New Delhi: Biologicals-E has sought India’s drug regulator for emergency use of its COVID-19 vaccine ‘Corbevax’ in the age group of 12 to 18 years. Official sources gave this information on Sunday. The Drug Controller General of India (DGCI) on December 28 had approved limited use of Corbevax, the country’s first indigenously developed RBD protein sub-unit vaccine against coronavirus infection, in adults in emergency situations.
In an application sent to the DGCI on February 9, Srinivasa Kosaraju, Head of Quality and Regulatory Affairs, Biologicals-E, said the company got the nod to conduct Phase II/III clinical trials of Corbevax on children and adolescents aged 15-18 years in September 2021. Was.
“Based on the no-objection certificate, Biologicals-E started clinical trials in October 2021 and assessed the available safety and immunity results of Phase II/3, which indicate that the vaccine is safe and effective,” he said.
Kosaraju said, “The proposed application is in Phase II/III clinical trials to allow limited use of Corbevax in emergency situations in adolescents aged 12 to 18 years, given the current pandemic in India and the widespread need for a COVID-19 vaccine.” based on the interim results of the
Corbevax vaccine is administered intramuscularly. Two doses are given at an interval of 28 days. Corbevax is available in 0.5 ml (single dose) and 5 ml (ten doses) vials. It is preserved at 2 to 8 °C.
According to the health ministry, Biologicals-e has conducted the first/second and second/third rounds of clinical trials in India. In addition to this, the company has also conducted Phase III active comparable clinical trials to evaluate its superiority over Covishield, the ministry said.
