Vaccine maker Biological E (BE) has applied to the Drug Controller General of India (DCGI) for emergency use authorisation for its Covid-19 vaccine, Corbevax, for the 12-to-18 years age group. According to sources in the Hyderabad-based company, all supporting data has been submitted to the drug regulator as BE had already obtained DCGI’s permission for conducting phase 2/3 clinical trials of Corbevax among children and adolescents in the age group of 5-18 years in September last year.
Corbevax will likely get final approval soon. The Corbevax will be the second vaccine after Covaxin which has received EUA for those below 18 years of age.
In December last year, DCGI had also granted approval for emergency use of Corbevax for adults. The company had earlier said that it planned to produce about 100 million doses per month from February 2022. Corbevax is India’s first indigenously developed protein sub-unit vaccine against Covid-19.
It has been developed by Biological E jointly with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.
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 temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack. The expected cost of the vaccine is ₹145 excluding taxes.
The central government has placed an order for Corbevax. The order has been placed for five crore doses. ANI