New Delhi, Dec 27: Aurobindo Pharma Ltd on Tuesday said its joint venture firm, Tergene Biotech, has received recommendation from subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) for pneumococcal 15-valent (PCV15) vaccine.
The subject expert committee (SEC) at its meeting held on December 21, 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 pediatric age group of 6, 10 and 14 weeks, Aurobindo Pharma said in a regulatory filing.
The PCV15 vaccine has been developed by Tergene Biotech and manufactured at AuroVaccines Pvt Ltd, a wholly-owned subsidiary of Aurobindo Pharma with capabilities in vaccines development and manufacturing, it added.
Aurobindo Pharma Vice Chairman & Managing Director K Nithyananda Reddy said, SEC’s recommendation is based on data from trials conducted in 1,130 pediatric 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.
Through the PCV15, he said, “… We are committed to protecting infants from pneumococcal disease by eliciting a strong immune response in them to each serotype covered in the vaccine.
“Further, we will continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come.” (PTI)
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