Ocugen and Bharat Biotech have entered into a definitive agreement to co-develop, supply, and commercialise Bharat Biotech’s COVAXIN, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.

Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialisation for the US market.
Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN in the US market with Bharat Biotech, with Ocugen retaining 45 per cent of the profits.

The collaboration will leverage the vaccine expertise of Ocugen’s leadership team. In preparation for the development of COVAXIN in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the US Food & Drug Administration (FDA) 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 US market for COVAXIN.

Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN to support its US immunisation programme.

“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 neutralising capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. Requiring only a standard vaccine storage temperature of 2-8oC and with the potential to treat all age-groups, COVAXIN may offer an important option to protect lives across America,” said Dr Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.

The Central Licensing Authority in India has granted permission for the sale or distribution of COVAXIN for restricted use in emergency situations in the public interest, in clinical trial mode. With the kickoff of what is likely to become the biggest national vaccination campaign in India’s history, COVAXIN is being administered as one of the two COVID-19 shots available under emergency authorisation with the first batch of 30 million doses being administered to health professionals and front-line workers.

“The COVID-19 pandemic has affected humanity at large. As a company determined to protect global public health, it has always been important for us to develop vaccines for a global cause. Our goal for all vaccines developed at Bharat Biotech is to provide global access. COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist. With the recent progression of COVAXIN use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring COVAXIN to the US market.,” said Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech.