Ocugen and Bharat Biotech Team Up on COVID-19 Vaccine for U.S.

Malvern, Pa.-based biotech Ocugen and India’s Bharat Biotech have agreed to work together to develop the Indian company’s COVID-19 vaccine for use in the U.S., a product that is already far along in clinical trials.

Bharat has evaluated its vaccine candidate, Covaxin, in approximately 1,000 participants in phase 1 and 2 trials in India and the studies have shown promising safety and immunogenicity results, according to the companies. The vaccine is currently going through a late-stage trial that has enrolled 26,000 volunteers in the country. The phase 3 study, which began on Nov. 16, is testing a two-dose regimen given approximately 28 days apart.

Unlike the two COVID-19 vaccines currently authorized in the U.S. that are based on messenger RNA technology, Covaxin is an inactivated vaccine. This traditional type of vaccine, which includes flu, polio, rabies and hepatitis A shots, uses inactivated versions of pathogens to generate immunity and it is a proven vaccine approach.

Inactivated vaccines are usually not as effective as live vaccines — which use weakened forms of pathogens that elicit a mild infection to generate antibodies against the actual disease — and the inactivated vaccines may require extra doses over time to provide ongoing immunity.

The deal secures Ocugen the U.S. rights to the vaccine and makes it responsible, in collaboration with Bharat, for the clinical development, registration and commercialization of Covaxin for the U.S. market.

Details of the agreement will be finalized in the coming weeks, but the collaboration is already under way and Ocugen has put together a scientific advisory board of academic and industry experts to guide its efforts to secure the FDA’s clearance. — James Miessler