Aurobindo Pharma JV Tergene gets CDSCO panel recommendation for 15-valent Pneumococcal Polysaccharide Conjugate Vaccine
Drugmaker, Aurobindo Pharma Ltd, has announced that Subject Expert Committee (SEC) of the Central Drugs StandardControl Organization (CDSCO), in its minutes for the meeting held on 21st Dec 2022, has recommended grant of permission to its JV company Tergene to manufacture and market 15-valent Pneumococcal PolysaccharideConjugate Vaccine with three dose schedule (3 +0) for administration into the pediatric age group of 6, 10 and 14weeks.
PCV15 vaccine was developed by Tergene Biotech Pvt. Ltd. and manufactured at AuroVaccines Pvt. Ltd.,which is a wholly owned subsidiary of Aurobindo Pharma Ltd with capabilities in vaccines development andmanufacturing.
Aurobindo Pharma Ltd holds 80% stake in the Joint Venture company, Tergene Biotech Pvt. Ltd.
Commenting on the development, Mr. K. Nithyananda Reddy, Vice Chairman & Managing Director said, “SEC’srecommendation is based on data from (3+0) trial conducted in 1130 pediatric subjects assessing safety, tolerability,and immunogenicity. By assessing opsonophagocytic activity (OPA) and Geometric Mean IgG Titers (GMTs), we havedemonstrated through our clinical data that our test product is non-inferior to the currently available 13-valentpneumococcal conjugate vaccine for the thirteen shared serotypes and provided good immune response for thetwo additional serotypes unique to our vaccine (serotypes 2 and 12F).”
“With SEC’s recommendation, we will take the procedural next steps as we expect formal approval from DCGI in thecoming weeks. At Aurobindo, through our 15 valent conjugate vaccine (serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F,14, 18C, 19A, 19F and 23F), we are committed to protecting infants from pneumococcal disease by eliciting a strongimmune response in them to each serotype covered in the vaccine. Further, we will continue to develop thisprogram for the WHO markets, thereby providing coverage and protection for more infants globally in time tocome.”