Patna’s All India Institute of Medical Sciences (AIIMS) on Tuesday commenced the phase II/III clinical trials of the indigenous Covaxin (Covid vaccine on children in the age group of 2 to 18 years. The vaccine, developed by Bharat Biotech International Limited, had received the DCGI approval on May 11.
Dr VK Paul, Member (Health), Niti Aayog had earlier said, “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.”
The Covaxin trials are also scheduled to take place in 525 subjects at various sites, including AIIMS, Delhi, and Meditrina Institute of Medical Sciences, Nagpur.
“After detailed deliberation, the committee recommended for the 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 had told news agency PTI.
As many as 54 children had registered at the institute for the trials of which 16 were in the 12-18 years age group, Hindustan Times said in its report.
Those participating in the trials would be given a flat conveyance reimbursement of ₹1,000 per visit to the institute, a doctor performing the trials told HT.
India has three COVID-19 vaccine – Bharat Biotech’s Covaxin, Serum Institute’s Covishield and Russia’s Sputnik V. Covaxin and Covishield are being manufactured in India.
For the uninformed, India began world`s largest vaccination drive on January 16 this year in a phased manner with healthcare workers (HCWs) getting inoculated first.
