Aurobindo Pharma Ltd. announced that the Central Drugs Standard Control Organization's (CDSCO) topic expert committee has recommended the pneumococcal 15-valent (PCV15) vaccine to its joint venture company, Tergene Biotech.
The 15-valent Pneumococcal Polysaccharide conjugate vaccine with three dose schedule for administration into the paediatric age group of 6, 10, and 14 weeks has been recommended for approval by the subject expert committee (SEC) at its meeting held on December 21, 2022, according to Aurobindo Pharma 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."
With inputs from Agencies.
