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.