CDSCO Approves India's First Dengue Vaccine, Strengthening National Dengue Prevention Efforts

Key Highlights:

• The Central Drugs Standard Control Organisation (CDSCO) approved India's first dengue vaccine, Qdenga®.
• The vaccine is a live, attenuated tetravalent type, manufactured by Takeda GmbH, Germany.
• It is indicated for individuals aged 4 to 60 years, administered in two doses at a three-month interval.
• Qdenga® has received regulatory approval in 42 countries and World Health Organization (WHO) prequalification.
• This approval strengthens India's National Vector Borne Disease Control Programme efforts against dengue.

Detailed Insights:

• The approval followed a comprehensive scientific evaluation under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
• The vaccine was developed using recombinant DNA technology and produced in Vero cells, containing genetically modified organisms (GMOs).
• Global clinical development included studies in over eight countries, with a pivotal Phase III study conducted in the Indian population.
• Over 24 million doses of the vaccine have been distributed globally, demonstrating a favorable safety profile.
• This milestone complements existing public health measures like vector control, surveillance, early diagnosis, and case management.

Scientific/Technical Concepts Involved:

• Dengue Tetravalent Vaccine: A vaccine designed to provide immunity against all four serotypes of the dengue virus.
• Live, Attenuated Vaccine: A vaccine containing a weakened form of the virus that stimulates an immune response without causing disease.
• Recombinant DNA Technology: A molecular biology technique used to combine genetic material from different sources to create new DNA sequences.
• Vero Cells: A continuous cell line derived from African green monkey kidney cells, widely used for vaccine production.