COVAXIN: Bharat Biotech applies for emergency use authorisation for its indigenous COVID vaccine

Bharat Biotech on December 7, 2020, applied for the emergency use authorisation to the Drugs Controller General of India (DGCI) for its indigenously developed COVID-19 vaccine ‘COVAXIN’.

With this step, Bharat Biotech based in Hyderabad has become the third applicant of the vaccine after Pfizer and Serum Institute of India to apply for the approval of emergency use in India. Serum Institute has applied for the vaccine which has been developed by AstraZeneca and Oxford University.

COVAXIN has been indigenously developed by Bharat Biotech in joint collaboration with the Indian Council of Medical Research- ICMR. The vaccine for the deadly virus is currently in phase 3 clinical trials which are being conducted at 18 sites across India with over 22 thousand volunteers.

How emergency use approval of drugs is granted?

The emergency use authorisation of any drug is granted only after there is sufficient evidence suggesting that the medical product is safe and effective. Final approval of the drug is granted by the Drugs Controller General of India only after the completion of the trials and analysis of complete data.

According to the Drugs Controller General of India, the application for the authorisation of emergency use approval for the vaccines developed by Serum Institute of India, Bharat Biotech and Pfizer will be taken up for the examination on December 9.

The emergency use approval will be allowing the vaccine to be administered to the people under certain conditions which means for a limited period of time or only on specific groups.