The recommendation has been sent to the DCGI for approval
The Subject Expert Committee (SEC), of the Central Drug Standard Control Organisation (CDSCO), has recommended granting restricted Emergency Use Authorisation for Corbevax, for age group 12 to 18 years, subject to certain conditions.
Corbevax is manufactured by Biologica E in Hyderabad.
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 an emergency situation in adults on December 28.
The recommendation has been sent to the Drugs Controller General of India (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.
"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)" Kosaraju had said in the application.