Bharat Biotech's US partner Ocugen submits 'Master File' on Covaxin to US FDA for review

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.

In its 'Master File' it has submitted scores of data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies to the FDA for review and input. This will be followed by seeking an EAU as well as a Biologic License Application (BLA) for the Indian vaccine. 

"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," Ocugen has said in a recent regulatory filing.

Ocugen awaiting Phase-3 trial data 

As per Ocugen, it 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.

"We are currently waiting for additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for an 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 and US-based biopharmaceutical company OcugenInc had entered into a definitive agreement with on February 2 for co-developing, supplying, and commercializing, the Indian vaccine maker's Covaxin for the US market. Covaxin's US rights lie with Ocugen which is responsible for clinical development, regulatory approval including Emergency Use Authorisation and commercialization for the US market. Ocugen is hoping to introduce Covaxin in American markets by the second half of 2021 and is targeting 100 million doses per annum.

(With Agency Inputs)