THD NewsDesk, New Delhi: Bharat Biotech’s Covid-19 vaccine “Covaxin” has been approved for the phase II/III clinical trial on those aged between two to 18 years.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) had a discussion upon Hyderabad-based Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials. It aimed at scrutinizing the the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
A source said,
“After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of 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.”
Earlier the proposal was discussed on February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, a product of Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India’s ongoing Covid-19 vaccination drive and till now have been given to the people above 45 years in the first phase and above 18 years in the second phase. If this trial proves to be successful, the vaccination drive of the age group below 18 could also be started soon.
Source: Deccan Herald