Ocugen Submits Covaxin Master File to FDA

Before applying for an emergency use authorization in the United States, Ocugen, Bharat Biotech’s American partner for the Covid-19 vaccine Covaxin, has sent a “Master File” to the US Food and Drug Administration. To date, Ocugen has submitted key details and data to the FDA as a Master File, including preclinical research, chemistry, production, and controls (CMC), and clinical studies, in preparation for a proposed EUA application.

It also mentioned that the company is awaiting additional data from Bharat Biotech from the ongoing Phase 3 clinical trial to submit a EUA. Bharat Biotech announced on February 2 that it had signed a definitive agreement with Ocugen Inc, a biopharmaceutical company headquartered in the United States, to co-develop, supply, and market the Indian vaccine maker’s Covaxin in the United States.

Ocugen will have US rights to the vaccine candidate and will be responsible for clinical research, regulatory approval, including Emergency Use Authorization, and commercialization for the US market, according to the terms of the agreement. According to the United States, the temporary suspension of Covid-19 vaccine exports by the Indian government could force Bharat Biotech to concentrate its resources, including Covaxin supply, on domestic needs, preventing it from shipping vaccine supplies abroad, including to the United States the risk factors.

Ocugen said, “We are currently waiting for additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission. Due to the current surge in Covid-19 cases in India, this process is taking longer than anticipated. We are continuing to monitor the situation and intend to file the EUA submission as soon as practicable. Any significant delays could adversely affect our business, results of operations, or financial condition.”