HYDERABAD: Vaccine maker
Bharat Biotech has inked a binding letter of intent (LoI) with US-based biopharmaceutical player Ocugen Inc for co-developing India’s first indigenous
Covid-19 vaccine candidate
Covaxin for the US market.
Covaxin, which is a whole-viron inactivated vaccine candidate developed on the vero cell manufacturing platform, is currently undergoing Phase III human clinical trials in India on 26,000 volunteers after having undergone Phase I and II trials involving 1,000 volunteers.
As per the LoI, Ocugen will have the US rights to Covaxin and in collaboration with Bharat Biotech will take up clinical development, registration, and commercialisation of the vaccine candidate for the US market.
This collaboration leverages Ocugen’s vaccine expertise, and its R&D and regulatory capabilities in the US, said Bharat Biotech, adding that the companies have begun collaborating and will finalise the details of the definitive agreement in the next few weeks.
“The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India. Covaxin has garnered interest from several countries worldwide for supplies and introduction and we are excited to collaborate with Ocugen to bring it to the US market,” said Bharat Biotech chairman and managing director Dr Krishna Ella.
In preparation for the development of Covaxin for the US market, Ocugen has already assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path for approval in the US market.
“Covaxin utilizes a historically proven approach to vaccine design. The adjuvanted inactivated virus vaccine candidate elicited strong IgG responses against spike (S1) protein, receptor-binding domain (RBD) and the nucleocapsid (N) protein of SARS-CoV-2 along with strong cellular responses in Phase 1 and 2 clinical trials. Covaxin offers a vaccine candidate that is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus,” said Harvey Rubin, of the University of Pennsylvania and a member of Ocugen’s Vaccine Scientific Advisory Board.
David Fajgenbaum, MD of University of Pennsylvania’s Division of Translational Medicine & Human Genetics, director of the Center for Cytokine Storm Treatment & Laboratory, and member of Ocugen’s Vaccine Scientific Advisory Board said, “The Covid-19 pandemic has caused unmatched devastation to individual patients and to the world. It is going to take the kind of unmatched collaboration and innovation that is occurring right now to effectively fight back. Vaccines such as Covaxin that can potentially elicit a broad immune response and may limit future Covid-19 severity could be important to have in our arsenal.”
“In the face of the coronavirus pandemic, it is incumbent upon all of us to find solutions that have the potential to save lives and restore normalcy to our day-to-day activities. We have been very pleased with the safety and immunogenicity demonstrated by the Phase I and Phase II trials of Covaxin and are encouraged with the progress of the Phase III trials in India. We believe this unique yet traditional approach to vaccination holds great potential to appeal to a broad range of the population,” said Dr Shankar Musunuri, chairman, CEO, and co-founder of Ocugen.