Ocugen, Jubilant HollisterStier partner for manufacturing Covaxin for US
Malvern: Ocugen, Inc. has recently announced that it has selected Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVAXIN to prepare for potential commercial manufacturing of COVAXIN for the US and Canadian markets.
"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.
"We are pleased to partner with Ocugen and support the ongoing fight against COVID-19. With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic," stated Pramod Yadav, CEO Jubilant Pharma Limited.
COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. This platform has an excellent safety track record of more than 300 million doses of various vaccines supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech's Phase 3 clinical trial.