the vaccine’s safety and effectiveness, particularly in endemic and non-endemic regions.
A pivotal Phase III study specifically targeted the Indian demographic, involving participants aged 4 to 60 years, underscoring the vaccine’s relevance and safety for the local population. This thorough assessment of Qdenga® is indicative of global standards, supported by a successful clinical development program.
Global Acceptance and Safety Profile
The vaccine has garnered regulatory approval in 42 countries, such as those in the European Union, the United Kingdom, Switzerland, and other Southeast Asian nations. Additionally, Qdenga® has received prequalification from the World Health Organization (WHO), and over 24 million doses have already been distributed worldwide. Post-marketing surveillance from various regions utilizing the vaccine demonstrates a favorable safety profile, with no major safety issues reported thus far.
India’s approval of the first dengue vaccine is a historic achievement, reinforcing the nation’s public health strategies in addressing dengue through ongoing vector control, surveillance, and early diagnosis initiatives as part of the National Vector Borne Disease Control Programme. The Ministry of Health and Family Welfare continues to prioritize access to safe, effective, and quality vaccines, substantiating its commitment to public health through a robust regulatory framework.
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