DCGI nod to phase 2, 3 trials of Biological E Corbevax in children

The phase 2 and 3 clinical trials have 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 a 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.