India / Bharat Biotech, Ocugen to co-develop Covaxin for US market

New Delhi: Bharat Biotech and Ocugen Inc, a US-based biopharmaceutical company have announced a binding letter of intent to co-develop COVAXIN for the United States market.

Covaxin is India's indigenous Covid-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.

The vaccine candidate is currently in Phase-3 clinical trials in India involving 26,000 volunteers.

As per the understanding, Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialisation for the US market.

The companies will finalise details of the definitive agreement in the next few weeks. This collaboration leverages Ocugen’s vaccine expertise, its R&D and regulatory capabilities in the US.

In preparation for the development of COVAXIN in the US, Ocugen has assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path to approval in the US market, Bharat Biotech said in a press release.

“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 Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech. 

“In the face of the 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 are very pleased with the safety and immunogenicity demonstrated by the Phase 1 and Phase 2 trials of COVAXIN™ and are encouraged with the progress of the Phase 3 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, Ocugen.

“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. COVAXINTM 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, M.D. PhD of the University of Pennsylvania, a member of Ocugen’s Vaccine Scientific Advisory Board.