Bharat Biotech applies for Emergency Use Authorisation (EUA) for its potential Covid vaccine

Hyderabad based Bharat Biotech on Monday applied for Emergency Use Authorisation (EUA) for its potential Covid vaccine, Covaxin, which is being developed with the Indian Council of Medical Research (ICMR).

“After Pfizer and Serum Institute of India, Bharat Biotech has also applied to the drug regulator for market authorisation approval now,” sources confirmed ET.

Covaxin is a fully indigenously developed COVID-19 vaccine, with the largest Phase 3 clinical trials conducted in India, on 26,000 subjects across 25 sites.

Covaxin is based on a two dose schedule and its efficacy is determined 14 days post the second dosage. “If all goes well, the company is expected to launch it by February,” sources further said.

The company received the drug regulatory authority’s approval for the final stage of testing of its coronavirus vaccine in India in October end. Phase III clinical Trials are currently ongoing in Delhi, Uttar Pradesh, Bihar, Maharashtra, Punjab, Assam and other states.

Covaxin is the first indigenous vaccine candidate. The vaccine was developed from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

The second phase was conducted on 375 volunteers enrolled at 12 sites in India.

Last week Haryana Home Minister Anil Vij tested positive for the viral disease despite taking the first shot. However, the health ministry and the company pointed out that the vaccine’s efficacy would be determined after volunteers receive the full dose.

The company termed its vaccine "safe and efficacious".

The Covaxin Phase III trial has been designed as a randomized, double-blind, placebo-controlled and multi-centre trial to evaluate the safety, immunogenicity and efficacy of the BBV152 vaccine or Covaxin.