An expert panel of India’s central drug authority recommended granting restricted emergency use authorisation to Biological E’s COVID-19 vaccine, Corbevax, for age group 12 to 18 years subject to certain conditions.
As per the reports, the government has still not not taken a decision on vaccinating those aged below 15 years. NITI Aayog member (Health) V K Paul at a press conference recently said that the additional need for vaccination and inclusion of population for vaccination is examined constantly.
The Drugs Controller General Of India (DCGI) has already approved Corbevax, which is India’s first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in emergency situation in adults on December 28. It has not been included in the country’s vaccination drive.
The recommendation has been sent to the DCGI for final approval. In an application sent to the DCGI on February 9, Srinivas Kosaraju, the head of Quality and Regulatory Affairs of Biological E Limited 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.
The Corbevax vaccine 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) and 5 ml (10 doses) vial pack.