The Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) on Tuesday recommended the grant of permission to Aurobindo Pharma's JV company Tergene to manufacture and market 15-valent pneumococcal Polysaccharide conjugate vaccine (PCV15). The vaccine is used to protect infants, young children and adults against pneumococcal infections.
Aurobindo Pharma said in the statement released on Tuesday that it would be marketed with three-dose schedule for administration into the paediatric age group of 6, 10 and 14 weeks.
PCV15 vaccine was developed by Tergene Biotech and manufactured at Auro Vaccines, which is a wholly-owned subsidiary of Aurobindo Pharma with capabilities in vaccines development and manufacturing. Aurobindo Pharma holds 80 per cent stake in the joint venture company, Tergene Biotech.
Under the Drugs and Cosmetics Act, CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standards for drugs.
K Nithyananda Reddy, Vice-Chairman and Managing Director, Aurobindo Pharma, said, "SEC's recommendation is based on data from (3+0) trial conducted in 1,130 paediatric subjects assessing safety, tolerability, and immunogenicity... 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 the SEC's recommendation, the MD said it would take the procedural next steps as formal approval from Drugs Controller General of India (DCGI) is expected in the coming weeks.
Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients.
( With inputs from ANI )
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