Why FDA Rejected Covaxin's Emergency Use in America?

Jun 11 2021 03:05 PM
Why FDA Rejected Covaxin's Emergency Use in America?

New Delhi: India Biotech, the manufacturer of the Corona vaccine Covaxin made in India, has suffered a major setback from the US. As per the information received, the US Food and Drug Regulator (FDA) has advised Okugen Inc., a US partner of India Biotech, to urge the Organic License Application (BLA) route with additional data to get permission to use the Corona vaccine Covaxin manufactured in India in the US.

It may be recalled that on Thursday, Okugen, a US partner at The India Biotech Company, had said that it would soon submit the BLA for the vaccine and provide all necessary documents as advised by the US Food and Drug Regulator. In fact, BLA is the FDA's "full approval" regime under which drugs and vaccines are flagged off. If the process of BLA is completed, it may take some time for the vaccine to get US approval.

Okugen said the company will no longer try to get emergency use permission (EUA) for the vaccine. The US Food and Drug Regulator has responded to OCugen regarding the master file and advised that Ocugen should file a BLA request instead of applying EUA for its vaccine. At the same time, some additional information and data have also been requested.

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