2 min read.Updated: 02 Sep 2021, 08:43 PM ISTLivemint
Biological E will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June
Hyderabad-based Biological E Limited is expected to launch its vaccine against coronavirus in October this year, Dr VK Paul, Member (Health), NITI Aayog said on Thursday.
Paul told news agency ANI that Phase 3 of Biological E's trial is underway. "Stockpile is being produced. We should wait for the results. We hope it'll be in next month or two. They've made a broad commitment that they'll supply a significant amount by year-end," he added.
Biological E's anti-coronavirus shot, Corbevax, which is a RBD protein sub-unit vaccine is currently undergoing phase 2/3 clinical trials on adults, as per earlier reports.
Biological E will supply 30 crore doses of Corbevax to India 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.
The Drugs Controller General of India (DCGI) has granted permission to Biological E to conduct phase 2/3 clinical trials of its 'Made in India' COVID-19 vaccine on children aged between 5 and 18 years with certain conditions.
The phase 2 and 3 clinical trials have be conducted as per approved protocol titled 'A Prospective, Randomised, Double-blind, Placebo controlled, Phase-2/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents'.
The trial will be conducted across 10 sites in the country.
The DCGI's permission was given based on the recommendations by the Subject Expert Committee (SEC) on Covid-19.
So far, indigenously developed Zydus Cadila's needle-free Covid-19 vaccine ZyCoV-D has received Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech's Covaxin in the age group 2 to 18 years is underway.
India's drug regulator in July granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.
The Biological E Covid-19 vaccine candidate has been supported by the Centre from preclinical stage to phase 3 studies. The Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over ₹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 had stated.
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