Wednesday, June 16, 2021

Ocugen expands Covaxin Commercialization Rights to include Canada

Ocugen, Inc. a biopharmaceutical company today announced that they have entered into an amendment to their Co-development, Supply, and Commercialization Agreement to expand Ocugen’s exclusive territory to commercialize COVAXIN to now also include Canada, in addition to Ocugen’s existing rights to commercialize COVAXIN in the United States.

“This amendment to expand our rights to commercialize COVAXIN®️ into Canada speaks about our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe COVAXIN®️ has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“COVAXIN®️ has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. In light of data from in-vitro studies which have suggested potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN®️ is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN®️ to the US market and now to the Canadian market,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

With more than 30 million doses supplied in India and other countries, COVAXIN®️ has an excellent safety record. EUA’s are approved in 13 countries and in process in more than 60 countries. COVAXIN®️, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN®️ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN®️ continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune responses against multiple antigens, COVAXIN®️ has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN®️ is packaged in multi-dose vials that can be stored at 2-8⁰C.

COVAXIN®️ studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN®️ vaccination may be effective against multiple SARS-CoV-2 variants.

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