Covaxin, India's first COVID-19 vaccine candidate has sought the drug regulator's approval to start the large scale phase III clinical trial in the country.
The Drugs Controller General of India asked the vaccine maker Bharat Biotech to submit "complete safety and immunogenicity data of the phase II trial" and some clarifications before proceeding for the next stage.Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, Covaxin is currently in the phase II clinical trial in the country.
Hyderabad-based Bharat Biotech earlier released the animal study results of Covaxin. "The vaccine candidate was found to generate robust immune responses.