In a big move, the Drugs Controller General of India (DCGI) has approved the Phase II/III clinical trial of indigenous Covid vaccine Covaxin in the age group of 2 to 18 years. DRugmake Bharat Biotech will conduct trials in 525 healthy volunteers.
The trial will take place 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 on Tuesday gave nod to Hyderabad-based Bharat Biotech's application seeking permission to conduct trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
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.