Hyderabad-based pharmaceutical company Biological E is expected to submit final data for its COVID-19 Corbevax vaccine by the end of November, official sources said on Thursday.
Regarding the approval for emergency use of Bharat Biotech’s Covaxin for the age group 2-18 years by the Drugs Controller General of India, the source said it was subject to the notice and to expert assessment.
The Central Medicines Authority’s COVID-19 Expert Committee (SEC) on Tuesday recommended granting emergency use authorization to Covaxin for children and adolescents aged 2 to 18 with certain conditions.
“Due to the delay in receiving raw materials from overseas, Biological E’s vaccine has been delayed, but the company is expected to submit data for its COVID-19 Corbevax vaccine by the end of November,” the company said. source.
Currently, phase 2/3 clinical trials of locally developed Corbevax, a subunit protein RBD vaccine, intended for administration to adults aged 18 to 80 years, are underway.
Biological E will deliver 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The ministry has finalized agreements with the Hyderabad-based vaccine maker to reserve 30 crore doses of vaccine, according to an official statement.
Biological E’s COVID-19 vaccine candidate was developed with support from the Department of Biotechnology and its Biotechnology Industry Research Assistance Board (BIRAC) at PSU, from preclinical to phase 3 studies .
The Biotechnology Department not only provided financial assistance in terms of the grant of over Rs 100 crore, but also partnered with Biological E to conduct all the provocation and animal testing studies through its Translational Health Science Technology Institute (THSTI) research institute, Faridabad, earlier said a statement from the Ministry of Health.
Bharat Biotech, which has completed Phase 2/3 trials of the COVID-19 Covaxin vaccine for use in children aged 2 to 18, had submitted the data to the Central Drugs Standard Control Organization (CDSCO) for verification and approval later for emergency use the jab authorization (EUA) earlier this month.
“After extensive deliberations, the committee recommended the granting of marketing authorization for the vaccine for the age group 2 to 18 years for restricted use in emergency situations subject to certain conditions. “the SEC recommendations said.
(Edited by : Jomy Jos Pullokaran)