New Dehi:The Drugs Controller General of India (DCGI) on Wednesday granted permission to Hyderabad-based Biological E Limited 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, sources said.
The phase 2 and 3 clinical trials have to 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’, a source said.
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.
Biological E’s anti-coronavirus shot, Corbevax, which is an RBD protein sub-unit vaccine is currently undergoing phase 2/3 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 Government of India 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 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 had stated.