Ocugen Will Go BLA Route for Covaxin in the US Per FDA Recommendation; seek emergency use clearance for Canada | India News

Ocugen Will Go BLA Route for Covaxin in the US Per FDA Recommendation;  seek emergency use clearance for Canada |  India News

HYDERABAD: Bharat BiotechUS partner Ocugen has abandoned plans to apply for an Emergency Use Authorization (US) for Covaxin and will follow the Biologics License Application (BLA) route as recommended by the US drug regulator.
However, for the Canadian market, Ocugen will seek authorization under an interim order for the use of Covaxin, it said in a regulatory filing with the Securities and Exchange Commission (SEC).
“… on the recommendation of US Food and Drug Administration (FDA), the company will seek the submission of a biologics license application (BLA) for its Covid-19 vaccine candidate, Covaxin. The Company will no longer seek an Emergency Use Authorization (US) for Covaxin, ”he said in the filing.
Ocugen said the FDA provided comments on the master file the company had previously submitted and recommended that Ocugen seek a BLA submission rather than a US application for its vaccine candidate and requested additional information and data.
“Ocugen is in discussions with the FDA to understand the additional information needed to support a BLA submission. The company anticipates that additional clinical trial data will be required to support the submission, ”he said. “Although we were close to finalizing our request for shipment from the US, we received a recommendation from the FDA to pursue a BLA pathway. While this will extend our timelines, we are committed to bringing Covaxin to the US, ”said Dr. Shankar Musunuri, Chairman of the Board, CEO and Co-Founder of Ocugen.
“This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect the US population. Long-term, ”Dr. Musunuri added.
Meanwhile, Bharat Biotech said that with good herd immunity and a significant percentage of the population vaccinated, the pandemic is slowing down in the United States.
“The USFDA had previously communicated that no new US will be approved for Covid vaccines. All applications must follow the biological license application process, which is the standard process for vaccines, ”said Bharat Biotech.
“Data from an additional clinical trial will be needed to support the submission of the marketing application for Covaxin, which has been received by the US from 14 countries with more than 50 countries in the pipeline,” he added.
According to Bharat Biotech, no vaccine manufactured or developed in India has received the EUA or full license from the USFDA, so when the vaccine is approved it will be a big step forward for vaccine innovation and manufacturing in India.


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