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 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.”