Ocugen, Bharat Biotech’s American partner for COVID-19 vaccine Covaxin, has submitted a “Master File” to the US Food and Drug Administration prior to seeking an emergency use authorization in that country.
Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input prior to a planned EUA submission.
“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,” Ocugen said. Bharat Biotech on February 2 said it has entered into a definitive agreement with OcugenInc, a US-based biopharmaceutical company, to co-develop, supply, and commercialize, the Indian vaccine maker’s Covaxin for the US market.
The Indian government’s temporary suspension of the export of COVID-19 vaccines may require Bharat Biotech to focus its resources, including Covaxin supply, on domestic requirements and thereby prevent it from shipping supply of the vaccines abroad, including to the United States, the American company said in the risk factors.
