Shares of Ocugen Inc. in premarket trading on Tuesday, after the company said it chose privately held pharmaceutical contract manufacturer Jubilant HollisterStier, to produce its COVID-19 vaccine (which is still in investigational stage) for the U.S. and Canada. The vaccine, called COVAXIN is not authorized in either country at this time.
“We are fully committed to bringing COVAXIN to the US and Canadian markets because we believe it has the potential to save lives by adding a weapon to the arsenal in the fight against emerging variants,” said J.P. Gabriel, Ocugen’s Senior Vice President, Manufacturing and Supply Chain. “Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada. Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN to our new partner.”
“We are excited to expand our basket of vaccine products and meet the increasing demand from our customers for COVID-19 vaccines in the US,” said Amit Arora, President Jubilant HollisterStier.
COVAXIN, India's COVID-19 vaccine by Bharat Biotech. It has a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, in second interim results of Bharat Biotech’s Phase 3 clinical trial.