Bharat Biotech, the Hyderabad-based pharmaceutical firm that has been developing coronavirus vaccine Covaxin, has applied to the central drug regulator seeking emergency use authorisation, sources said today.
It is the third firm after Serum Institute of India and American pharma giant Pfizer to apply for emergency use approval.
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 on at 18 sites across the country with over 22,000 volunteers.
An emergency use approval of a drug can be 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.
An emergency authorisation is also granted in situations like the present one when the entire world has been grappling with the coronavirus pandemic that has affected millions across the globe and killed over 1.5 million. In such situations, regulatory authorities around the world use this mechanism to grant interim approvals to drugs.
The emergency use authorisation will allow the vaccine to be administered to people under certain conditions – for a limited period of time or on specific groups.
On December 4, Prime Minister Narendra Modi at an all-party meeting had expressed hope that a COVID-19 vaccine may be ready in a few weeks.
On the same say, the Indian arm of Pfizer sought emergency use approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.
The Serum Institute has also asked for the approval for the Oxford COVID-19 vaccine, Covishield, on December 6.
The emergency use authorisation application for the vaccines developed by Pfizer, Serum Institute of India, and Bharat Biotech will be taken up for examination on Wednesday, sources in the Drugs Controller General of India have told NDTV.
India, that has been inching close to the 1 crore-mark in coronavirus cases is the world’s second-worst hit by the pandemic after the US, and has registered more than 1,40,000 deaths.
Union Health Minister Dr Harsh Vardhan has said that the first in line for the vaccine would be health workers, other frontline workers including the police, paramilitary and those working in sanitisation, as well as elderly people above 65-years of age.