The Subject Expert Committee (SEC) of the Central Drug Standards Control Organisation (CDSCO) is understood to have recommended Phase II and III clinical trials of Covaxin on children aged between 2 and 18 years.
Hyderabad-based maker of the vaccine, Bharat Biotech, had submitted a proposal in this regard and was asked to submit a revised clinical trial protocol.
The company was also asked to submit the interim safety data of Phase II clinical trials along with the DSMB (Data and Safety Monitoring Board) recommendations to the CDSCO before proceeding to Phase III of the study, according to sources.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is presently being used in adults in India’s ongoing Covid-19 vaccination drive along with Serum Institute’s Covishield.
The permission for trials on those in the 2-18 years age group assumes significance as so far the vaccination has been confined to only those above 18 years.
The vaccine-maker is likely to conduct the trials at some select locations including Pune.
According to Suchitra Ella, Joint Managing Director, Bharat Biotech, the company has already been supplying Covaxin directly to 14 States including Delhi and Maharashtra.