HomeLatest NewsUS FDA denies emergency use approval to Covaccine

US FDA denies emergency use approval to Covaccine


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New Delhi. In a major setback to Hyderabad-based Bharat Biotech, the US Food and Drug Regulator (FDA) has refused to approve its covaccine for emergency use in the US.

While currently refusing to approve emergency use of an indigenous anti-Covid-19 vaccine, OcuGen, the US partner of the Indian vaccine producer, has been advised to provide more dates for approval for the use of the Indian vaccine.

The FDA has asked OcuGen to request a biological license application (BLA) instead of an EUA (Emergency Use Permission) application. Also, asked to provide additional information and data.

The company anticipates that data from an additional clinical trial will be needed to support the submission.

“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.

He clarified that the covaccine has the capability to deal with SARS-CoV-2 variants including the delta variant.

Occugen recently announced that it has acquired exclusive rights to sell the vaccine in Canada. If emergency use of covaccine was approved in the US, it would have been a success for India’s indigenous vaccine.

Let us tell you that Occugen US is a biopharma company, which is working with Hyderabad-based Bharat Biotech to make the vaccine.

After this decision of the FDA, now the company will have to wait a little longer to launch its vaccine in America. Let us tell you that a few days ago, the US partner for Covaccine, Ocugen, had sought permission from the US drug regulator FDA for emergency use of this vaccine.

Covaccine studies show that it effectively neutralized SARS-CoV-2, B11282, the first identified in Brazil, as well as the alpha variant, B117, which was first identified in the UK. It is also said to be effective against the Delta variant, the B1617, which was first identified in India.

More than 30 million doses have been supplied to India and other countries. It is currently administered under emergency use authorizations in 13 countries and applications for emergency use authorization are pending in more than 60 additional countries.

–IANS

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