After FDA's Recommendation, Ocugen To Seek Full Approval For Bharat Biotech's Covaxin In US

After FDA's Recommendation, Ocugen To Seek Full Approval For Bharat Biotech's Covaxin In USBharat Biotech’s COVAXIN, India’s first indigenous vaccine against coronavirus. (Swarajya Magazine)

United States based biotech firm Ocugen has announced that based upon the recommendation from the Food and Drug Administration (FDA), it will no longer pursue an Emergency Use Authorization (EUA) for Bharat Biotech's Covaxin and will instead go for full approval for the 'Made in India' Covid-19 vaccine from the US drug regulator.

Ocugen has signed agreement with Bharat Biotech to co-develop, supply and commercialise Bharat Biotech's Covaxin, an advanced stage whole-virion inactivated Covid-19 vaccine candidate, for the United States market.

The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a Biologics License Application (BLA) submission instead of an EUA application for Covaxin and requested additional information and data, the company said in a statement on Thursday (10 June).

The BLA submission is an FDA review process that needs longer-term follow-up data for acceptance and approval.

The company further said that it was in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission, it added.

“Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term,” said Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

Ocugen recently announced that it secured exclusive rights to commercialize Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval. The company will pursue expedited authorisation for Covaxin under the 'Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada', the statement said.

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