Huge Setback for Covaxin, FDA didn’t allow emergency use of Covaxin

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New Delhi, 11/6 (Ao Bureau): Bharat Biotech’s corona vaccine ‘Covaxin’ has suffered a setback. The US has refused to grant Emergency Use Approval (EUA) to this vaccine. It is being said that this decision has been taken due to lack of complete data. The US Food and Drug Regulator (FDA) has advised its US partner, OcuGen Inc., to re-apply under the Biological License Application (BLA) with more data to gain approval for the use of the Indian vaccine. Let us tell you that Covaccine is India’s first and currently the only indigenous vaccine.
In a statement on Thursday, OcuGen said that it will file a BLA for Covaccine in accordance with the advice of the FDA. BLA is the FDA’s ‘full approval’ mechanism, 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 try to get permission for emergency use for the vaccine. Along with this, a request has also been made for some additional information and data.
Are there any drawbacks to the vaccine?
Let us tell you that not getting approval for emergency use in America does not mean that there is a shortage in the vaccine. Rather, the US FDA wants to see some more results of the vaccine trial. For example, the FDA wants to know how safe and effective this vaccine is. Let us tell you that the vaccine has not been approved by the WHO as of now.
Vaccine will definitely be launched in America

“While we are very close to finalizing our EUA application, the FDA has advised us to make the request through the BLA,” said Shankar Musunuri, CEO and Co-Founder of OcuGen. It will take longer, but we are determined to bring the vaccine to the US.

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