Aurobindo Pharma yesterday said its joint venture firm, Tergene Biotech, has received recommendation from Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for pneumococcal 15-valent (PCV15) vaccine.
The SEC, at its meeting held on 21st December, 2022, has recommended grant of permission to Tergene to manufacture and market 15-valent Pneumococcal Polysaccharide conjugate vaccine with three-dose schedule for administration into the paediatric age group of six, 10 and 14 weeks, Aurobindo Pharma said in a regulatory filing.
The PCV15 vaccine has been developed by Tergene Biotech and manufactured at AuroVaccines, a wholly-owned subsidiary of Aurobindo Pharma with capabilities in vaccines’ development and manufacturing, it added.
K Nithyananda Reddy, Vice Chairman and Managing Director (MD), Aurobindo Pharma, said, SEC’s recommendation is based on data from trials conducted in 1,130 paediatric subjects assessing safety, tolerability and immunogenicity.
“With SEC’s recommendation, we will take the procedural next steps as we expect formal approval from DCGI in the coming weeks,” he added.
Edits by EP News Bureau