Ocugen Inc, Bharat Biotech’s American partner for COVID-19 vaccine Covaxin, has submitted a Master File to the US Food and Drug Administration before seeking an emergency use authorization in that country. The biotech company is evaluating the clinical and regulatory path for COVAXIN in the United States including obtaining Emergency Use Authorization from the US Food and Drug Administration.
The biotech company said in the regulatory filing that biologic license application approval in the United States, as well as the company’s commercialization strategy if authorized or approved. Ocugen Inc has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls and clinical studies as a Master File for FDA review and input before a planned EUA submission
Under the terms of the agreement, the US-based biotech company Will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval including Emergency Use Authorisation and commercialization 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 factorsThe initial US supply will be done by Bharat Biotech upon receiving authorisation from the FDA and also there will be technology transfer to US facilities. Ocugen is targeting 100 million doses per annum beginning 2021