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Bharat Biotech’s US Partner Submits Covaxin’s “Master File” To FDA Prior To Seeking Emergency Use Authorisation In US
Bharat Biotech’s COVAXIN, India’s first indigenous vaccine against coronavirus. (Swarajya Magazine)
In a boost for India’s maiden indigenously developed COVID-19 vaccine Covaxin, Hyderabad-based vaccine maker Bharat Biotech’s partner in the United States (US), Ocugen has submitted the vaccine’s “Master File” to the US Food and Drug Administration (FDA), reports Economic Times.
Ocugen has submitted key information and data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input before applying for an emergency use authorisation (EUA).
Bharat Biotech had entered into a partnership with Ocugen on 2 February. Ocugen is a biopharmaceutical company and as per the definitive agreement signed by it with Bharat Biotech, the two will engage to co-develop, supply, and commercialise Covaxin in the US.
The terms of the agreement state that Ocugen will have the US rights to the vaccine and will be responsible for clinical development, regulatory approvals and commercialisation.
As per a statement issued by Ocugen, the company is presently awaiting additional data from Bharat biotech from the ongoing third phase clinical trial for a EUA submission to FDA. The process is said to be taking longer due to the surge in COVID-19 cases in India. The company is expecting to roll out Covaxin in the US markets in the second half of the year.
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