Bharat Biotech's US partner Ocugen Inc said that the company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN and the US Food and Drug Administration (FDA) has recommended that the company go for the Biologics Licence Application (BLA) route, which is for full approval, with additional data.
"Ocugen Inc today announced that upon recommendation from the U.S. Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN. The Company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN," the company statement reads.
The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data.
"Ocugen is 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," the statement added.
Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen Dr Shankar Musunuri said," Although we were close to finalizing 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."
As per the company, Ocugen recently announced that it has secured exclusive rights to commercialize COVAXIN in Canada and initiated discussions with Health Canada for regulatory approval. The Company will pursue expedited authorization for COVAXIN under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.
Bharat Biotech has responded to the news reports and said, "With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines."
It further said Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval. "All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN. This process will extend our timelines."
The Hyderabad-based company also specified that Covaxin has received EUA's from 14 countries with more than 50 countries in the process.
"No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved," it added.
( With inputs from ANI )
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