Indian vaccine manufacturer Bharat Biotech’s Kovid-19 vaccine has given a blow to Covaxin.
Indian vaccine manufacturer Bharat Biotech’s Kovid-19 vaccine has given a blow to Covaxin. The US food and drug regulator has advised its US partner OcuGen Inc to request the biological license application (BLA) route with additional data to gain approval for use of the Indian vaccine. Also Read – Screening of children begins at AIIMS to test Covaxin
In a statement on Thursday, OcuGen said it would file a BLA for Covaccine in accordance with the FDA’s advice. Also Read – Covaxine Or Covishield: Covishield is better than Covaxine in defeating Corona, what is the difference between the two, know
The BLA is the FDA’s “full approval” system, under which drugs and vaccines are approved. In such a situation, it may take some more time for Covaccine to get US approval. Also Read – Government sharing data with WHO to get ‘Covaccine’ recognized, made a big statement about vaccination
OcuGen said, “The company will no longer seek emergency use permission (EUA) for the vaccine. 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.
OcuGen said that due to this, there may be a delay in the introduction of Covaccine in the US. OcuGen is in discussion with the FDA to understand the additional information required for the BLA request.
The company anticipates 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 of OcuGen. It will take longer, but we are committed to bringing the vaccine to the US.