New Delhi: The Drugs Controller General of India (DCGI) on September 1 granted permission for Hyderabad-based Biological E Limited to conduct phase 2 and 3 clinical trials of its homegrown COVID-19 vaccine among children aged 5-18 years with certain conditions, sources said.
The phase 2 and 3 clinical trials have to be conducted as per approved protocol, a source said. It is entitled ‘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, the indigenous Zydus Cadila needle-free COVID-19 vaccine, dubbed ZyCoV-D, has received emergency use authorisation from the drug regulator, making it the first vaccine to be administered among people aged 12-18 years in the country.
Meanwhile, the data of phase 2 and 3 clinical trials of Bharat Biotech’s Covaxin in the age group 2-18 years is underway.>
India’s drug regulator in July granted permission to Serum Institute of India (SII) for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years with certain conditions.>
Biological E’s anti-coronavirus shot, Corbevax – an RBD protein sub-unit vaccine – is currently undergoing phase 2 and 3 clinical trials on adults, sources had said earlier.>
Biological E plans to supply 30 crore doses of Corbevax to the Centre by December 2021, the Union health ministry said in June.
The Biological E COVID-19 vaccine candidate has been supported by Government of India from the pre-clinical trial stage.>
The Department of Biotechnology has provided financial assistance, as a grant-in-aid of over Rs 100 crore, and partnered with Biological E to conduct all animal challenge and assay studies through its Translational Health Science Technology Institute (THSTI), Faridabad, a health ministry statement said.>