SEC recommends nod for Aurobindo JV’s 15-valent pneumococcal polysaccharide vax for infants | India News
HYDERABAD: Aurobindo Pharma on Tuesday said the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has recommended that its joint venture company Tergene Biotech Pvt Ltd be granted permission for manufacturing and marketing its 15-valent pneumococcal polysaccharide conjugate vaccine.
The vaccine, which offers protection to serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C, 19A, 19F and 23F, has been recommended a nod for the three-dose vaccine that has to be administered to infants at the ages of six, 10 and 14 weeks.
Pointing out that the decision was taken by the SEC during a meeting held on December 21, 2022, Aurobindo said in a regulatory filing: “With SEC’s recommendation, we will take the procedural next steps as we expect formal approval from DCGI in the coming weeks.”
Aurobindo Pharma vice chairman & managing director K Nithyananda Reddy said the SEC’s recommendation was based on data from (3+0) trial conducted in 1,130 pediatric subjects to assess 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 13 shared serotypes and provided good immune response for the two additional serotypes unique to our vaccine (serotypes 2 and 12F),” he added.
“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 programme for the WHO markets, thereby providing coverage and protection for more infants globally in time to come,” Reddy added.
The vaccine has been developed by Tergene and manufactured by Aurobindo’s wholly-owned subsidiary AuroVaccines Pvt Ltd.
The vaccine, which offers protection to serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C, 19A, 19F and 23F, has been recommended a nod for the three-dose vaccine that has to be administered to infants at the ages of six, 10 and 14 weeks.
Pointing out that the decision was taken by the SEC during a meeting held on December 21, 2022, Aurobindo said in a regulatory filing: “With SEC’s recommendation, we will take the procedural next steps as we expect formal approval from DCGI in the coming weeks.”
Aurobindo Pharma vice chairman & managing director K Nithyananda Reddy said the SEC’s recommendation was based on data from (3+0) trial conducted in 1,130 pediatric subjects to assess 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 13 shared serotypes and provided good immune response for the two additional serotypes unique to our vaccine (serotypes 2 and 12F),” he added.
“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 programme for the WHO markets, thereby providing coverage and protection for more infants globally in time to come,” Reddy added.
The vaccine has been developed by Tergene and manufactured by Aurobindo’s wholly-owned subsidiary AuroVaccines Pvt Ltd.
