The Bharat Biotech’s COVID-19 vaccine Covaxin has been recommended by an expert panel for phase 2 and 3 clinical trials on children aged between 2 to 18, the official sources said on Wednesday.
The trial of the COVID-19 vaccine Covaxin will take place in 525 subjects at various sites. These include AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
As per the report, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated upon the Bharat Biotech’s application seeking permission to conduct phase 2 and 3 clinical trials to evaluate the safety, of Covaxin in children aged 2 to 18 years.
A source said that the committee, after detailed deliberation, recommended for the conduct of proposed phase 2 and 3 clinical trials of COVID-19 vaccine in the 2 to 18 years age group subject to the condition that the company should submit the interim safety data of phase 2 clinical trial along to the CDSCO before proceeding to phase 3.
Earlier, it was discussed in the Subject Expert Committee meeting on February 24. The firm was asked to submit a revised clinical trial protocol.
Covaxin is indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It is already being used in adults amid the ongoing COVID-19 vaccination.
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