Explained: Why US FDA declined emergency use authorization to Covaxin?

The FDA has recommended Ocugen Inc, the US partner of the Indian vaccine maker to go for the Biologics Licence Application (BLA) route with additional data which will delay the launch of Covaxin in the USA.


The United States Food and Drug Administration (FDA) has decided not to give emergency use authorization (EUA) to Bharat Biotech’s coronavirus vaccine, Covaxin. The FDA has recommended Ocugen Inc, the US partner of the Indian vaccine maker to go for the Biologics Licence Application (BLA) route with additional data which will delay the launch of Covaxin in the USA.

Ocugen on Thursday announced that as recommended by FDA, it will pursue submission of BLA for Covaxin. “The company will no longer pursue an Emergency Use Authorisation for the vaccine candidate. 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 a EUA application for its vaccine candidate and requested additional information and data,” said Ocugen in a statement.


What is Covaxin?

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It is India’s first domestically-developed anti-Covid vaccine. The Hyderabad-based Bharat Biotech’s Covaxin is an inactivated vaccine made up of killed coronaviruses. Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus.

The vaccine received properly restricted emergency use permission in India in March.

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Why US FDA declined EUA for Covaxin?

The main reason for the EUA decline by FDA is insufficient information. According to Ocugen, the US FDA has recommended going for a Biological License Application. Along with this, the FDA has requested additional information and data. Ocugen is in discussion with the regulator to understand what additional information is required for BLA submission, expecting it to be the data from an additional clinical trial.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Cpoviaxin to the US,” said Dr. Shankar Musunuri, Chairman of the board and chief executive officer and co-founder of Ocugen.

Is Covaxin unsafe?

No, US FDA declined EUA because it will need to see more information from more human clinical trials. This is to convince that the vaccine is safe, prompts an immune response and has acceptable efficacy.

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