US FDA Denies Bharat Biotech’s Covaxin Emergency Use Approval

Health minister Harsh Vardhan holds a vial of Covaxin during a vaccination camp at AIIMS, New Delhi. Photo: Reuters/Adnan Abidi

Bengaluru: A vaccine that has been administered in India to the tune of 29 million doses has been denied emergency-use approval in the US.

Covaxin is the name of a whole-virus inactivated vaccine manufactured by Bharat Biotech, Hyderabad. It received accelerated approval in India on January 3, 2021, after which it became one of the two major vaccines in India’s COVID-19 inoculation drive.

However, because India’s drug regulator okayed Covaxin without any data from its phase 3 clinical trial, it was met with considerably vaccine hesitancy that the government itself was forced to acknowledge.

Virologist Shahid Jameel had told The Wire Science in Janaury 2021 that Covaxin is in all likelihood safe and meaningfully efficacious, but that the opacity surrounding its approval in India would undermine public confidence.

Bharat Biotech had also applied for approvals with the US Food and Drug Administration (FDA) and the WHO.

In its new announcement, the FDA has denied emergency use approval for Covaxin. Instead, it has asked Ocugen, Bharat Biotech’s trial partner in the US, to conduct a new local trial, and added that the vaccine will be re-evaluated based on this trial’s findings.

Note that if the vaccine is approved based on the local trial, it will become eligible for a full approval.

LiveMint quoted a statement from Ocugen as saying: “The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.”

Without being approved by the WHO or the FDA, Covaxin is unlikely to be accepted as a legitimate vaccine by many countries.

Also read: COVAX Is Broken

Earlier, in march 2021, the FDA had said that it would no longer consider further vaccine applications for approval in the US. However, the Ocugen statement expressed confidence that this rule wouldn’t apply to Covaxin because Ocugen has been in discussions with the FDA since last year.

On the contrary, Covishield – the other vaccine in India’s vaccination drive – enjoys approval in Europe as well as with the WHO. It was developed by researchers at the University of Oxford, licensed to AstraZeneca and is manufactured, among others, by Serum Institute of India.

The FDA’s verdict is the second roadblock Bharat Biotech has faced with respect to rolling Covaxin out in other parts of the world.

In the first, Brazil’s health regulator denied a ‘good manufacturing practices’ certificate to Bharat Biotech’s facilities in India that make the vaccine, and disallowed Covaxin from being imported into Brazil.

A month later, in May, the regulator approved Bharat Biotech’s application to conduct phase 3 trials in Brazil, saying it would fill the gaps in the data the company had already submitted.

Last week, the regulator announced that Bharat Biotech would be allowed to import and administer Covaxin in the country, but with strict conditions of manufacturing, quality-control and delivery. It also restricted the import to 4 million doses, instead of the original 20 million.

On June 9, Bharat Biotech also announced that it would conduct phase 4 clinical trials of Covaxin, to assess the beleaguered vaccine’s real-world effectiveness. The company also added that data from the phase 3 trials would be available only in July, and not June as it had said earlier.

Bharat Biotech has come under considerable flak in India for not having released any data – except for some interim numbers in early March, that too via press release – from the phase 3 trials even though it continues to tout its quality.

Thus far, India has administered 242.6 million vaccine doses – 213.6 million of Covishield and 29 million of Covaxin. As of June 9 morning, 14% of Indians have received at least one doses of either vaccine and 3.3% have received both doses.

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