FDA lifts clinical hold on IND filing for COVID-19 vaccine COVAXIN

The US Food and Drug Administration has lifted its clinical hold on the Investigational New Drug (IND) application to evaluate the vaccine candidate, BBV152, known as COVAXIN outside the USA, that was submitted by Ocugen (Nasdaq: OCGN), sending the US biotech firm’s shares up 28% to $4.43 in after-hours trading on Friday.

COVAXIN is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

“We are pleased to be able to move our clinical program for COVAXIN forward, which we hope will bring us closer to offering an alternative COVID-19 vaccine,” said Dr Shankar Musunuri, chairman of the board, chief executive and co-founder of Ocugen, adding: “We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate.”