The US Food and Drug Administration has approved Bharat Biotech’s COVID-19 vaccine Covaxin for clinical trials in adults (FDA). Bharat Biotech and its US partner Ocugen expressed their commitment to bringing Covaxin to the US and Canada for all age groups in a statement issued on Monday.
According to the statement, Covaxin has been cleared by the US FDA for adult clinical trials.
“Recently, the US Food and Drug Administration (FDA) approved Ocguen’s phase 2/3 investigational drugs application for Covaxin for conducting clinical trials in adults,” according to the statement. It also stated that Ocugen intends to continue working with the FDA to evaluate the regulatory pathway for Covaxin’s pediatric use.
Notably, Hyderabad-based Bharat Biotech previously announced that Covaxin will be tested as a vaccine candidate for the disease in the United States.
“Ocugen, Inc. (NASDAQ: OCGN) 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, also known as Covaxin outside the US. In the United States and Canada, Ocugen, Inc is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 with Bharat Biotech,” read the statement from Bharat Biotech.