Pennsylvania-based Ocugen just signed an agreement giving in the rights to the Bharat Biotech Covid-19 vaccine candidate, Covaxin, in the United States. Ocugen will be responsible for clinical development, regulatory approval (including Emergency Use Authorization) and commercialization of this Indian vaccine in America.
Covaxin is an advanced stage whole-virion inactivated vaccine for then novel Coronavirus and seems to work well with the new mutants of the virus.
Bharat Biotech, based in Hyderabad, Telengana will supply initial doses to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support technology transfer for manufacturing in the United States. Ocugen will get to keep 55% of the profits from the sale of product in America.
“Our 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,” Ocugen Chairman Shankar Musunuri said.
Requiring only a standard vaccine storage temperature of 2-8 degree celcius and with the potential to treat all age-groups, Covaxin may offer an important option to protect lives across America, he added.
Ocugen has initiated discussions with the US Food & Drug Administration and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the U.S. market.
Last updated: December 26th, 2025
