Covid-19 vaccine: Biological E’s Corbevax gets EUA for use in 12-18 year age group

Biological E, a Hyderabad-based vaccine manufacturer, on Monday received emergency use authorisation (EUA) from India’s drug regulator for their Covid-19 vaccine for the 12 to 18-year age group. The Drugs Controller General of India (DCGI) had already approved Biological E’s Corbevax for restricted use in emergency situation among adults on December 28, 2019. Now, the DCGI approval has been extended to adolescents aged between 12 and 18 years, based on interim results of the ongoing Phase II/III clinical study, the company said.

At present, the country’s national Covid-19 vaccination programme covers children in the 15-18 years group and only Bharat Biotech’s Covaxin has been approved for this group, with 7.65 crore vaccine doses administered till date. Around 80% of this age group has been covered.

With the Corbevax approval, vaccination could now be extended to the 12-15 year group. The Union government had made an advance payment of Rs 1,500 crore in June 2021 for reserving 30 crore doses.

Corbevax is India’s first indigenously-developed receptor binding domain (RBD) protein sub-unit vaccine against Covid-19. Mahima Datla, MD, Biological E, with this significant development, they would be able to take Corbevax to the age group of 12 to 18 years in the country.

Once fully vaccinated, children can resume their activities and educational pursuits in schools and colleges without any apprehension, Datla said.

The company had earlier said it would make 100 -plus million doses per month from February 2022.  The company said it would also deliver more than one billion additional doses globally.

Datla said for clinical trials the company received support from the Biotechnology Industry Research Assistance Council, the Department of Biotechnology and Translational Health Science and Technology Institute.

Biological E had got approval to to conduct a Phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years in September 2021. The clinical study indicated that the vaccine was safe and immunogenic, the company said.

Corbevax is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees’ Celsius, and presented as 0.5 ml (single dose), 5 ml (10 doses) vial and 10 ml (20 doses) vial packs.