CDSCO Approves India's First Dengue Vaccine Qdenga, Boosts Prevention Efforts
UPSC / SSC current affairs note
Why in news
The Central Drugs Standard Control Organisation (CDSCO) has approved Qdenga, India's first dengue vaccine, for individuals aged 4-60 years. This marks a milestone in India's public health response to dengue, complementing existing vector control and patient management measures under the National Vector Borne Disease Control Programme.
Background
Dengue is a major public health concern in India, with outbreaks occurring annually. Previously, no dengue vaccine was approved in India. The vaccine, developed by Takeda GmbH, Germany, has been approved in 42 countries and has WHO prequalification.
Key facts
CDSCO approved Qdenga (tetravalent live attenuated dengue vaccine) for marketing in India.
The vaccine is for individuals aged 4 to 60 years.
It is administered as two 0.5 ml doses subcutaneously, three months apart (0 and 3 months).
The vaccine uses recombinant DNA technology and is produced in Vero cells.
Approval based on comprehensive scientific evaluation of quality, safety, and efficacy under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
Clinical trials included participants from over 8 countries, including a Phase III study in India.
Approved in 42 countries including EU, UK, Switzerland, Indonesia, Malaysia, Thailand.
Has WHO prequalification and over 24 million doses distributed globally.
Post-marketing surveillance data confirm safety with no serious concerns reported.
The vaccine contains genetically modified organisms.
Prelims pointers
- CDSCO: Central Drugs Standard Control Organisation under Ministry of Health and Family Welfare.
- Qdenga: Brand name of dengue vaccine by Takeda GmbH, Germany.
- Tetravalent live attenuated vaccine: Targets all four dengue serotypes.
- WHO prequalification: Ensures vaccine meets global standards.
- Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945: Regulatory framework.
- National Vector Borne Disease Control Programme (NVBDCP): Programme under which dengue control measures are implemented.
- Vero cells: Cell line used for vaccine production.
- Recombinant DNA technology: Used to develop the vaccine.
- Phase III clinical trial: Conducted in India with Indian participants.
- Age group: 4 to 60 years.
Mains angles
- GS2 Health: Discuss the significance of India's first dengue vaccine approval in strengthening public health response and reducing disease burden.
- GS3 Science and Technology: Evaluate the role of recombinant DNA technology in vaccine development and its regulatory approval process in India.
- GS2 Government Policies: Critically examine the regulatory framework for vaccine approval in India (CDSCO, Drugs and Cosmetics Act) and its effectiveness in ensuring safety and efficacy.
- GS2 Health: Analyze the challenges in dengue prevention and control in India and how the new vaccine can complement existing vector control measures.
- GS3 Science and Technology: Discuss the global clinical trial data and post-marketing surveillance that supported the vaccine's approval, and the importance of such evidence in public health decisions.