Bharat Biotech applied for ‘Emergency Use Authorisation’

The developer of indigenous COVID-19 vaccine, Bharat Biotech, has applied to the central drug regulator (DCGI) and asked for the permission of emergency use authorisation for its vaccine called COVAXIN.

Highlights

• The Bharat Biotech which is a Hyderabad based firm has become the third applicant to apply for the approval of emergency use of COVID-19 vaccine.
• Other two firm that has applied for emergency use authorization include- the Serum Institute of India and Pfizer.  

COVAXIN

• COVAXIN is India’s indigenously developed vaccine.
• It has been developed by Bharat Biotech.
• Vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR).
• This vaccine is currently undergoing the Phase 3 of the trials.
• The trials are being conducted at 18 sites in India on over 22 thousand volunteers.

What does ‘Emergency Use Authorisation’ mean?

Emergency use approval for a drug is granted only after there is sufficient evidence suggesting that the medical product is safe and effective. However, the final approval is granted only after completion of the trials and by proper analysis of full data.

Background

The Indian arm of Pfizer has also asked for the emergency use approval for its vaccine. The vaccine of Pfizer was co-developed with BioNTech in the United States. Pfizer has already got the emergency usage clearance in the UK and Bahrain. The other firm, that is Serum Institute, has also applied for approval of Oxford COVID-19 Vaccine called COVISHIELD. The COVISHIELD vaccine has been developed in collaboration with the Pharma Company AstraZeneca and Oxford University.