India-based Bharat Biotech will evaluate its COVID-19 vaccine in a Phase 2/3 clinical trial on children in the 2-18 age group. According to PTI report, the study will be performed on approximately 525 participants at several sites in India.
Recently, the COVID-19 vaccine developed by Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) obtained the Emergency Use Authorization (EUA) in the US for children aged 12-15 years. With the approval, the two partners became the first manufacturers to get their vaccine approved for adolescents. On 11 May 2021, Bharat Biotech’s COVID-19 vaccine, Covaxin, was recommended for a Phase 2/3 clinical trial by an expert panel on children aged between 2 to 18.
The COVID-19 Expert Committee of the CDSCO (Central Drugs Standard Control Organization) has given approval to the Indian firm to conduct the clinical study. The trial will evaluate the safety, reactogenicity as well as immunogenicity of Covaxin shots in children.