U.S. biopharmaceutical firm Ocugen and Bharat Biotech have signed a binding letter of intent (LOI) to co-develop India’s COVID-19 vaccine candidate Covaxin for the United States market.
The decision comes amid the ongoing Phase III clinical trials for Covaxin in India and the “promising safety and immunogenicity data” that emerged from the Phase I and Phase II.
The companies have begun collaborating and will finalise details of the definitive agreement in the next few weeks, they said in a joint statement on Tuesday.
Ocugen will get U.S. rights to the vaccine candidate and with Bharat Biotech, it will be responsible for clinical development, registration and commercialisation for the U.S. market. The collaboration seeks to leverage Ocugen’s vaccine expertise as well as its research and development capabilities and regulatory compliance rigour in the U.S. Earlier in the day, Bharat Biotech, which is developing Covaxin with Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), said it had recruited 13,000 of the 26,000 volunteers for Phase III trials that got under way last month. In Phase I and II trials, Covaxin was evaluated in about 1,000 subjects.
In preparation for development of Covaxin in the U.S., Ocugen has assembled a vaccine scientific advisory board with leading academic and industry experts to evaluate the clinical and regulatory path to approval in the U.S. market.
“Covaxin offers a vaccine candidate that is different from other options currently available in the U.S. 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. Covaxin utilises 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, the release said.
“We are delighted to collaborate with Bharat Biotech to potentially bring Covaxin to the US market,” Ocugen chairman, CEO and co-founder Shankar Musunuri said. The unique yet traditional approach to vaccination holds great potential to appeal to a broad range of the population, he said.
Bharat Biotech CMD Krishna Ella said Covaxin has garnered interest from several countries worldwide for supplies and introduction.
