By PTI
NEW DELHI: Hyderabad-based pharmaceutical company Biological E is likely to submit the final data of its COVID-19 vaccine Corbevax by November-end, official sources said on Thursday.
On the emergency use approval for Bharat Biotech’s Covaxin for the 2-18 years age group by the Drugs Controller General of India, the source said it is under expert opinion and evaluation.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drug Authority on Tuesday recommended granting emergency use authorisation to Covaxin for children and adolescents in the 2 to 18 years age group with certain conditions.
“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.
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Currently, phase 2/3 clinical trials of the indigenously developed Corbevax, an RBD protein sub-unit vaccine, to be administered in adults aged 18 years to 80 years is underway.
Biological E will supply 30 crore doses of Corbevax to the central government by December as announced by the Union Health Ministry in June.
The ministry finalised arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses an official statement had said.
Biological E’s COVID-19 vaccine candidate 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 provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a Health Ministry statement earlier had stated.
Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between 2 to 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for verification and subsequent approval for emergency use authorisation (EUA) of the jab in the beginning 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.
