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FDA Rejects Covaxin's emergency authorisation application in the US, seeks more data!
By: Tupaki Desk | 11 Jun 2021 8:29 AM GMT
Hyderabad-based Bharat Biotech, the pharma giant, which is behind India's first made-in India vaccine Covaxin, has applied for the emergency use authorisation of the vaccine in the United States.
However, the public health-promoting body Food and Drug Administration (FDA) rejected the application. It is said that the health regulatory body has asked the pharma company to submit more data of the clinical trials,
It is said that the FDA refused to approve the authorisation as only partial data of the clinical trials was only submitted by Bharat Biotech. Earlier the FDA said until complete data is submitted, vaccines will not be approved for authorisation.
The pharma company has reportedly completed the Phase III of clinical trials and phase IV trials are underway, to measure the efficacy of the vaccine candidate. The data of Phase III is likely to be made public in July.
After the application rejection, US-based Ocugen Inc, which had joined hands with Bharat Biotech said that instead of emergency use, they will apply for the full approval of the vaccine in the country.
Several countries have made it mandatory to submit the complete data of the clinical trials in order to get the authorisation. A few countries had earlier rejected Bharat Biotech's application.
However, the public health-promoting body Food and Drug Administration (FDA) rejected the application. It is said that the health regulatory body has asked the pharma company to submit more data of the clinical trials,
It is said that the FDA refused to approve the authorisation as only partial data of the clinical trials was only submitted by Bharat Biotech. Earlier the FDA said until complete data is submitted, vaccines will not be approved for authorisation.
The pharma company has reportedly completed the Phase III of clinical trials and phase IV trials are underway, to measure the efficacy of the vaccine candidate. The data of Phase III is likely to be made public in July.
After the application rejection, US-based Ocugen Inc, which had joined hands with Bharat Biotech said that instead of emergency use, they will apply for the full approval of the vaccine in the country.
Several countries have made it mandatory to submit the complete data of the clinical trials in order to get the authorisation. A few countries had earlier rejected Bharat Biotech's application.
