New Delhi: Bharat Biotech’s Covaxin approved by an expert panel on Tuesday. Clinical Trial for phase II/III to be commenced soon for those aged between 2 to 18 years, claimed by the official sources.
The trial to be conducted on 525 subjects at various locations including AIIMS (Delhi and Patna), Meditrina Institute of Medical Sciences (Nagpur). The Central Drugs Standard Control Organization’s (CDSCO) and Subject Expert Committee (SEC) considered Hyderabad-based Bharat Biotech’s application to initiate clinical trials for children and teens, aged between 2 to 18 years. It’s a huge step forward that will thereby decide the efficacy, reactogenicity, and immunogenicity of the Covaxin jabs.
After detailed deliberation, the committee recommended for the conduct of proposed phase II/III clinical trial of the whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” a source said.
Bharat Biotech Covaxin approval was initially proposed on 24 February 2021 at an SEC meeting. Although, SEC requested the firm to submit a revised proposal for clinical trial protocols.
Covaxin, India’s first indigenous COVID-19 vaccine developed by Bharat Biotech in collaboration with ICMR (Indian Council of Medical Research) is a huge part of India’s vaccination drive, being used to vaccinate 18+ aged individuals across the nation.
World’s Largest Vaccination Drive
India’s vaccination drive began on January 16, with two vaccines Covisheild and Covaxin. Bharat Biotech’s Covaxin approval for children can have a cosmic impact on the current pandemic situation and may open Schools, Colleges, and universities in near future.