Bharat Biotech, developer of indigenous COVID-19 vaccine, COVAXIN has applied to the central drug regulator, DCGI, seeking emergency use authorisation for its vaccine. With this, the Hyderabad based firm, Bharat Biotech has become the third applicant after Serum Institute of India and Pfizer to apply for approval of emergency use of COVID-19 vaccine in the country.
COVAXIN is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is currently in Phase 3 trials. The trials are being conducted at 18 sites across the country with over 22 thousand volunteers.
Emergency use approval of a drug is granted after there is sufficient evidence to suggest that the medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data.
The Indian arm of Pfizer sought emergency use approval for its vaccine, which has been co-developed with BioNTech in the United States. The firm has already secured emergency usage clearance in the UK and Bahrain. Pune based Serum Institute, which is also the World’s largest vaccine manufacturer has applied for approval of Oxford COVID-19 vaccine, COVISHIELD, which has been co-developed by Pharma company AstraZeneca and Oxford University.