The Central Drugs Standards Control Organization’s (CDSCO) Subject Expert Committee (SEC) recommended on Tuesday that Aurobindo Pharma’s joint venture business Tergene be granted authorization to produce and distribute a 15-valent pneumococcal Polysaccharide conjugate vaccine (PCV15). The vaccination protects against pneumococcal infections in newborns, young children, and adults.
In a statement issued on Tuesday, Aurobindo Pharma stated that it will be sold with a three-dose regimen for administration to children aged 6, 10, and 14 weeks. Tergene Biotech created the PCV15 vaccine, which was produced by Auro Vaccines, an Aurobindo Pharma wholly-owned subsidiary with vaccine development and production capabilities. Tergene Biotech, a joint venture business, is owned by Aurobindo Pharma to the tune of 80%.
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).”
The MD stated that with the SEC’s advice, it will proceed with the procedural next steps, as formal clearance from the Drugs Controller General of India (DCGI) is expected in the following weeks.
Aurobindo Pharma Limited is a global pharmaceutical manufacturing firm based at HITEC City in Hyderabad, India. The firm produces generic medications as well as active pharmaceutical components.
