Ocugen Will Seek Full US Approval for Covaxin Through BLA Instead of US | India News

India
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.The process is scheduled to extend the timelines for launching the vaccine in the US market.
“… on the recommendation of US Food and Drug Administration (FDA), the company will seek to file a BLA for its Covid-19 vaccine candidate, Covaxin. The company will no longer seek an EUA for Covaxin, ”Ocugen said in a regulatory filing with the Securities and Exchange Commission (SEC).
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 in a statement.
“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.
Explaining the reasons for the move, Bharat Biotech said: “With good herd immunity and a significant percentage of the vaccinated population, the pandemic is shrinking in the United States. Apart from this, the USFDA had previously communicated that no new US will be approved for the new Covid-19 vaccines. ”
“Our US partner, Ocugen, has received a recommendation from the FDA to go the BLA path for Covaxin, which is a full approval. All applications must follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, additional clinical trial data will be required to support the Covaxin marketing application submission. This process will extend our timelines, ”said Bharat Biotech.
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.
Look US FDA Rejects Emergency Use Authorization for Covaxin

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