Bharat Biotech‘s Covid-19 vaccine Covaxin was recommended by an expert panel for phase II/III clinical trial on those aged between 2 to 18 years, said official sources. The trial will take place on 525 subjects at various sites, including AIIMS, Delhi; AIIMS, Patna; and Meditrina Institute of Medical Sciences, Nagpur.
The nod from the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) came after it deliberated the application of Hyderabad-based Bharat BioTech seeking permission to conduct phase 2 and phase 3 human clinical trials to evaluate the safety, reactogenicity and immunogenicity of its COVID-19 vaccine jab, Covaxin, in children aged between 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,” a source said.
Earlier, the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Recently, Bharat Biotech had announced a drop in the price of Covaxin. The vaccine will now be available at Rs 400 per dose instead of Rs 600 for state government hospitals.
Covaxin is the country’s first indigenous vaccine that has been developed by Bharat Biotech with the help of the Indian Council of Medical Research (ICMR) and National Institute of Virology.
