US FDA Denies Emergency Use Approval to Bharat Biotech’s Covaxin

Bharat Biotech has announced it will now proceed with an application, seeking full approval for Covaxin in the US.

Bharat Biotech’s Covaxin

(Photo: The Quint)

Bharat Biotech's application for emergency use of its COVID-19 vaccine Covaxin in the United States was denied by the US Food and Drugs Administration on Friday, June 11.

"With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new Emergency Use Authorization (EUA) would be approved for new COVID-19 vaccines (sic)," a statement by the Covaxin manufacturer read.

The FDA’s refusal to grant emergency use authorisation to the Indian drugmaker’s vaccine has also been attributed to the lack of data made available on the clinical trials for the vaccine.

The Hyderabad-based pharmaceutical company had submitted only partial data of its clinical trials, which excluded its phase-3 trial data, as per a Hindustan Times report.

Bharat Biotech has announced that it no longer intends to seek an emergency-use authorisation from the US authority. "The Company will no longer pursue an Emergency Use Authorization for COVAXIN (developed by Bharat Biotech & ICMR) (sic)," its US partner Ocugen said, as per ANI.

Rather, it will now proceed with an application, seeking full approval for its COVID-19 vaccine in the US.

Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN. This process will extend our timelines.

Bharat Biotech’s Statement

Covaxin has received emergency use authorisation in 14 countries, including Phillipines, Mauritius, and Mexico so far, and is pushing for approval in 50 other nations.

(With inputs from The Hindustan Times and ANI)