The Drugs Controller General of India (DCGI) has provided approval to Hyderabad based-Bharat Biotech for conducting clinical trials on children for the Covid-19 vaccine Covaxin, thereby becoming the first Covid-19 vaccine which will be subjected to testing on children in India.
DCGI has given the approval to conduct trials for children between the age group from 2 to 18 years. Official sources revealed that the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Tuesday gave the approval for the trials with some terms and conditions. An official who wants to keep identity concealed stated, “The panel approval is for the phase II/III trials under certain conditions.”
The trials are planned to be conducted on 525 participants at multiple locations, as per the reports and the hospitals include All India Institute of Medical Sciences (AIIMS), Delhi, and AIIMS in Patna.
The clinical trials are going to be conducted with the purpose of assessing the efficacy of Covaxin in children and also evaluate the parameters of safety, reactogenicity, and immunogenicity.
Earlier on, Bharat Biotech had applied to DCGI for permission to conduct clinical trials for the age group from 5 to 18 years, however, the company was instructed to present the efficacy data of the vaccine in adults prior to commencing the testing in children. Further on, the pharmaceutical company was also asked to submit an updated protocol for clinical trials in children amid the SEC meeting of CDSCO dated February 24.
As of now, the vaccine developed by Pfizer-BioNTech has been granted the approval by US-FDA for children from 12 – 15 years of age in the United States.
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