Biological E's anti-coronavirus shot, Corbevax is an RBD protein sub-unit vaccine. It will supply 30 crore doses of Corbevax to the Central government by December, as announced by the Union Health Ministry in June.
The Drugs Controller General of India (DCGI) has granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trials of its 'Made in India' COVID-19 vaccine on children aged between 5 and 18 years with certain conditions, sources said. The phase 2 and 3 clinical trials to 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 an 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 the Government of India from the 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.