Indian EUA for indigenously-developed COVID-19 vaccine Corbevax

Indian vaccine maker Biological E Limited (BE) has announced that its Corbevax vaccine, which is India's first indigenously developed receptor binding domain (RBD) protein sub-unit vaccine against COVID-19, has received emergency use authorization (EUA) from India's drug regulator for the 12 to 18-year age group. Adult EUA was approved in December.

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

Biological E’s managing director Mahima Datla commented: “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. We truly believe that with this approval, we are even more closer to finishing our global fight against the COVID-19 pandemic. Once fully vaccinated, children can resume their activities and educational pursuits in schools and colleges without any apprehension.”