Syllabus section: Science and Technology

 

Why in News?

Bharat Biotech has applied for the emergency use authorization to the Drugs Controller General of India (DGCI) for its indigenously developed COVID-19 vaccine ‘COVAXIN’ recently.

Other Highlights

• 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.

About 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 is Emergency Use Authorization’ 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.

 

Source: The Hindu