With an aim to expand India’s COVID-19 vaccination drive to adolescents, the Subject Expert Committee (SEC) on Tuesday gives a green signal to Bharat BioTech’s Covaxin vaccine against the coronavirus for phase 2 and phase 3 clinical trials on children aged between 2 to 18 years according to an official report.
The clinical trial will take place in 525 subjects at various sites, including AIIMS, Delhi, Patna and Meditrina Institute of Medical Sciences, Nagpur.
“After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole version inactivated corona virus 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 report said.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India’s ongoing COVID-19 vaccination drive.