The Drugs Controller General of India (DCGI) yesterday granted permission to Hyderabad-based Biological E to conduct phase-II/III clinical trials of its ‘Made in India’ COVID-19 vaccine on children aged between five and 18 years with certain conditions, sources said.
The phase-II and -III clinical trials have to be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo-controlled, Phase-II/III Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents,’ a source said.
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-II/III clinical trials of Bharat Biotech’s Covaxin in the age group two-to-18 years is underway.
India’s drug regulator in July granted permission to the Serum Institute of India (SII) for conducting phase-II/III trials of Covovax on children aged two-to-17 years with certain conditions.
Biological E’s anti-coronavirus shot, Corbevax, which is an RBD protein sub-unit vaccine, is currently undergoing phase-II/III clinical trials on adults, sources had said earlier.
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.
The Biological E COVID-19 vaccine candidate has been supported by the Government of India from the pre-clinical stage to the phase-III studies. The Department of Biotechnology (DBT) has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crores, 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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