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Two-dose COVAXIN currently under EUA in India
Ocugen, Inc., a biopharma company, and Bharat Biotech, a vaccines specialist, have entered into a definitive agreement to co-develop, supply and commercialize COVAXIN, Bharat's Covid-19 vaccine candidate, for the US market.
Per the deal, Ocugen will be granted US rights to the vaccine candidate and will be in charge of clinical development, regulatory approval (including emergency use authorization, or EUA) and commercialization for the US market. India-based Bharat will supply initial doses for the US once Ocugen is granted EUA. Further, Bharat will support the technology transfer for it to be manufactured in the states. Ocugen will keep 45% of the profits from the sale of COVAXIN in the US.
Dr. Shankar Musunuri, chairman, CEO and co-founder of Ocugen, says that the COVAXIN vaccine offers features that could help support its effectiveness and address storage issues.
“The evaluation of COVAXIN has resulted in several unique product characteristics, including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants,” Musunuri explained. “Requiring only a standard vaccine storage temperature of 2-8oC [35.6-46.4 oF] and with the potential to treat all age groups, COVAXIN may offer an important option to protect lives across America.”
COVAXIN was previously granted EUA by India’s Central Licensing Authority in January, but is still undergoing Phase III trials, according to Bharat's website. It is to be administered in two doses, 28 days apart.