Covaxin receives approval for clinical trials on children
1 min read 13 May 2021, 10:54 AM ISTCovaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults
PremiumBharat Biotech's COVID-19 vaccine Covaxin was on Thursday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, an official statement said.
The trial will take place in 525 subjects at various sites.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, indigenously developed by 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.
