Of late Hyderabad’s Bharat Biotech vaccine Covaxin against COVID-19 has been recommended by an expert panel for conducting phase 2/3 clinical trials on 2-18-year-olds. The trial will be held in 525 subjects at numerous sites, constituting AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur
AIIMS Delhi will now begin clinical Trials of Covaxin on Children from Today. AIIMS Patna has been already been conducting a second phase of the Paediatric clinical trial of Covaxin after Bharat Biotech received a nod from the Drugs Controller General of India (DCGI) to start paediatric clinical studies on May 11.
At AIIMS Patna, trials for children aged between 12 to 18 have started. Succeeding it, trials will be conducted for the age groups of 6-12 years and 2-6 years, Dr Prabhat Kumar Singh, Director, AIIMS, Patna, stated. Earlier, VK Paul, Member (Health), Niti Aayog had told, “Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years.”
In this regard, after completing second phase, the consideration for third phase was done by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) based on evaluation of the safety, reactogenicity and immunogenicity of Covaxin doses after determining the phase 2 clinical trial interim report.