Dr VK Paul, member (health) of Niti Aayog, said on Tuesday that Bharat Biotech is set to begin the phase II and III clinical trials for Covaxin in children in the age group of 2 to 18 years in the next 10-12 days. "Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. Covaxin received the Drugs Controller General of India's (DCGI) nod to conduct clinical trials in children on May 11. Bharat Biotech approached the central drug regulator with a proposal for conducting clinical trials in children within the age group of 5-18 back in February. The proposal was rejected and the company was asked to produce the data of the vaccine's efficacy in adults first.

Source: Hindustan Times May 18, 2021 12:14 UTC