NITI Aayog member (health), Dr VK Paul declared on Tuesday that Bharat Biotech will be commencing with the phase II and phase III clinical trials for Covid-19 vaccine Covaxin among the children in the age group from 2 to 18 years within the next 10 -12 days.
Amid a press conference Paul 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. I have been told that trials will begin in the next 10-12 days.”
The Drugs Controller General of India (DCGI) has granted approval to the Covaxin for conducting clinical trials on May 11 in children. DCGI followed the given recommendations of the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CSDCO), who granted permit for the trials with prescribed terms and conditions.
Earlier, in February, Bharat Biotech had approached the DCGI with their proposal for conducting clinical trials of Covaxin for the children with the age group of 5 -18 years. However, the drug regulator rejected the proposal and Bharat Biotech was asked to submit the data of efficacy among adults first.
In the meeting which happened on February 24, Bharat Biotech was told, “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.”
The clinical trials will be conducted among 525 participants throughout several hospitals of the country.
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