Biological E's Corbevax gets nod for phase 2/3 trials on those aged 5-18

India's drug regulator has granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trials of its COVID-19 vaccine on children aged between 5 and 18 years with certain conditions , PTI has reported.

Biological E's indigenous anti-coronavirus shot, Corbevax, which is a RBD protein sub-unit vaccine, is currently undergoing phase 2/3 clinical trials on adults. The Drugs Controller General of India's permission was given based on the recommendations by the Subject Expert Committee.

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.

Zydus Cadila's needle-free vaccine ZyCoV-D was the first vaccine in the country to be administered in the age group of 12-18 years. The data of phase 2/3 clinical trials of Bharat Biotech's Covaxin in the age group 2 to 18 years is underway. Also in July, permission was granted to Serum Institute of India for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.

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 vaccine has been supported by the Government of India from preclinical stage to phase 3 studies.