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Ocugen, Bharat Biotech’s American partner for COVID-19 vaccine Covaxin, has submitted a “Master File” to the US Food and Drug Administration (USFDA) prior to seeking an emergency use authorisation in that country.

“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 licence application (BLA) approval in the United States, as well as the company’s commercialisation strategy, if authorised or approved,” Ocugen has said in a recent regulatory filing.

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.

The company is currently awaiting additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission, it further said.

Bharat Biotech on February 2 said it has entered into a definitive agreement with Ocugen Inc, a US-based biopharmaceutical company, to co-develop, supply, and commercialise, the Indian vaccine maker’s Covaxin for the US market.

Under the terms of the agreement, Ocugen will have the US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval including Emergency Use Authorisation, and commercialisation for the US market.

The Indian governments 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.

“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.

In an investor presentation, Ocugen said it is expecting the vaccine to be rolled out in the US during the second half of the current year.

The 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.