Biological E seeks emergency use authorization for Corbevax for 5-12 year age group
The data has been submitted by the company to the subject expert committee (SEC) for beneficiaries between 5-12 years of age.
By Sumit Jha Published on 9 March 2022 10:44 AM GMT
Hyderabad: Hyderabad-based pharmaceutical company Biological E has applied for emergency use authorisation (EUA) for its COVID-19 vaccine Corbevax for the 5-12 year age group, according to a news report by ANI.
The data has been submitted by the company to the subject expert committee (SEC) for beneficiaries between 5-12 years of age.
On 21 February, Corbevax, India's first indigenously-developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, had received emergency use authorisation from India's drug regulator for the 12-18 age group based on interim results (of the ongoing phase I1/I clinical study).
The Drugs Controller General of India (DCGI) is expected to give the final EUA to Corbevax soon for the 5-12 age group. The SEC recommended EUA only after seeing the safety and immunogenicity data amongst this group.
The expected cost of the vaccine is Rs. 145 excluding taxes. It will be administered two times within prescribed intervals.
The Central government has already purchased about five crore Corbevax and also delivered them to some states.
The DCGI had approved Corbevax for restricted use in emergency situation among adults on 28 December 2021.
Last September, BE received approval to conduct phase II/Il clinical trial of Corbevax on children and adolescents aged five to 18 years. Based on the no-objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/Il study, which indicated that the vaccine is safe and immunogenic.
