Hyderabad-based Aurobindo Pharma advanced 1.21% to Rs 442.55 after the firm's joint venture company Tergene Biotech received recommendation from the CDSCO's expert committee for grant of permission for pneumococcal 15-valent (PCV15) vaccine.
In an exchange filing made during market hours today, the company said that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), in its minutes for the meeting held on 21 December 2022, has recommended grant of permission to its joint venture company (JVC) 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.
PCV15 vaccine was developed by Tergene Biotech and manufactured at AuroVaccines, which is a wholly owned subsidiary of Aurobindo Pharma.
Aurobindo Pharma holds 80% stake in the joint venture company, Tergene Biotech.
Pneumococcal conjugate vaccine is a pneumococcal vaccine and a conjugate vaccine used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine.
The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.
Nithyananda Reddy, vice chairman & managing director, stated, SEC's recommendation is based on data from trial conducted in 1130 pediatric subjects assessing safety, tolerability, and immunogenicity.
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"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, Nithyananda Reddy said.
He further added: With SEC's recommendation, we will take the procedural next steps as we expect formal approval from DCGI in the coming weeks. At Aurobindo, through our 15 valent conjugate vaccine, 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.
Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
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