India's Covid-19 vaccine -- Covaxin -- will be evaluated as a vaccine candidate in the United States, Bharat Biotech said on Saturday.
Covaxin is India's indigenous Covid-19 vaccine manufactured by Bharat Biotech, which has been developed in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).
"Covaxin will be evaluated as a Covid-19 vaccine candidate in the United States. US biotech company Ocugen announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the company's Investigational New Drug Application (IND) to evaluate the Covid-19 vaccine candidate, BBV152, known as Covaxin outside the United States," the Hyderabad-based vaccine manufacturer said in a statement.
Ocugen is co-developing Bharat Biotech's Covaxin vaccine candidate for Covid-19 in the US and Canada.
Covaxin is one of the two vaccines which is being administered mainly in India.
Covaxin has already been granted Emergency Use Listing (EUL) in 13 countries so far, according to the World Health Organization.
It was given emergency use approval by the Drugs Controller General of India (DCGI) for the 12-18 age group on December 24, 2021.