Jubilant HollisterStier LLC, a step down subsidiary of Jubilant Pharmova, has entered into a manufacturing partnership with Ocugen, a biopharmaceutical company. This agreement is for manufacturing of vaccine candidate Covaxin for the US and Canadian markets.
“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.
J P Gabriel, Senior Vice President, Manufacturing and Supply Chain with Ocugen, said, “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 commercialising vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of Covaxin to our new partner.”
The US Food and Drugs Food and Drug Administration has denied emergency usage approval to Covaxin in the US. According to reports, the makers of India's first homegrown COVID-19 vaccine have been asked to apply for a full license approval instead. Meanwhile, Bharat Biotech is also seeking emergency use listing for Covaxin from the World Health Organization.
Covaxin has been used in India for several months, however, the vaccine is yet to be granted global recognition.
Bharat Biotech's US partner, Ocugen, is in discussions with the FDA to understand what additional information will be required to support an application for a full license.
While third phase interim data for Covaxin had been released some time ago, the final data is yet to be made available. According to the company, this is expected in July. Peer review will take another 2-4 months.