The Drugs Controller General of India (DCGI) on Monday granted final approval to Biological E's COVID-19 vaccine Corbevax, for children between 12-18 years of age in India.
Till now India has been administering Bharat Biotech's Covaxin to teens between 15 and 18 years old since January 3.
The EUA, short for emergency use authorisation, for Corbevax's restricted use in emergency among adults was cleared by the regulator Drugs Controller General of India in December 2019.
Corbevax is being billed as India's first homegrown "receptor-binding domain protein sub-unit vaccine against COVID-19". A receptor-binding domain is a key part of a virus located on its "spike" domain that allows it to dock to body receptors to enter and infect cells. These are also the primary targets in the prevention and treatment of viral infections.
Last September, Biological E got permission to conduct phase II and III clinical trials on Corbevax in children and adolescents aged 5 to 18 years.
Corbevax is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degree Celsius. It comes in 0.5 ml (single dose), 5 ml (10 doses) and 10 ml (20 doses) vial packs, BE said.