Bharat Biotech's US Partner Ocugen Submits Covaxin Master File for FDA Review

Ocugen Inc OCGN, India-based Bharat Biotech’s U.S. partner for COVID-19 vaccine Covaxin, has submitted a “Master File” to the FDA before seeking an emergency use authorization (EUA) in the U.S.
Ocugen submitted key information and data to date, including preclinical studies, chemistry, manufacturing, controls, and clinical studies as a Master File and input before a planned EUA submission.
As per Ocugen, it is still waiting for data from Bharat Biotech’s Phase-3 trials for Covaxin to apply for the EUA, which has been delayed due to the second wave in India.
The delay is primarily attributed to India’s decision to temporarily suspend the export of COVID-19 vaccines directing all resources domestically amid the resurgence of infections.
In February, Bharat Biotech entered into a definitive agreement with Ocugen to co-develop, supply, and commercialize, Covaxin for the U.S. market.
Ocugen said it is expecting Covaxin to roll out in the U.S. during the second half of the current year in an investor presentation.
The initial U.S. supply will be done by Bharat Biotech upon receiving authorization from the FDA, followed by a technology transfer to U.S. facilities.
Ocugen is targeting 100 million doses per annum beginning 2021.
Separately, The World Health Organisation has said “more information is required” from Bharat Biotech, which is seeking an emergency use listing for Covaxin.
Meanwhile, Bharat Biotech said that it had submitted 90% of the documents to WHO, and the remaining documents are expected to be submitted by June.
Price Action: OCGN shares are up 1.51% at $8.08 during the premarket session on the last check Tuesday.

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