Biological E's Corbevax Vaccine gets DCGI nod for phase 2/3 trials in children aged 5-18

In another positive development to the country's vaccination efforts, the Drugs Controller General of India (DCGI) granted Biological E Limited permission on Wednesday to conduct phase 2/3 clinical trials of its indigenous COVID-19 vaccine 'Corbevax' in children aged between 5 and 18 years. The phase 2 and 3 clinical trials have to be conducted with certain conditions, 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 trial will be held across ten sites in India. 

The DCGI's nod was based on the recommendations by the Subject Expert Committee (SEC) on COVID-19. Biological E's anti-coronavirus shot, Corbevax, an RBD protein subunit vaccine, had earlier conducted phase 2/3 clinical trials on adults. So far, Zydus Cadila's made-in-India needle-free COVID-19 vaccine 'ZyCoV-D' has received Emergency Use Authorisation from DCGI, making it the first vaccine for the age group of 12-18 years in the country.

Meanwhile, the Phase 2/3 clinical trials of Bharat Biotech's Covaxin in the age group 2 to 18 years are underway. Besides this, DCGI had 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 to supply 30 crore doses to Govt

Meanwhile, Biological E is set to supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The ministry had finalized arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses.

The Government of India supported the Biological E COVID-19 vaccine candidate 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. However, it has partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad.

(With inputs from agency)

Image Credit: Unsplash