OcuGen Inc. said it would submit a BLA application with additional data to obtain approval to use Covaxin.
Bharat Biotech’s Covaxin (File photo)
After the US Food and Drug Administration (FDA) denied Bharat Biotech’s Covaxin emergency use approval, OcuGen Inc said it would seek approval through the Biologics License Application (BLA). Ocugen Inc. is a partner company of Bharat Biotech in the US. After the approval for emergency use was rejected, the FDA has suggested it to the company.
OcuGen Inc. said in a statement on Thursday that it will submit a BLA application with additional data as advised by the FDA to obtain approval to use Covaxin. BLA is the FDA’s ‘Full Approval’ process, under which drugs and vaccines are approved. In such a situation, it may take some more time for Covaxin to get US approval.
According to news agency PTI, Ocugen said in its statement, “The company will no longer seek to obtain Emergency Use Permission (EUA) for Covaxin. The FDA has given a response to the master file to OcuGen. It has been advised that OcuGen should file a BLA request instead of an EUA application for its vaccine. Along with this a request has also been made for some additional information and data.
Data from an additional clinical trial needed
OcuGen said that due to this, the launch of Covaxin in the US may be delayed. OcuGen is in discussion with the FDA regarding additional information required for the BLA application. The company estimates that an additional clinical trial data will be needed for the application to be approved.
“While we are very close to finalizing our EUA application, the FDA has advised us to make the request through the BLA,” said Shankar Musunuri, CEO and Co-Founder, Okugen. It will take longer, but we are determined to bring Covaxin to the US.”
He said that this vaccine is effective against different forms of COVID-19 including the delta variant. Ocugen recently announced that it has acquired the rights to use Covaxin in Canada and has started negotiations with Health Canada for approval.
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