The US drug regulator has rejected Ocugen’s application for emergency use. With this move, it may take time for the vaccine to arrive in the US.
Bharat Biotech’s corona vaccine ‘Covaccine’ has suffered a setback in the US. US drug regulator USFDA has rejected Ocugen’s application for emergency use. Ocugen is an American partner firm of Bharat Biotech. The Government of India has given a slow response to the non-approval of Covaxin. He has said that India respects the regulatory system of every country. This move will not affect its vaccine program.
The USFDA has advised OcuGen Inc. to request the Biological License Application (BLA) route with additional data to obtain approval for use of the Indian vaccine. In a statement on Thursday, OcuGen said it would file a BLA for Covaccine in accordance with the FDA’s advice.
What is BLA?
BLA is the FDA’s ‘Full Approval’ arrangement. Medicines and vaccines are approved under this. In such a situation, it may take some more time for Covaccine to get US approval.
“The company will no longer seek emergency access permission (EUA) for Covaccine,” OcuGen said. The FDA has given a response to the master file to Okuzane. 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.
The company is discussing
OcuGen said this could lead to delays in the launch 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.
“While we are very close to finalizing our EUA application, the FDA has advised us to make the request via BLA,” said Shankar Musunuri, CEO and Co-Founder of Ocugen. It will take longer, but we are determined to bring the vaccine to the US.