Hyd-based Biological E's Corbevax vaccine approved for 12-18 age group

Hyderabad: Hyderabad-based Biological E. Limited (BE) on Monday announced that its COVID-19 vaccine Corbevax, India's first indigenously-developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18 age group.

The Drugs Controller General of India (DCGI) had approved Corbevax for restricted use in emergency situation among adults on 28 December 2021. Now, BE has received approval for restricted use in an emergency situation among adolescents aged 12 to 18 years based on interim results (of the ongoing phase I1/I clinical study).

Mahima Datla, the managing director of Biological E. Limited, said, "We are pleased with this significant development, which helps extend the reach of our vaccine to the age group of 12 to 18 years in our country. Once fully vaccinated, children can resume their activities and educational pursuits in schools and colleges without any apprehension."

Last September, BE received approval to conduct phase II/Il clinical trial of Corbevax in children and adolescents aged five to 18 years. Based on the no-objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/Il study, which indicated that the vaccine is safe and immunogenic.

Corbevax is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8°Celsius. It comes in 0.5 ml vial (single dose), 5 ml (10 doses) vial, and 10 ml (20 doses) vial pack. BE conducted phase I/II and I1/I clinical trials for Corbevax for adults in the country. In addition, it conducted phase lIl active comparison clinical trial to evaluate superiority over the Covishield vaccine.