An expert panel on Tuesday recommended Bharat Bioetech’s Covid-19 vaccine Covaxin for phase-2 and phase-3 clinical trials on those aged between two to 18 years, reports said.
The trial will take place in 525 subjects 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) on Tuesday sought permission to use Hyderabad-based Bharat Biotech’s Covaxin 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 SEC 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.
The nationwide Covid-19 vaccination in India began on January 16 with healthcare workers, sanitation workers, defence forces, police and other paramilitary forces getting to be the first to get the jab. The second phase of Covid-19 inoculation drive commenced on March 1 for those above 60 years of age and for people aged 45 and above with co-morbidities. The central government had decided to start the Covid-19 vaccination for all adults from May 1.
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Covishield and Covaxin, made by Bharat Biotech of Hyderabad, are the two vaccines being used in India.