Kushal Kumar Jha
After Pfizer & SII, now Bharat Biotech seeks emergency use authorisation for its 'COVAXIN' in India
Hyderabad-based pharma firm Bharat Biotech, which is the developer of India's indigenous COVID-19 vaccine 'COVAXIN' has now applied to the Drugs Controller General of India (DCGI) for emergency use authorisation in India. The development comes days after Pfizer and Serum Institute of India seeking the same approval for their respective COVID-19 vaccines. COVAXIN is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is currently under Phase III clinical trials at 18 sites across the country with over 22 thousand volunteers. The emergency use approval of a drug is granted after there is sufficient evidence suggesting that the medical product is safe and effective. Final approval is granted only after the completion of the trials and analysis of full data. On December 4, Pfizer India sought emergency use authorisation for its vaccine, which has been co-developed with Germany's BioNTech in the United States. Pfizer-BioNtech's two-dose mRNA-based COVID-19 vaccine has already got approval for emergency use in the UK and Bahrain. Pune-based Serum Institute of India, which is also the World's largest vaccine manufacturer, has also applied for emergency use authorisation for their COVID-19 vaccine, COVISHIELD in India, which has been co-developed by Pharma company AstraZeneca and Oxford University.