Subject Expert Committee (SEC) on Wednesday gave nod to Bharat Biotech's Covaxin for phase 2 and 3 human clinical trials on 2 to 18-year-olds.
Covaxin is developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. It is one of the two vaccines against COVID-19 being manufactured in India currently.
A committee of experts on corona from the Central Drug Standards Control Organization (CDSCO) on Tuesday discussed the application filed by Bharat Biotech.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur, officials said.
“After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus 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,” an official 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.