The final data of the Hyderabad-based pharmaceutical company Biological E on its Covid-19 vaccine Corbevax is likely to be submitted by November-end, official sources said on Thursday.
According to the source the emergency approval for Bharat Biotech’s Covaxin for the 2-18 years age group by the Drugs Controller General of India and it is under expert evaluation and opinion.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drug Authority on Tuesday recommended granting emergency use approval to Covaxin for children and adolescents in the 2 to 18 years age group with certain health issues.
“Due to the delay in receiving raw materials from abroad, Biological E’s vaccine got delayed but the company is likely to submit data of its COVID-19 vaccine Corbevax by November end,” the source said.
Presently, phase 2/3 clinical trials of the developed Corbevax is being manufactured indigenously, an RBD protein sub-unit vaccine, to be given to adults aged 18 years to 80 years is underway.
As announced by the Union Health Ministry in June, biological E will supply 30 crore doses of Corbevax to the central government by December.
The ministry finalised arrangements with the Hyderabad- grounded vaccine manufacturer to reserve 30 crore vaccine boluses an sanctioned statement had said. Biological E’s COVID-19 vaccine seeker has been developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) rom preclinical stage to phase-3 studies.
The Department of Biotechnology has not only handed fiscal backing in terms of entitlement-in- aid of over Rs 100 crore but has also partnered with Biological E to conduct all beast challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a Health Ministry statement before had stated.
Bharat Biotech, which completed the phase2/3 trials of COVID-19 vaccine Covaxin for use in children progressed between 2 to 18 times, had submitted the data to the Central Medicines Standard Control Organisation (CDSCO) for verification and posterior blessing for exigency use authorisation (EUA) of the poke in the morning of this month.”
After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the SEC recommendations stated.