Bharat Biotech to begin clinical trial of Covaxin in children in 10-12 days: VK Paul
The Drugs Controller General of India's (DCGI) has already given its approval to conduct Covaxin clinical trials among children
Bharat Biotech will begin the phase II and III clinical trial of Covaxin in the children in the age group of 2 to 18 years in the next 10-12 days, Dr V K Paul, NITI Aayog member told the press on Tuesday.
“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. I have been told that trials will begin in the next 10-12 days,” Dr Paul said.
On May 11, the Drugs Controller General of India's (DCGI) gave its approval to Covaxin to conduct clinical trials in children.
In February, Bharat Biotech had approached the central drug regulator with a proposal for conducting clinical trials in children within the age group of 5-18. The proposal was rejected and the company was asked to produce the data of the vaccine's efficacy in adults first.
“After detailed deliberation, the committee recommended that the firm should submit efficacy and safety data of the ongoing Phase III clinical trial in adults along with the age subgroup analysis. The design of the trial should be revised to Phase II/III. Sample size and other consequential changes should be made to the protocol, accordingly. Accordingly, the firm shall submit revised clinical trial protocol for review of the committee,” Bharat Biotech was told in a meeting on February 24.
The clinical trials are expected to be conducted in 525 participants at various hospitals.
Earlier, AIIMS Director Dr Randeep Guleria had said that the need of the hour is some quick data and risk-benefit analysis of the vaccine's use in children.