VK Paul said that India respects the regulatory system of every country, it will not have any effect on our vaccination program. ANI
USFDA rejecting emergency use authorization for Covaxin: The FDA has advised Bharat Biotech’s partner, Ocugen Inc., to request additional data through the biological license application (BLA) route.
New Delhi. On the matter of the US Food and Drug Regulator (FDA) not approving Bharat Biotech’s Kovid-19 vaccine for emergency use, NITI Aayog Member (Health) VK Paul said that India respects the regulatory system of every country. It will not have any effect on our vaccination programme. The FDA has advised Bharat Biotech’s partner, 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. 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. 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 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. “However, we were very close to finalizing our EUA application,” said Shankar Musunuri, CEO and co-founder of OcuGen. , but FDA has advised us to request through BLA. It will take longer, but we are committed to bringing the vaccine to the US.