Covaxin Denied Emergency Use Approval by the US: Here's Why

The US Food and Drug Administration (FDA) sought more clinical trial data while rejecting the application.

<div class="paragraphs"><p>USFDA has denied emergency use approval for Bharat Biotech's Covaxin.&nbsp;</p></div>

Covaxin, India's indigenous vaccine made by Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology has been denied emergency use approval (EUA) in the United States.

The US Food and Drug Administration (FDA) sought more clinical trial data while rejecting the application.

Bharat Biotech is yet to release full phase 3 clinical trial data despite completing the trials by mid-March 2021. The vaccine has been part of India's inoculation drive since January 2021 and has been given to millions of people here already.

The company has recently said that they will be releasing full trial data to India's Central Drugs Standard Control Organisation (CDSCO) by July, followed by publishing it in peer-reviewed journals.


What Does Bharat Biotech Say?

The pharma company in a release claimed that since a significant population has been inoculated, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be given for new COVID-19 vaccines.

It further says, "Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval."

The company said that a BLA will require additional clinical trials, and will extend their timelines.

In an earlier report to ANI, the company had said it will apply for full approval after releasing the phase 3 data in July. Bharat Biotech had also said that it will conduction Phase-4 trials to check the "real-world effectiveness" of the vaccine.

What Does Earlier Trial Data Indicate?

On 21 April, Bharat Biotech announced that their COVID vaccine, Covaxin, was found to have an efficacy of 78 percent in a second interim trial result.

The first Interim results of the phase 3 trials published back in March had found the vaccine to be 81 percent effective in preventing COVID.

The second interim results showed that their vaccine was 78 percent effective in preventing mild, moderate, and severe COVID-19 disease, and 70 percent effective against asymptomatic COVID-19 infection, and 100 percent effective against severe illness and hospitalisation.

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