Biological E has applied for Emergency Use Authorisation (EUA) for its COVID-19 vaccine Corbevax for the 5-12 year age group, official sources said on Wednesday, according to a news report by ANI The data has been submitted by the company to the Subject Expert Committee for beneficiaries between 5-12 years of age, the sources told ANI.
Earlier, Corbevax which is 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-year age group.
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 Last September, Biological E received approval to conduct a Phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years.
Based on the no-objection certificate, Biological E initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic.