Covaxin is indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based firm is conducting phase-3 clinical trial of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow.
Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, official sources said.
Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.
DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9,” a source said.
