Bharat Biotech was on Tuesday recommended by an expert panel has allowed to send its COVID-19 vaccine ‘Covaxin’ for phase II and phase III clinical trials on children between the age of two and 18 years.
An approval to vaccinate the younger population would be a major breakthrough as it would mean reopening of schools and normal classes.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) 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.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur, officials said.