In a breakthrough, an expert panel recommended Bharat Biotech was on Tuesday to send its COVID-19 vaccine ‘Covaxin’ for phase II and phase III clinical trials on children between the ages of two and 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.
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.
“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,” an official told news agency PTI.
Indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), Covaxin is being used to inoculate adults in India amid the COVID-19 vaccination drive.
