Covaxin to be evaluated as COVID-19 vaccine candidate in US: Bharat Biotech

COVAXIN will be evaluated as a COVID-19 vaccine candidate in the United States, said Bharat Biotech in a statement.

In an official communication, Bharat Biotech said that Ocugen has announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold on the company’s Investigational New Drug (IND) application to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN outside the US. Ocugen is co-developing COVAXIN for COVID-19 in the US and Canada.

Covaxin has already been granted Emergency Use Listing (EUL) in 13 countries as on January 31 according to the WHO. Covaxin was granted EUL by the national regulator, Drugs Controller General of India (DCGI), in the age group 12 to 18 years on December 24, 2021.

Covaxin is India’s indigenous COVID-19 vaccine by Bharat Biotech and has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). According to Bharat Biotech, they contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.