Aurobindo Pharma JV gets SEC recommendation for pneumococcal 15 valent (PCV15) vaccine

28 Dec 2022 , 09:17 AM

Aurobindo Pharma Ltd announced that Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), in its meeting minutes held on December 21, 2022, has recommended grant of permission to its JV company Tergene.

As per the said press release, the permission grant to its JV company is to manufacture and market 15-valent Pneumococcal Polysaccharide Conjugate Vaccine with three dose schedule (3 +0) for administration into the pediatric age group of 6, 10 and 14 weeks. 

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 and manufacturing. Aurobindo Pharma Ltd holds 80% stake in the Joint Venture company, Tergene Biotech Pvt. Ltd.

Commenting on the development, K. Nithyananda Reddy, Vice Chairman & Managing Director said, “SEC’s recommendation 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 have demonstrated through our clinical data that our test product is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine for the thirteen shared serotypes and provided good immune response for the two 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 the coming weeks.’

On Wednesday early morning trade, Aurobindo Pharma was trading at Rs442.95 per share higher by 0.26% on the BSE.

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