COVID-19: FDA gives clearance to Covaxin for clinical trials in adults in US
Mar 07, 2022
New Delhi [India], March 7 : Bharat Biotech's COVID-19 vaccine Covaxin has been given clearance for clinical trials in adults by the US Food and Drug Administration (FDA).
In a statement on Monday, Bharat Biotech and its US partner Ocugen expressed their commitment towards bringing Covaxin to the US and Canada for all age groups.
The statement informed that Covaxin has been cleared by the US FDA for conducting clinical trials in adults.
"Recently, Ocguen's phase 2/3 investigational drugs application for Covaxin was cleared by the US Food and Drug Administration (FDA) for conducting clinical trials in adults," read the statement.
It further said that Ocugen intends to continue working with FDA to evaluate regulatory pathway for the pediatric use of Covaxin.
Notably, Hyderabad-based Bharat Biotech had earlier informed that Covaxin will be evaluated 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, known as Covaxin outside the United States. Ocugen, Inc is co-developing Bharat Biotech's Covaxin vaccine candidate for COVID-19 in USA and Canada," read Bharat Biotech's statement.
