COVAXIN from Bharat Biotech gets DCGI nod for Phase III clinical trials

Covaxin, the COVID-19 vaccine candidate from Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR), has received approval from DCGI for phase III clinical trials.

On October 2, Bharat Biotech had applied to the DCGI for permission to conduct Phase III trials.

As per reports, the approval was given based on the recommendation of an expert panel at the Central Drugs Standard Control Organisation (CDSCO).

The recommendation was reportedly given after evaluating the safety and immunogenicity data of phase 1 and 2 clinical trials, official sources said.

In its application, the company has said that the study would comprise 28,500 subjects aged 18 years and above from 19 sites across 10 states including Delhi, Mumbai, Patna and Lucknow.

The dosage proposed for phase III clinical trials is 0.5 ml on day 0 and 28, as per reports.