Official sources reported on Sunday that Biological E has requested emergency use authorization from India’s medicines authority for its Covid-19 vaccine Corbevax for children aged 12 to 18.
On December 28, the Drugs Controller General of India (DCGI) authorised Corbevax, India’s first indigenously manufactured RBD protein sub-unit vaccine against Covid-19, for limited use in adult emergency situations.
Srinivas Kosaraju, Director of Quality and Regulatory Affairs at Biological E Limited, stated in an application to DCGI on February 9 that the company had got authorisation to begin a phase 2/3 clinical research of Corbevax in children and adolescents aged 5 to 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 proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase 2/3 clinical study) considering the current pandemic and widespread of Covid-19 vaccine in India,” Kosaraju said in the application.
The Corbevax vaccine is administered through 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.
According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its Covid-19 vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.