Hyderabad: Bharat Biotech and Ocugen, a US biopharmaceutical company on Tuesday have entered into an agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN in the US market.
According to the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval including emergency use approval (EUA) and commercialization for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of a EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US.
Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN to support its US immunization program.
“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,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.
“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,” Krishna Ella 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 neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
Central Licensing Authority in India has granted permission for the sale or distribution of Hyderabad-developed Covaxin for restricted use in emergency situations in the public interest.