Covid-19 vaccine update: Bharat Biotech, Ocugen sign pact for supply of Covaxin to US market

By: |
February 2, 2021 10:04 PM

Under the terms of the agreement, Pennsylvania-based Ocugen will have rights to the vaccine candidate in the US and will be responsible for clinical development, regulatory approval (including Emergency Use Authorisation) and commercialisation for the US market.

The broad-based MCA (as the agreement is being referred to) enables the partners to take up futuristic development activities in other related areas as well.”The broad-based MCA (as the agreement is being referred to) enables the partners to take up futuristic development activities in other related areas as well.”

Bharat Biotech and Ocugen Inc have inked a pact to co-develop, supply and commercialise COVID-19 vaccine, Covaxin, for the US market, the companies said in a joint statement on Tuesday.

The companies have entered into a definitive agreement for Covaxin, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the US market, the companies said.

Under the terms of the agreement, Pennsylvania-based Ocugen will have rights to the vaccine candidate in the US and will be responsible for clinical development, regulatory approval (including Emergency Use Authorisation) and commercialisation for the US market.

Bharat Biotech on the other hand 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.

The US-firm would retain 45 per cent of the profits.

“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,” Bharat Biotech CMD Krishna Ella said.

With the recent progression of Covaxin use under EUA in India, the company is confident that it will be able to work with Ocugen to develop a plan to bring the vaccine to the US market, he added.

“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,” 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.

In preparation for the development of the Covaxin in the US, Ocugen has 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.

The company is also in active discussions with manufacturers in the US to produce a significant number of doses of the Covaxin to support immunisation program in the US.

In India the nationwide vaccination drive began from January 16 where doses of Covaxin and Covishield are being administered to healthcare and frontline workers.

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