Hyderabad: In a setback to Bharat Biotech’s Kovid-19 vaccine, the US food and drug regulator has advised its US partner OcuGen Inc. to take additional steps to get approval for the use of the Indian vaccine. Request organic license application (BLA) route with data.
Ocugen said, ‘‘The company will no longer seek to obtain 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 discussions 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.
No vaccine made or developed in India has ever received EUA or full license from USFDA. Meanwhile, Bharat Biotech said that once approved, it will be a major step towards innovation and manufacturing of vaccines in India.
Ocugen recently announced that it has received exclusive rights to commercialize Covaccine in Canada and is in discussion with Health Canada for regulatory approval.