Indian vaccine manufacturer Bharat Biotech’s American partner Ocugen submitted a ‘Master File’ to the US Food and Drug Administration on Tuesday in regards to its Coronavirus vaccine candidate– Covaxin. Ocugen which is evaluating the clinical and regulatory path for Covaxin in the United States is working on obtaining the EUA for its commercialization in the US.
Ocugen has submitted scores of data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies to the FDA for review and input in its ‘Master File’.
In a recent regulatory filing, Ocugen has said. “The company is currently evaluating the clinical and regulatory path for COVAXIN in the United States including obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Also, eventually biologic license application (BLA) approval in the United States, as well as the company’s commercialization strategy, if authorized or approved.”
As per Ocugen, the company is still waiting for data from Bharat Biotech’s Phase-3 trials for Covaxin to apply for the EAU which has been delayed due to the second wave in India. The delay is primarily being attributed to India’s decision to temporarily suspend the export of COVID-19 vaccines directing all resources domestically amid the resurgence of infections.