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6/12/21

Covexin not approved in US, application for urgent use canceled due to clinical trial details





Vaccination in the US:  




The US FDA has said that applying for a biological license is approved
The US company, a subsidiary of Bharat Biotech, had applied to the US
Not having the vaccine approved does not mean that there is anything wrong with the vaccine: experts



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The US Food and Drug Administration (FDA) has not approved India Biotech's vaccine covacin for emergency use. This halted the launch of Covexin in the United States. The FDA has asked India Biotech's US affiliate Occusen to conduct additional testing so that the company can file a Biological License Application (BLA). This will allow the vaccine to be fully approved.


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Ocuzen said the FDA has asked to focus on BLA submissions for the vaccine and provide additional information. "Even if it delays, we are committed to bringing covacin to the United States," said Shankar Musunuri, co-founder of Occusen. Occusen sent a master file of preclinical studies, chemical, manufacturing and control and clinical trial results to the FDA for review. To date, no vaccine manufactured or developed in India has been approved by the FDA.

Not having the vaccine approved does not mean that there is anything wrong with the vaccine: experts

1. Does not being approved in the US mean there is a problem with covacin?
No. According to experts, this means that the FDA wants certain facts about the clinical trial of the vaccine on humans, to ensure that the covacin is fairly safe and effective against infection.

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2. Covexin not allowed for foreign travel, do I have to take CoveShield?
Love Agarwal, joint secretary in the Union Health Ministry, said there was no need. Bilateral talks are underway with countries that are denying visas to Coxsackie recipients. The government is also in technical and scientific communication with the WHO.




3. How can a person who has taken a dose of covacin go abroad for study, job or other work?
External Affairs Ministry spokesperson Arindam Bagchi said that India Biotech has urged the WHO to include Covexin in its list of emergency uses. Russia has also sought approval for Sputnik-V. This will help the covexin. As far as the emigration of students and others is concerned, the Ministry of External Affairs is working to protect the interests of such people. Talks are underway with the countries concerned. Those affected should contact the Ministry of External Affairs.

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