Big blow to covacin, US FDA refuses to approve emergency use, how will the vaccine be allowed? | American FDA rejects Bharat Biotech covaxin eua application
Ocugen Inc. said the company would file a BLA application with additional data on the FDA’s advice to allow the use of the covacin vaccine.
New Delhi: The US Food and Drug Administration (FDA) has rejected a proposal to approve the immediate use of Covaxin vaccine manufactured by Bharat Biotech. India Biotech’s US-based subsidiary Occugen Inc. has said it will apply for a biologics license to allow the use of the vaccine. Occugen Inc. is a US subsidiary of Bharat Biotech. The FDA has suggested a route to the company after rejecting an emergency use permit. (American FDA rejects Bharat Biotech covaxin eua application)
How to get permission for covacin
Ocugen Inc. said the company would file a BLA application with additional data on the FDA’s advice to allow the use of the covacin vaccine. The use of vaccines is approved as per the BLA application from the FDA. Therefore, it may take some time for the approval of the covacin vaccine in the United States.
Will not apply for emergency use permission
According to PTI, Ocugen INC will no longer apply to the FDA for permission for emergency use of the covacin vaccine. This is because the FDA recommends applying for a biologics license application instead of applying for a license for emergency use of the covacin vaccine. Application for BLA will be made accordingly. However, no application will be made for EUA.
According to Ocugen, it could take time for the vaccine to be launched in the United States. Ocugen will have to undergo additional clinical trials of the covacin vaccine, according to discussions with the FDA. Ocugen CEO Shankar Musunuri said the FDA has asked him to apply for a BLA license. It will take some time, but we are committed to bringing the covacin vaccine to the United States, said Shankar Musunuri. Covacin vaccine by Shankar Munusuri is effective on different variants of Corona. Okuzen has also sought approval for the covacin vaccine in Canada.
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(American FDA rejects Bharat Biotech covaxin eua application)
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