The Drugs Controller General of India (DCGI) has granted permission to Hyderabad-based Biological E to conduct phase 2/3 clinical trials of its Covid-19 vaccine on children aged between 5 and 18 years subject to certain conditions.

The phase 2 and 3 clinical trials have been 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 official added.

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.

Biological E's Covid-19 vaccine, Corbevax, which is an RBD protein sub-unit vaccine is currently undergoing phase 2/3 clinical trials on adults.

Biological E will supply 30 crore doses of Corbevax to the Centre by the year-end 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 indicated.

So far, indigenously developed Zydus Cadila's 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 vaccine under development by Biological E has received support from the Centre from the pre-clinical stage to Phase 3 studies. The Department of Biotechnology has provided financial assistance in the form of grand-in-aid of Rs 100 crores also helped conduct all animal challenge and assay studies, a health ministry statement noted.