Vaccine manufacturer Biological E. Ltd on Monday announced that its Covid-19 vaccine Corbevax has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group.
According to the Hyderabad-based firm, Corbevax is India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine against Covid-19.
The Drugs Controller General of India (DCGI) had already approved Corbevax for restricted use in emergency situation among adults on December 28, 2019. 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 2/3 clinical study).
Biological E. Managing Director Mahima Datla said that the development would help extend the reach of the vaccine to the age group of 12 to 18 years. "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," she said.
She thanked all the participants in the clinical trials, the Biotechnology Industry Research Assistance Council (BIRAC) and the Centre's Department of Biotechnology, the Translational Health Science and Technology Institute (TSTHI), and the principal investigators and clinical site staff who have extended their support during the last several months.
Last September, BE received approval to conduct a Phase 2/3 clinical trial on Corbevax in children and adolescents aged 5 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 2/3 study, which indicated that the vaccine is safe and immunogenic.
The Corbevax vaccine is administered through intramuscular route with two doses, scheduled 28 days apart, and is stored at 2 to 8 degrees Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.
BE conducted phase 1/2, 2/3 clinical trials of its Corbevax vaccine for adults in the country. In addition, it conducted a Phase 3 active comparison clinical trial to evaluate superiority over Covishield vaccine.