The Drugs Controller General of India (DCGI) on Monday granted emergency use authorization (EUA) to Hyderabad-based Biological E Limited's Corbevax vaccine for administration to the 12 to 18 age group.
Corbevax is India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19. The DCGI has already approved Corbevax, which is India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in an emergency situation in adults on December 28.
In an application sent to the DCGI on February 9, Srinivas Kosaraju, the head of Quality and Regulatory Affairs of Biological E Limited had said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.
"Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has 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 an 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) and 5 ml (10 doses) vial pack.
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